This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. conditions: Long COVID conditions: Long Coronavirus Disease 2019 (Covid19) conditions: Long Covid-19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: IVIG (intravenous immunoglobulin) name: IVIG Placebo name: Coordinated Care name: Usual Care measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) measure: Change in Malmo POTS Symptom Score measure: Change in Active Stand Test measure: Change in blood pressure measure: Change in heart rate (HR) measure: Change in 6-min Walk Test measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) + 2 Questionnaire measure: Change in step count as measured by a wearable device measure: Change in heart rate as measured by a wearable device measure: Proportion of participants who experience individual (SAEs measure: Proportion who experience any one or more ( Serious Adverse Event) SAEs measure: Incidence of SAEs leading to discontinuation measure: Incidence of Events of Special Interest (ESIs) measure: Changes in Autonomic Function Testing measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS) measure: Change in PASC Symptom Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: All sites listed under NCT06305780 city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06305780 id: Pro00112597 id: OTA-21-015G type: OTHER domain: NIH Grant to RTI; RTI subcontracting with DCRI briefTitle: RECOVER-AUTONOMIC Platform Protocol overallStatus: ENROLLING_BY_INVITATION date: 2024-03-11 date: 2025-12 date: 2026-03 date: 2024-03-12 date: 2024-04-08 name: Kanecia Obie Zimmerman class: OTHER briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. conditions: Long COVID conditions: Long Covid19 conditions: Long Covid-19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 380 type: ESTIMATED name: IVIG + Coordinated Care name: IVIG Placebo + Coordinated Care name: Ivabradine + Coordinated Care name: Ivabradine Placebo + Coordinated Care name: IVIG + Usual Care name: IVIG Placebo + Usual Care name: Ivabradine + Usual Care name: Ivabradine Placebo + Usual Care measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) measure: Change in Malmo POTS Symptom Score measure: Change in Active Stand Test measure: Change in blood pressure measure: Change in heart rate (HR) measure: Change in 6-min Walk Test measure: Change in PROMIS-29 + 2 Questionnaire measure: Change in step count as measured by a wearable device measure: Change in heart rate as measured by a wearable device measure: Proportion of participants who experience individual SAEs measure: Proportion who experience any one or more SAEs measure: Incidence of SAEs leading to discontinuation measure: Incidence of Events of Special Interest (ESIs) measure: Changes in Autonomic Function Testing measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS) measure: Change in PASC Symptom Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Rush University Medical Center - Appendix A & B city: Chicago state: Illinois zip: 60612 country: United States lat: 41.85003 lon: -87.65005 facility: NorthShore University HealthSystem - Evanston Hospital - Appendix B Only city: Evanston state: Illinois zip: 60201 country: United States lat: 42.04114 lon: -87.69006 facility: University of Kansas Medical Center CTSU Fairway - Appendix A & B city: Fairway state: Kansas zip: 66205 country: United States lat: 39.02223 lon: -94.6319 facility: St. Lawrence Health Medical Campus - Appendix A & B city: Canton state: New York zip: 13617 country: United States lat: 44.59562 lon: -75.16909 facility: Sentara Norfolk General Hospital - Appendix A and B city: Norfolk state: Virginia zip: 23507 country: United States lat: 36.84681 lon: -76.28522 facility: Providence Medical Research Center - Appendix A & B city: Spokane state: Washington zip: 99204 country: United States lat: 47.65966 lon: -117.42908 hasResults: False

 nctId: NCT06305767 id: V940-005 id: V940-005 type: OTHER domain: Merck id: U1111-1292-1952 type: OTHER domain: WHO id: 2023-505658-17 type: OTHER domain: EU CT briefTitle: A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005) overallStatus: RECRUITING date: 2024-03-28 date: 2026-10-08 date: 2031-04-08 date: 2024-03-12 date: 2024-04-25 name: Merck Sharp & Dohme LLC class: INDUSTRY name: ModernaTX, Inc. briefSummary: The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Pembrolizumab name: V940 name: Placebo measure: Disease Free Survival (DFS) measure: Overall Survival (OS) measure: Distant Metastasis-Free Survival (DMFS) measure: Number of Participants Who Experience an Adverse Event (AE) measure: Number of Participants Who Discontinue Study Treatment Due to an AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102) status: RECRUITING city: Orlando state: Florida zip: 32804 country: United States name: Study Coordinator role: CONTACT phone: 205-520-6512 lat: 28.53834 lon: -81.37924 facility: One Clinical Research ( Site 1807) status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Study Coordinator role: CONTACT phone: +61862799466 lat: -31.98184 lon: 115.8073 facility: Centre Hospitalier de l'Université de Montréal ( Site 0005) status: RECRUITING city: Montréal state: Quebec zip: H2X 3E4 country: Canada name: Study Coordinator role: CONTACT phone: 5148908000 lat: 45.50884 lon: -73.58781 facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 status: RECRUITING city: Quebec City state: Quebec zip: G1J 1Z4 country: Canada name: Study Coordinator role: CONTACT phone: 4185254444 lat: 46.81228 lon: -71.21454 facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801) status: RECRUITING city: Bydgoszcz state: Kujawsko-pomorskie zip: 85-796 country: Poland name: Study Coordinator role: CONTACT phone: 48501446778 lat: 53.1235 lon: 18.00762 facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003) status: RECRUITING city: Pozuelo de Alarcon state: Madrid zip: 28223 country: Spain name: Study Coordinator role: CONTACT phone: +34914521987 lat: 40.43293 lon: -3.81338 hasResults: False

 nctId: NCT06305754 id: 2870-009 id: 2023-504910-31 type: REGISTRY domain: EU CT id: U1111-1288-3804 type: OTHER domain: UTN id: MK-2870-009 type: OTHER domain: Merck briefTitle: Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-09-12 date: 2030-06-14 date: 2024-03-12 date: 2024-04-29 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs).

The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS). conditions: Non-small Cell Lung Cancer (NSCLC) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Unblinded Open-label whoMasked: OUTCOMES_ASSESSOR count: 520 type: ESTIMATED name: Sacituzumab tirumotecan name: Pemetrexed name: Carboplatin name: Antihistamine name: H2 Receptor Antagonist name: Acetaminophen (or equivalent) name: Dexamethasone (or equivalent) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score measure: Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 measure: Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13) measure: Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13 measure: Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30 measure: TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 measure: TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13 measure: TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13 measure: Number of Participants Who Experience One or More Adverse Events (AEs) measure: Number of Participants Who Discontinue Study Treatment Due to an AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305741 id: 24-060 briefTitle: A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers overallStatus: RECRUITING date: 2024-03-05 date: 2026-03 date: 2026-03 date: 2024-03-12 date: 2024-03-12 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers. conditions: Cancer Patients conditions: Care Givers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Managing Anxiety from Cancer (MAC) measure: percentage of participants to complete all study procedures sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 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: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 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: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 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: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 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: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 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: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (All Protocol Activities) status: RECRUITING city: Rockville Centre state: New York zip: 11553 country: United States name: Kelly McConnell, PhD role: CONTACT phone: 646-888-0026 lat: 40.65871 lon: -73.64124 hasResults: False

 nctId: NCT06305728 id: 23-367 briefTitle: A Study of Early Cancer Detection in People at High Risk of Developing Pancreatic Ductal Adenocarcinoma (PDAC) overallStatus: RECRUITING date: 2024-03-04 date: 2030-03-04 date: 2030-03-04 date: 2024-03-12 date: 2024-03-12 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:

* The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1
* The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan) conditions: Pancreatic Cyst studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: 89Zr-DFO-HuMab-5B1 immunoPET name: HP MRI name: Blood assay measure: Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma 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: Kevin Soares, MD role: CONTACT phone: 212-639-3195 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: Kevin Soares, MD role: CONTACT phone: 212-639-3195 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: Kevin Soares, MD role: CONTACT phone: 212-639-3195 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: Kevin Soares, MD role: CONTACT phone: 212-639-3195 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: Kevin Soares, MD role: CONTACT phone: 212-639-3195 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: Kevin Soares, MD role: CONTACT phone: 212-639-3195 lat: 40.71427 lon: -74.00597 facility: Weill Cornell Medical Center (Specimen Analysis Only) status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States name: David Lyden, MD role: CONTACT phone: 212-746-6565 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: Kevin Soares, PhD role: CONTACT phone: 212-639-3195 lat: 40.65871 lon: -73.64124 hasResults: False

 nctId: NCT06305715 id: IIT-THOMPSON-RADIANCE-LUNG-X briefTitle: Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-06-15 date: 2028-06-15 date: 2024-03-12 date: 2024-03-12 name: Medical College of Wisconsin class: OTHER briefSummary: This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI). conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Radiation Therapy name: Targeted TKI therapy measure: Progression Free Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Froedtert Hospital & the Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Jonathan Thompson, MD, MS role: CONTACT phone: 414-805-4600 email: jrthomps@mcw.edu lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06305702 id: LZRXN-001 briefTitle: Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer overallStatus: COMPLETED date: 2022-07-01 date: 2023-12-31 date: 2024-01-31 date: 2024-03-12 date: 2024-03-12 name: Liaoning Tumor Hospital & Institute class: OTHER briefSummary: A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy. conditions: HER2-positive Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 500 type: ACTUAL name: inetetamab measure: Progression Free Survival(PFS) measure: objective response rate (ORR) measure: Adverse events (AEs) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Liaoning Cancer Hospital &Institue city: Shenyang country: China lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06305689 id: 79144 briefTitle: Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking* acronym: ITW overallStatus: RECRUITING date: 2022-01-01 date: 2024-07-01 date: 2024-12-31 date: 2024-03-12 date: 2024-04-03 name: Shriners Hospitals for Children class: OTHER briefSummary: To compare and contrast the clinical, gait and parent-reported outcomes following either non-operative (casting) or operative treatment for children with idiopathic toe walking (ITW) and determine whether there are specific genes associated with ITW. conditions: Idiopathic Toe Walking studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Surgery name: Serial Casting measure: Gait parameters: Velocity measure: Gait Paremeters:Stride Length (m) measure: Three dimensional Gait Analysis:Kinematics (degrees) measure: Dynamic Motor Control Index during Walking (Walk-DMC) measure: Three dimensional Gait Analysis:Kinetics (nm/kg) measure: Quantitative Assessment of Toe Walking measure: Pediatric Outcomes Data Collection Instrument measure: Passive Range of Motion measure: Muscle Strength measure: The Toe Walking Tool measure: Selective Motor Control measure: Coactivation Tool measure: Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) measure: Genomics sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Shriners Hospitals for Children status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Vincent Basas role: CONTACT phone: 916-453-2132 email: vincent.basas@shrinenet.org name: Jon R Davids, MD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: Shriners Hospitals for Children status: RECRUITING city: Chicago state: Illinois zip: 60707 country: United States name: Ann Flanagan role: CONTACT phone: 773-622-5400 email: aflanagan@shrinenet.org name: Kelsey Davidson, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Shriners Hospitals for Children status: RECRUITING city: Lexington state: Kentucky zip: 40508 country: United States name: Daniella Hudgins role: CONTACT phone: 859-268-5772 email: Daniella.Hudgins@shrinenent.org name: Rebekah Leet, MD role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: Shriners Hospitals for Children status: RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Paige Lemhouse role: CONTACT phone: 971-544-3377 email: plemhouse@shrinenet.org name: Jeremy Bauer, MD role: PRINCIPAL_INVESTIGATOR name: Susan Sienko, PhD role: SUB_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Shriners Hospitals for Children status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19140 country: United States name: Natalie Williams role: CONTACT phone: 215-430-4248 email: Natalie.Wiliams@shrinenet.org name: Sean Waldron, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Shriners Hospitals for Children status: RECRUITING city: Greenville state: South Carolina zip: 29605 country: United States name: Brittney Southerland role: CONTACT phone: 864-255-7955 email: Brittney.Southerland@shrinenet.org name: Lauren Hyer, MD role: PRINCIPAL_INVESTIGATOR name: David Westberry, MD role: SUB_INVESTIGATOR lat: 34.85262 lon: -82.39401 facility: Shriners Hospitals for Children status: RECRUITING city: Salt Lake City state: Utah zip: 84103 country: United States name: Lisa Certer role: CONTACT phone: 801-536-3807 email: Lcarter@shrinenet.org name: Kristin Carroll, MD role: PRINCIPAL_INVESTIGATOR name: Bruce MacWilliams, PhD role: SUB_INVESTIGATOR lat: 40.76078 lon: -111.89105 facility: Shriners Children's Spokane status: RECRUITING city: Spokane state: Washington zip: 99204 country: United States name: Charlotte Preuschoff role: CONTACT phone: 509-623-0427 email: cpreuschoff@shrinenet.org name: Ted Sousa, MD role: PRINCIPAL_INVESTIGATOR lat: 47.65966 lon: -117.42908 hasResults: False

 nctId: NCT06305676 id: MCC-23073 briefTitle: Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC) acronym: BASH OPC overallStatus: RECRUITING date: 2024-01-22 date: 2029-01 date: 2029-01 date: 2024-03-12 date: 2024-03-13 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: National Institutes of Health (NIH) briefSummary: Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh). conditions: Oropharyngeal Cancer conditions: HPV-Related Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: combined HPV 16 DNA and host gene methylation oral biomarker panel measure: Diagnostic Sensitivity measure: Diagnostic Specificity 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: Kimberly Isaacs-Soriano role: CONTACT phone: 813-745-6992 email: kimberly.Isaacs-Soriano@moffitt.org name: Anna Giuliano, PhD role: PRINCIPAL_INVESTIGATOR name: Antonio Amelio, PhD role: PRINCIPAL_INVESTIGATOR name: Jimmy Caudell, MD, PhD role: SUB_INVESTIGATOR name: Christine Chung, MD role: SUB_INVESTIGATOR name: Bruce Wenig, MD role: SUB_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Jose P. Zevallos, MD, PhD role: CONTACT email: zevallosjp@upmc.edu name: Robert Ferris, PhD role: CONTACT email: ferrrl@UPMC.EDU lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06305663 id: 921 briefTitle: A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2027-01-31 date: 2027-01-31 date: 2024-03-12 date: 2024-03-12 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The identity of the study eye will be masked to subjects, assessors, and other masked personnel while masking is maintained.. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 418 type: ESTIMATED name: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) name: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens measure: Mean change from baseline in axial length. measure: Mean change from baseline in cycloplegic SERE. sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Site 105 city: Beijing state: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Site 107 city: Dongcheng state: Beijing zip: 100730 country: China facility: Site 109 city: Xiamen state: Fujian zip: 361004 country: China lat: 24.47979 lon: 118.08187 facility: Site 111 city: Haikou state: Hainan zip: 570311 country: China lat: 20.04583 lon: 110.34167 facility: Site 110 city: Wuhan state: Hubei zip: 430012 country: China lat: 30.58333 lon: 114.26667 facility: Site 102 city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 facility: Site 106 city: Taiyuan state: Shanxi zip: 030072 country: China lat: 37.86944 lon: 112.56028 facility: Site 108 city: Shenzhen state: Shenzhen zip: 518040 country: China lat: 22.54554 lon: 114.0683 facility: Site 103 city: Chengdu state: Sichaun Province zip: 610044 country: China lat: 30.66667 lon: 104.06667 facility: Site 104 city: Nankai state: Tianjin zip: 300392 country: China facility: Site 101 city: Wenzhou state: Zhejiang zip: 325027 country: China lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06305650 id: WK2024001 briefTitle: Probiotic Influence on Obesity-Related Lipidemia overallStatus: RECRUITING date: 2024-03-20 date: 2024-06-20 date: 2024-07-30 date: 2024-03-12 date: 2024-04-09 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m\^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements. conditions: Overweight or Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Double（Participant,Investigator） whoMasked: PARTICIPANT count: 72 type: ESTIMATED name: Probiotic measure: Effect on body mass index (BMI) values. sex: ALL minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan zip: 471000 country: China name: Ying Wu, Dr. role: CONTACT phone: +86 18639283502 email: wuying2000@126.com lat: 34.68361 lon: 112.45361 hasResults: False

 nctId: NCT06305637 id: KTCS-2302 briefTitle: A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. overallStatus: COMPLETED date: 2023-12-04 date: 2024-02-10 date: 2024-02-10 date: 2024-03-12 date: 2024-03-12 name: Taro Pharmaceuticals USA class: INDUSTRY briefSummary: To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor. conditions: Tinea Versicolor studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 430 type: ACTUAL name: Ketoconazole Shampoo, 2% name: Ketoconazole Shampoo, 2% (Reference Standard) name: Placebo measure: To demonstrate the therapeutic equivalence and safety of the Investigational Product sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taro city: Hawthorne state: New York zip: 10532 country: United States lat: 41.10732 lon: -73.79597 hasResults: False

 nctId: NCT06305624 id: 2024-0130 id: 1R01DA047279-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA047279-01 id: A532000 type: OTHER domain: UW Madison id: Protocol Version 2/21/2024 type: OTHER domain: UW Madison briefTitle: Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease acronym: IMPACT-ALD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-10 date: 2027-10 date: 2024-03-12 date: 2024-03-15 name: University of Wisconsin, Madison class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months. conditions: Alcohol Use Disorder conditions: Alcohol-related Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, controlled, Type 1 hybrid implementation-effectiveness trial. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 298 type: ESTIMATED name: Connections App measure: Days of Alcohol Abstinence in ALD Participants measure: Number of Standard Drinks Consumed in ALD Participants measure: Change in Patient Health Questionnaire (PHQ-8) Score measure: Change in PROMIS Global Health Score measure: Change in Generalized Anxiety Disorder (GAD-7) Score measure: Change in Insomnia Severity Index (ISI) Score measure: Change in Pain Interference (PEG) Score measure: Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score measure: Change in CHESS Bonding Scale Score measure: Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score measure: Change in Treatment Self-Regulation Questionnaire (TSRQ) Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UM General Hepatology Clinic city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: UM Multidisciplinary ALD Clinic city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: UW General Hepatology Clinic city: Madison state: Wisconsin zip: 53705 country: United States lat: 43.07305 lon: -89.40123 facility: UW Multidisciplinary ALD Clinic city: Madison state: Wisconsin zip: 53705 country: United States lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06305611 id: KIWI briefTitle: European and North Indian Cohort of KaWasaki dIsease overallStatus: RECRUITING date: 2021-07-13 date: 2024-07-15 date: 2024-10-30 date: 2024-03-12 date: 2024-03-12 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success. conditions: Kawasaki Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 103 type: ESTIMATED measure: IVIG resistance rate measure: percentage of IVIG-resistant patients sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Universidade Federal do Rio de Janeiro status: RECRUITING city: Rio de Janeiro country: Brazil name: Adriana Fonseca role: CONTACT lat: -22.90278 lon: -43.2075 facility: Children's Hospital Zagreb status: RECRUITING city: Zagreb country: Croatia name: Alenka Gagro role: CONTACT lat: 45.81444 lon: 15.97798 facility: University Hospital Centre Zagreb, University School of Medicine status: RECRUITING city: Zagreb country: Croatia name: Marija Jelusic role: CONTACT lat: 45.81444 lon: 15.97798 facility: Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI status: NOT_YET_RECRUITING city: Le Kremlin-Bicêtre country: France name: Isabelle Koné-Paut role: CONTACT lat: 48.81471 lon: 2.36073 facility: Manipal Hospital status: NOT_YET_RECRUITING city: Bangalore country: India name: Anand Prahalad Rao role: CONTACT lat: 12.97194 lon: 77.59369 facility: Postgraduate Institute of Medical Education and Research status: RECRUITING city: Chandigarh country: India name: Vignesh Pandiarajan role: CONTACT lat: 30.73629 lon: 76.7884 facility: Sri Ramachandra Medical Centre status: NOT_YET_RECRUITING city: Chennai country: India name: Mahesh Janarthanan role: CONTACT lat: 13.08784 lon: 80.27847 facility: Amrita Institute of Medical Sciences status: NOT_YET_RECRUITING city: Kochi country: India name: Suma Balan role: CONTACT lat: 9.93988 lon: 76.26022 facility: Institute of Child Health status: RECRUITING city: Kolkata country: India name: Priyankar Pal role: CONTACT lat: 22.56263 lon: 88.36304 facility: Vivekananda Institute of Medical Sciences status: NOT_YET_RECRUITING city: Kolkata country: India name: SUPARNA GUHA role: CONTACT lat: 22.56263 lon: 88.36304 facility: Meir Medical Centre status: NOT_YET_RECRUITING city: Kfar Saba country: Israel name: Ruby Haviv role: CONTACT lat: 32.175 lon: 34.90694 facility: ASST Papa Giovanni XXIII status: RECRUITING city: Bergamo country: Italy name: Lucio Verdoni role: CONTACT lat: 45.69601 lon: 9.66721 facility: Spedali Civili status: RECRUITING city: Brescia country: Italy name: Marco Cattalini role: CONTACT lat: 45.53558 lon: 10.21472 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Gabriele Simonini role: CONTACT email: gabriele.simonini@meyer.it lat: 43.77925 lon: 11.24626 facility: IRCCS Istituto Giannina Gaslini status: RECRUITING city: Genova country: Italy name: Silvia Rosina role: CONTACT lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milano country: Italy name: Giovanni Filocamo role: CONTACT lat: 45.46427 lon: 9.18951 facility: P.O. "Giovanni Di Cristina" status: NOT_YET_RECRUITING city: Palermo country: Italy name: Maria Cristina Maggio role: CONTACT lat: 38.13205 lon: 13.33561 facility: Università di Torino status: RECRUITING city: Torino country: Italy name: Francesco Licciardi role: CONTACT lat: 45.07049 lon: 7.68682 facility: IRCCS Burlo Garofolo status: RECRUITING city: Trieste country: Italy name: andrea Taddio role: CONTACT lat: 45.64953 lon: 13.77679 facility: Beatrix Kinderkliniek, University Medical Center status: NOT_YET_RECRUITING city: Groningen country: Netherlands name: Wineke Armbrust role: CONTACT lat: 53.21917 lon: 6.56667 facility: Hospital de Sabadell status: RECRUITING city: Barcellona country: Spain name: Judith Sanchez Manubens role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Sant Joan de Déu status: RECRUITING city: Barcellona country: Spain name: Jordi Anton role: CONTACT lat: 41.38879 lon: 2.15899 facility: Chiang Mai University Hospital status: RECRUITING city: Chiang Mai country: Thailand name: Watchareewan Sontichai role: CONTACT lat: 18.79038 lon: 98.98468 facility: Hacettepe University Children's Hospital status: RECRUITING city: Ankara country: Turkey name: Seza Ozen role: CONTACT lat: 39.91987 lon: 32.85427 facility: Health Sciences University, Umraniye Education and Research Hospital status: RECRUITING city: Istanbul country: Turkey name: Betul Sozeri role: CONTACT lat: 41.01384 lon: 28.94966 facility: Istanbul Uni. Istanbul Med.Fac status: NOT_YET_RECRUITING city: Istanbul country: Turkey name: Nuray Aktay Ayaz role: CONTACT lat: 41.01384 lon: 28.94966 facility: Royal Hospital for Children status: RECRUITING city: Bristol country: United Kingdom name: Athimalaipet Ramanan role: CONTACT lat: 51.45523 lon: -2.59665 hasResults: False

 nctId: NCT06305598 id: I-3298823 id: NCI-2024-01390 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3298823 type: OTHER domain: Roswell Park Cancer Institute briefTitle: Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer overallStatus: RECRUITING date: 2024-06-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-12 date: 2024-04-25 name: Roswell Park Cancer Institute class: OTHER briefSummary: This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression. conditions: Castration-Resistant Prostate Carcinoma conditions: Metastatic Prostate Carcinoma conditions: Stage IVB Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Biopsy name: Bone Scan name: Computed Tomography name: Leuprolide Acetate name: Magnetic Resonance Imaging name: Survey Administration name: Testosterone Cypionate measure: Androgen receptor (AR) activity measure: Incidence of adverse events measure: Incidence of serious adverse events measure: Prostate specific antigen (PSA) 50 measure: Measurable disease response measure: Progression free survival measure: Overall survival measure: Assess Quality of life measure: Assess Quality of Life measure: Assess Fatigue measure: Assess change in Fatigue sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute status: RECRUITING city: Buffalo state: New York zip: 14263 country: United States name: Gurkamal S. Chatta role: CONTACT phone: 716-845-3117 email: Gurkamal.Chatta@RoswellPark.org name: Gurkamal S. Chatta role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06305585 id: IRB# 23-214 briefTitle: Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-12 date: 2024-03-12 name: University of Idaho class: OTHER name: CJ Brush name: Jayme Baker name: Sydney Leverett briefSummary: Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs. conditions: Psychological Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Primal Reflex Release Technique (PRRT) measure: ECG Data measure: ICG Data measure: Depression Anxiety Stress Scale-21 (DASS-21) - Depression measure: Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety measure: Depression Anxiety Stress Scale-21 (DASS-21) - Stress measure: Simple Physical Activity Questionnaire (SIMPAQ) measure: Self Assessment Manikin (SAM) - Valence measure: Self Assessment Manikin (SAM) - Arousal sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: ISMaRT Clinic city: Moscow state: Idaho zip: 83843 country: United States name: Jayme Baker, DPT role: CONTACT phone: 208-885-1055 email: jaymeb@uidaho.edu lat: 46.73239 lon: -117.00017 hasResults: False

 nctId: NCT06305572 id: H-1903-013-1014 briefTitle: Diagnostic Accuracy of Quantitative Flow Ratio overallStatus: COMPLETED date: 2019-07-30 date: 2023-03-25 date: 2023-09-26 date: 2024-03-12 date: 2024-03-12 name: Seoul National University Hospital class: OTHER name: Inje University Ilsan Paik Hospital name: Keimyung University Dongsan Medical Center name: Ulsan Medical Center name: Bucheon Sejong Hospital name: Chosun University Hospital name: Severance Hospital name: Ulsan University Hospital name: Uijeongbu Eulji Medical Center briefSummary: The aim of this study was to investigate the accuracy of quantitative flow ratio (QFR) for predicting fractional flow reserve (FFR) ≤0.80 in an independent core laboratory. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 280 type: ACTUAL name: QFR measure: Diagnostic accuracy of QFR measure: Sensitivity of QFR measure: Specificity of QFR measure: Correlation sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06305559 id: OBEZ-302 briefTitle: A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque acronym: REMBRANDT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2027-03 date: 2024-03-12 date: 2024-03-12 name: NewAmsterdam Pharma class: INDUSTRY briefSummary: This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA). conditions: Lipidemia conditions: Coronary Artery Disease conditions: Plaque, Atherosclerotic studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Double blind set-up; post randomization LDL values are not provided to sites (alert triggers are programmed for urgent follow-up) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: obicetrapib 10 mg + ezetimibe 10 mg FDC daily name: Placebo measure: • To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months. measure: Absolute change from baseline to 18 months in total NCPV in all major epicardial coronary arteries, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo. measure: Percent change from baseline to 18 months in LDL-C in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared to placebo. measure: Percent change from baseline to 18 months in non-calcified coronary atherosclerotic plaque volume in the most diseased coronary segment (NCPVMD), as measured by CCTA, in participants treated with FDC therapy vs placebo measure: Absolute change from baseline to 18 months in NCPVMD, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo. measure: Change in perivascular fat attenuation index (FAI), FAI score and its age- and gender specific centile in the principal epicardial coronary arteries as measured by CCTA in participants treated with FDC therapy compared with placebo. sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305546 id: 2911 briefTitle: Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients overallStatus: COMPLETED date: 2023-04-01 date: 2023-10-31 date: 2023-10-31 date: 2024-03-12 date: 2024-03-13 name: Anam Sattar class: OTHER briefSummary: Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene. This creates plaque retention sites which can lead to developing white spot lesions, caries, and periodontitis conditions: Gingivitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The trial was a double blinded (patients and investigators). We were helped from a member of our department who is not a part of the study, to transfer the gels from commercial tubes to blank containers. The randomization codes remained unknown until data analysis was completed. Randomization was done by computer-generated software. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Chlorhexidine Gluconate name: Metronidazole name: combination gel (chlorhexidine and metronidazole) name: Placebo measure: gingival index measure: bleeding index measure: orthodontic plaque index sex: ALL minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Dow University of Health Sciences city: Karachi state: Sindh country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06305533 id: 854623 briefTitle: Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis overallStatus: RECRUITING date: 2024-03-01 date: 2024-09 date: 2024-10 date: 2024-03-12 date: 2024-03-12 name: University of Baghdad class: OTHER briefSummary: The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:

Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.

Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.

All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.

All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is 3 arm, split-mouth, double blinded, randomized clinical trial. The first group will receive RSD only, the second group will be treated with RSD + aPDT with ICG as a PS, and the last group will receive RSD + Laser disinfection. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Sites will randomly be assigned to test or control groups according to a computer-generated list. Allocation concealment will be assured by opaque, sealed envelopes prepared and sequentially numbered by a person not otherwise involved in the study. The person responsible for delivering treatment will be aware about allocation of the groups, while the assessor will be blinded. whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: LASER disinfection name: Photodynamic therapy name: Root surface debridement measure: Probing Pocket Depth (PPD) measure: Bleeding on probing (BOP) measure: Plaque index (PI) measure: Clinical attachment loss (CAL) measure: Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: College of Dentistry, University of Baghdad status: RECRUITING city: Baghdad zip: 10047 country: Iraq role: CONTACT phone: +964 14169394 email: master@codental.uobaghdad.edu.iq lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06305520 id: BPLUS-NASAL-02 id: CRIS NO. : KCT0008113 type: REGISTRY domain: The Clinical Research Information Service (CRIS) in KOREA briefTitle: Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds acronym: BPLUS-02 overallStatus: ENROLLING_BY_INVITATION date: 2023-03-10 date: 2024-09-30 date: 2024-10-31 date: 2024-03-12 date: 2024-03-15 name: Bioplus class: INDUSTRY name: Seoul National University Hospital name: Asan Medical Center name: Soonchunhyang University Hospital briefSummary: Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.

Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design

Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)

Population: Number of subject 100

\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design). conditions: Nasal Disease conditions: Nasal Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Medical Device primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Investigational medical device (SkinPlus-HYAL Implant Lidocaine) name: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine) measure: Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device measure: Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application measure: Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application measure: Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application. sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul state: Jongnogu zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06305507 id: 30923-N briefTitle: Differents Laser Applications on Plantar Fasciitis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-07 date: 2024-03-12 date: 2024-03-13 name: University of Seville class: OTHER briefSummary: The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology, entitled \&#34;Effect of different laser applications on Plantar Fasciitis\&#34;, is to evaluate and compare the effectiveness of laser therapy low-level (LLLT) in local spot mode versus sweep mode in the reduction of pain associated with plantar fasciitis.

The main questions it seeks to answer are:

* What is the comparative effectiveness between low-level laser therapy in local spot mode and sweep mode in reducing pain in patients with plantar fasciitis?
* What are the optimal therapeutic parameters (session duration, frequency and power) for LLLT in both modes, maximizing pain reduction in patients with plantar fasciitis?

Participants in this study will perform the following tasks:

* Undergo low-level laser therapy sessions in local spot mode or sweep mode.
* Comply with the instructions on the duration and frequency of the sessions.
* Record the pain levels experienced before and after each session.

The investigators will compare the group undergoing local spot mode low-level laser therapy with the group undergoing sweeping mode low-level laser therapy to evaluate whether there are significant differences in pain reduction effects. conditions: Fasciitis, Plantar studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 62 type: ESTIMATED name: Focussed laser therapy name: Shower laser therapy measure: Pain Reduction in Patients with Plantar Fasciitis Treated with Laser Therapy (LLLT): Comparison between Local Spot Mode and Sweep Mode" measure: Fascia thickness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Área Clínica de Podología city: Sevilla state: Andalucía zip: 41004 country: Spain lat: 37.38283 lon: -5.97317 facility: Facultad de Podologia city: Sevilla zip: 41009 country: Spain name: Aurora Castro, Prof titular role: CONTACT phone: 954486500 lat: 37.38283 lon: -5.97317 hasResults: False

 nctId: NCT06305494 id: HE671008 briefTitle: Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors overallStatus: RECRUITING date: 2024-03-14 date: 2024-12 date: 2024-12 date: 2024-03-12 date: 2024-04-25 name: Khon Kaen University class: OTHER briefSummary: Women often face common cancers like ovarian, uterine, and cervical cancers. Improvements in cancer detection and treatment mean more women survive. However, survivors can encounter challenges like ongoing pain, treatment complications, and fertility issues.

Treating these cancers often involves surgeries that might include removing ovaries or using pelvic radiation. This can trigger menopause in younger women, causing problems like vaginal dryness, itching, and urinary issues.

Women who've gone through menopause often deal with these symptoms, affecting their daily lives, confidence, and intimate relationships. Though treatments are available, lack of awareness, embarrassment, and not discussing these issues with doctors can make managing them difficult.

The main treatment for these symptoms is using vaginal estrogen, but it might not be suitable for some cancer survivors. Non-hormonal options like lubricants and moisturizers are alternatives. This study in Thailand aiming to explore how common these issues are among gynecological cancer survivors, their feelings about it, and how it affects their quality of life. conditions: Atrophic Vaginitis conditions: Gynecologic Cancer conditions: Lower Urinary Tract Symptoms studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 425 type: ESTIMATED measure: Prevalence of genitourinary syndrome of menopause measure: Severity of genitourinary syndrome of menopause measure: Quality of life of gynecologic cancer survivor measure: Attitude toward genitourinary syndrome of menopause in gynecologic cancer survivor sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Khon Kaen University status: RECRUITING city: Khon Kaen zip: 40002 country: Thailand name: Apiwat Jongjakapun, MD role: CONTACT email: apiwjo@kku.ac.th lat: 16.44671 lon: 102.833 hasResults: False

 nctId: NCT06305481 id: OPT1099 briefTitle: Glaucoma Evaluation With the P200TE overallStatus: RECRUITING date: 2024-02-13 date: 2024-09-30 date: 2024-09-30 date: 2024-03-12 date: 2024-03-12 name: Optos, PLC class: INDUSTRY briefSummary: Images captured on the P200TE device on glaucoma patients conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 75 type: ESTIMATED name: P200TE measure: Number of images collected sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Werner Optometry status: RECRUITING city: Cajon state: California zip: 92019 country: United States name: Kristen Mendenhall role: CONTACT phone: 619-937-1056 email: kristen@wernerod.com lat: 34.29889 lon: -117.45644 facility: Specialty Eyecare Centre status: RECRUITING city: Bellevue state: Washington zip: 98004 country: United States name: Renee Cook role: CONTACT phone: 425-454-3937 email: rcook@specialtyeyecarecentre.com lat: 47.61038 lon: -122.20068 hasResults: False

 nctId: NCT06305468 id: APHP240055 briefTitle: Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis acronym: TOXIC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-12 date: 2024-03-12 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Toxoplasmosis is a common infection whose clinical severity can sometimes justify admission to intensive care, especially in immunocompromised patients.

This study should make it possible to evaluate the impact of different anti-infective treatment regimens and to highlight clinical-biological and prognostic differences depending on the type of underlying immunosuppression. conditions: Toxoplasmosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED measure: Mortality rate in intensive care. measure: Hospital mortality rate measure: Length of stay in intensive care measure: Duration of mechanical ventilation sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cochin hospital city: Paris zip: 75014 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06305455 id: HSD135 briefTitle: Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-10 date: 2024-03-12 date: 2024-03-12 name: José Raimundo Araujo de Azevedo class: OTHER briefSummary: The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit. conditions: Antimicrobial Resistance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Escherichia coli ESBL measure: Prevalence of Escherichia coli resistance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305442 id: PR-24031 briefTitle: Microbiota Directed Food for Children With Moderate Acute Malnutrition overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-10-31 date: 2026-02-28 date: 2024-03-12 date: 2024-04-24 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Washington University School of Medicine briefSummary: Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food. The investigator propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF. conditions: Moderate Acute Malnutrition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, randomized, parallel group, clinical trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 230 type: ESTIMATED name: Microbiota-Directed Food name: Ready-to-Use Supplementary Food measure: Mean change in Weight-for-Length Z-score (WLZ) measure: Microbial community repair measure: Validated plasma and faecal biomarkers of health status (prioritized Luminex/ELISA panel including mediators of growth, systemic inflammation, gut inflammation/entero-pathogen burden) measure: Mean change in Weight-for-Age Z-score (WAZ) measure: Mean change in Length-for-Age Z-score (LAZ) measure: Mean change in body composition (% body fat mass and % fat-free mass) measure: Bayley Scales of early childhood development (cognitive, motor, language development) sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Mirpur Study site city: Dhaka country: Bangladesh name: Dr. Jinat Alam, MPH, MBBS role: CONTACT phone: +8801676742255 email: jinat.alam@icddrb.com lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06305429 id: HABITE briefTitle: Encouraging Positive Parenting Habits acronym: HABITE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-09 date: 2024-03-12 date: 2024-04-02 name: D'Or Institute for Research and Education class: OTHER name: Okinawa Institute of Science and Technology Graduate University briefSummary: This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open, single-group trial primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: HabitE (effective parenting habit) program (in Brazilian Portuguese) measure: Number of videos viewed measure: Percentage of completed daily ratings measure: Participant satisfaction measure: Parent-rated child's difficulties with daily transitions measure: Parent-rated child's impairment related to transition difficulties measure: Inconsistent parenting measure: Use of physical control measure: Hostility toward child measure: Parent Stress measure: ADHD symptoms measure: ODD symptoms measure: Irritability measure: Proactive parenting measure: Use of positive reinforcement sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06305416 id: 2023/CT/01 briefTitle: A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema overallStatus: RECRUITING date: 2024-03-20 date: 2025-02 date: 2025-04 date: 2024-03-12 date: 2024-03-13 name: Incepta Pharmaceuticals Ltd class: INDUSTRY name: Institute for Developing Science and Health Initiatives, Bangladesh briefSummary: Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature. This compromise of the blood-retinal barrier leads to the leakage of plasma constituents into the surrounding retina with subsequent retinal edema. Hypoxia produced by this mechanism can also stimulate the production of vascular endothelial growth factor (VEGF). Vascular endothelial growth factor (VEGF) increases retinal vascular permeability, causes breakdown of the blood-retina barrier and results in retinal edema.

Diabetic macular edema (DME) is the most common cause of visual reduction in patients with Diabetes Mellitus. The prevalence of DME globally is around 6.8 %. Diabetic Retinopathy (DR) is the most common microvascular complication of diabetes and the leading cause of blindness worldwide. DME is a complication of diabetic retinopathy that affects the macula, which is located at the center of the retina and responsible for central vision. Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 7.1 million (5.3-12.0). In Bangladesh, it is therefore expected that diabetic secondary complications, like DR, will increase along with the rising trend of diabetes mellitus.

The use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases. In recent years, millions of patients have been successfully treated with these biological agents. Ranibizumab is one such therapeutic monoclonal antibody for intraocular use. Ranibizumab is a humanized, recombinant, immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A (VEGF-A) and thus prevents choroidal neovascularization. The small size of ranibizumab allows for enhanced diffusion into the retina and choroid. conditions: Diabetic Macular Edema conditions: Diabetic Retinopathy conditions: Macular Edema conditions: Macular Degeneration conditions: Retinal Disease conditions: Retinal Degeneration studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: Ranibizumab 10mg/ml Injection name: Lucentis measure: Changes in Best Corrected Visual Acuity (BCVA) from Baseline measure: Changes in Central Subfield Thickness (CST) from Baseline measure: Proportion of patients who lost fewer than 15 letters (approximately 3 lines) from baseline visual acuity measure: Proportion of patients who gained ≥15 letters (approximately 3 lines) from baseline visual acuity measure: Evaluation and comparison of safety between reference vs. test drug. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bangladesh Eye Hospital & Institute status: RECRUITING city: Dhaka zip: 1209 country: Bangladesh name: Dr. Niaz Abdur Rahman role: CONTACT phone: +8801711590333 email: drniazrahman@gmail.com name: Dr. Niaz Abdur Rahman role: PRINCIPAL_INVESTIGATOR lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06305403 id: VEXUS1 briefTitle: VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-18 date: 2025-05-18 date: 2024-03-12 date: 2024-04-23 name: Inonu University class: OTHER briefSummary: In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.

To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO.

According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not.

By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined. conditions: Sepsis conditions: Acute Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: serum creatinin level measure: ngal measure: VEXUS measure: MORTALİTY sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305390 id: 2022-003905-31 briefTitle: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer. acronym: RF2021-1237227 overallStatus: RECRUITING date: 2023-12-04 date: 2024-07 date: 2025-07 date: 2024-03-12 date: 2024-04-12 name: IRCCS San Raffaele class: OTHER briefSummary: This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).

Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa. conditions: Clinical Suspicion of Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 167 type: ESTIMATED name: PET/MRI measure: To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa) measure: To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: U.O. of Nuclear Medicine, ,Ospedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Maria Picchio, MD role: CONTACT phone: 02-26436117 email: Picchio.maria@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06305377 id: DESPED-T1 study briefTitle: Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-03-30 date: 2024-03-30 date: 2024-03-12 date: 2024-03-13 name: Giulio Frontino class: OTHER briefSummary: The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: Tandem Control IQ measure: Glucometric data sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06305364 id: CL-1001 briefTitle: Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue overallStatus: RECRUITING date: 2023-08-01 date: 2024-12-01 date: 2024-12-01 date: 2024-03-12 date: 2024-03-20 name: Jubaan Ltd. class: INDUSTRY briefSummary: This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance. conditions: Colorectal Neoplasms conditions: Gastrointestinal Microbiome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE maskingDescription: Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score. count: 800 type: ESTIMATED name: Gixam measure: Primary Safety Endpoint - Number of device related adverse events and serious adverse events measure: Primary Efficacy Endpoint - Gixam's diagnostic accuracy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westside GI status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Theodore Bortz role: CONTACT lat: 40.71427 lon: -74.00597 facility: NewYork-Presbyterian / Columbia University Irving Medical Center status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Elissa Lynch role: CONTACT name: Daniel Freedberg, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06305351 id: K-757 P008 briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-12-07 date: 2024-07 date: 2024-07 date: 2024-03-12 date: 2024-03-12 name: Kallyope Inc. class: INDUSTRY briefSummary: This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM) conditions: Obesity conditions: Type 2 Diabetes Mellitus (T2DM) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 32 type: ESTIMATED name: K-757 and K-833 QD name: K-757 and K-833 BID name: Matching placebo to K-757 and K-833 QD name: Matching placebo to K-757 and K-833 BID measure: Proportion of participants who experienced 1 or more treatment-emergent AEs measure: Proportion of participants who discontinued study medication due to an AE measure: Area under the concentration-time curve [AUC] of plasma K-757 measure: AUC of plasma K-833 measure: Maximum concentration [Cmax] of plasma K-757 measure: Cmax of plasma K-833 measure: Time of maximum concentration [Tmax] of plasma K-757 measure: Tmax of plasma K-833 measure: Clearance [Cl] of plasma K-757 measure: Cl of plasma K-833 measure: Volume of distribution at steady-state [Vdss] of plasma K-757 measure: Vdss of plasma K-833 measure: Half-life [t1/2] of plasma K-757 measure: t1/2 of plasma K-833 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: QPS Miami status: RECRUITING city: Miami state: Florida zip: 33143 country: United States lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06305338 id: KUK-Ophthalmology-009 briefTitle: Predicting Intraocular Lens Tilt Using OCT Measurements and Partial Least Squares Regression Modelling acronym: Tilt overallStatus: COMPLETED date: 2022-04-12 date: 2023-04-01 date: 2023-04-26 date: 2024-03-12 date: 2024-03-12 name: Johannes Kepler University of Linz class: OTHER briefSummary: During cataract surgery an artificial intraocular lens (IOL) is implanted in the eye to replace the lens and to correct the refraction for distance vision. Misalignment of IOLs can cause severe loss of visual quality. Different types of misalignment are known. Tilt, one type of IOL misalignment is thought to play a negative role for the optical performance in eyes with IOL designs, especially, if they have aspheric, toric, or multifocal optics.

Various methods to measure IOL misalignments have been described. Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess IOL decentration and tilt. The subjective grading at the slitlamp may display considerable variability between examiners. This method is more qualitative than quantitative and does not allow fine resolution when reporting IOL tilt. The fact that the patient has no standardized target to focus on makes the method even less reliable. Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the IOL position. Additionally, it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference. Scheimpflug camera images have been used for assessing IOL tilt previously, but erroneous results, often due to corneal magnification, have diminished their widespread use. Another possibility to assess tilt is the use of Purkinje reflexes. The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized. Since light is reflected at all interfaces of media with a difference in refractive index, these reflections, called Purkinje images, can be used to assess tilt and decentration of IOLs. Two different clinically applicable Purkinjemeter system provide the measurement of IOL decentration and tilt. The main problem with Purkinje meters is accessibility, as there are only a few prototypes available worldwide.

The most recently developed method for tilt quantification is the use of optical coherence tomography. This method has several advantages compared to the previous methods: OCT based devices are available in most clinics, the resolution of modern OCT devices is high, and the measurements are reproducible.

Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression. This method was developed by Wold and introduced to ophthalmology previously. conditions: Intraocular Lens conditions: Cataract studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ACTUAL name: Optical Coherence Tomography measure: post operative IOL tilt measure: Comparison of tilt prediction measure: comparion of three measurement methods measure: Comparison of tilt pre- versus post operative sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Matthias Bolz city: Linz state: Oberösterreich zip: 4020 country: Austria lat: 48.30639 lon: 14.28611 hasResults: False

 nctId: NCT06305325 id: 35957 briefTitle: Coparenting Intervention to Prevent Postpartum Depression overallStatus: COMPLETED date: 2018-09-23 date: 2019-11-22 date: 2020-02-22 date: 2024-03-12 date: 2024-03-12 name: Brock University class: OTHER name: University of Toronto briefSummary: The goal of this pilot randomized controlled trial was to examine the feasibility and acceptability of an ehealth antenatal coparenting intervention (eACoP) in primiparous Pakistani women. The secondary purpose of the study was to see the effectives of the intervention in prevention postpartum depression in women. Two hundred and twelve primiparous couples were randomized into an intervention or a control group from the Aga Khan University Hospital. Couples were randomized using consecutively numbered sealed envelopes. Couples in the intervention group received the eACoP intervention during pregnancy, consist of eight online videos in addition to the standard care provided at the center. Both the intervention group and control group received standard care. conditions: Postpartum Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: coparenting framework: it has 3 levels. First is the individual level, which consists of the parent's individual characteristics, which comprises of attitudes, parental beliefs, and emotional and mental health. It has a bidirectional relationship with coparenting and the overall inter-parental relationship. Individual child factors, such as temperament may also play a role in shaping the coparenting relationship. The second level is the family level. It comprises the overall interpersonal relationship, referring to the existing ability of couples to demonstrate support and respect for each other. It could influence the coparental relationship or in reverse, the coparental relationship may influence the overall inter-parental relationship. The third level is the extra-familial level. It has two components: support and stress that are based on a stress-coping perspective. The role of environmental support is viewed as enhancing the coparenting relationship primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 106 type: ACTUAL name: eHealth Antenatal Coparenting Intervention measure: feasibility-recruitment rate, adherence, and follow-up rate measure: Acceptability- Participants satisfaction measure: Depressive Symptoms measure: anxiety measure: Coparenting Relationship measure: Relationship Satisfaction- couple relationship satisfaction to discriminate between distressed and non-distressed relationship. measure: Postpartum Childcare Stress measure: Infant Development measure: partner support sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aga Khan University city: Karachi state: SinDH country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06305312 id: HCI166685 id: 1R01CA282409-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01CA282409-01 briefTitle: Community Services Navigation to Advance Health Equity in Breast Cancer Screening acronym: B-SINCERE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-09 date: 2028-09 date: 2024-03-12 date: 2024-04-17 name: University of Utah class: OTHER name: National Institutes of Health (NIH) name: National Cancer Institute (NCI) briefSummary: The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1450 type: ESTIMATED name: Community Service Navigation name: Usual Care measure: Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener measure: Episode Completion (EC). EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences city: Salt Lake City state: Utah zip: 84112 country: United States name: Elissa Ozanne, PhD role: CONTACT phone: 801-213-4130 email: Elissa.Ozanne@hsc.utah.edu name: Tracy Onega, PhD role: SUB_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06305299 id: LCCC2152-ATL briefTitle: Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-03 date: 2026-03 date: 2024-03-12 date: 2024-04-23 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated.

There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy. conditions: Ovary Neoplasm conditions: Ovarian Cancer conditions: Epithelial Ovarian Cancer conditions: Recurrent studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: iC9-CAR.B7-H3 T cells name: Cyclophosphamide name: Fludarabine measure: Toxicity: NCI-CTCAE measure: Toxicity: Cytokine Release Syndrome (CRS) measure: Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) measure: The recommended phase 2 dose (RP2D) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: The disease control rate (DCR) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lineberger Comprehensive Cancer Center city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Caroline Babinec role: CONTACT email: Caroline_babinec@med.unc.edu name: Linda Van Le role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06305286 id: IRB23-1367 briefTitle: Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) overallStatus: RECRUITING date: 2024-03-04 date: 2029-03 date: 2029-03 date: 2024-03-12 date: 2024-03-27 name: University of Chicago class: OTHER name: Juvenile Diabetes Research Foundation name: Cure Alliance briefSummary: AT-1501 is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the subject's immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. AT-1501 is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. AT-1501 is an experimental agent that is anticipated to prevent rejection without harming the islet cells. conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ESTIMATED name: AT-1501 measure: Number of Participants who are insulin-independent post- first and final transplant measure: Number of Participants with glycosylated hemoglobin (HbA1c) <7.0% measure: Number of Participants with free of serious hypoglycemic events (SHEs) post-first and final transplant measure: Number of Participants with HbA1c ≤6.5% AND free from SHEs post-first and final transplant. measure: Number of Participants with graft failure post final transplant. measure: Number of participants with impaired awareness of hypoglycemia after final islet cell transplant and after discontinuation of AT-1501. measure: Change in glycemic lability after final islet cell transplant and years after discontinuation of AT-1501 measure: Change in albumin excretion ratio (AER) post-first and final transplant. measure: Change in estimated glomerular filtration rate (eGFR) post-first and final transplant. measure: Change in percent new macroalbuminuria post-first and final transplant. measure: Change in variability after final islet cell transplant and years after discontinuation of AT-1501 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Piotr Witkowski, MD PhD role: CONTACT phone: 773-702-2447 email: pwitkowski@surgery.bs.uchicago.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06305273 id: 23-0150-A briefTitle: Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2025-03-01 date: 2025-03-01 date: 2024-03-12 date: 2024-03-20 name: Mount Sinai Hospital, Canada class: OTHER briefSummary: It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height.

There is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees , it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study is a prospective randomized cross-over trial to be conducted at Mount Sinai Hospital (Toronto, Ontario, Canada). primaryPurpose: PREVENTION masking: NONE count: 38 type: ESTIMATED name: Head position for face mask ventilation during induction supine name: Head position for face mask ventilation during induction head elevated measure: Average tidal volume measure: Predictors for difficult mask ventilation like BMI measure: Predictors for difficult mask ventilation like presence of beard measure: Predictors for difficult mask ventilation like Mallampati classification III or IV measure: Predictors for difficult mask ventilation like age of 57 yo or older. measure: Predictors for difficult mask ventilation like severely limited mandibular protrusion measure: Predictors for difficult mask ventilation like history of snoring. measure: Oropharyngeal airway measure: Insufficient mask ventilation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305260 id: STUDY00000324 briefTitle: LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40 acronym: LOTUS overallStatus: ENROLLING_BY_INVITATION date: 2023-11-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-12 date: 2024-03-20 name: MetroHealth Medical Center class: OTHER briefSummary: The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \>40) obstetric patient population. The main questions it aims to answer are:

* Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?
* Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement. conditions: Obesity, Morbid conditions: Labor Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Lumbar Ultrasound measure: Epidural Redirects measure: Total time to epidural space measure: Number of attempts at a different level measure: Epidural replacement rate measure: Patient satisfaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MetroHealth Hospital city: Cleveland state: Ohio zip: 44109 country: United States lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06305247 id: CLIN-01194-450 id: 2023-506228-10-00 type: OTHER domain: Ipsen briefTitle: A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours overallStatus: RECRUITING date: 2024-04-03 date: 2028-03-20 date: 2028-03-20 date: 2024-03-12 date: 2024-04-19 name: Ipsen class: INDUSTRY briefSummary: The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.

The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.

In this study, all participants will receive the study drug, which will be taken by mouth (orally). conditions: Melanoma conditions: Head and Neck Squamous Cell Carcinoma conditions: Pancreatic Ductal Adenocarcinoma conditions: Colorectal Cancer conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase I is a dose escalation with backfill in participants with selected MAPKm advanced solid tumours.

Phase IIa (cohort expansion) is an open label randomised study. primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: IPN01194 name: IPN01194 measure: Phase 1: Percentage of participants with dose limiting toxicity (DLT) measure: Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs) measure: Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations measure: Phase 2a: Objective response rate (ORR) measure: Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194 measure: Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194 measure: Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194 measure: Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state measure: Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state measure: Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state measure: Phase 1: Prolongation of corrected QT interval (QTc) measure: Phase 1: Objective response rate (ORR) measure: Phase 2a: Duration of response (DoR) measure: Phase 2a: Progression-free survival (PFS) measure: Phase 2a: PFS rate at 4 months measure: Phase 2a: Disease control rate (DCR) measure: Phase 2a: Percentage of participants with TEAEs and TE SAEs measure: Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Angeles Clinic and Research Institute - California status: NOT_YET_RECRUITING city: Los Angeles state: California zip: 90025 country: United States lat: 34.05223 lon: -118.24368 facility: UC San Diego Health System - La Jolla status: NOT_YET_RECRUITING city: San Diego state: California zip: 92037 country: United States lat: 32.71533 lon: -117.15726 facility: Yale Cancer Center - New Heaven status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States lat: 41.30815 lon: -72.92816 facility: Sarah Cannon Research Institute (SCRI) - Nashville status: NOT_YET_RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: Virginia Cancer Specialist status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 facility: Centre Léon Bérard - Lyon status: NOT_YET_RECRUITING city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Paris Saint-Louis status: NOT_YET_RECRUITING city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut de Cancerologie de l'Ouest (St-Herblain) status: NOT_YET_RECRUITING city: Saint-Herblain country: France lat: 47.21765 lon: -1.64841 facility: IGR-Villejuif status: NOT_YET_RECRUITING city: Villejuif country: France lat: 48.7939 lon: 2.35992 facility: Barcelona - Val D'Hebron status: NOT_YET_RECRUITING city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Fundacion Jimenez Diaz - Madrid status: NOT_YET_RECRUITING city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: M.D. Anderson Cancer Center Madrid status: NOT_YET_RECRUITING city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06305234 id: 165-503 briefTitle: A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) overallStatus: RECRUITING date: 2024-01-20 date: 2033-11-18 date: 2033-11-18 date: 2024-03-12 date: 2024-03-12 name: BioMarin Pharmaceutical class: INDUSTRY briefSummary: This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503. conditions: Phenylketonuria (PKU) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Pegvaliase measure: To evaluate immunologic and inflammatory responses associated with occurrences of measure: Evaluation of immunologic and/or inflammatory responses over time measure: Evaluation of immunologic responses over time sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tulane University School of Medicine status: RECRUITING city: New Orleans state: Louisiana zip: 70112 country: United States lat: 29.95465 lon: -90.07507 hasResults: False

 nctId: NCT06305221 id: opioid-free analgesia briefTitle: Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy overallStatus: RECRUITING date: 2024-03-09 date: 2025-03-31 date: 2025-03-31 date: 2024-03-12 date: 2024-04-16 name: Beijing Friendship Hospital class: OTHER briefSummary: The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain. conditions: Opioid-Free Anesthesia conditions: Laparoscopic Sleeve Gastrectomy conditions: Postoperative Vomiting conditions: Postoperative Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Opioid-free Analgesics (esketamine, dexmedetomidine) name: Opioid Anesthetics (sufentanil and remifentanil) measure: 15-item recovery quality scale score 48 hours after surgery measure: 15-item recovery quality scale score 24 hours before surgery measure: Dosage of postoperative analgesics measure: Duration of until postoperative PACU Aldrete score> 9 points measure: anesthesia-related complication measure: time to first exhaust gas after surgery measure: time of first postoperative mobilization measure: Overall benefit of analgesic score satisfaction in pain treatment measure: Acute pain numeric rating scale score measure: Rhodes Index of Nausea, Vomiting, and Retching measure: Rhodes Index of Nausea, Vomiting, and Retching sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: bijia Song status: RECRUITING city: Beijing country: China name: bijia Song role: CONTACT phone: 18309845273 email: songbijia@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06305208 id: CCLR-23-018 briefTitle: A UK Registry for Metabolic and Bariatric Endoscopic Interventions acronym: UK-ENDOMAB overallStatus: RECRUITING date: 2024-02-01 date: 2034-02-01 date: 2039-02-01 date: 2024-03-12 date: 2024-03-15 name: Cleveland Clinic London class: OTHER briefSummary: In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments. conditions: Obesity conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Endoscopic gastric suturing name: Endoscopic gastric plication name: Revisional gastroplasty name: Transoral outlet reduction endoscopy (TORe) name: Duodenal mucosal resurfacing (DMR) name: Intragastric balloon(s) measure: Total body weight loss percentage (TBWL%) measure: Change in glycated haemoglobin (HbA1c; mmol/mol) measure: Change in the number and dose of anti-diabetic medications measure: Procedure time (mins) measure: Inpatient stay (days) measure: Adverse events measure: Change in systolic blood pressure measurements (mmHg) measure: Change in diastolic blood pressure measurements (mmHg) measure: Changes in number and dose of anti-hypertensive medications (n) measure: Changes in low-density lipoprotein cholesterol (mmol/L) measure: Changes in triglycerides (mmol/L) measure: Changes in high-density lipoprotein cholesterol (mmol/L) measure: Changes in total cholesterol (mmol/L) measure: Changes in alanine transaminase (IU/L) measure: Changes in aspartate aminotransferase (IU/L) measure: Changes in Fibrosis-4 Index for Liver Fibrosis measure: Changes in non-alcoholic fatty liver disease fibrosis score measure: Changes in weight (kg) measure: Changes in body mass index (kg/m2) measure: Changes in glycated haemoglobin (HbA1c; mmol/mol) measure: Changes in number and dose of anti-diabetic medications (n) measure: Changes in number and dose of anti-obesity medications (n) measure: Changes in health-related quality of life scores (EuroQol-5D-5L) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic London status: RECRUITING city: London zip: SW1X 7HY country: United Kingdom name: Benjamin Norton, MD role: CONTACT email: cclendoscopyresearch@ccf.org name: Rehan Haidry, MD role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06305195 id: 0107766 briefTitle: Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome overallStatus: RECRUITING date: 2023-08-23 date: 2024-09-01 date: 2026-10-21 date: 2024-03-12 date: 2024-03-12 name: Alexandria University class: OTHER briefSummary: The study aims to assess the beat-to-beat Heart rate variability (HRV) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals.

Heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators. conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 155 type: ESTIMATED name: heart rate variability test measure: Beat-to-beat Heart rate variability measure: body mass index measure: Valsalva ratio measure: Stand 30:15 ratio measure: deep breath test interpretation measure: Framingham risk score (FRS) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alexandria university status: RECRUITING city: Alexandria country: Egypt name: Hala A. Abo El-Hassan, MSc role: CONTACT phone: 02/01114851485 email: hala.aboelhassan@pua.edu.eg name: Noha A. Hamdy, Dr role: CONTACT phone: 02/01005182151 email: noha.alaaeldine@alexu.edu.eg lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06305182 id: BASEC 2022-01328 briefTitle: Metreleptin in Anorexia Nervosa acronym: METRAN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-01 date: 2026-02-01 date: 2024-03-12 date: 2024-03-15 name: Gabriella Milos class: OTHER briefSummary: The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreleptin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight. conditions: Anorexia Nervosa studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Placebo-controlled, double-blind, randomized trial. The efficacy of Metreleptin in Anorexia Nervosa patients will be tested against an inactive Placebo. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Metreleptin name: Sodium chloride measure: Clinician-rated depression on the 17 point Hamilton Depression Scale (HAMD-17) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Body weight status in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Subjective depression by the Beck Depression Inventory-II (BDI-II) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Functional brain connectivity in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Anorexia Nervosa psychopathology assessed by the Eating Disorders Examination Questionnaire (EDE-Q) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: External rated hyperkinesia assessed by the Structured Inventory for Anorexic and Bulimic Eating Disorders (SIAB, item 42) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Subjective hyperkinesia assessed by the Exercise and Eating Disorders Questionnaire (EED) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Autism symptoms assessed by the Autism-Spectrum Quotient-short version (AQ-k) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Patient's quality of life by items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 from the WHO Quality of Life Questionnaire (WHOQOL-BREF) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Visual Analog Scale (VAS) about key Anorexia Nervosa and depression symptoms in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich city: Zurich zip: 8091 country: Switzerland name: Florian Remund, MSc. Business Administration role: CONTACT name: Gabriella Milos, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR name: Lisa Guth, MSc role: SUB_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06305169 id: 1.4 briefTitle: Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-12 date: 2024-03-12 name: Sandwell & West Birmingham Hospitals NHS Trust class: OTHER briefSummary: Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.

The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.

To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.

A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 440 type: ESTIMATED name: Gastropanel measure: Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer measure: Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sandwell General Hospital city: Birmingham state: West Midlands zip: B71 4HJ country: United Kingdom lat: 52.48142 lon: -1.89983 hasResults: False

 nctId: NCT06305156 id: CT_BMD_1 briefTitle: Protocol Optimization in CT for the Quantification of BMD overallStatus: RECRUITING date: 2024-03-13 date: 2025-03 date: 2025-03 date: 2024-03-12 date: 2024-03-20 name: Hatem Alkadhi class: OTHER briefSummary: Bone mineral density is an important measurement to detect osteoporosis.

The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:

* How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA
* How can we optimize the CT scan for bone mineral density

Participants will undergo:

* Clinically indicated CT scan on day of inclusion
* Study related DXA scan on a separate appointment conditions: Osteoporosis, Osteopenia conditions: Bone Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Bone Mineral Density quantification measure: Bone mineral density CT measure: Bone mineral density Dual-energy x-ray absorptiometry (DXA) measure: Correlation between age and bone mineral density measure: Correlation between sex and bone mineral density measure: Correlation between height and bone mineral density measure: Correlation between weight and bone mineral density measure: Correlation between body mass index (BMI) and bone mineral density sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diagnostic and Interventional Radiology, University Hospital Zurich status: RECRUITING city: Zürich zip: 8091 country: Switzerland name: Hatem Alkadhi, MD, MPH role: CONTACT phone: +41 44 255 36 62 email: hatem.alkadhi@usz.ch lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06305143 id: YFZXYDK202402 briefTitle: Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-07-01 date: 2024-03-12 date: 2024-03-12 name: Shanghai Eye Disease Prevention and Treatment Center class: OTHER name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine briefSummary: The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR).

The main questions it aims to answer are:

* mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment
* proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment
* proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment
* mean changes in BCVA and CMT from baseline to monthly follow-up time point
* complications and adverse effects conditions: Diabetic Macular Edema studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: Conbercept measure: improvement of visual acuity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Eye Diseases Prevention &Treatment Center status: RECRUITING city: Shanghai state: Shanghai zip: 201103 country: China name: Tao Sun role: CONTACT phone: +8618916576690 email: drsuntao@yeah.net lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06305130 id: KMUHIRB-E(I)-20180214 briefTitle: Prognostic Value of Performance Scores in Patients Undergoing Surgery for Upper Tract Urothelial Carcinoma overallStatus: COMPLETED date: 1988-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-12 date: 2024-03-12 name: Kaohsiung Medical University class: OTHER briefSummary: Aim: to comprehensively evaluate the prognostic value of preoperative ECOG-PS scores and ASA scores in patients undergoing radical nephroureterectomy (RNU) for upper tract urothelial carcinoma.

Methods: multicentered cohort study conditions: Carcinoma, Transitional Cell (RENI) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2515 type: ACTUAL name: No intervention measure: Overall survival measure: Cancer-specific survival measure: Disease-free survival measure: Bladder recurrence-free survival measure: Number of patients with major postoperative complication measure: Number of patients with postoperative renal failure sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305117 id: PP202304-37-1 id: 101227 type: OTHER_GRANT domain: Association Ruban Rose briefTitle: Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1 acronym: VRtuose1 overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2025-05 date: 2025-05 date: 2024-03-12 date: 2024-03-12 name: International Agency for Research on Cancer class: OTHER name: Centre Leon Berard briefSummary: The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life.

The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting.

In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Distraction strategy measure: Patients' acceptance rate regarding the use of the distraction strategy. measure: Accessibility of the strategy measure: Duration of use of the strategy by patients measure: Type of video content chosen by participants measure: Type of music content chosen by participants measure: Patients' perception of factors limiting the use of the strategy measure: Healthcare providers' perception of factors limiting the use of the strategy measure: Workload for strategy administrators measure: Strategy administrators ability to use the strategy measure: Patients' satisfaction regarding the use of the strategy measure: Healthcare providers' satisfaction regarding the strategy measure: Prevalence of adverse events related to the use of the strategy measure: Type of adverse events related to the use of the strategy measure: Severity of adverse events related to the use of the strategy measure: Acceptance rate to fill in questionnaires measuring clinical outcomes measure: Time taken to fill in questionnaires measuring clinical outcomes measure: Completeness of questionnaires measuring clinical outcomes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Léon Bérard city: Lyon country: France name: Olivier Trédan, MD role: CONTACT email: olivier.tredan@lyon.unicancer.fr name: Olivier Trédan, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06305104 id: KN-EEC-II briefTitle: Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old. overallStatus: RECRUITING date: 2023-07-18 date: 2024-05-30 date: 2024-06-30 date: 2024-03-12 date: 2024-03-12 name: Chengdu CoenBiotech Co., Ltd class: INDUSTRY name: Beijing Chest Hospital, Capital Medical University name: Wuhan Institute for Tuberculosis Control name: The Public Health Clinical Center of Chengdu name: Xuzhou Infectious Disease Hospital name: Jiangsu Province Centers for Disease Control and Prevention name: Changde First People's Hospital briefSummary: This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.

In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.

In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old. conditions: Tuberculosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: 2.5μg/ml EEC name: 5μg/ml EEC name: 5 unit（U） EC measure: Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ; measure: specificity of different doses of EEC and control EC in healthy subjects aged 18 to 65 years and patients with non-tuberculous lung disease ; measure: The skin test site specific reaction at 4h,8h (only for stage 2);24h, 48h, 72h, 96h, and 7 days after skin test. Those with average diameter of induration/redness is ≥5 mm will be considered to positive. measure: Receiver operator characteristic curve(ROC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug. measure: Area under the curve(AUC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug. measure: In healthy people, patients with tuberculosis and patients with non-tuberculous lung diseases, the consistency rates of the three detection reagents EEC , EC and IGRA were evaluated respectively. measure: Incidence of adverse events and serious adverse events at injection and non-injection sites，abnormal incidence of laboratory indicators and vital signs during the study period. sex: ALL minimumAge: 3 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Chest Hospital status: RECRUITING city: Beijing state: Beijing zip: 101149 country: China name: Tongqun Zhang role: CONTACT phone: 010-89509134 email: Zhangtongqun@sina.com name: Naihui Chu, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Wuhan Institute for Tuberculosis Control status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Min Wang role: CONTACT phone: 13871221841 email: whsfkyyllsc@163.com name: Juan Du, Bachelor role: PRINCIPAL_INVESTIGATOR name: Ronghui Du, Bachelor role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Changde First People's Hospital status: RECRUITING city: Changde state: Hunan zip: 415000 country: China name: Shuxiang Zhou role: CONTACT phone: 0736-7788890 email: 450717196@qq.com name: Tianli Wang, master role: PRINCIPAL_INVESTIGATOR lat: 29.04638 lon: 111.6783 facility: Jiangsu Province Centers for Disease Control and Prevention status: RECRUITING city: Nanjing state: Jiangsu zip: 212400 country: China name: Xiaoyan Ding role: CONTACT phone: 025-83759406 email: ec@jscdc.cn name: Limei Zhu, master role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Xuzhou Infectious Disease Hospital status: RECRUITING city: Xuzhou state: Jiangsu country: China name: Tingting Liu role: CONTACT phone: 0516-68900929 email: xcyllb123@163.com name: Ruimei Zhang, Bachelor role: PRINCIPAL_INVESTIGATOR lat: 34.18045 lon: 117.15707 facility: Public health clinical center of chengdu status: RECRUITING city: Chengdu state: Sichuan zip: 610066 country: China name: Qing Yang role: CONTACT phone: 028-64369118 email: crbykjk@126.com name: Guihui Wu, master role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06305091 id: 1681559 briefTitle: DNA Methylation Markers in Veterans Exposed to Open Burn Pits overallStatus: RECRUITING date: 2023-03-13 date: 2027-03-31 date: 2027-03-31 date: 2024-03-12 date: 2024-03-12 name: Central Arkansas Veterans Healthcare System class: FED name: United States Department of Defense name: University of Arkansas briefSummary: Background: The VA and DoD estimate that 3.5 million Veterans and Service Members were exposed to open burn pits used for waste disposal during military deployments to countries such as Kuwait, Afghanistan, and Iraq since 1990. Since the lasting adverse effects of this exposure on health are unknown, the VA Airborne Hazards and Open Burn Pit Registry (AHOBPR) was created. More than 209,000 participants to date have answered the registry questionnaire about the extent of exposure to burn pits and other airborne hazards. The questions attempted to quantify the duration of exposure, the severity of acute health effects, and the relative timing of onset or worsening of chronic respiratory, cardiovascular, neurological, and other illnesses. However, the AHOBPR interview lacks specific inquiry about mental health and biomarkers. The proposed study will recruit AHOBPR participants and non-participant for a follow-up enhanced evaluation of their health in a translational research study to better characterize their psychological, physical health profile, and potentially harmful epigenetic and biochemical exposure-related alterations.

Hypothesis: The investigators hypothesize that 1) the severity of individual exposure to burn pits will be positively correlated with levels of persistent organic pollutants in blood and metals in urine and specific epigenetic alterations in DNA methylation; and 2) levels of toxic chemicals and alterations in the methylation of specific genes will be positively correlated with chronic problems involving the cardiovascular, respiratory, neuropsychiatric and other systems.

Specific Aims: (1) Describe and quantify relationships of the intensity and duration of exposure with persistent organic chemicals/metals in the registry participants and ascertain their relationships with health outcomes linked to burn pit exposure. (2) Discover and validate DNA methylation marks that best distinguish between individuals exposed to burn pits and those not; then describe and quantify the relationships between DNA methylation, intensity and duration of exposure, and health outcomes. Completion of these aims will allow quantitation of the relationships between toxic chemicals, DNA methylation, and individual health problems.

Study Design: A clinical study will be conducted at the Central Arkansas Veterans Healthcare System and the University of Arkansas for Medical Sciences. The AHOBPR registry and non-specific recruitment will be used to enroll OBP exposed (N=220) and age and gender-matched unexposed (N=110) veterans. The unexposed veterans will be given the same questions as in the AHOBPR to determine their open burn pit exposure status with a confirmation of no exposure. A single study visit per participant will strengthen the registry by validating its contents using the electronic patient record and adding new study data on physical and mental function, including effects of epigenetic and toxicant measures obtained from blood and urine samples. Linear and logistic regression modeling will be used to determine the relationships described by the study aims while controlling for confounding variables and false discovery rates.

Long-term and Short-term Impact on Patient Populations: The immediate goal of the study is to measure exposure-related differences in levels of potentially toxic chemicals present in blood and urine and differences in DNA methylation. The study will then determine the relationships between exposure, the biochemical and molecular measures, and the presence of health problems. The value of this information is high since the effects of burn pit exposure are largely unknown but potentially serious. The longer-term goal for this line of investigation is to enable personalized and tailored health management for exposed individuals. The investigators believe that the biochemical and molecular measures may become novel biomarkers that enable the prediction of risk for disease and adverse disease outcomes such that preventative measures can be employed. Furthermore, the results will be highly relevant to other occupations in which exposure to airborne pollutants is high. conditions: Open Burn Pit Exposure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 330 type: ESTIMATED name: Health survey for physical and mental health comorbidities, epigenetic marker and heavy metals in blood and urine samples measure: DNA methylation markers and heavy metals measure: Physical and mental health comorbidities sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Arkansas Veterans Healthcare System (3J/NLR) status: RECRUITING city: North Little Rock state: Arkansas zip: 72114 country: United States name: Kalpana Padala, MD role: CONTACT phone: 501-257-2044 email: kalpana.padala@va.gov name: Trent Trice, BS role: CONTACT phone: 501-257-2403 email: trent.trice@va.gov name: Kalpana Padala, MD role: PRINCIPAL_INVESTIGATOR lat: 34.76954 lon: -92.26709 hasResults: False

 nctId: NCT06305078 id: 2023-0528 briefTitle: Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study overallStatus: RECRUITING date: 2023-11-10 date: 2024-08-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Children's Hospital Medical Center, Cincinnati class: OTHER briefSummary: The primary goal of the project is to test personalized medication experiments to inform decisions about future medication use. Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use. The investigators view this open label trial as a pilot study to test the feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial. conditions: Attention Deficit Hyperactivity Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open Label Trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: None (open-label) count: 30 type: ESTIMATED name: Personalized ADHD Medication Experiment measure: Decision-Making Involvement Scale measure: Decisional Conflict Scale (DCS) measure: Behavioral Intention Questions measure: System Usability Scale measure: Implementation of Decision sex: ALL minimumAge: 11 Years maximumAge: 15 Years stdAges: CHILD facility: Cincinnati Children's Hospital Medical Center status: RECRUITING city: Cincinnati state: Ohio zip: 45220 country: United States name: William Brinkman, MD role: CONTACT phone: 513-636-2576 email: bill.brinkman@cchmc.org name: William Brinkman, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-10 uploadDate: 2024-01-26T17:55 filename: Prot_SAP_000.pdf size: 1393239 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-10 uploadDate: 2024-01-26T18:00 filename: ICF_001.pdf size: 1084823 hasResults: False

 nctId: NCT06305065 id: 2024.089 briefTitle: Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-05 date: 2024-03-12 date: 2024-03-19 name: Chinese University of Hong Kong class: OTHER briefSummary: REAL INTELLIGENCE™ CORI™ (CORI Surgical System) is a computer-assisted orthopedic surgical system. CORI Surgical System is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures.

CORI Surgical System is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Surgical System software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module.

Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model.

The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments. conditions: Knee Osteoarthritis conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Subjects will be randomly assigned to the KUNWU navigational or CORI Surgical System or conventional manual instrumentation groups according to a balanced randomization procedure using a 1:1:1 allocation ratio. To ensure balanced group assignment, a block randomization schedule will be generated. All subjects who sign the ICF and meet all inclusion and exclusion criteria will be randomized in a 1:1:1 randomization allocation ratio. The block size should be sufficiently small to allow approximately equal allocation of subjects in each group should the study be terminated prematurely whilst also being large enough so as the next treatment cannot be guessed. The study is non-blinded. count: 90 type: ESTIMATED name: KUNWU Navigation TKA procedure name: CORI Surgical System TKA procedure name: Conventional TKA procedure measure: Post-operative leg alignment - Hip-knee-ankle axis (HKA axis) measure: Lateral View measure: Standard Radiographic Evaluation - Femoral coronal alignment (FCA) measure: Standard Radiographic Evaluation - Femoral sagittal alignment (FSA) measure: Standard Radiographic Evaluation - Femoral component rotation (FCR) measure: Standard Radiographic Evaluation - Tibial coronal alignment (TCA) measure: Standard Radiographic Evaluation - Tibial slope measure: Standard Radiographic Evaluation - Joint line distance measure: Knee Society Score (KSS) measure: Oxford Knee Score (OKS) measure: HEALTH ECONOMICS/QUALITY OF LIFE - EQ-5D-5L measure: Forgotten Joint Score (FJS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06305052 id: estimulation-taste-olfactory id: 65635922.0.0000.5201 type: OTHER domain: CAAE (Certificate of Presentation of Ethical Review) briefTitle: Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-04 date: 2024-04 date: 2024-04 date: 2024-03-12 date: 2024-03-13 name: Professor Fernando Figueira Integral Medicine Institute class: OTHER briefSummary: The objective of this clinical trial is to test the effects of olfactory and taste stimulation with milk or water in premature newborns with a gestational age between 28 and 32 weeks.

The main question researchers want to resolve is: • Does olfactory and gustatory stimulation in these newborns reduce the time spent with an oral or nasogastric feeding tube and bring forward oral feeding? Participants will be stimulated with milk or water depending on the randomly chosen group. 1: the olfactory stimulus (with smell) will be performed with a sterile cotton swab close to the nostrils immediately before feeding through the tube, 2: the gustatory stimulus (taste) will be performed with a sterile cotton swab on which a drop of milk or water will be applied on the newborn's tongue if they are awake or on their lips if they are sleeping, and is performed immediately before tube feeding. conditions: Weight, Birth conditions: Premature Birth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 63 type: ACTUAL name: Milk name: Water measure: Comparison of the period between the beginning of the intervention and enteral feeding. measure: Describe the gestational age of the newborn measure: Describe the sex of the newborn. measure: Describe the type of birth. measure: Describe the APGAR score. measure: Describe birth weight and birth weight z-score. measure: Describe head circumference at birth and head circumference z-score at birth measure: Describe birth length and birth length z-score. measure: Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h. measure: Compare the time, in days, of feeding via oral/nasal gastric tube. measure: Compare the total duration, in days, of parenteral nutrition (TPN) use. measure: Compare the type of food at discharge (natural, artificial or mixed). measure: Compare weight gain and weight Z score, at 28 days of life and at discharge from the neonatal ICU, as well as anthropometric parameters: head circumference and length with their respective Z score at discharge from the NICU. measure: Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU. measure: Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis. measure: Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours. sex: ALL minimumAge: 28 Weeks maximumAge: 32 Weeks stdAges: CHILD facility: Instituto de Medicina Integral Professor Fernando Figueira city: Recife state: Pernambuco zip: 50070-550 country: Brazil lat: -8.05389 lon: -34.88111 hasResults: False

 nctId: NCT06305039 id: 2089705 id: 1R01DC020506-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DC020506-01A1 briefTitle: Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments overallStatus: ENROLLING_BY_INVITATION date: 2023-12-19 date: 2028-05-31 date: 2028-05-31 date: 2024-03-12 date: 2024-03-12 name: University of Maryland, College Park class: OTHER name: National Institute on Deafness and Other Communication Disorders (NIDCD) name: Walter Reed National Military Medical Center name: Vanderbilt University briefSummary: Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs. conditions: Hearing Loss conditions: Hearing Loss, Sensorineural conditions: Cochlear Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 300 type: ESTIMATED name: Diagnostic tests of cochlear implant or acoustic hearing function name: Targeted aural rehabilitation of the poorer performing ear measure: Perceptual responses to sound level measure: Speech understanding in the presence of masking sounds measure: Computed-tomography scan measure: Electrode impedance (transelectrode impedance matrix) measure: Electrically evoked compound action potentials (ECAPs) measure: Sound Localization measure: Perceptual Fusion measure: Spectrotemporal ripple sensitivity sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center city: Bethesda state: Maryland zip: 20889 country: United States lat: 38.98067 lon: -77.10026 facility: University of Maryland, College Park city: College Park state: Maryland zip: 20742 country: United States lat: 38.98067 lon: -76.93692 hasResults: False

 nctId: NCT06305026 id: S-20190160 briefTitle: Protocol for a Diagnostic Test Accuracy of Histological Muscle and Skin Biopsies of Rheumatoid Arthritis Patients Revealing Objective Chronic Widespread Pain Phenomena Related to Fibromyalgia overallStatus: RECRUITING date: 2024-02-07 date: 2024-08-31 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: Hospital of South West Jutland class: OTHER name: Odense University Hospital briefSummary: Background: Chronic widespread pain is challenging in the management of the patient with rheumatoid arthritis (RA), affecting approximately one third of this patient population. However, pain is not always caused by disease activity (inflammation) but can be associated to central pain mechanisms as seen in fibromyalgia (FM). FM is characterized by widespread pain and tenderness; often accompanied by disturbed sleep, fatigue, cognitive impairment, emotional distress and multiple symptoms from various organ systems. Among patients with RA the prevalence of concomitant FM is reported to be 12-17% compared to 1-3% in the general population. In general the pain, felt by the fibromyalgia patients is considered to be due to lower pain thresholds because of abnormal central pain processing. Pain reported by RA patients with concomitant FM could potentially be explained by this phenomenon. Little is known about RA patients fulfilling criteria for FM. Muscles-studies of FM patients have not found any histopathological explanation of the pain felt, however an old study of muscle changes in RA patients found changes that could explain muscle pain. Small fiber neuropathy (SFN) is a condition associated with autoimmune diseases, and evidence suggests that SFN is likely to contribute to the pain observed in FM.

Objectives: To determine the diagnostic test accuracy (sensitivity and specificity) of both muscle- and skin-biopsies for fibromyalgia phenotyping and detection by clinical referral (RA with concomitant FM) as the reference standard (i.e. fulfilment of 2016 FM criteria).

Data collection: Will be done as study subjects are included and stored in REDCAP.

Eligibility criteria for participants and settings where the data will be collected: RA patients will be assessed in the daily clinic in Esbjerg and Odense and examined for concomitant FM (I.e. satisfying the 2016 criteria for FM). Patients will afterwards be invited to participate in the study. Inclusion will continue until 25 RA patients fulfilling FM criteria and thus based on the expected prevalence at least 25 (- and maximum 50) RA patients not fulfilling FM critieria has undergone the index tests.

Whether participants form a consecutive, random, or convenience series: Participants form a consecutive series.

Description of the index test and reference standard: Twenty-five RA patients with concomitant FM and more than 25 (- maximum 50 patients) RA patients not fulfilling FM criteria will undergo the index tests. Muscle and skin biopsies will be performed in each group using standardized techniques. The reference standard will be fulfillment of the 2016 criteria for fibromyalgia.

Estimates of diagnostic accuracy and their precision: Regarding muscle- and skin biopsies sensitivity, specificity and positive predictive value will be calculated using two times two table. Regarding skin biopsies, median values in the two groups (RA +/- FM) will be compared using a two-sample t-test. conditions: Rheumatoid Arthritis conditions: Fibromyalgia, Secondary conditions: Widespread Chronic Pain conditions: Muscle Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Muscle- and skin biopsies measure: Muscle pathology measure: Skin biopsies measure: Cold pressure test measure: Pain pressure threshold (PPT) measure: Computerized Cuff pressure algometry (CPA) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Esbjerg Hospital status: RECRUITING city: Esbjerg zip: 6700 country: Denmark name: Philip R LageHansen, MD role: CONTACT phone: +4530114582 email: philip.rask.lage-hansen3@rsyd.dk name: Philip LageHansen, MD role: PRINCIPAL_INVESTIGATOR name: Torkell Ellingsen, Professor role: PRINCIPAL_INVESTIGATOR lat: 55.47028 lon: 8.45187 hasResults: False

 nctId: NCT06305013 id: SIMU PEA 2024 briefTitle: PEA: The Ability of Nurses To Recognize It (PEA: ANTRI) acronym: PEARECOG overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-06-01 date: 2024-03-12 date: 2024-04-19 name: Brno University Hospital class: OTHER name: Department of Simulation Medicine, Faculty of Medicine, Masaryk University briefSummary: The Ability to recognize cardiac arrest is crucial in emergency situations and all health care professionals should be able to do so. The identification of pulseless electrical activity can be difficult even if the theoretical knowledge of this state is well known. This research will be performed at the Simulation centre of Medical Faculty, Masaryk university and it will be focused on nurses who will come to the simulation course. All the participants will get prelearning theoretical materials that will contain chapter about pulseless electrical activity and its recognition. In the beginning of the course they will be asked to fill up the questionnaire with four different pictures of patient´s monitor in cardiac arrest. It will be evaluated whether the pulseless electrical activity will be recognized. conditions: Pulseless Electrical Activity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Pulseless electrical activity recognition measure: Pulseless electrical activity recognition, sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty hospital Brno status: RECRUITING city: Brno state: Jihomoravský Kraj zip: 62500 country: Czechia name: Martina Kosinova, MD., Ph.D. role: CONTACT phone: 532234692 phoneExt: 00420 email: kosinova.martina@fnbrno.cz lat: 49.19522 lon: 16.60796 hasResults: False

 nctId: NCT06305000 id: 2015-KAEK-80-23-25 briefTitle: Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2025-03-10 date: 2025-05-10 date: 2024-03-12 date: 2024-03-27 name: Biruni University class: OTHER briefSummary: This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:

Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone?

Our study consists of 4 groups:

Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.

Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis. conditions: Peri-implant Mucositis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Non-surgical treatment name: Free gingival graft measure: Inflammatory parameter levels in peri-implant crevicular fluid measure: Inflammatory parameter levels in peri-implant crevicular fluid measure: Inflammatory parameter levels in peri-implant crevicular fluid measure: Inflammatory parameter levels in peri-implant crevicular fluid measure: Plaque index (Silness & Löe, 1964) measure: Plaque index (Silness & Löe, 1964) measure: Plaque index (Silness & Löe, 1964) measure: Plaque index (Silness & Löe, 1964) measure: Gingival Index ( Löe & Silness,1963) measure: Gingival Index ( Löe & Silness,1963) measure: Gingival Index ( Löe & Silness,1963) measure: Gingival Index ( Löe & Silness,1963) measure: Bleeding on probing (Ainamo & Bay 1975) measure: Bleeding on probing (Ainamo & Bay 1975) measure: Bleeding on probing (Ainamo & Bay 1975) measure: Bleeding on probing (Ainamo & Bay 1975) measure: Keratinized mucosa width measure: Keratinized mucosa width measure: Keratinized mucosa width measure: Keratinized mucosa width measure: Probing depth measure: Probing depth measure: Probing depth measure: Probing depth sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biruni University city: Istanbul country: Turkey name: Ayse E Selman role: CONTACT phone: +905366393184 email: aselman@biruni.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06304987 id: BFH-niCRT-05 briefTitle: Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-05 date: 2024-03-12 date: 2024-03-19 name: Beijing Friendship Hospital class: OTHER name: Peking Union Medical College Hospital name: Peking University Cancer Hospital & Institute name: Changhai Hospital briefSummary: This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer. conditions: Locally Advanced Rectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor Control: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor name: Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor measure: CR measure: AE rate measure: NAR score measure: OPR measure: ORR measure: immune-related adverse event rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06304974 id: BL-B01D1-305 briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-03-19 date: 2026-05 date: 2026-05 date: 2024-03-12 date: 2024-03-28 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy. conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 488 type: ESTIMATED name: BL-B01D1 name: Irinotecan name: paclitaxel name: docetaxel 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: Cmax measure: T1/2 measure: Anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing state: Beijing country: China name: Lin Shen role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06304961 id: D9180C00011 briefTitle: A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers overallStatus: RECRUITING date: 2024-04-08 date: 2024-09-05 date: 2024-09-05 date: 2024-03-12 date: 2024-04-23 name: AstraZeneca class: INDUSTRY briefSummary: The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Tozorakimab measure: Area under the concentration-time curve from time 0 to infinity (AUCinf) measure: Area under the concentration-curve from time 0 to the last quantifiable concentration (AUClast) measure: Maximum observed drug concentration (Cmax) measure: Time to reach peak or maximum observed concentration following tozorakimab administration (tmax) measure: Terminal elimination half-life (t1/2) measure: Terminal rate constant (λz) measure: Apparent total body clearance (CL/F) measure: Apparent volume of distribution based on the terminal phase (Vz/F) measure: Number of participants with adverse events (AEs) measure: Number of participants with presence of Anti-Drug Anitbodies (ADAs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Research Site status: RECRUITING city: Berlin zip: 14050 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06304948 id: Vitamin D and migraine briefTitle: The Link Between Human Cytomegalovirus Gene Expression and Glutamate Level in Migraine;Relation to Vitamin D Deficiency overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-02 date: 2024-03-12 date: 2024-03-26 name: Assiut University class: OTHER briefSummary: 1. To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks
2. To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine.
3. To correlate the serum level of glutamate with gene expression of in migraine conditions: Migraine studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 72 type: ESTIMATED measure: The Link between human cytomegalovirus gene expression and glutamate levels in Migraine :relationship to the Vit D Deficiency sex: ALL minimumAge: 15 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06304935 id: IPRF effect post tonsillectomy briefTitle: Injectable Platelet Rich Fibrin Post Tonsillectomy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-07-01 date: 2024-03-12 date: 2024-04-19 name: Assiut University class: OTHER briefSummary: To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy conditions: IPRF Post Tonsillectomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control measure: IPRF effect on healing measure: IPRF effect on post tonsillectomy pain and bleeding sex: ALL minimumAge: 5 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304922 id: BRCA 1/2 in cancer ovary briefTitle: BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-03-12 date: 2024-03-12 name: Assiut University class: OTHER briefSummary: The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer. conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer measure: Objective response rate. measure: Progression free survival measure: Overall survival and toxicity sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304909 id: 2080278 briefTitle: Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-03 date: 2025-03 date: 2024-03-12 date: 2024-04-23 name: Assiut University class: OTHER briefSummary: Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block. conditions: Trauma Injury studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 111 type: ESTIMATED name: Dexmedetomidine injection measure: The incidence of rebound pain. sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06304896 id: #18240343 briefTitle: Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy acronym: BASiC-CIC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-12-01 date: 2024-03-12 date: 2024-03-12 name: Arab Contractors Medical Centre class: OTHER briefSummary: BASiC-CIC Trial is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate whether repurposing colchicine or a combination of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins will be effective as a prophylactic treatment for the prevention of chemotherapy-induced cardiomyopathy, reduction of major adverse cardiovascular events, and all-cause mortality. conditions: Chemotherapy Induced Systolic Dysfunction studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: Carvedilol name: Ramipril name: Rosuvastatin name: Colchicine name: Placebo measure: Chemotherapy-induced cardiomyopathy measure: Chemotherapy-induced cardiomyopathy measure: Major Adverse Cardiovascular Events measure: All-Cause Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arab Contractors Medical Centre city: Cairo country: Egypt name: Eslam Abbas, MBChB, MSc role: CONTACT phone: 01023054574 phoneExt: +2 email: islam.omr@med.au.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06304883 id: ALZ-801-AD351 briefTitle: Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects acronym: APOLLOE4-LTE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-01 date: 2024-03-12 date: 2024-04-10 name: Alzheon Inc. class: INDUSTRY briefSummary: This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801. conditions: Early Alzheimer's Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a multi-center, open-label, single group, long-term extension study. primaryPurpose: TREATMENT masking: NONE count: 285 type: ESTIMATED name: Experimental: ALZ-801 measure: Primary cognitive efficacy endpoint 1 measure: Primary cognitive efficacy endpoint 2 measure: Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs) measure: Primary imaging biomarker endpoint 1 measure: Primary imaging biomarker endpoint 2 measure: Secondary functional efficacy endpoint measure: Secondary global assessment efficacy endpoint measure: Secondary cognitive efficacy endpoint 1 measure: Secondary cognitive efficacy endpoint 2 measure: Secondary cognitive efficacy endpoint 3 measure: Secondary imaging biomarker endpoint measure: Secondary fluid biomarker endpoint sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xenoscience, Inc. city: Phoenix state: Arizona zip: 85004 country: United States name: Stephen Flitman role: CONTACT phone: 602-274-9500 email: sflitman@xenoscience.com name: Stephen Flitman role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Banner Sun Health Research Institute city: Sun City state: Arizona zip: 85351 country: United States name: Michele R Gutierrez role: CONTACT phone: 623-832-5706 email: Michele.Gutierrez@bannerhealth.com name: Alireza Atri role: PRINCIPAL_INVESTIGATOR lat: 33.59754 lon: -112.27182 facility: ATP Clinical Research city: Costa Mesa state: California zip: 92626 country: United States name: Bobby Shih role: CONTACT phone: 714-277-4472 email: bshih@atpcr.com name: Gustavo Alva role: PRINCIPAL_INVESTIGATOR lat: 33.64113 lon: -117.91867 facility: Torrance Clinical Research Institute city: Lomita state: California zip: 90717 country: United States name: Valeria Herrera role: CONTACT phone: 310-373-8120 email: mraikhel@msn.com name: Marina Raikhel role: PRINCIPAL_INVESTIGATOR lat: 33.79224 lon: -118.31507 facility: Sutter Health city: Sacramento state: California zip: 95816 country: United States name: Dawn R Lenakakis role: CONTACT phone: 916-887-4734 email: Dawn.Lenakakis@sutterhealth.org name: Shawn Kile role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: Tilda Research, Inc. city: Tustin state: California zip: 92780 country: United States name: Shahrnaz Jamshidi role: CONTACT phone: 949-569-6444 email: shahrnaz.jamshidi@tilda.bio name: Erik Geiger role: PRINCIPAL_INVESTIGATOR lat: 33.74585 lon: -117.82617 facility: JEM Research Institute, Headlands Site city: Atlantis state: Florida zip: 33462 country: United States name: Mark Goldstein role: CONTACT phone: 561-968-2933 email: Mgoldstein@jemri.net name: Mark Goldstein role: PRINCIPAL_INVESTIGATOR lat: 26.5909 lon: -80.10088 facility: Bradenton Research Center city: Bradenton state: Florida zip: 34205 country: United States name: Michelle Scott role: CONTACT phone: 941-708-0005 email: michellescott@bradentonresearch.com name: Eric Folkens role: PRINCIPAL_INVESTIGATOR lat: 27.49893 lon: -82.57482 facility: Alphab Global Research city: Jupiter state: Florida zip: 33458 country: United States name: Teresa Villena role: CONTACT phone: 561-301-8286 email: t.villena@aol.com name: Gerald O'Connor role: PRINCIPAL_INVESTIGATOR lat: 26.93422 lon: -80.09421 facility: K2 Medical Research, LLC city: Maitland state: Florida zip: 32751 country: United States name: Gina Cedano role: CONTACT phone: 321-221-7806 email: Gina.Cedano@k2med.com name: Brandon Lenox role: PRINCIPAL_INVESTIGATOR lat: 28.62778 lon: -81.36312 facility: Mount Sinai Medical Center city: Miami Beach state: Florida zip: 33140 country: United States name: Mileidys Herrera role: CONTACT phone: 350-674-2121 phoneExt: 54881 email: Mileidys.herrera@msmc.com name: Ranjan Duara role: PRINCIPAL_INVESTIGATOR lat: 25.79065 lon: -80.13005 facility: Aqualane Clinical Research city: Naples state: Florida zip: 34105 country: United States name: Kelly Calistri role: CONTACT phone: 239-434-0332 email: Kelly@aqualaneresearch.com name: William Justiz role: PRINCIPAL_INVESTIGATOR lat: 26.14234 lon: -81.79596 facility: Headlands Research Orlando city: Orlando state: Florida zip: 32819 country: United States name: Jennifer Thompson role: CONTACT phone: 407-705-3471 email: jennifer.thompson@headlandsresearch.com name: Theodore Lee role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: Progressive Medical Research city: Port Orange state: Florida zip: 32127 country: United States name: Chantelle Funge role: CONTACT phone: 386-304-7070 phoneExt: 3205 email: chantellef@progressivemedicalresearch.com name: Alexander White role: PRINCIPAL_INVESTIGATOR lat: 29.13832 lon: -80.99561 facility: ALZ Research and Treatment Center (A.R.T.C.) city: Stuart state: Florida zip: 34997 country: United States name: David Watson role: CONTACT phone: 772-675-0000 email: dwatson@researchalz.com name: David Watson role: PRINCIPAL_INVESTIGATOR lat: 27.19755 lon: -80.25283 facility: ALZ Research and Treatment Center (A.R.T.C.) city: Wellington state: Florida zip: 33414 country: United States name: David Watson role: CONTACT phone: 561-209-2400 email: dwatson@researchalz.com name: David Watson role: PRINCIPAL_INVESTIGATOR lat: 26.65868 lon: -80.24144 facility: Premiere Research Institute city: West Palm Beach state: Florida zip: 33407 country: United States name: Paul Winner role: CONTACT phone: 561-845-0500 phoneExt: 102 email: Pwinner777@aol.com name: Paul Winner role: PRINCIPAL_INVESTIGATOR lat: 26.71534 lon: -80.05337 facility: Charter Research city: Winter Park state: Florida zip: 32792 country: United States name: Celynez Gomez role: CONTACT phone: 407-337-1000 phoneExt: 3001 email: celynez.gomez@charterresearch.com name: Edgardo J Rivera role: PRINCIPAL_INVESTIGATOR lat: 28.6 lon: -81.33924 facility: Columbus Memory Center city: Columbus state: Georgia zip: 31909 country: United States name: Jonathan Liss role: CONTACT phone: 706-653-8455 email: jliss@researchcmc.com name: Jonathan Liss role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: Fort Wayne Neurological Center city: Fort Wayne state: Indiana zip: 46804 country: United States name: Patti Case role: CONTACT phone: 260-436-3991 phoneExt: 2202 email: pcase@fwnc.com name: James Stevens role: PRINCIPAL_INVESTIGATOR lat: 41.1306 lon: -85.12886 facility: Headlands Research Eastern MA city: Plymouth state: Massachusetts zip: 02360 country: United States name: Brandon Hatch role: CONTACT phone: 508-746-5060 email: brandon.hatch@headlandsresearcheema.com name: Donald Marks role: PRINCIPAL_INVESTIGATOR lat: 41.95844 lon: -70.66726 facility: Advanced Memory Research Center city: Toms River state: New Jersey zip: 08755 country: United States name: Anna Brocco role: CONTACT phone: 732-341-9500 email: ABrocco@amrinj.com name: Sanjiv Sharma role: PRINCIPAL_INVESTIGATOR lat: 39.95373 lon: -74.19792 facility: Neurological Associates of Albany city: Albany state: New York zip: 12208 country: United States name: Richard Holub role: CONTACT phone: 518-426-0575 email: research@naaresearch.com name: Richard Holub role: PRINCIPAL_INVESTIGATOR lat: 42.65258 lon: -73.75623 facility: NYU Alzheimer's Disease Research Center city: New York state: New York zip: 10016 country: United States name: Brittany Marti role: CONTACT phone: 212-263-5708 email: Brittany.Marti@nyulangone.org name: Thomas Wisniewski role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Kline Institute for Psychiatric Research city: Orangeburg state: New York zip: 10962 country: United States name: Nunzio Pomara role: CONTACT phone: 845-398-5579 email: Nunzio.Pomara@nki.rfmh.org name: Nunzio Pomara role: PRINCIPAL_INVESTIGATOR lat: 41.04649 lon: -73.94958 facility: University of Rochester Medical Center city: Rochester state: New York zip: 14620 country: United States name: Nancy A Kowalski role: CONTACT phone: 585-602-5205 email: Nancy_Kowalski@urmc.rochester.edu name: Emily Clark role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: Triad Clinical Trials city: Greensboro state: North Carolina zip: 27410 country: United States name: Scott Whitt role: CONTACT phone: 336-235-0991 email: swhitt@triadclinicaltrials.com name: Richard Montgomery role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: AMC Research city: Matthews state: North Carolina zip: 28105 country: United States name: Shereen Bolouri role: CONTACT phone: 704-364-4000 phoneExt: 235 email: ssbolouri@amcneurology.com name: Mohammad R Bolouri role: PRINCIPAL_INVESTIGATOR lat: 35.11681 lon: -80.72368 facility: Center for Cognitive Health city: Portland state: Oregon zip: 97225 country: United States name: Ericka Eyton role: CONTACT phone: 503-548-0908 email: ericka@centerforcognitivehealth.com name: Michael Mega role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Abington Neurological Associates city: Abington state: Pennsylvania zip: 19001 country: United States name: Kareema Murray role: CONTACT phone: 215-957-9250 email: kareemamurray.ana@gmail.com name: David Weisman role: PRINCIPAL_INVESTIGATOR lat: 40.12067 lon: -75.11795 facility: Rhode Island Mood & Memory Research Institute city: East Providence state: Rhode Island zip: 02914 country: United States name: Lynn Rainville role: CONTACT phone: 401-435-8950 email: lrainville@rimmri.com name: John Stoukides role: PRINCIPAL_INVESTIGATOR lat: 41.81371 lon: -71.37005 facility: UT Health Science Center at Houston city: Houston state: Texas zip: 77054 country: United States name: Alexa Bavero role: CONTACT phone: 713-486-0501 email: Alexa.Bavero@uth.tmc.edu name: Paul Schulz role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Re:Cognition Health city: Fairfax state: Virginia zip: 22031 country: United States name: Maria Toor role: CONTACT phone: 703-520-9703 email: mtoor@re-cognitionhealth.com name: Raymond S Turner role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 facility: Northwest Clinical Research Center city: Bellevue state: Washington zip: 98007 country: United States name: Arifulla Khan role: CONTACT phone: 425-453-0404 email: study.coordinator@nwcrc.net name: Arifulla Khan role: PRINCIPAL_INVESTIGATOR lat: 47.61038 lon: -122.20068 facility: OCT Research ULC (dba Okanagan Clinical Trials) city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada name: Robert Goldberg role: CONTACT phone: 250-862-8141 email: Robert@oktrials.ca name: Eugene Okorie role: PRINCIPAL_INVESTIGATOR lat: 49.88307 lon: -119.48568 facility: Centricity Research city: Halifax state: Nova Scotia zip: B3S 1N2 country: Canada name: Gagan Oberoi role: CONTACT phone: 902-431-8783 phoneExt: 7107 email: Gagan.oberoi@centricityresearch.com name: Fred Archibald role: PRINCIPAL_INVESTIGATOR lat: 44.64533 lon: -63.57239 facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic city: Ottawa state: Ontario zip: K1Z 1G3 country: Canada name: Richard Bergeron role: CONTACT phone: 613-702-1000 email: rbergeron@cliniquememoire.ca name: Richard Bergeron role: PRINCIPAL_INVESTIGATOR lat: 45.41117 lon: -75.69812 facility: Kawartha Centre - Redefining Healthy Aging city: Peterborough state: Ontario zip: K9H 2P4 country: Canada name: Jill MacPhee role: CONTACT phone: 705-749-3906 phoneExt: 213 email: jill@kawarthacentre.com name: Katie Krause role: PRINCIPAL_INVESTIGATOR lat: 44.30012 lon: -78.31623 facility: Toronto Memory Program city: Toronto state: Ontario zip: M3B 2S7 country: Canada name: Justine Reaume role: CONTACT phone: 416-386-9761 phoneExt: 364 email: jreaume@memorydisorders.ca name: Sharon Cohen role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Re-Cognition Health Ltd Plymouth city: Plymouth state: Devon zip: PL6 8BT country: United Kingdom name: Victoria Evans role: CONTACT phone: +44 1752875604 email: vevans@re-cognitionhealth.com name: Stephen Pearson role: PRINCIPAL_INVESTIGATOR lat: 50.37153 lon: -4.14305 facility: Re-Cognition Health Ltd London city: London state: Greater London zip: W1G 9JF country: United Kingdom name: Josephine E MacSweeney role: CONTACT phone: +44 2033553536 email: emacsweeney@re-cognitionhealth.com name: Josephine E MacSweeney role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: NeuroClin Glasgow Ltd city: Motherwell state: North Lanarkshire zip: ML1 4UF country: United Kingdom name: Jennifer Lynch role: CONTACT phone: +44 1419480206 email: jennifer.lynch@neuroclin.co.uk name: Jennifer Lynch role: PRINCIPAL_INVESTIGATOR lat: 55.78924 lon: -3.99187 facility: Re-Cognition Health Ltd Guildford city: Guildford state: Surrey zip: GU2 7YD country: United Kingdom name: Nicholas Mannering role: CONTACT phone: +44 1483941982 email: NMannering@re-cognitionhealth.com name: Nicholas Mannering role: PRINCIPAL_INVESTIGATOR lat: 51.23536 lon: -0.57427 facility: Re-Cognition Health Ltd Birmingham city: Birmingham state: West Midlands zip: B16 8LT country: United Kingdom name: Conor Clerkin-Oliver role: CONTACT phone: +44 1216550166 email: cclerkin@re-cognitionhealth.com name: Conor Clerkin-Oliver role: PRINCIPAL_INVESTIGATOR lat: 52.48142 lon: -1.89983 facility: Re-Cognition Health Ltd Bristol city: Bristol zip: BS32 4SY country: United Kingdom name: Daniel Lashley role: CONTACT phone: +44 1174623600 email: dlashley@re-cognitionhealth.com name: Daniel Lashley role: PRINCIPAL_INVESTIGATOR lat: 51.45523 lon: -2.59665 facility: Re-Cognition Health Ltd Winchester city: Winchester zip: SO21 1HU country: United Kingdom name: Anna Podonyi role: CONTACT phone: +44 1962588420 email: apodonyi@re-cognitionhealth.com name: Steven J Allder role: PRINCIPAL_INVESTIGATOR lat: 51.06513 lon: -1.3187 hasResults: False

 nctId: NCT06304870 id: SYB-reflux briefTitle: Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Lidocaine name: Injection measure: Rosenbek penetration-aspiration scale measure: Gastroesophageal Reflux Disease Questionnaire measure: Pressure pain threshold sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304857 id: 2022/ABM/01/00039 id: 2023-506631-15-00 type: OTHER domain: EUCT briefTitle: CardioPROTECTion With Dapagliflozin in Breast Cancer Patients Treated With AnthrAcycline - PROTECTAA TRIAL acronym: PROTECTAA overallStatus: RECRUITING date: 2024-04-15 date: 2026-12-31 date: 2027-12-31 date: 2024-03-12 date: 2024-04-25 name: 4th Military Clinical Hospital with Polyclinic, Poland class: OTHER briefSummary: The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment. conditions: Breast Cancer conditions: Heart Failure studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 188 type: ESTIMATED name: Dapagliflozin name: Placebo measure: Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months. measure: Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months. measure: Change in left ventricular ejection fraction at 6 and 12 months. measure: Change in left ventricular diastolic function at 6 and 12 months. measure: Change in Troponin I after 6 and 12 months. measure: Change in NTproBNP levels at 6 and 12 months. measure: Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire. measure: Occurrence of death from any cause. measure: Composite endpoint of cardiovascular events. measure: Occurrence of death from any cardiovascular reasons. measure: Occurrence of non-fatal myocardial infarction. measure: Occurrence of non-fatal stroke. measure: Occurrence of hypoglycaemia. measure: Occurrence of ionic disorders. measure: Occurrence of renal failure. measure: Occurrence of hypersensitivity to investigated drug. measure: Occurrence of allergic reactions. measure: Occurrence of infection. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 4th Military Clinical Hospital with Polyclinic status: RECRUITING city: Wrocław state: Dolnośląskie zip: 50-981 country: Poland name: Bartosz Krakowiak, PhD, MD role: CONTACT phone: +48 261 660 234 email: bkrakowiak@4wsk.pl lat: 51.1 lon: 17.03333 facility: Lower Silesian Centre for Oncology, Lung Diseases and Hematology status: RECRUITING city: Wrocław state: Dolnośląskie zip: 53-413 country: Poland name: Rafał Matkowski, PhD, MD role: CONTACT lat: 51.1 lon: 17.03333 facility: Military Medical Institute status: NOT_YET_RECRUITING city: Warsaw state: Mazowieckie zip: 04-141 country: Poland name: Paweł Krzesiński, PhD, MD role: CONTACT lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06304844 id: Soh-Med-24-02-06MD briefTitle: Risk of CKD in Diabetic Patients With MAFLD overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-10-01 date: 2025-02-01 date: 2024-03-12 date: 2024-03-18 name: Sohag University class: OTHER briefSummary: This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions. conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: transient elastography (Fibroscan) measure: Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304831 id: SwissTI briefTitle: Use of Facility Ratings to Improve Satisfaction With Heath Care for Children overallStatus: RECRUITING date: 2024-03-11 date: 2024-06-14 date: 2024-09-06 date: 2024-03-12 date: 2024-04-11 name: Swiss Tropical & Public Health Institute class: OTHER name: Lao Tropical and Public Health Institute briefSummary: Despite increasing options for public and private health care providers in Laos, choosing a high-quality health provider or a facility is difficult because timely and reliable information about providers is not readily available. People rely on social networks or previous experiences to select providers. However, in Laos, only 28% describe their recent visit to a health care provider as high-quality suggesting that while there are increasing options for care, people may need support to find providers that meet their quality needs. Rapid adoption of mobile phones in Laos, particularly in urban areas, offer opportunities to enhance people's access to timely quality information about health care providers. The study team will use mobile phones to collect and disseminate quality information about providers - known to be valued by Laotians - to improve their access to quality care as well as their overall satisfaction with care. conditions: Quality of Health Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: This study consists of a randomized controlled experiment involving 660 mothers with children less than 2 years old. Participants will be randomly assigned to one of two groups: 1) a control group that will not receive any information about providers and 2) an intervention group that will receive biweekly updates about quality ratings based on reviews collected from mothers of young children in the study areas. The unit of randomization will be the individual participant. A simple random number draw generated by the ODK package installed on the tablets will be used to assign participants to treatment and control with equal probability. primaryPurpose: OTHER masking: NONE count: 660 type: ESTIMATED name: Quality ratings of health care providers for children measure: Proportion of mothers that change their preferred health care providers for children for non-urgent care measure: Proportion of mothers satisfied with health care for their children of their most recent visit measure: Number and type of health care providers used in the past 3 months measure: Proportion of mothers that change their most recently visited health care providers for children measure: Proportion of mothers choosing the preferred facility for non-urgent care because of online or digital information sources measure: Proportion of mothers that change their preferred health care providers for children for urgent care measure: Proportion of mothers confident they can identify the best place for getting care for sick children sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lao Tropical and Public Health Institute status: RECRUITING city: Vientiane state: Vientiane Capital country: Lao People's Democratic Republic name: Dr Somphou Sayasane, PhD role: CONTACT phone: +856 20 55 679 60 email: somphou.sayasone@gmail.com lat: 17.96667 lon: 102.6 hasResults: False

 nctId: NCT06304818 id: SCTB14-X101 briefTitle: Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours. overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-12-30 date: 2028-12-30 date: 2024-03-12 date: 2024-03-15 name: Sinocelltech Ltd. class: INDUSTRY briefSummary: This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial. conditions: Advanced Malignant Solid Tumours studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 515 type: ESTIMATED name: SCTB14 measure: Dose-Limiting toxicity(DLT) measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304805 id: TGRX-326-1002 briefTitle: TGRX-326 Phase I/II Pharmacokinetic Study overallStatus: COMPLETED date: 2023-12-13 date: 2024-01-12 date: 2024-01-19 date: 2024-03-12 date: 2024-04-10 name: Shenzhen TargetRx, Inc. class: INDUSTRY name: First Affiliated Hospital Bengbu Medical College briefSummary: A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is a PK assessment study, hence only bio-sample analysis personnel were masked for the type of treatment received for each sample to avoid bias in analysis. Other study personnel, including participants, investigators and staffs were not masked for treatment types. whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: cycle 1: treatment drug name: cycle 1: reference drug name: cycle 1: fasted name: cycle 1: food name: cycle 2: treatment drug name: cycle 2: reference drug name: cycle 2: fasted name: cycle 2: food name: cycle 3: treatment drug name: cycle 3: reference drug name: cycle 3: fasted name: cycle 3: food measure: Plasma Cmax measure: Plasma AUC(0-t) measure: Plasma AUC(0-inf) measure: Plasma Tmax measure: terminal elimination rate constant (lambda-z) measure: Elimination half-life (T1/2-Z) measure: AUC(%Extrap) measure: Plasma volume of distribution (Vz/F) measure: Plasma clearance (CL/F) measure: Adverse events/serious adverse events sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: First Affiliated Hospital Bengbu Medical College city: Bengbu state: Anhui zip: 233004 country: China lat: 32.94083 lon: 117.36083 hasResults: False

 nctId: NCT06304792 id: H-22030591 briefTitle: Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer overallStatus: RECRUITING date: 2024-02-01 date: 2028-08-01 date: 2028-08-01 date: 2024-03-12 date: 2024-03-12 name: Rigshospitalet, Denmark class: OTHER briefSummary: The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval (immediate) is non-inferior to single blastocyst transfer in a subsequent cycle (postponed) in stimulated or programmed cycle frozen embryo transfer (FET). The primary outcome is live birth rate. conditions: Infertility conditions: IVF studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 464 type: ESTIMATED name: Immediate FET in a stimulated or programmed cycle measure: Live birth rate measure: Live birth rate per blastocyst transfer measure: Ongoing pregnancy rate measure: Miscarriage rate measure: Cancelled cycle rate and reason for cancelled cycles measure: Endocrinology of the luteal phase measure: Number of ovarian follicular structures >10 mm measure: Time-to-pregnancy measure: Time-to-live-birth measure: Pregnancy related complications measure: Neonatal outcomes (weight in kilograms) measure: Neonatal outcomes (length in cm) measure: Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum) measure: Quality of life based on the Copenhagen Multicenter Psychosocial Infertility (COMPI) stress scale questionnaires sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Fertility Departmen, Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Anja B. Pinborg, Prof., DMSC role: CONTACT phone: 0045 35 45 64 30 email: anja.bisgaard.pinborg@regionh.dk name: Clara Colombo, MD role: CONTACT email: clara.colombo@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06304779 id: V3.0.2023.11.29 briefTitle: The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-31 date: 2025-09-30 date: 2026-06-30 date: 2024-03-12 date: 2024-03-12 name: Shanghai Zhongshan Hospital class: OTHER name: Tianjin Medical University General Hospital name: The Affiliated Hospital of Xuzhou Medical University name: West China Hospital briefSummary: The main purpose of this study is to evaluate the impact of continuous 24-hour intravenous infusion of lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for intra-abdominal infection (IAI).The secondary objectives of this study are to assess the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, length of hospital stay, and outcomes within 30 days postoperatively. conditions: Postoperative Pulmonary Complications conditions: Intra-abdominal Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Lidocaine group: Patients receive a loading dose of 1.5 mg/kg 2% lidocaine at anesthesia induction, followed by continuous intravenous infusion at 1.5 mg/kg/h until 24 hours postoperatively Control group: Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 428 type: ESTIMATED name: Lidocaine name: Placebo measure: The impact of continuous 24-hour intravenous lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for IAI. measure: the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period measure: To observe the impact of continuous perioperative lidocaine infusion on the levels of neutrophil extracellular traps (NETs) postoperatively sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital,Fudan university city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06304766 id: H-23015954 briefTitle: Open Versus Laparoscopic Ablation of Liver Malignancies acronym: OPTIMAL overallStatus: RECRUITING date: 2023-12-15 date: 2025-12 date: 2025-12 date: 2024-03-12 date: 2024-03-13 name: Rigshospitalet, Denmark class: OTHER briefSummary: The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery. conditions: Hepatocellular Carcinoma conditions: Cholangiocarcinoma conditions: Liver Metastases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment. primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Laparoscopic ablation name: Open ablation measure: Complications measured by the comprehensive complication index. measure: Tumor ablation completeness. measure: Quality of Recovery score (QoR) measure: Quality of Life score (QoL) measure: Overall survival sex: ALL minimumAge: 18 Years 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 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-01 uploadDate: 2023-10-06T05:58 filename: Prot_SAP_000.pdf size: 192543 hasResults: False

 nctId: NCT06304753 id: BOT119435 briefTitle: ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction acronym: BOT-IMPROVE-HF overallStatus: RECRUITING date: 2023-10-27 date: 2025-07-01 date: 2025-12-01 date: 2024-03-12 date: 2024-03-12 name: I.M. Sechenov First Moscow State Medical University class: OTHER briefSummary: BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes. conditions: Chronic Heart Failure With Low Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Telebot measure: All-cause mortality measure: Heart failure decompensation measure: Change in NT-proBNP measure: Change in Quality of life measure: Changes in medical adherence sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University status: RECRUITING city: Moscow zip: 119435 country: Russian Federation name: Maria Kozhevnikova role: CONTACT phone: +7 (499) 248-46-43 email: kozhevnikova_m_v@staff.sechenov.ru name: Aleksei Emelianov role: CONTACT phone: +7 (999) 830-57-85 email: emelyanov_a_v@staff.sechenov.ru lat: 55.75222 lon: 37.61556 facility: State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow". status: RECRUITING city: Moscow zip: 129327 country: Russian Federation name: Maria Kozhevnikova role: CONTACT phone: +74992484643 email: kozhevnikova_m_v@staff.sechenov.ru name: Aleksei Emelianov role: CONTACT phone: +79998305785 email: emelyanov_a_v@staff.sechenov.ru lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06304740 id: IMG-007-102 briefTitle: Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants overallStatus: RECRUITING date: 2024-03-06 date: 2024-09 date: 2024-09 date: 2024-03-12 date: 2024-03-22 name: Inmagene LLC class: INDUSTRY briefSummary: This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: IMG-007 name: Placebo measure: Adverse Event Evaluation measure: Pharmacokinetic Parameters, Cmax measure: Pharmacokinetic Parameters, Tmax measure: Pharmacokinetic Parameters, AUC0-t sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Linear Clinical Research status: RECRUITING city: Perth country: Australia lat: -31.95224 lon: 115.8614 hasResults: False

 nctId: NCT06304727 id: 23-5064 id: Easydore type: OTHER domain: 69HCL23_0736 briefTitle: Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment acronym: 1TreSBCD overallStatus: RECRUITING date: 2022-11-21 date: 2024-06-01 date: 2024-06-30 date: 2024-03-12 date: 2024-03-12 name: Hospices Civils de Lyon class: OTHER briefSummary: The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.

A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.

A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management. conditions: Bronchiolitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: clinical data review measure: Feasibility of the short enteral feeding protocol sex: ALL minimumAge: 8 Weeks maximumAge: 1 Year stdAges: CHILD facility: Hopital Femme Mere Enfant status: RECRUITING city: Bron country: France name: Dominique PLOIN, MD role: CONTACT phone: 0427855642 phoneExt: +33 email: dominique.ploin@chu-lyon.fr name: Côme HORVAT, MD role: CONTACT phone: 0427855634 phoneExt: +33 email: come.horvat@chu-lyon.fr lat: 45.73333 lon: 4.91667 hasResults: False

 nctId: NCT06304714 id: 20_RIPH3-16 id: 2022-A00162-41 type: OTHER domain: ANSM (National Agency for the Safety of Medicines and other health products ) briefTitle: Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana acronym: WBOTHROPS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-08 date: 2025-10-08 date: 2024-03-12 date: 2024-03-12 name: University Hospital Center of Martinique class: OTHER name: University Hospital, Lille briefSummary: In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.

Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.

The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.

The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.

This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients. conditions: Snake Envenomation conditions: Thrombi conditions: Coagulopathy conditions: Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Patients suffering from envenomation by Bothrops measure: Plasma Willebrand factor (VW:Act) activity prior to administration of the anti-venom (Bothrofav® or Antivipmyn-tri®). measure: Plasma VW factor activity (VW:Act/VW:Ag ratio) measure: Hemostasis abnormalities measure: Plasma levels of high-molecular-weight VW factor multimers assessed by electrophoresis technique measure: Plasma concentrations of soluble forms of the endothelial adhesion molecules sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304701 id: PI-2023-08 briefTitle: Handwritten Text Production in Adults With Autism acronym: PEMTAA overallStatus: RECRUITING date: 2023-11-29 date: 2025-05 date: 2025-05 date: 2024-03-12 date: 2024-03-12 name: Centre Hospitalier de Niort class: OTHER name: University of Poitiers briefSummary: The main objective is to assess the psycholinguistic and graphomotor characteristics of written production in patients with ASD.

The secondary objectives are:

* Identifying links between specific deficits of ASD and difficulties in written production.
* Identifying links between the severity of ASD and difficulties in written production.

The primary evaluation criterion is the quantity of written production, namely the number of words produced in 5 minutes on a text copying task (BHK) and in 15 minutes on each of the two written production tasks (descriptive and persuasive).

The secondary evaluation criteria are:

* Graphomotor indicators of written production (writing speed, pre-writing time, pause time, writing time, handwriting size, results obtained in BHK (number of words produced, letter height, line parallelism, telescoping, ambiguous letters).
* Cognitive and psycholinguistic indicators of written production (presence of titles, presence of paragraphs, number of sentences, number of words per sentence, lexical richness, lexical field, number of action verbs, morphological complexity, number of syntactic markers related to oneself, number of syntactic markers related to others, number of spelling errors, evaluation of the overall quality of the produced text).
* Results obtained in tests (writing habits questionnaire, Autism Diagnostic Observation Scale (second edition), Wechsler Adult Intelligence Scale (fourth edition) - Similarities subtest, Wechsler Adult Intelligence Scale (fourth edition) - Vocabulary subtest, Rey Figure, MASC). conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is part of category 2 of research involving humans and which corresponds to an interventional study with minimal risks and constraints. The patient is asked to return to carry out this study. primaryPurpose: DIAGNOSTIC masking: NONE count: 38 type: ESTIMATED name: Cognitive and writing tests measure: Assessment of psycholinguistic and graphomotor characteristics of written production in patients with autism spectrum disorder (asd) measure: Identifying links between specific deficits of ASD and difficulties in written production measure: Identifying links between the severity of ASD and difficulties in written production sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Niort status: RECRUITING city: Niort zip: 79000 country: France name: Diane D Chuillet-Moreau, Mrs role: CONTACT phone: +33549782049 email: diane.chuillet-moreau@ch-niort.fr lat: 46.32313 lon: -0.45877 hasResults: False

 nctId: NCT06304688 id: University of Jaén_24 briefTitle: Yoga and Diet on Cognitive, Nutritional Status, Mental and Functional Abilities in Older Adults overallStatus: COMPLETED date: 2023-11-13 date: 2024-02-05 date: 2024-02-12 date: 2024-03-12 date: 2024-04-04 name: University of Jaén class: OTHER briefSummary: Yoga has emerged as a powerful therapeutic practice for enhancing physical and mental health across all age groups, including older adults and younger individuals. For seniors, yoga aids in maintaining flexibility, muscle strength, balance, and posture, thereby reducing the risk of falls and injuries. It also alleviates chronic pain, enhances sleep quality, and mitigates stress and anxiety, contributing to improved overall mental and emotional well-being in this demographic. As individuals age, they undergo physical and mental changes that impact their quality of life. Yoga offers tailored benefits for older adults by preserving joint mobility and flexibility, lowering the risk of falls, and easing chronic pain associated with conditions like arthritis and osteoporosis. Moreover, it fosters stress reduction, anxiety relief, and depression mitigation, fostering emotional equilibrium. The practice of yoga from a young age yields numerous advantages for both physical and mental health, including enhanced concentration, attention, and memory-beneficial qualities for university students. Moreover, yoga aids in stress and anxiety reduction, fosters positive body image, and bolsters self-esteem, contributing to vitality and active aging. Yoga is efficacious in enhancing quality of life and facilitating healthy aging by offering adaptable, gentle exercise that caters to individual needs and limitations. Its mindfulness and body awareness aspects foster a stronger mind-body connection, fostering overall well-being and balance. With its adaptability and accessibility, yoga transcends socioeconomic barriers and physical conditions, making it a viable option for people of all backgrounds. In a society marked by rising stress and lifestyle-related ailments, yoga emerges as an invaluable therapeutic avenue for promoting health and well-being. Its holistic approach and adaptability to individual needs make it an appealing option for individuals seeking sustainable improvements in physical and mental health. Thus, the integration and promotion of yoga as a therapeutic modality in health and wellness domains are warranted. Also, Nutrition plays a fundamental role in the health and well-being of individuals at all stages of life, but it is especially crucial in old age due to the physiological and metabolic changes that occur during the aging process. Maintaining a healthy and balanced diet is essential for providing the necessary nutrients for proper body function, strengthening the immune system, and maintaining the health of bone and cardiovascular structures. Specifically, the Mediterranean diet is a traditional dietary pattern based on foods commonly consumed in Mediterranean regions such as Greece, Italy, and Spain. It is characterized by high consumption of fruits, vegetables, legumes, nuts, whole grains, fish, and olive oil, along with moderate intake of dairy and red wine, and limited con-sumption of red meat and processed products. This eating style has been the subject of numerous scientific studies highlighting its multiple health benefits. Apart from the physical health benefits for older adults, the Mediterranean diet has consistently been associated with positive effects such as reduced risk of cardiovascular pathologies, de-creased chronic diseases and pro-inflammatory factors, as well as contributing to the prevention of obesity and cognitive decline. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 125 type: ACTUAL name: Yoga and Mediterranean Diet intervention measure: TMT (Trail Making Test) measure: SFT (Senior Fitness Test) measure: Handgrip Strength measure: Mindful Attention Awareness Scale (MAAS) measure: Digit symbol substitution test (DSST) measure: D2 test measure: Isaac test measure: Anxiety and Depression measure: Sleep quality measure: Balance measure: Nutritional status sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Agustín Aibar Almazán city: Jaén zip: 23007 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False

 nctId: NCT06304675 id: 905055423985 briefTitle: Manageable Environmental Factors in Migraine overallStatus: COMPLETED date: 2023-09-30 date: 2024-02-15 date: 2024-03-04 date: 2024-03-12 date: 2024-03-12 name: Samsun University class: OTHER briefSummary: There is limited and insufficient information on the effects of inappropriate living environments, exposure to allergens, electromagnetic fields and stress factors on the chronicity of migraine. The aim of this study is to investigate the frequency of environmental variables/triggers in episodic and chronic migraine patients and their relationship with clinical variables in the chronic migraine group. The results obtained will be shared not only in the scientific community, but also on workplace health and employer-related platforms, including "Wellbeing" groups. conditions: Migraine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ACTUAL name: no intervention measure: 1. Environmental factors/triggers affecting the chronicity of migraine measure: 2.Environmental factors/triggers and migraine treatment sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsun University city: Samsun zip: 55100 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06304662 id: *University of Jaén briefTitle: Yoga for Physical and Mental Health overallStatus: COMPLETED date: 2023-11-13 date: 2024-02-09 date: 2024-02-19 date: 2024-03-12 date: 2024-03-26 name: University of Jaén class: OTHER briefSummary: In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future. conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 142 type: ACTUAL name: Yoga intervention measure: D2 test measure: Mindful Attention Awareness Scale (MAAS) measure: Handgrip Strength measure: Anxiety and Depression measure: Sleep quality measure: Stress level measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) measure: State Anxiety Inventory (STAI) measure: Attentional Control: Shifting and Distraction (AC-S and AC-D) measure: Positive and Negative Affect Schedule measure: Difficulties in Emotion Regulation Scale (DERS) sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Agustín Aibar Almazán city: Jaén zip: 23007 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False

 nctId: NCT06304649 id: Cast21CHLA2023Study1SAP briefTitle: Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures acronym: Cast21 SAP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: Cast21 class: INDUSTRY briefSummary: The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.

A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product. conditions: Fractures, Closed conditions: Fractures Bone conditions: Fracture conditions: Fractures conditions: Radius; Fracture, Lower or Distal End conditions: Ulna Fractures conditions: Radius Distal Fracture studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Cast or brace alternative measure: Clinical determination of healing (standard of care) measure: Range of Motion (standard of care) measure: Patient Reported Outcomes - Pain measure: Patient Reported Outcomes - Satisfaction measure: Physical Therapy Referral sex: ALL minimumAge: 3 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06304636 id: DC15-MM-01 briefTitle: Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma acronym: DC15-MM-01 overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-01 date: 2027-10-01 date: 2024-03-12 date: 2024-03-12 name: Cartesian Therapeutics class: INDUSTRY briefSummary: This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15 conditions: Refractory Multiple Myeloma conditions: Relapsed Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms. primaryPurpose: TREATMENT masking: NONE count: 41 type: ESTIMATED name: Descartes-15 measure: Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM) measure: To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Cancer and Blood Disorders (AON) status: RECRUITING city: Bethesda state: Maryland zip: 20817 country: United States lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06304623 id: CIRE.112 briefTitle: SVF for Treating Pulmonary Fibrosis Post COVID-19 acronym: SVFCOVID-19 overallStatus: COMPLETED date: 2020-05-05 date: 2024-03-01 date: 2024-03-01 date: 2024-03-12 date: 2024-03-12 name: Michael H Carstens class: OTHER name: Ministerio de Salud de Nicaragua name: Wake Forest University name: National Autonomous University of Nicaragua briefSummary: General description of the study

This is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF.

Primary objective

The purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19.

Secondary objective

To evaluate the efficacy of the initial treatment with SVF IV. conditions: Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Autologous adipose-derived SVF IV administration measure: Safety of treatment with SVF IV measure: Efficacy of the initial treatment with SVF IV measure: Effectiveness of the initial treatment with SVF IV sex: ALL minimumAge: 18 Years maximumAge: 85 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: NCT06304610 id: ONZ-2024-0044 briefTitle: Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador acronym: ELEVATE-Pilot overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-28 name: University Hospital, Ghent class: OTHER name: Horizon 2020 - European Commission name: Universidad de Cuenca briefSummary: ELEVATE is a six-year project, conducted by an international research alliance led by Ghent University, aiming to develop a new test and approach for cervical cancer screening in hard-to-reach populations.

In this final stage of the project, a hospital-based validation study is deployed in Belgium and Ecuador to clinically validate the new ELEVATE screening test based on self-samples and endocervical samples. The simultaneous detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer.

At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear result will be recruited in the colposcopy waiting room. After registration and signing the informed consent form, each woman will be asked to fill out a short self-administered questionnaire for socio-demographic information. Each woman will provide a self-sample as well as an endocervical sample before the colposcopy examination. Both samples of all 200 women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE screening test, using 400 ELEVATE cartridges, as well as with standard tests.

Besides analyzing all samples on the new ELEVATE screening test, the following standard tests will also be performed on all samples (at Ghent University - including the shipped samples of Ecuador):

* AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test
* ELISA protein detection: only available comparison test

In order to generate HPV DNA results locally, that can be communicated to the participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results after shipment to Belgium), in Ecuador the following additional standard test will be performed on the100 endocervical samples (before shipment to Belgium):

• HPV DNA Mole Bioscience test

Concordance between the test results of the ELEVATE screening test and standard lab tests on both type of samples will be defined, for HPV DNA as well as protein detection. Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of the ELEVATE screening test will be defined, according to clinically relevant outcomes. conditions: Cervical Cancer conditions: HPV Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: all participants receive the same tests primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Questionnaire name: HPV self-sample name: Endocervical sample measure: Clinical validation measure: Concordance measure: HPV DNA test validation measure: Protein test validation sex: FEMALE minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent University Hospital city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Steven Weyers, MD,PhD,Prof role: CONTACT phone: 09 332 37 83 email: steven.weyers@uzgent.be name: Philippe Tummers, MD,PhD,Prof role: CONTACT phone: 09 332 37 83 email: philippe.tummers@uzgent.be name: Philippe Tummers, MD,PhD,Prof role: PRINCIPAL_INVESTIGATOR name: Heleen Vermandere, PhD role: SUB_INVESTIGATOR name: Marie Hendrickx, MSC role: SUB_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: SOLCA University Hospital city: Cuenca country: Ecuador name: Bernardo José Vega Crespo role: CONTACT phone: 0998276441 email: bernardo.vegac@ucuenca.edu.ec name: Bernardo José Vega Crespo role: PRINCIPAL_INVESTIGATOR name: Dayanara Delgado role: SUB_INVESTIGATOR name: Vivian Alejandra Neira Molina role: SUB_INVESTIGATOR lat: -2.90055 lon: -79.00453 hasResults: False

 nctId: NCT06304597 id: 17651 briefTitle: Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy acronym: PREDICT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-06-01 date: 2024-03-12 date: 2024-03-12 name: University Medical Center Groningen class: OTHER briefSummary: Colorectal cancer (CRC) claims 10% of global cancer-related deaths annually, with rising incidence. Locally advanced rectal cancer (LARC) requires improved diagnostic techniques. This study focuses on dual-wavelength quantitative fluorescence molecular endoscopy (qFME) using PD-1/PD-L1-targeted tracers for LARC patients undergoing neoadjuvant treatment. Eighteen patients will receive nivolumab-800CW and durvalumab-680LT before qFME procedures, assessing programmed death-1/programmed death ligand-1 (PD-1/PD-L1) expression. We want to test the feasibility of qFME and ex vivo fluorescence imaging after intravenous administration of nivolumab-800CW, targeting PD-1, and durvalumab-680LT, targeting PD-L1, to visualize PD-L1 and PD-1 expression before and after CRT in LARC patients. If successful, this method can potentially be used in the future to see which patients most likely benefit from additional immunotherapy beforehand. The non-randomized, prospective phase 1 intervention explores biomarkers' role in treatment response prediction. Tracer administration poses minimal risks. Patients will not directly benefit, but the study aims to establish the utility of nivolumab-800CW and durvalumab-680LT in determining PD-1/PD-L1 expression during endoscopy. conditions: Locally Advanced Rectal Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 18 type: ESTIMATED name: Imfinzi name: Opdivo measure: Safety of nivolumab-800CW in combination with durvalumab-680LT measure: To investigate the feasibility of using fluorescence molecular endoscopy (FME) and ex vivo FMI to detect nivolumab-800CW and durvalumab-680LT signals indicating PD1 and PD-L1 expression. measure: Heart rate measure: Blood pressure systolic and diastolic measure: Temperature measure: Determine the PD-1 and PD-L1 expression and the changes in PD-1 and PD-L1 expression before and after nCRT in patients with LARC. measure: Determine the PD-1 and PD-L1 expression and the changes in PD-1 and PD-L1 expression before and after nCRT in patients with LARC. measure: Quantify in vivo fluorescence signals of nivolumab-800CW and durvalumab-680LT before and after CRT by using MDSFR/SFF spectroscopy/UNSB/SFF spectroscopy and correlate these measurements to, in vivo fluorescence intensities and PD1/PD-L1 expression measure: Quantify in vivo fluorescence signals of nivolumab-800CW and durvalumab-680LT before and after CRT by using MDSFR/SFF spectroscopy/UNSB/SFF spectroscopy and correlate these measurements to, in vivo fluorescence intensities and PD1/PD-L1 expression measure: Perform real-time polymerase chain reaction (qPCR) and western blot on biopsies to determine whether there is genetic downregulation or protein degradation of PD-1 and PD-L1 after chemoradiotherapy measure: Compare immune cell composition between the radiated and non-radiated area of the bowel. measure: Evaluate targeted detection with nivolumab-800CW and durvalumab-680LT of the tumor by ex vivo visualization of the resection specimen with PEARL Trilogy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen city: Groningen zip: 9713 GZ country: Netherlands name: Wouter B Nagengast, Prof. role: CONTACT email: w.b.nagengast@umcg.nl name: Lisanne E van Heijst, Bsc. role: SUB_INVESTIGATOR name: Pia Volkmer, Drs. role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06304584 id: P-2023-143 briefTitle: Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture overallStatus: RECRUITING date: 2023-05-15 date: 2024-09-15 date: 2025-05-15 date: 2024-03-12 date: 2024-03-12 name: University Hospital Bispebjerg and Frederiksberg class: OTHER name: Frederiksberg Municipality briefSummary: The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip.

The main questions aim to answer:

* how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered
* what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture

Participants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation. conditions: Hip Fractures conditions: Rehabilitation conditions: Recovery of Function studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED measure: Recovery of pre-fracture function measure: Basic mobility measure: 30 second chair stand test (CST) measure: Timed Up & Go test (TUG) measure: Hip related pain measure: Hand Grip Strength (HGS) measure: Health questionnaire measure: Physical activity (weekly) measure: Physical activity / upright time (time standing and walking) measure: Frailty measure: Fear of falling measure: Comorbidity measure: Cognitive status measure: Number of falls measure: Residential status / discharge destination measure: Length of stay in acute hospital measure: Number of weekly exercise sessions with therapist in all settings measure: Number of rehab weeks measure: Type of training in Municipality measure: Training after discharge from 24-hour setting measure: Home care, nurse/other health assistance, times pr week measure: Data 30 days post-discharge measure: Data 3 months post-discharge measure: Data 1 year post-discharge sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Department of Physio- and Occupational Therapy and Othopedic Surgery, University Hospital Bispebjerg and Frederiksberg status: RECRUITING city: Copenhagen zip: 2400 country: Denmark name: Morten T Kristensen, Professor role: CONTACT email: morten.tange.kristensen@regionh.dk name: Camilla K Zilmer, MSc, PT role: CONTACT email: camilla.kampp.zilmer@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06304571 id: HC006-001 briefTitle: A Study of HC006 in Subjects With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-02-27 date: 2026-03-15 date: 2026-07-16 date: 2024-03-12 date: 2024-03-12 name: HC Biopharma Inc. class: INDUSTRY briefSummary: The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: HC006 measure: Incidence of Dose Limiting Toxicities(DLTs) measure: Incidence of adverse events(AEs) measure: Incidence of Serious adverse events(SAEs) measure: Clinically Significant changes in safety assessments measure: Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax) measure: PK Parameter:Time to reach Cmax (Tmax) measure: PK Parameter:Area Under the Concentration-time Curve (AUC) measure: Immunogenicity measure: Objective Response Rate (ORR) per RECIST 1.1 measure: progression-Free Survival (PFS) per RECIST 1.1 measure: Overall Survival (OS) measure: Disease Control Rate (DCR) per RECIST 1.1 measure: Duration of response (DOR) per RECIST 1.1 measure: Time to progression (TTP) per RECIST 1.1 measure: Time To Response (TTR) per RECIST 1.1 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai East Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200120 country: China name: Ye Guo, MD role: CONTACT email: pattrickguo@gmail.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06304558 id: CI 240228, 2024-480 briefTitle: "Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects. overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-04 date: 2024-06 date: 2024-03-12 date: 2024-03-12 name: Universidad Europea de Madrid class: OTHER briefSummary: The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.

As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results. conditions: Sexual Satisfaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The Placebo group will mimic the Intervention group, but the device will not be connected. With this non-invasive neuromodulation, patiens do not experiment any sensation when the device is connected. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Non-Invasive Neuromodulation (NESA) measure: Sexual satisfaction measure: Stress levels measure: Blood Pressure (Sistolic and diastolic) measure: Heartbeats per minute measure: Sleep Quality sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304545 id: SHR-1210-HLJ-081 briefTitle: Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-08-16 date: 2027-03-15 date: 2024-03-12 date: 2024-03-12 name: Harbin Medical University class: OTHER briefSummary: This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation. conditions: Rectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Camrelizumab name: Chemotherapy name: Radiotherapy measure: Pathological Complete Response rate measure: Objective Response Rate measure: Disease Control Rate measure: Anal preservation rate measure: Disease-free Survival measure: Overall Survival measure: AEs measure: 3-years Overall Survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304532 id: HU123 briefTitle: Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H. Pylori Infection overallStatus: COMPLETED date: 2023-08-15 date: 2024-03-05 date: 2024-03-06 date: 2024-03-12 date: 2024-03-13 name: Hamdard University class: OTHER briefSummary: Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (\<20 years) group. In young age (20-40) and old age (\>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively.

In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects \& a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy. conditions: H. Pylori Infection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 69 type: ACTUAL measure: H. pylori stool for antigen test will screened before and after treatment. sex: ALL minimumAge: 15 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Shifa Ul Memorial Hospital-Hamdard University city: Karachi state: Sindh country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06304519 id: 1986626-1 briefTitle: Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke overallStatus: RECRUITING date: 2023-03-01 date: 2026-02-28 date: 2026-02-28 date: 2024-03-12 date: 2024-03-12 name: University of Delaware class: OTHER briefSummary: Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Dynamic ankle-foot orthosis measure: Mechanical Cost of Transport of the Lower Extremities measure: Sagittal plane ankle moment during stance measure: Sagittal plane ankle angle during stance measure: Self-selected walking speed measure: a candidate set of clinical outcome measures sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Delaware STAR Campus status: RECRUITING city: Newark state: Delaware zip: 19713 country: United States name: Elisa Arch, Ph.D. role: CONTACT phone: 302-831-7268 email: schranke@udel.edu lat: 39.68372 lon: -75.74966 hasResults: False

 nctId: NCT06304506 id: 514-0894/23-3000 briefTitle: Effect of Obesity on Extracellular Matrix Composition acronym: EOBECM overallStatus: RECRUITING date: 2024-03-15 date: 2024-11-15 date: 2024-12-30 date: 2024-03-12 date: 2024-03-12 name: University of Copenhagen class: OTHER briefSummary: The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.

The main questions to answer,

- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men conditions: Adipose Tissue studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cross sectional study with three groups primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Cross sectional study measure: The effect of obesity and age on adipose tissue extracellular matrix composition sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xlab, Faculty of Health and Medical Sciences, University of Copenhagen status: RECRUITING city: Copenhagen zip: 2200 country: Denmark name: Jørn M Helge, PhD role: CONTACT phone: +4528757506 email: jhelge@sund.ku.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06304493 id: 23-2470 briefTitle: REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-12 date: 2024-03-12 name: University of Colorado, Denver class: OTHER briefSummary: The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders. conditions: Postoperative Atelectasis conditions: Postoperative Hypoxemia conditions: Postoperative Pneumonia conditions: Postoperative Pulmonary Complications conditions: Patient Adherence conditions: Incentive Spirometry conditions: Respiratory Therapy conditions: Respiratory Insufficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pragmatic single-center cluster study of surgical patients receiving incentive spirometry devices during their PACU stay, with either automatic alarms "ON" or "OFF" in alternating weeks. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Outcome collection and data analysis will be performed by investigators blinded to the patient's cluster allocation (alarms "ON" or "OFF"). whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Alarms measure: Rate of adequate IS breaths achieved in PACU measure: Rate of IS breaths attempted in PACU measure: Time to first adequate IS breath measure: Duration of postoperative O2 therapy measure: Presence of postoperative pulmonary complications measure: Individual postoperative pulmonary complications measure: Need for ICU Admission after PACU measure: PACU Length of Stay sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CU Anschutz city: Aurora state: Colorado zip: 80045 country: United States name: Emily G Helmer role: CONTACT phone: 303-724-2938 email: emily.helmer@cuanschutz.edu name: Carolyn Gronowski role: CONTACT email: carolyn.gronowski@cuanschutz.edu name: Ana Fernandez-Bustamante, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06304480 id: AFCRO-179 briefTitle: Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-07-31 date: 2024-07-31 date: 2024-03-12 date: 2024-03-12 name: University College Cork class: OTHER name: AIT Austrian Institute of Technology GmbH briefSummary: There is a growing understanding of the functioning and interconnectedness of microbiomes in the food system which offers great potential for enabling the development of new solutions contributing to achieving important food and nutrition goals including those requested by FOOD 2030. Of relevance in this regard is the provision of sustainable and healthy protein sources. Because of the obvious environmental and climate concerns associated with the production of animal-derived protein, a transition is needed to healthier and more environment-friendly diets, including a moderate-level consumption of red and processed meat and greater emphasis on plant-based foods.

As well as impact of meat production on the climate, it is well established that eating a diet rich in red meat promotes the growth of gut microbiome members that drive or exacerbate inflammation. Plant protein does not have these associations, and in fact it is often accompanied by fibre ingestion, which favours growth of health-promoting gut microbes. Replacing meat with plant protein offers the prospect of improving consumer health by improving the gut microbiome. The EU funded project MICROBIOMES4SOY will assess the effect of replacing animal protein with soya-derived protein on the human gut microbiome and whether this replacement can reduce the risk of inflammation-related diseases by gut microbiome modulation. This knowledge will provide a baseline for establishing new dietary pathways making use of soya protein and support dietary transition for EU citizens. conditions: Gut Microbiome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised, open label, controlled, parallel study in healthy males and females. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Randomised, open label, controlled, parallel study in healthy males and females. count: 50 type: ESTIMATED name: 100g fermented Tofu measure: To evaluate the effect of replacing animal protein in a typical Western diet with plant-derived protein delivered in a (soy-based) tofu on gut microbiome composition. measure: To evaluate the functional activity of the gut microbiome, and any alterations caused by the soya replacement. measure: To evaluate the metabolome of urine and faecal samples and any alterations caused by the soya replacement. measure: To measure the effect of the meat substitution on a panel of proinflammatory cytokines, based on the observation that particular taxa are associated with an inflammatory phenotype. measure: To measure the effect of the meat substitution on cholesterol and serum triglycerides. measure: To measure the effect of the meat substitution on blood pressure. measure: To measure the effect of the meat substitution on body mass index (BMI). sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06304467 id: IRB#23-001133 briefTitle: CM for Patients With ALD After Liver Transplant overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2026-03-01 date: 2024-03-12 date: 2024-03-12 name: Arpan A. Patel, MD class: OTHER briefSummary: Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use.

The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility. conditions: Alcohol Use Disorder conditions: Alcohol; Liver conditions: Post Liver Transplant conditions: Contingency Management conditions: Alcohol Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Contingency Management measure: Number of Non-Drinking Days measure: Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr)) measure: Client Satisfaction Questionnaire-8. sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304454 id: P5_BG briefTitle: Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-02-29 date: 2024-03-15 date: 2024-03-12 date: 2024-03-12 name: Brain In Game scientific-technical service class: OTHER briefSummary: Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi \& Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms.

The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group. conditions: Kindergarten Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster RCT primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Double (outcomes assessor and participants) whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 26 type: ACTUAL name: Board game intervention measure: Visual Memory measure: Processing speed and inhibition measure: Affect recognition measure: Hollingshead Index (Hollingshead, 1975) measure: CHEXI (Giménez et al. 2022) sex: ALL minimumAge: 5 Years maximumAge: 6 Years stdAges: CHILD facility: Faculty of Education, Psychology and Social Work; University of Lleida city: Lleida zip: 25001 country: Spain lat: 41.61674 lon: 0.62218 hasResults: False

 nctId: NCT06304441 id: IPVO briefTitle: Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer overallStatus: RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-03-12 date: 2024-03-12 name: Guangzhou Medical University class: OTHER briefSummary: Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined. conditions: Leptomeningeal Metastasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Osimertinib name: Pemetrexed measure: Clinical response rate measure: Overall survival measure: Incidence of treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University) status: RECRUITING city: Huizhou state: Guangdong country: China name: Zhenyu Pan role: CONTACT phone: +8615804302753 email: dr-zypan@163.com name: Guozi Yang role: CONTACT phone: +8615804302755 email: guoziyang_1982@163.com lat: 23.11147 lon: 114.41523 hasResults: False

 nctId: NCT06304428 id: Pro00114580 briefTitle: Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications acronym: PRISM overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2028-07-01 date: 2028-07-01 date: 2024-03-12 date: 2024-03-12 name: Duke University class: OTHER name: Patient-Centered Outcomes Research Institute name: Hebrew SeniorLife name: Brown University name: The American Health Care Association name: University of North Carolina, Chapel Hill briefSummary: The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone.

The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders.

The main questions this study aims to answer are:

* Which of the three models is more effective in preventing falls with fractures?
* What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling.
* What are the differences in osteoporosis treatment and medication burden?

The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services.

42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team.

This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol. conditions: Accidental Falls/Prevention and Control conditions: Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 3780 type: ESTIMATED name: Deprescribing Care Model name: Bone Health Service Model name: Injury Prevention Service Model measure: Injurious falls measure: Number of patients who initiate treatment for osteoporosis measure: Medication Possession Ratio during follow-up, as measured by EHR and Medicare claims measure: Number of patients who had deprescribing ordered measure: Modified Drug Burden Index during follow-up, as measured by EHR and Medicare claims measure: Patient medication side effect burden, measured via Living with Medicines Questionnaire (LMQ3). measure: Patient falls self-efficacy (i.e. fear of falling), measured via Falls Efficacy Scale measure: Patient pain, measured via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form measure: Patient depression, measured via Patient Health Questionnaire survey (PHQ-8) measure: Patient anxiety, measured via PROMIS anxiety short form survey measure: Patient sleep, measured via PROMIS sleep disturbance short form sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304415 id: CIRB2023/2651 briefTitle: Elevated Lipoprotein(a) in Hospital Staff acronym: LPACO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2035-12-01 date: 2036-12-31 date: 2024-03-12 date: 2024-03-13 name: Changi General Hospital class: OTHER briefSummary: The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population. conditions: Hypercholesterolemia conditions: Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2800 type: ESTIMATED measure: Distribution and prevalence of elevated Lipoprotein(a) measure: Correlation of lipoprotein(a) with cardiovascular outcomes measure: Genetic variants of lipoprotein(a) and cardiovascular outcomes atherosclerotic events sex: ALL minimumAge: 21 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trials & Research Unit city: Singapore zip: 529889 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06304402 id: 7978-GOA briefTitle: Comparing Shoulder Stretching and Percussive Massage on Shoulder Rotation and Attack Speed in Female Volleyball Players overallStatus: RECRUITING date: 2024-03-10 date: 2024-05-01 date: 2024-06-01 date: 2024-03-12 date: 2024-04-22 name: Dokuz Eylul University class: OTHER briefSummary: This study aims to investigate the acute effects of PNF modified sleeper stretches and percussive massage treatment on shoulder rotation movements and attack speed in female volleyball players and compare these applications. conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: The Percussive Massage Treatment name: The Proprioceptive Neuromuscular Facilitation Stretching measure: Shoulder internal rotation range of motion measure: Attack Speed sex: FEMALE minimumAge: 14 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Dokuz Eylul University, School of Physical Therapy and Rehabilitation status: RECRUITING city: İzmir state: Balçova zip: 35340 country: Turkey name: Gonca Sahiner, PhD role: CONTACT lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06304389 id: BLUELIGHT-VNS briefTitle: Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy acronym: BLUELIGHTVNS overallStatus: RECRUITING date: 2023-07-01 date: 2023-07-01 date: 2026-04 date: 2024-03-12 date: 2024-03-12 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS. conditions: Refractory Epilepsy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with refractory epilepsy (divided in non responders \& responders), and healthy subjects primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 34 type: ESTIMATED name: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration name: transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration measure: Effect of blue light on VNS biomarkers measure: Effect of blue light on VNS biomarkers measure: Effect of blue light on VNS biomarkers sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cliniques Universitaires Saint Luc status: RECRUITING city: Woluwe-Saint-Lambert zip: 1200 country: Belgium name: Inci Cakiroglu, Phd student role: CONTACT phone: +32470612917 email: inci.cakiroglu@uclouvain.be name: Inci Cakiroglu, Phd student role: SUB_INVESTIGATOR lat: 50.84389 lon: 4.42912 hasResults: False

 nctId: NCT06304376 id: OMFS/FSDC002 briefTitle: Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting acronym: Alveolar cleft overallStatus: COMPLETED date: 2022-03-12 date: 2023-11-30 date: 2024-02-22 date: 2024-03-12 date: 2024-03-12 name: October 6 University class: OTHER name: Ministry of Health, Kuwait briefSummary: This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT. conditions: Alveolar Cleft conditions: Alveolar Ridge Cleft studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: Alveolar ridge grafting measure: Volumetric bone gain measure: Eruption of the tooth in the cleft sex: ALL minimumAge: 7 Years maximumAge: 14 Years stdAges: CHILD facility: Ministry of Health, Farwaniya Hospital city: Al Farwānīyah zip: 81004 country: Kuwait lat: 29.2775 lon: 47.95861 hasResults: False

 nctId: NCT06304363 id: Braining booster briefTitle: Braining - Evaluation of Acute Effects of Physical Exercise overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Region Stockholm class: OTHER_GOV name: Karolinska Institutet briefSummary: "Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period.

The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes. conditions: Psychiatric Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Braining measure: Anxiety Visual Analogue Scale (VAS) measure: Beck Anxiety Inventory BAI measure: Montgomery-Åsberg Depression Rating Scale MADRS measure: High sensitivity C-reactive protein hsCRP measure: Brain-derived neurotrophic factor BDNF measure: Telomerase activity measure: Motivational factors of continued exercise sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest) city: Stockholm zip: 14186 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06304350 id: SGHDOT-24-20 briefTitle: Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-02-17 date: 2026-02-25 date: 2026-12-31 date: 2024-03-12 date: 2024-03-13 name: Tongji University class: OTHER briefSummary: This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Combination of pembrolizumab and platinum containing dual drugs measure: Pathological complete remission (pCR) measure: Major pathological remission (MPR) measure: R0 resection rate measure: Progression free survival (PFS) measure: Total survival time (OS) measure: Safety (incidence of adverse drug reactions) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai General Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200080 country: China name: Jiang Fan, MD role: CONTACT phone: 02163240090 email: fan_jiang@tongji.edu.cn name: Jiang Fan, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06304337 id: YXLL-KY-2023(162) briefTitle: Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy overallStatus: NOT_YET_RECRUITING date: 2024-03-03 date: 2024-10-10 date: 2025-03-03 date: 2024-03-12 date: 2024-03-12 name: Qianfoshan Hospital class: OTHER briefSummary: The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2\<90%, t\>10s) and severe hypoxia (Spo2\<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients. conditions: Airway Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 228 type: ESTIMATED name: New oropharyngeal airway group measure: Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation measure: The incidence of choking, reflux aspiration and laryngeal spasm were recorded measure: The dose of additional drugs during the operation measure: Endoscopist satisfaction measure: Record adverse events that occur throughout the process sex: ALL minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304324 id: 18/2023 briefTitle: Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-04-30 date: 2024-03-12 date: 2024-03-12 name: Poznan University of Medical Sciences class: OTHER briefSummary: Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery. conditions: Ankle Disease conditions: Ankle Injuries and Disorders conditions: Foot Injury conditions: Foot Diseases 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: 0.9% Sodium chloride name: 0.1mg/kg Dexamethasone name: 0.05ug/kg Dexmedetomidine measure: time to the first need of opiate following the procedure measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Neutrophil-to-lymphocyte ratio measure: Platelet-to-lymphocyte ratio measure: Platelet-to-lymphocyte ratio measure: Time to mobilization sex: ALL minimumAge: 3 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland city: Poznań state: Wielkopolska zip: 61-545 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06304311 id: MAHSA/PHD/SON/2024/01 briefTitle: Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida overallStatus: COMPLETED date: 2022-10-02 date: 2023-10-02 date: 2024-01-04 date: 2024-03-12 date: 2024-03-12 name: University of Lahore class: OTHER name: Mahsa University briefSummary: The study aims to investigate the effects of a combination of Lamaze breathing exercises and backside massage on the labor experiences of primigravidae in Pakistan. Labour pain, if left unaddressed, can lead to abnormal labor, hence the importance of effective pain management techniques. Lamaze breathing techniques are non-pharmacological methods aimed at psychologically and physically preparing mothers for drug-free childbirth. Backside massage therapy is another non-invasive intervention that can help to reduce pain and anxiety during labor. The study will involve a randomized controlled trial with two groups: an intervention group receiving backside massage and Lamaze breathing along with standard labor care, and a control group receiving only standard labor care. Primigravidae between 26 to 34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal departments. Eligible participants will be randomly allocated to either group to minimize bias. The backside massage therapy intervention will be administered by trained massage therapists. Outcome measures include level of labor pain and anxiety levels, maternal stress hormone levels (adrenocorticotropic hormone, cortisol, and oxytocin), maternal vital signs, fetal heart rate, labor duration, APGAR scores, and maternal satisfaction and self-efficacy. The sample size of 90 participants (45 in each group) has been determined to achieve a 95% power level with a 5% error rate, accounting for a 20% attrition rate. Data analysis will employ mixed-effect regression models, time series analyses, paired t-tests, or equivalent non-parametric tests to assess between-group and within-group outcome measures. The study aims to provide valuable insights into the efficacy of combining Lamaze breathing exercises and backside massage therapy as complementary interventions for managing labor pain and anxiety among primigravidae in Pakistan, potentially reducing the need for medically unnecessary cesarean sections and improving maternal and neonatal outcomes. conditions: Labor Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 90 type: ACTUAL name: Routine Obstetrics care & Lamaze breathing techniques and backside massage measure: Labour pain intensity measure: Anxiety level measure: Duration of Labour measure: Maternal self-efficacy sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Lady Wallingdon Hospital city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06304298 id: 10/2023 briefTitle: NLR and PLR Levels Following iPACK Block in Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-07-01 date: 2025-08-01 date: 2024-03-12 date: 2024-03-12 name: Poznan University of Medical Sciences class: OTHER briefSummary: Effect of iPACK block on NLR and PLR following knee arthroplasty conditions: Knee Arthropathy conditions: Knee Osteoarthritis conditions: Knee Pain Chronic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 0.9% Sodium Chloride Injection name: Ropivacaine 0.2% Injectable Solution measure: Neutrophil-to-lymphocyte ratio measure: Neutrophil-to-lymphocyte ratio measure: Neutrophil-to-lymphocyte ratio measure: PLR measure: PLR measure: PLR measure: first need of opiate measure: Opioid Consumption measure: Pain score measure: Pain score measure: Pain score measure: Pain score measure: Pain score measure: Pain score measure: Pain score sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304285 id: 2023-ky421 briefTitle: A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: The First Affiliated Hospital of University of Science and Technology of China class: OTHER briefSummary: The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD conditions: Parkinson's Disease conditions: Chronic Appendicitis conditions: Acupuncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Acupuncture treatment name: Sham acupuncture treatment measure: Score of MDS Unified-Parkinson Disease Rating Scale III sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of University of Science and Technology of China status: RECRUITING city: Hefei state: Anhui zip: 230001 country: China name: Yuhua Chen, M.M.S. role: CONTACT phone: +8615955236270 email: yh1215@mail.ustc.edu.cn name: Chao Han, M.D. role: CONTACT phone: +8615255629713 email: chaohan@ustc.edu.cn lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06304272 id: Irrigation briefTitle: Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-09 date: 2027-12 date: 2024-03-12 date: 2024-03-12 name: Patan Academy of Health Sciences class: OTHER briefSummary: There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound. It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast. There are no high level evidence to support one type of solution over other, systematic review have found no difference in wound infection between irrigation with normal saline vs tap water. There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016. These RCT are analyzed in three systemic review and meta-analysis published on 2016, 2019, 2022, which showed that tap water and normal saline has no difference in terms of infection rate. The infection rate observed in various studies ranges from 0-11.5% in normal saline group and 0-12.6% in tap water group with no statistically significant difference. conditions: Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double blinded, parallel, non-inferiority trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 440 type: ESTIMATED name: Irrigating Traumatic Wound with Drinking Water measure: Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304259 id: 24428 briefTitle: Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-10-01 date: 2024-03-12 date: 2024-03-26 name: October 6 University class: OTHER briefSummary: Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab. conditions: Endodontic Disease conditions: Endodontically Treated Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Saline name: Saline measure: postoperative pain measure: postoperative pain measure: postoperative pain measure: Substance P level measure: Substance P level measure: Substance P level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry, Ain shams University city: Cairo zip: 4543070 country: Egypt name: Yara Adel, BDs role: CONTACT phone: 00201000099191 email: yara.adel170496@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06304246 id: FU-S.OZCAN 001 briefTitle: The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-30 date: 2024-10-30 date: 2024-03-12 date: 2024-03-12 name: Firat University class: OTHER briefSummary: Adipokines are bioactive substances secreted from adipose tissue and have various functions on appetite, energy, lipid, carbohydrate metabolism, regulation of blood pressure, and inflammation. One of these is asprosin, discovered in 2016, which is secreted from white adipose tissue. It has been shown that the level of asprosin encoded by the Fibrillin 1 gene can vary in metabolic syndrome associated with obesity, diabetes, and insulin resistance . Some adipokines such as leptin, adiponectin, or resistin are found in increasing levels in the blood and placenta as pregnancy progresses. The detection of high concentrations of adipokines in cord blood has shown that they play an important role in fetal development and metabolism, can interfere with placental development, and affect pregnancy outcomes and fetal growth. Adipokines associated with appetite, energy, lipid, and carbohydrate metabolism have been shown to be effective in modulating pain in recent years. High levels of leptin have been shown to be associated with decreased preoperative pain threshold and increased postoperative analgesic consumption. Recent studies have indicated that asprosin also exhibits analgesic effects in neuropathic pain models and may have clinical benefits in alleviating chronic pain associated with diseases and injuries originating from peripheral structures.

It is known that one of the most important factors affecting mothers\&amp;#39; approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain. Almost one in five patients experiences severe acute pain after Cesarean section. Pain can be perceived differently by patients, and even with the same anesthesia technique, some patients may experience more severe pain. Patients\&amp;#39; perception of pain is influenced by many factors such as pain threshold, mood, hormonal balance, central sensitization, and genetic factors.

We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period. Additionally, we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels.

In this study, we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use. conditions: Obstetric Pain conditions: Cesarean Section conditions: Postoperative Pain studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Measurement Pain Threshold name: Measurement of Serum Asprosin measure: Preoperative Asprosin Level measure: Postoperative Pain measure: Postoperative analgesic consumption sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06304233 id: 606103 briefTitle: The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease overallStatus: RECRUITING date: 2023-12-13 date: 2024-12 date: 2038-06 date: 2024-03-12 date: 2024-03-12 name: Norwegian University of Science and Technology class: OTHER name: St. Olavs Hospital briefSummary: To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia. conditions: Heart Diseases conditions: Heart; Functional Disturbance conditions: Schizophrenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Echocardiography name: Cardiac Magnetic Resonance Imaging name: Electrocardiography name: Blood sampling measure: Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography measure: Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography measure: DISC1 mRNA quantification measure: Levels of high sensitive-CRP measure: Levels of CK-MB measure: Levels of Troponin T measure: Levels of Troponin I measure: Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter measure: Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter measure: Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter measure: Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter measure: Left ventricular mass measured by echocardiography measure: Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography measure: Fractional shortening measured by echocardiography measure: Global longitudinal strain (GLS), echocardiographic parameter measure: TAPSE echocardiographic parameter of right ventricular longitudinal systolic function measure: Echocardiographic parameter MPI, Myocardial performance index measure: Echocardiographic parameter Mitral E/A ratio measure: Echocardiography parameter of peak E velocity measure: Echocardiography parameter of E wave deceleration time measure: Echocardiography parameter of ratio of E/e' measure: Echocardiographic parameters septal e' and lateral e' velocities measure: Echocardiographic parameter LAVI, left atrial volume indexed measure: Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity measure: Echocardiographic parameter, S wave velocity measure: Echocardiographic parameter, Indexed LV and RV stroke volumes measure: Levels of NT-proBNP measure: Levels of IGF1 measure: Levels of ANP measure: Levels of BDNF, brain derived neurotrophic factor measure: Levels of Tumor Necrosis Factor alpha measure: Levels of Transforming Growth Factor Beta measure: Levels of cardiac Myosin-Binding Protein C measure: Interleukin levels measure: native T1 time, cardiac MRI measure: Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI measure: Indexed LV mass, cardiac MRI measure: LV Ejection Fraction, cardiac MRI measure: ECG corrected QT interval measure: Number of participants with and abnormal ECG measure: Number of participants with abnormal liver function measure: Number of participants with abnormal kidney function measure: Number of participants with abnormal thyroid function measure: Number of participants with low Vitamin D levels measure: Incidence of cardiovascular disease or mortality as registered in a health registry on follow up measure: Triglyceride levels measure: High-density lipoprotein, HDL-cholesterol levels measure: Low-density lipoprotein, LDL-cholesterol levels measure: Fasting glucose levels measure: Glycated Hemoglobin (HbA1c) levels measure: Heart rate measured on ECG measure: Systolic Blood Pressure measure: Diastolic Blood Pressure measure: Lipoprotein a measure: Magnesium levels measure: Calcium levels measure: Sodium levels measure: Potassium levels measure: Alcohol intake at baseline using The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire measure: Average length of inpatient stay for schizophrenia related admissions measure: Need of Care based on number of total hospital admission for schizophrenia measure: Severity scoring of psychiatric symptoms using Clinical Global Impressions (CGI) Scale - Severity measure: Schizophrenia symptom severity as scored on the Positive and Negative Syndrome Scale (PANSS) measure: Duration of schizophrenia measure: Length of treatment with an antipsychotic medication measure: Antipsychotic dosage in daily equivalent dosage of chlorpromazine measure: Smoking status measure: Waist Hip Ratio measure: Body Mass Index measure: Body fat percent measure: Physical Activity measure: Body muscle composition measure: Smoking history measure: Age of participant measure: Gender of participant sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Norwegian University of Science and Technology status: RECRUITING city: Trondheim country: Norway name: Morten A Høydal, PhD role: CONTACT phone: +47 48134843 email: morten.hoydal@ntnu.no name: Rita Brekke, MD, MSc role: CONTACT phone: +47 45111574 email: rita.brekke@ntnu.no lat: 63.43049 lon: 10.39506 facility: St Olavs Hospital, Trondheim University Hospital status: RECRUITING city: Trondheim country: Norway name: Mette E Tunset, MD role: CONTACT email: mette.elise.tunset@stolav.no name: Morten B Schou, PhD role: CONTACT email: morten.brix.schou@stolav.no lat: 63.43049 lon: 10.39506 hasResults: False

 nctId: NCT06304220 id: MedroGestrel briefTitle: Comparison of Two PPOS Models for Pituitary Suppression overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: NextFertility class: INDUSTRY name: SINAE SL briefSummary: The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients. conditions: Infertility, Female conditions: Fertility Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 210 type: ESTIMATED name: Cerazet measure: Total number of oocytes retrieved from follicular puncture measure: Number of mature oocytes (MII) retrieved from follicular puncture measure: Oocyte quality variables measure: Ovarian sensitivity index (OSI measure: Follicles sex: FEMALE minimumAge: 18 Years maximumAge: 34 Years stdAges: ADULT facility: NextFertility city: Valencia state: Comunidad Valenciana zip: 46009 country: Spain name: Luis Quintero role: CONTACT phone: +34 963160240 email: luis.quintero@next-clinics.com lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06304207 id: 300423 briefTitle: Telehealth and Onsite Maintenance Exercise in COPD acronym: COPD overallStatus: RECRUITING date: 2023-09-01 date: 2025-12-30 date: 2026-03-01 date: 2024-03-12 date: 2024-03-12 name: MGH Institute of Health Professions class: OTHER briefSummary: The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with COPD.

The specific aims of the study are:

* To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with COPD following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.
* To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with COPD following discharge from traditional onsite outpatient rehabilitation.

Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention. conditions: Copd conditions: COPD Exacerbation conditions: COPD Bronchitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design will be a pilot randomized controlled, assessor-blinded trial with three groups: 1) Tele-rehab where patient will be at home but will receive supervised intervention remotely, 2) Onsite outpatient physical therapy, 3) Control group. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: All baseline and follow up outcomes assessment will be conducted by a study team member blinded to the subject group allocation. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Onsite Maintenance Exercise Training name: Telehealth Maintenance Exercise measure: Exercise Capacity measure: Exercise Capacity measure: Exercise Capacity measure: Dyspnea measure: Dyspnea measure: Dyspnea measure: Physical Function measure: Physical Function measure: Physical Function measure: Quality of life measure measure: Quality of life measure measure: Quality of life measure measure: Inspiratory muscle strength measure: Inspiratory muscle strength measure: Inspiratory muscle strength measure: Physical activity measure: Physical activity measure: Physical activity measure: Participants adherence to the program measure: Healthcare utilization measure: Adverse events measure: PROMIS Global 10 score measure: PROMIS Global 10 score measure: PROMIS Global 10 score sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MGH Institute of Health Professions status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Shweta Gore, PhD role: CONTACT phone: 617-643-6326 email: sgore@mghihp.edu name: Jane Bladwin, DPT role: CONTACT email: jbaldwin@mghihp.edu lat: 42.37787 lon: -71.062 hasResults: False

 nctId: NCT06304194 id: BIOMARC_ONCO briefTitle: Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology overallStatus: RECRUITING date: 2023-07-05 date: 2027-07-05 date: 2028-07-05 date: 2024-03-12 date: 2024-03-12 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.

In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.

This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection. conditions: Oncologic Disease conditions: Hematologic Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 340 type: ESTIMATED name: Analysis of biological samples measure: Average sample delivery time and % of accepted sample measure: Appropriateness sample labelling measure: Percentage of sample suitable for RNA extraction measure: Quantity and quality of extracted material. measure: Research report production time measure: Genetic variants measure: Completed patient cards sex: ALL minimumAge: 0 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Marinella Veltroni role: CONTACT email: marinella.veltroni@meyer.it lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero-Universitaria Pisana status: RECRUITING city: Pisa country: Italy name: Gabriella Casazza role: CONTACT lat: 43.70853 lon: 10.4036 facility: Azienda Ospedaliero-Universitaria Senese status: RECRUITING city: Siena country: Italy name: Salvatore Grosso role: CONTACT lat: 43.31822 lon: 11.33064 hasResults: False

 nctId: NCT06304181 id: KY-2023-195 briefTitle: Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08-01 date: 2024-12-30 date: 2024-03-12 date: 2024-03-12 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group. conditions: Postoperative Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 90 type: ESTIMATED name: Paracetamol and Mannitol Injection name: Parecoxib measure: NRS scores measure: RASS score measure: Time of first use of remedial analgesics or analgesic pump measure: Total analgesic pump drug use measure: Postoperative liver enzyme level measure: Postoperative bilirubin level measure: Postoperative creatinine level measure: Postoperative cortisol level measure: Postoperative IL-6 level measure: Postoperative IL-8 level sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06304168 id: 19-000890 id: NCI-2024-00954 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-000890 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study overallStatus: RECRUITING date: 2019-05-13 date: 2028-05-15 date: 2028-05-15 date: 2024-03-12 date: 2024-03-12 name: Mayo Clinic class: OTHER briefSummary: This study explores the potential value of a new blood test approach for early detection of cancer. conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Malignant Solid Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5850 type: ESTIMATED name: Non-Interventional Study measure: Overall cancer (Y/N) - blood test measure: Overall cancer (Y/N) - urine test measure: Cancer specific site prediction - blood samples/MDM measure: Cancer specific site prediction - urine samples/MDM measure: Cancer specific site prediction - blood samples/RNA measure: Cancer specific site prediction - urine samples/RNA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: John B. Kisiel, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06304155 id: 202437 briefTitle: Application of FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-12 date: 2024-03-15 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: According to statistics, in 2020, new head and neck malignancies in the world accounted for 4.9% (931931 cases) of malignant tumors in the whole body, and the new death cases were 467125, accounting for 4.7% of malignant tumors in the whole body. The high incidence rate and mortality brought great burden to the medical system. In addition, due to various types of head and neck cancer, hidden location, impact on function and quality of life, and low overall survival rate, this type of disease has seriously threatened human health and social development. The incidence of oropharyngeal cancer and laryngeal cancer is more subtle. Traditional examination methods include CT(computer tomography), MR(magnetic resonance), and laryngoscopy, but they cannot make accurate judgments on the systemic TNM(primary tumor, regional nodes, metastasis) staging of oropharyngeal cancer and laryngeal cancer. 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/CT examination can better diagnose and stage compared to traditional examination methods. However, due to the interference of more inflammatory lesions or physiological uptake in the pharynx, the false positive rate of 18F-FDG PET/CT examination is significantly increased, 18F-FAPI(18F-fibroblast activation protein inhibitors) is a novel broad-spectrum tumor imaging agent that can be specifically uptake by fibroblasts in the tumor microenvironment, and has lower physiological uptake and acute inflammatory lesion uptake in the larynx. 18F-FAPI PET/CT examination can more accurately stage tumors throughout the body than 18F-FDG PET/CT examination. Combined with PET/MR local scanning, it will further improve the accuracy of T and N staging of local tumors. Therefore, It is of great significance for clinical diagnosis and treatment to effectively and reliably determine the systemic TNM staging of oropharyngeal and laryngeal cancer through non-invasive methods. conditions: Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Diagnostic efficacy,SUV measure: Diagnostic efficacy measure: SUV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Xiao Chen, Ph.D role: CONTACT phone: 15922970174 email: xiaochen229@foxmail.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06304142 id: SGB-reflux briefTitle: Effect of Lidocaine Block on Gastroesophageal Reflux Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 10 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom. conditions: Gastroesophageal Reflux Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Injection name: Lidocaine hydrochloride measure: Gastroesophageal Reflux Disease Questionnaire measure: Pressure pain threshold measure: Modified Mayo Clinic Dysphagia-30 questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304129 id: 2023-A00709-36 briefTitle: Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers acronym: PLASM-ALZ overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2026-01-02 date: 2026-09-02 date: 2024-03-12 date: 2024-03-12 name: Central Hospital, Nancy, France class: OTHER name: Thérèse Jonveaux name: Laure Joly name: Lucie Hopes name: Maia Simon name: Franck Schreiner briefSummary: .The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:

* to define a threshold value for each of the plasma,
* to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,
* to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes
* to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital. conditions: Alzheimer Blood Biomarkers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 189 type: ESTIMATED name: Blood ponction measure: Aβ40 and Aβ42, P-Tau, Tau and NFL measure: Sensitivity/specificity measure: Co-mobidity measure: Final diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU De Nancy city: Nancy state: Grand Est zip: 54500 country: France lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06304116 id: SGB-TBI briefTitle: Effect of Lidocaine Block in Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Stellate ganglion block name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Swallowing duration measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304103 id: AND017-MDS-206 briefTitle: A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2026-12 date: 2027-05 date: 2024-03-12 date: 2024-03-15 name: Kind Pharmaceuticals LLC class: INDUSTRY briefSummary: This is a Phase 2, multicenter, randomized, open-lable study to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS)in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB). conditions: Myelodysplastic Syndromes studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: AND017 measure: Percentage of HI-E/RBC-TI responding subjects measure: Mean level and change from baseline in untransfused Hb throughout the first 8 weeks of treatment measure: Mean level and change from baseline in untransfused Hb at each visit throughout the treatment period and measure: Percentage of visits in which untransfused Hb was maintained in this range after reaching two consecutive increases of ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period measure: Mean time required after two consecutive increases in untransfused Hb ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period measure: For changes in mean transfusion units throughout the treatment period compared to baseline (mean transfusion units 16 weeks prior to first dose) measure: For LTB cohorts, the average time required to reach first transfusion independence throughout the treatment period measure: Levels of reticulocyte count at each visit and change from baseline measure: Levels of hematocrit at each visit and change from baseline measure: Levels of mean corpuscular volume at each visit and change from baseline measure: Levels of mean corpuscular hemoglobin at each visit and change from baseline sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304090 id: SGB-NT briefTitle: Efficacy of Lidocaine Block in Children With Cerebral Palsy and Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Stellate ganglion block name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD hasResults: False

 nctId: NCT06304077 id: 2023-01894 id: 000005739 type: REGISTRY domain: Swiss National Clinical Trial Portal (SNCTP) briefTitle: Restorative Environments for Gait Therapy With VR acronym: REGaitVR overallStatus: RECRUITING date: 2024-03-01 date: 2025-02 date: 2025-02 date: 2024-03-12 date: 2024-03-12 name: ETH Zurich class: OTHER briefSummary: The aim of our study is to investigate the effects of landscapes during gait therapy. The investigators will evaluate the impacts of restorative landscapes as they occur in urban, rural and forest environments. Older people will experience those landscapes using virtual reality (VR) goggles during their gait training. The investigators expect the landscapes to have an effect on the following three aspects: (1) stress reduction, (2) restoration of attention and (3) change in gait parameters. For this purpose, volunteers who are currently inpatient in one of our study centers and already participating in gait therapy will be assigned to a group. The control group will receive the standard therapy. The participants of the intervention groups will receive five additional VR training sessions to the standard therapy. In these sessions, the participants will walk through urban, rural and forest landscapes and perform balance improvement exercises. The five training sessions will take place within ten days. Allocation to the control or intervention groups and their landscapes is random. At the start and end of participation, tests defining stress levels and gait parameters are carried out so that comparisons can be made between before and after treatment. The goal of the study is to find out which type of landscape supports restoration and can therefore contribute to greater gait stability. The investigators expect that improved gait stability will be promoted by stress reduction and increased attention induced by the virtual environments. The investigators are investigating the consequences of repeated application of virtual landscapes and the relationship between the effect of the landscape and the preferences and habits of the study participants. conditions: Gait Analysis conditions: Virtual Reality conditions: Attention conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, multi-arm (4-arm), open-label pilot controlled trial with an allocation ratio of 1:1:1:1 (per intervention group (urban, rural, forest) : control). The study setup is multicentric (Geriatrische Klinik St. Gallen, Spitäler Schaffhausen, Spital Zollikerberg). primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: Forest name: Urban name: Rural measure: Gait Stability measure: Variability (Gait Parameter) measure: Speed (Gait Parameter) measure: Asymmetry (Gait Parameter) measure: Stance (Gait Parameter) measure: Max. Heel Clearance (Gait Parameter) measure: 1-Minute-Sit-to-Stand Test (1-Min-STST) measure: Perceived Restorativeness Scale (PRS) (Attention Restoration) measure: Perceived Stress Scale (PSS) (Stress Reduction) measure: Skin Conductance Levels (SCL) (Stress Reduction) measure: Non-Specific Skin Conductance Responses (NS-SCRs) (Stress Reduction) measure: Event-related Skin Conductance Responses (ER-SCRs) (Stress Reduction) measure: Standard deviation of all NN (normal-to-normal) intervals (SDNN) (Heart Rate Variability (HRV), Stress Reduction) measure: Root Mean Square of Successive Differences (RMSSD) (Heart Rate Variability (HRV), Stress Reduction) measure: LF/HF-ratio (Heart Rate Variability (HRV), Stress Reduction) measure: Heart Rate change (ΔHR) (Meaning / Valence of Landscapes) measure: Questionnaire / structured interview on landscape preferences and meanings ascribed to landscapes (Meaning / Valence of Landscapes) measure: Gaze patterns measure: Age (Demographic data) measure: Height (Demographic data) measure: Weight (Demographic data) measure: Gender (Demographic data) measure: Education (Demographic data) measure: Diagnosis and reason for gait stability training measure: Time since last fall sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Geriatrische Klinik St. Gallen status: NOT_YET_RECRUITING city: St. Gallen state: Saint Gallen zip: 9000 country: Switzerland name: Dzuza Papik role: CONTACT phone: +41 (0)71 243 88 30 email: dzuza.papik@geriatrie-sg.ch lat: 47.42391 lon: 9.37477 facility: Spital Zollikerberg status: RECRUITING city: Zollikerberg state: Zürich zip: 8125 country: Switzerland name: Cor Dekker role: CONTACT phone: +41 (0)44 397 27 11 email: cor.dekker@therapien-zollikerberg.ch lat: 47.3451 lon: 8.60088 facility: Spitäler Schaffhausen status: NOT_YET_RECRUITING city: Schaffhausen zip: 8208 country: Switzerland name: Eliane Hepfer role: CONTACT phone: +41 (0)52 634 83 50 email: eliane.hepfer@spitaeler-sh.ch lat: 47.69732 lon: 8.63493 hasResults: False

 nctId: NCT06304064 id: CAP-1002-DMD-03 briefTitle: Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE) acronym: HOPE-OLE overallStatus: COMPLETED date: 2018-06-21 date: 2019-03-06 date: 2019-03-06 date: 2024-03-12 date: 2024-04-24 date: 2024-04-24 name: Capricor Inc. class: INDUSTRY briefSummary: This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up.

The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months. conditions: Duchenne Muscular Dystrophy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ACTUAL name: Allogeneic Cardiosphere-Derived Cells (CAP-1002) measure: Number of Participants Experiencing Acute Respiratory Decompensation measure: Number of Participants With Hypersensitivity Reactions measure: All-cause Mortality measure: Number of Treatment-emergent Adverse Events (TEAEs) Related to Investigational Product or Administration and Serious Adverse Events (SAEs) measure: Number of Participants With Immune Sensitization Syndrome sex: MALE minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States lat: 29.65163 lon: -82.32483 facility: Cincinnati Children's Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2018-02-12 uploadDate: 2024-03-29T13:28 filename: Prot_000.pdf size: 2102667 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2019-03-26 uploadDate: 2024-03-29T13:25 filename: SAP_001.pdf size: 741616 hasResults: True

 nctId: NCT06304051 id: Naochuxue-IOE briefTitle: Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage overallStatus: COMPLETED date: 2023-01-17 date: 2023-05-10 date: 2023-06-01 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.

The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.

Participants will be divided into two groups randomly, with different nutritional support respectively. conditions: Intracerebral Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 118 type: ACTUAL name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Number of cases of successful extubation measure: Body mass index measure: Serum albumin level measure: Hemoglobin level measure: Clinical Pulmonary Infection Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hongkong central Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06304038 id: 2018 briefTitle: Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome overallStatus: COMPLETED date: 2017-10-16 date: 2018-04-29 date: 2019-11-14 date: 2024-03-12 date: 2024-03-12 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Flu vaccination, as well as being effective to prevent seasonal influenza, decreases staff illness and absenteeism and reduces costs resulting from loss of productivity. Despite the effectiveness of flu vaccination, the seasonal coverage among healthcare workers is usually low. The aim of this retrospective observational study is to analyze the vaccination coverage rate among all employees (healthcare workers and administrative staff) of a large teaching hospital in Rome during the 2017-2018 influenza season, to perform a cost-consequence analysis of influenza vaccination (by evaluating the absenteeism due to illness in the epidemic period), and to assess the impact of vaccination in terms of both costs and sick days. conditions: Influenza Vaccine conditions: Cost-Benefit Analysis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 5483 type: ACTUAL name: Flu Vaccine measure: Effectiveness of the quadrivalent vaccine measure: Economic impact of the quadrivalent vaccine measure: Expected economic savings for each one percentage point increase in vaccination coverage measure: Non-economic incentives for healthcare personnel who decide to vaccinate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario "A.Gemelli" IRCCS city: Rome zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06304025 id: GvHD 01 briefTitle: Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment acronym: GvHD overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-08 date: 2024-03-12 date: 2024-03-12 name: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle class: OTHER name: Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS briefSummary: Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs).

The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib. conditions: Graft Versus Host Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental (pilot clinical study), randomized, blind, and parallel. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 10 type: ESTIMATED name: Wharton's jelly mesenchymal stem cells (WJ-MSCs) measure: Incidence of treatment-emergent adverse events: safety and tolerability measure: Efficacy clinic profile: response of acute GVDH measure: Efficacy clinic profile : duration of response measure: Efficacy clinic profile: decrease in treatments measure: Efficacy biological profile: secretion pattern of soluble factors measure: Efficacy biological profile: cell populations measure: Efficacy biological profile: ocrrelation of the biological markers with the clinical response sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06304012 id: IOE-TBI lao briefTitle: Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-17 date: 2023-06-01 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ACTUAL name: Nasogastric tube feeding name: Intermittent Oro-esophageal Tube Feeding name: Rehabilitation therapy measure: Concentration of hemoglobin measure: Concentration of albumin measure: Concentration of prealbumin measure: Nutritional status-body mass index measure: Complications-Pulmonary Infections measure: Complications-Gastroesophageal Reflux measure: Complications- Gastrointestinal Bleeding measure: Complications-Gastric Retention measure: Complications-Diarrhea measure: Complications-Constipation measure: Decannulation of tracheostomy tube-placement duration measure: Level of consciousness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiansheng Hos. city: Yilan country: Taiwan lat: 24.757 lon: 121.753 hasResults: False

 nctId: NCT06303999 id: IOE-Small lao briefTitle: Effect of Oral Enteral Nutrition on Cerebral Small Vessel Disease overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-02 date: 2023-06-15 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Intermittent Oro-esophageal Tube name: Nasogastric tube measure: Functional Oral Intake Scale measure: Body mass index measure: Serum albumin measure: Hemoglobin measure: Pneumonia measure: Activities of daily living measure: World Health Organization Quality of Life Assessment Instrument Brief Version sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huimin Hos. city: Pengfu country: Taiwan lat: 24.98333 lon: 121.41667 hasResults: False

 nctId: NCT06303986 id: NAS-002 briefTitle: Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process overallStatus: RECRUITING date: 2024-03-18 date: 2024-06-30 date: 2024-06-30 date: 2024-03-12 date: 2024-03-22 name: Rekovar Inc. class: INDUSTRY name: Johns Hopkins University name: Children's Hospital of Orange County name: Children's Hospital Los Angeles name: University of New Mexico briefSummary: Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS). The prevalence of opioid use during pregnancy has increased by 333% from 2013 to 2014 and continues to rise. Approximately 1 in 3 women were prescribed opioids during pregnancy from 2008 to 2012. In the US, NAS was diagnosed every 25 minutes in 2014. By 2019, it became every 15 minutes. Although there are medication-based interventions for the treatment of NAS, used in up to 80% of opioid-exposed infants, these treatments carry risks of toxicity and drug interactions. Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias, resulting in poorer clinical outcomes, such as longer lengths of stay in the Neonatal Intensive Care Unit (NICU), for these babies. Studies have shown that continuous vital sign monitoring improves outcomes and decreases the length of stay in general practice. Preliminary machine learning models have been able to predict pharmacological treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). This project will collect physiological and behavioral data of NAS patients to develop an AI algorithm and establish the advantages of continuous monitoring in NAS. The AI algorithm, processed by machine learning, will help predict NAS symptoms, automate scoring, and provide healthcare personnel with predictive analytics to guide suggested treatments. conditions: Neonatal Abstinence Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Neomonki measure: Training/validation data collection measure: Continuous Monitoring sex: ALL maximumAge: 4 Weeks stdAges: CHILD facility: John Hopkins University status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: Krystle McConnell, MPH role: CONTACT phone: 410-550-8779 email: kgreen39@jhmi.edu name: Lauren Jansson, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: University of New Mexico status: RECRUITING city: Albuquerque state: New Mexico zip: 87106 country: United States name: Sandra S Beauman, MSN, RNC-NIC role: CONTACT phone: 505-272-0363 email: sbeauman@salud.unm.edu name: Jessie R Maxwell, MD, MBA role: PRINCIPAL_INVESTIGATOR lat: 35.08449 lon: -106.65114 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-03-23 uploadDate: 2024-02-26T15:29 filename: ICF_000.pdf size: 230657 hasResults: False

 nctId: NCT06303973 id: IOE-PRS briefTitle: Effect of Oral Enteral Nutrition in Pierre Robin Syndrome overallStatus: COMPLETED date: 2022-01-10 date: 2023-06-02 date: 2023-06-15 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. conditions: Pierre Robin Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: IOE name: PNG measure: Number of patients diagnosed as the pulmonary infection "Positive". measure: Nutritional status-total protein measure: Nutritional status-hemoglobin measure: Nutritional status-albumin measure: Nutritional status-prealbumin measure: Body weight measure: Swallowing function sex: ALL minimumAge: 1 Month maximumAge: 12 Months stdAges: CHILD facility: Renai Hospital city: Yilan country: Taiwan lat: 24.757 lon: 121.753 hasResults: False

 nctId: NCT06303960 id: Cerebellar DBS for stroke briefTitle: Bilateral or Unilateral Cerebellar Deep Brain Stimulation for Chronic Post-stroke Motor Rehabilitation overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-07 date: 2026-03-07 date: 2024-03-12 date: 2024-03-27 name: Qilu Hospital of Shandong University class: OTHER briefSummary: Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. We hypothesized that bilateral stimulation was superior to unilateral stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum. conditions: Stroke studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Bilateral Cerebellar deep brain stimulation name: Unilateral Cerebellar deep brain stimulation measure: safety and feasibility of bilateral cerebellar DBS measure: FM-UE scores between bilateral and unilateral cerebellar DBS measure: Arm Motor Ability Test (AMAT) bilateral and unilateral cerebellar DBS measure: the Nine-Hole Peg Test between bilateral and unilateral cerebellar DBS measure: the Bilateral Box and Block Test between bilateral and unilateral cerebellar DBS measure: Short Form Health Survey (SF-12) between bilateral and unilateral cerebellar DBS measure: the EuroQol Five Dimensions Questionnaire (EQ-5D) between bilateral and unilateral cerebellar DBS measure: the Beck Depression Inventory or the Beck Anxiety Inventory between bilateral and unilateral cerebellar DBS measure: nerve conduction velocity between bilateral and unilateral cerebellar DBS sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chao Zhang status: RECRUITING city: Jinan state: Sichuan zip: 250100 country: China name: chao zhang role: CONTACT phone: +8613969007232 email: chao_zhang@sdu.edu.cn lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06303947 id: IOE-PKS briefTitle: Effect of Oral Enteral Nutrition Feeding in Parkinson Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-07 date: 2024-07 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.

Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube name: Nasogastric tube name: Comprehensive rehabilitation training measure: Serum albumin level measure: Hemoglobin measure: Modified Barthel Index measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303934 id: IOE-NT briefTitle: Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-15 date: 2023-06-30 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: systemic therapy name: Intermittent Oro-Esophageal Tube Feeding name: Persistent Nasogastric Tube Feeding measure: The Oral Motor Assessment Scale measure: Pneumonia measure: Hemoglobin measure: Total Protein measure: Albumin measure: Prealbumin measure: body weight measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale for Infants measure: Feeding amount sex: ALL minimumAge: 6 Months maximumAge: 12 Months stdAges: CHILD facility: River First Hos. city: Pingdong country: Taiwan lat: 24.46667 lon: 118.41667 hasResults: False

 nctId: NCT06303921 id: 854681 briefTitle: Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503 overallStatus: RECRUITING date: 2024-02-16 date: 2029-02 date: 2029-02 date: 2024-03-12 date: 2024-04-25 name: University of Pennsylvania class: OTHER briefSummary: The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites. conditions: Tauopathies studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: 11C-M503 PET name: Brain MRI name: Amyloid PET name: Neurological assessments measure: Organ Biodistribution or Dosimetry measure: PET Uptake of Tracer measure: Adverse Events sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Erin Schubert role: CONTACT phone: 215-662-3041 email: erinshu@pennmedicine.upenn.edu name: IIya Nasrallah, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06303908 id: Commu-PKS briefTitle: How Traditional Chinese Medicine Exercise Improves Parkinson Disease overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2024-12 date: 2024-12 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Simple Gymnastics Training measure: Unified Parkinson's Disease Rating Scale measure: The Berg Balance Scale measure: Patient Health Questionnaire-9 measure: Generalized Anxiety Disorder-7 sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303895 id: Acu-PKS-new briefTitle: How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-13 name: Muhammad class: OTHER briefSummary: This study is focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine rehabilitation training name: Swallowing rehabilitation training name: Acupuncture therapy measure: Penetration-Aspiration Scale-liquid measure: Penetration-Aspiration Scale-paste measure: Swallowing time measure: body mass index measure: Serum Albumin measure: Prealbumin measure: Hemoglobin measure: Swallowing Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303882 id: AI-Dysphagia briefTitle: Effect of Computer-based Cognitive Function Training on Cognitive Dysphagia After Stroke overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Computer-assisted Cognitive Function Training name: conventional cognitive training measure: Montreal Cognitive Assessment measure: The coordination of swallowing measure: Penetration-Aspiration Scale measure: Swallowing duration measure: Swallowing reflex sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303869 id: STUDY22070043 briefTitle: Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-10 date: 2024-03-12 date: 2024-04-03 name: Jorge Gonzalez-Martinez class: OTHER briefSummary: The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life. conditions: Stroke conditions: Brain Disease conditions: Central Nervous System Diseases conditions: Nervous System Diseases conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized, open-label, descriptive, experimental. primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Deep Brain Stimulation (DBS) of the Motor Thalamus measure: Adverse Events measure: Discomfort and Pain measure: Dysphagia measure: Hand dexterity measure: Muscle weakness measure: Dexterity of Articulation AMRs measure: Dexterity of Articulation SMRs measure: Intelligibility of Speech measure: Spasticity measure: Range of Motion (ROM) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Cierra Clark, MS role: CONTACT phone: 240-441-4216 email: cic27@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06303856 id: ABE-OLDer briefTitle: How Active Breathing Training Improves Dysphagia in Elderly People overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-12 date: 2024-03-13 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Active Breathing Exercises measure: Eating Assessment Tool-10 measure: Time consumed in eating measure: Swallowing-Related Quality of Life Questionnaire sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303843 id: 13.04.2023 briefTitle: The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre overallStatus: COMPLETED date: 2023-05-02 date: 2024-02-15 date: 2024-02-15 date: 2024-03-12 date: 2024-03-12 name: Uşak University class: OTHER briefSummary: The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group.

Translated with DeepL.com (free version) conditions: Anxiety conditions: Preoperative Anxiety conditions: Pediatric Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 118 type: ACTUAL name: Transfer with an electric ride-on car measure: Perioperative anxiety sex: ALL minimumAge: 2 Years maximumAge: 10 Years stdAges: CHILD facility: Usak University Training and Research Hospital city: Usak zip: 64100 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06303830 id: BACA2019 briefTitle: Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate overallStatus: COMPLETED date: 2019-04-16 date: 2020-12-17 date: 2021-10-01 date: 2024-03-12 date: 2024-03-12 name: University of Sao Paulo class: OTHER briefSummary: Inorganic nitrite and nitrate can be reduced to NO and NO-related species such as S-nitrosothiols via the nitrate-nitrite-NO pathway. This is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to NO depending on the acidic pH on the stomach or by enzymes with nitrite-reductase activity. The acidic environment of the stomach is very important to the formation of NO and S-nitrosothiols and several studies suggest that changes in gastric pH can affect this conversion. In this context, bariatric surgery, by altering the anatomy of the stomach and increasing gastric pH, can affect the nitrate-nitrite-NO pathway and change the antihypertensive and antioxidant effect of sodium nitrate. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Sodium nitrate measure: Assess changes in s-nitrosothiols measure: Assess changes in blood pressure measure: Assess changes in endotelial function measure: Assess changes in Vascular stiffness measure: Assess changes in nitrate concentration measure: Assess changes in nitrite concentration sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão city: Ribeirão Preto state: São Paulo zip: 14.048-900 country: Brazil lat: -21.1775 lon: -47.81028 hasResults: False

 nctId: NCT06303817 id: 1812 briefTitle: Double Knots Versus Triple Knots Facia Closure Method; is There a Difference in Pain Sensation or Cosmetic Satisfaction? overallStatus: COMPLETED date: 2022-03-01 date: 2022-06-01 date: 2023-01-01 date: 2024-03-12 date: 2024-03-12 name: Adana City Training and Research Hospital class: OTHER briefSummary: The study included women who were scheduled for an elective or had an emergency cesarean section. Age, body mass index (BMI), obstetric history, education status, smoking status and C-section indications of the patients were recorded. Patients with a previous suprapubic scar, medical conditions affecting wound healing (such as diabetes or chronic corticosteroid use), those needing a vertical incision (e.g., placenta previa), individuals with postoperative wound infection or under 18 years old were excluded. Data were collected in standardized data form by a research assistant. Pre- and post-surgery treatments and/or interventions were standardized. All patients received antimicrobial prophylaxis with cefazolin before the operation. The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion. Technical differences such as blunt and sharp dissection, uterus exteriorization vs in situ, or parietal peritoneum closure were left to the surgeon's discretion. The procedures for facia closure are as follows; in Group I (Double knots group), the edge of the fascia was determined with a Kocher clamp. The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture (Figure 2; a-b). In Group II (Triple knots group), the edge of the fascia was fixed with the same suture material instead of the Kocher clamp, and the fascia was closed similarly, starting from the opposite corner via the second loop. Then the loops from the first suture were tied to the second suture (Figure 2; c-d). After the incision was irrigated with sterile saline solution, the subcutaneous space was closed if the thickness was 2 cm or more. Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture, which was removed on the 10th day postoperatively. A closed subcutaneous suction drain was not used in any of the patients. Postoperative pain at and around the incision line was measured on the 1st, and 10th days postoperatively on the NRS (Numeric Rating Scale), with "0" being "no pain" and "10" being "the worst pain imaginable." The 1st measurements were made face-to-face, and the 10th-day evaluation was made via telephone interviews by the same research assistant. conditions: Cesarean Section conditions: Pain conditions: Cosmetics Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 203 type: ACTUAL name: Double knots facia closure method during cesarean section name: Triple knots facia closure method during cesarean section measure: Change from baseline in pain on NRS (Numeric Rating Scale) at 10 days measure: Change from baseline in aesthetic results at 3 months sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Adana Şehir Eğitim ve Araştırma Hastanesi city: Adana state: Yüreğir zip: 01120 country: Turkey lat: 37.00167 lon: 35.32889 hasResults: False

 nctId: NCT06303804 id: HSC-SPH-23-0837 briefTitle: Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores conditions: Opioid Misuse studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Educational videos measure: Acceptability of the educational materials presented via the educational videos, including cultural congruence as assessed by a questionnaire measure: Changes in opioid related knowledge as assessed by a questionnaire 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: Alejandra Fernandez, PhD role: CONTACT phone: 972-546-2920 email: Alejandra.Fernandez@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06303791 id: 1905517 briefTitle: Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders acronym: INPSYD overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-07 date: 2024-05 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: University of Valencia class: OTHER briefSummary: The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support (randomized and with a control group) that will be conducted virtually and synchronously to families of children with autism spectrum disorder (ASD) and families of children with Attention Deficit with hyperactivity Disorder (ADHD). The main questions it aims to answer are:

1. Will the program impact on different variables in the parents' domain (parental stress variables, quality of life/social support and coping skills),
2. Will the program impact on different variables in the children's domain (daily life functioning, social behavioral variables, and executive functioning).
3. Treatment outcomes will be assessed at pre-test, post-test, and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress, coping skills, social support, and children's dysfunctional outcomes

Parents and teachers will complete different questionnaires to see if there are improvements on parent's and children outcomes.

Researchers will compare intervention group and control group to see if there are improvements on parent's domains (parenting stress, coping skills, social support) and children's dysfunctional outcomes (daily life functioning, social behavioral variables, and executive functioning). conditions: Autism Spectrum Disorder conditions: Attention Deficit Hyper Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To test the proposed objectives, a design will be used with a between-groups factor (type of therapy) and a intra-groups with pre-treatment (T0), post-treatment (T1) and follow-up measurements at 6 months (T2). Participants will be randomly assigned (1:1) to the two conditions; a group that will receive the intervention of the structured psychosocial program with digital support (experimental group) and an active control group. The experimental group will undergo an evaluation prior to the intervention, one immediately after it, and a third follow-up evaluation. In the case of the control group, it will be evaluated through the pretest phases, posttest and follow-up. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Families/children who meet the inclusion criteria will be randomly assigned to one of the two conditions (intervention group or control group) using a controlled design. Block randomization will be applied to each of the diagnostic groups (ASD, ADHD) to ensure that participants were of approximately similar size (1:1 ratio) in the treatment and control conditions. After determining the size of each block in the sample (#ASD and #ADHD) the treatment allocation of each individual participant will be done randomly.A blind procedure will be used: participating families will not know the group to which participants will be assigned, and the researchers who will collect and enter the data will also have no knowledge of the condition to which the families will be assigned. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Digital Psychosocial intervention measure: Parental stress in The Parenting Stress Index - Short Form (PSI-SF) Spanish adaptation measure: Social support: The Social Functional Support Questionnaire Duke-UNC measure: Coping Skills using The Brief COPE measure: Children's social problems using Strengths and Difficulties Questionnaire (SDQ) measure: Daily life executive functioning using the BRIEF measure: Children Sleep problems: using The Sleep Disturbance Scale for Children (SDSC) measure: Behavioral problems using The Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P) measure: Children Learning Behavior using Learning behavior scale (LBS) sex: ALL minimumAge: 7 Years maximumAge: 11 Years stdAges: CHILD facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06303778 id: IIR 22-141 id: HX003742-01A1 type: OTHER_GRANT domain: VA HSR&D briefTitle: Combining a Smartphone App With Medications to Manage Heavy Drinking overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-06-01 date: 2028-06-01 date: 2024-03-12 date: 2024-03-12 name: VA Office of Research and Development class: FED briefSummary: One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally. conditions: Alcohol Use Disorder (AUD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Following completion of informed consent and baseline assessments, participants will be randomized in a 1:1 ratio to MAUD+SD-App or MAUD only conditions. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 330 type: ESTIMATED name: Stand Down mobile app name: Standard Care measure: Change in Percent Heavy Drinking Days measure: Semi-structured qualitative interview data from patients, providers, clinical leaders measure: Change in Short Inventory of Problems - Revised version (SIP-R) measure: Change in World Health Organization (WHO) Risk Levels measure: Change in Client Satisfaction Questionnaire (CSQ) Scores measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores measure: Change in Veterans RAND 12 Item Health Survey Scores measure: Change in Percent Heavy Drinking Days measure: Change in Short Inventory of Problems - Revised version (SIP-R) measure: Change in World Health Organization (WHO) Risk Levels measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores measure: Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment measure: Number of Participants Receiving VA Emergency Department Services measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores measure: Change in Veterans RAND 12 Item Health Survey Scores sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Alabama Veterans Health Care System West Campus, Montgomery, AL city: Montgomery state: Alabama zip: 36109 country: United States name: Sebastian Skordallos, PharmD role: CONTACT email: Sebastian.Skordallos@va.gov lat: 32.36681 lon: -86.29997 facility: Phoenix VA Health Care System, Phoenix, AZ city: Phoenix state: Arizona zip: 85012 country: United States name: Courtney Speaks, PharmD role: CONTACT email: Courtney.Speaks@va.gov lat: 33.44838 lon: -112.07404 facility: VA Northern California Health Care System, Mather, CA city: Sacramento state: California zip: 95655-4200 country: United States name: Christine Johnston, PharmD role: CONTACT email: Christine.Johnston2@va.gov lat: 38.58157 lon: -121.4944 facility: Carl Vinson VA Medical Center, Dublin, GA city: Dublin state: Georgia zip: 31021 country: United States name: Deborah Hobbs, PharmD role: CONTACT email: Deborah.Hobbs@va.gov lat: 32.54044 lon: -82.90375 facility: Battle Creek VA Medical Center, Battle Creek, MI city: Battle Creek state: Michigan zip: 49037 country: United States name: Elizabeth Ratti, PharmD role: CONTACT email: Elizabeth.Ratti@va.gov lat: 42.3173 lon: -85.17816 facility: Minneapolis VA Health Care System, Minneapolis, MN city: Minneapolis state: Minnesota zip: 55417-2309 country: United States name: Elizabeth Welch, PharmD role: CONTACT phone: 612-618-8725 email: Elizabeth.Welch@va.gov lat: 44.97997 lon: -93.26384 facility: Kansas City VA Medical Center, Kansas City, MO city: Kansas City state: Missouri zip: 64128-2226 country: United States name: Kyleigh Gould, PharmD role: CONTACT email: Kyleigh.Gould@va.gov lat: 39.09973 lon: -94.57857 facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN city: Nashville state: Tennessee zip: 37212-2637 country: United States name: Matthew Phillips, PharmD role: CONTACT email: Matthew.Phillips1@va.gov lat: 36.16589 lon: -86.78444 facility: South Texas Health Care System, San Antonio, TX city: San Antonio state: Texas zip: 78229-4404 country: United States name: Cynthia Mascarenas, PharmD role: CONTACT email: Cynthia.Mascarenas@va.gov lat: 29.42412 lon: -98.49363 facility: VA Salt Lake City Health Care System, Salt Lake City, UT city: Salt Lake City state: Utah zip: 84148-0001 country: United States name: Chad Nelson, PharmD role: CONTACT email: Chad.Nelson@va.gov lat: 40.76078 lon: -111.89105 facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA city: Seattle state: Washington zip: 98108-1532 country: United States name: Thomas S Bundt, FACHE role: CONTACT phone: 253-583-3500 email: thomas.bundt@va.gov name: Susan Perez, BA role: CONTACT phone: (202) 461-6910 email: susan.perez@va.gov name: Eric J. Hawkins, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06303765 id: 13Nov2023PReDAS Study briefTitle: Evaluating the Practice Resource for Driving After Stroke overallStatus: RECRUITING date: 2024-02-01 date: 2024-07-01 date: 2024-08-31 date: 2024-03-12 date: 2024-04-09 name: Western University, Canada class: OTHER briefSummary: After stroke, individuals must be assessed to determine if they can resume driving. Return to driving is very important to people who have experienced a stroke. Unfortunately, health care providers face challenges in addressing driving after stroke. Common issues include being unsure of the best screening practices, difficulty discussing driving with patients, and challenges making informed recommendations about driving that balance the risk of public safety along with supporting patient goals. Occupational Therapists (OTs) are health care providers that provide screening, assessment, and intervention for driving to individuals who have had a stroke. OTs working in stroke care have highlighted the urgency for evidence-based resources to support practice to address driving with patients. The Practice Resource for Driving After Stroke (PReDAS), is an evidenced-based resource to support the clinical practice of OTs in addressing driving in acute stroke settings. A previous pilot study has demonstrated that the PReDAS is considered useful by both health care providers and patients. Further study is needed to evaluate how the PReDAS can support OTs in addressing driving with patients. The current study proposes to provide the PReDAS as an intervention to OTs working in acute stroke settings to see if the intervention increases OT's self efficacy and clinical reasoning for addressing driving. The study will take repeated measures of self-efficacy and clinical reasoning among participating OTs to determine if the PReDAS intervention supports improved self-efficacy and clinical reasoning. conditions: Stroke, Acute conditions: Driving conditions: Occupational Therapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: multiple baseline study primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Practice Resource for Driving After Stroke (PReDAS) measure: clinical reasoning measure: self-efficacy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Western University status: RECRUITING city: London state: Ontario zip: N6G 1H1 country: Canada name: April K Vander Veen, PhD (c) role: CONTACT phone: 519-661-2111 phoneExt: 89153 email: afrankr2@uwo.ca name: Liliana Alvarez, PhD role: CONTACT phone: 519-661-2111 phoneExt: 88957 email: lalvare2@uwo.ca lat: 42.98339 lon: -81.23304 hasResults: False

 nctId: NCT06303752 id: 260-2021-NQ id: 2022-502659-73 type: EUDRACT_NUMBER briefTitle: Tissue Therapy of Transsphincteric Anal Fistula acronym: REP-PAF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-04-30 date: 2024-03-12 date: 2024-04-12 name: University of Southern Denmark class: OTHER briefSummary: This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics. conditions: Anal Fistula 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: 75 type: ESTIMATED name: ADRC injection name: ADRC001 injection measure: Healing rate (percentage) measure: QoL measure: Fecal Incontinence measure: Risk factors for recurrence of fistula. measure: Radiological healing. measure: Treatment efficacy. measure: Cellular composition measure: Transplantation-related alloantibodies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Odense University Hospital city: Odense zip: 5000 country: Denmark name: Karam M Sørensen, Ph.D role: CONTACT phone: +4565415190 email: ouh.a.forskningsenheden@rsyd.dk name: Tina D Hansen role: CONTACT phone: +4565415190 email: ouh.a.forskningsenheden@rsyd.dk lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06303739 id: 22-1421 briefTitle: Psilocybin-Assisted Therapy in Treatment-Resistant Depression overallStatus: RECRUITING date: 2024-04-19 date: 2025-09 date: 2026-09 date: 2024-03-12 date: 2024-04-23 name: University of North Carolina, Chapel Hill class: OTHER name: Foundation of Hope, North Carolina briefSummary: The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are:

* Does psilocybin with assisted therapy help improve symptoms for people with depression?
* How long do the effects of this treatment last?

Participants will:

* Take part in a couple of screening and preparation visits.
* Be given psilocybin in one or two treatment sessions.
* Attend a series of follow-up sessions over the following year.
* Complete forms and surveys to test how their symptoms have changed and what they thought of their experience.

Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants. conditions: Refractory Depression conditions: Treatment Resistant Depression studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized into one of two groups and will receive either one single treatment of psilocybin-assisted therapy with follow-up therapy and assessments or two treatments spaced two weeks apart with follow-up therapy and assessments. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the nature of the study and limitations of study staffing, only those conducting assessments and ratings throughout the study will be masked to the treatments. All others, including participants, therapists, investigators, and study coordinator, will not be masked to the number of treatments a participant receives. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: psilocybin measure: Change in HAM-D-17 Scores between Baseline and 2 Weeks after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 2 Weeks after Treatment measure: Number of Participants Achieving Remission 2 Weeks after Treatment measure: Number of Participants Achieving Response 2 weeks after treatment measure: Number of Participants Achieving Remission at 6 Weeks measure: Number of Participants Achieving Response at 6 Weeks measure: Number of Participants Achieving Remission at 3 Months measure: Number of Participants Achieving Response at 3 Months measure: Number of Participants Achieving Remission at 6 Months measure: Number of Participants Achieving Response at 6 Months measure: Number of Participants Achieving Remission at 9 Months measure: Number of Participants Achieving Response at 9 Months measure: Number of Participants Achieving Remission at 12 Months measure: Number of Participants Achieving Response at 12 Months measure: Time to Relapse in Participants Who Showed Remission at 2 weeks measure: Time to Relapse in Participants Who Showed Response at 2 Weeks measure: Change in HAM-D-17 Scores between Baseline and 6 Weeks after Treatment measure: Change in HAM-D-17 Scores between Baseline and 3 Months after Treatment measure: Change in HAM-D-17 Scores between Baseline and 6 Months after Treatment measure: Change in HAM-D-17 Scores between Baseline and 9 Months after Treatment measure: Change in HAM-D-17 Scores between Baseline and 12 Months after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 6 Weeks after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 3 Months after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 6 Months after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 9 Months after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 12 Months after Treatment sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Chapel Hill Medical Center status: RECRUITING city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Mary Pruden, BA role: CONTACT name: Robert K McClure, MD role: PRINCIPAL_INVESTIGATOR name: Amanda Tow, MD, PhD role: SUB_INVESTIGATOR name: Lindley Reynolds, MSW role: SUB_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06303726 id: IRP-2021/02-19 briefTitle: Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-25 date: 2024-04-01 date: 2024-06-25 date: 2024-03-12 date: 2024-03-12 name: University Medical Centre Maribor class: OTHER briefSummary: The goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined).

The main question it aims to answer are:

* which surgery gives better outcome in patients (short- and long-term results)?
* are there any sings of osteoarthritis in an injured knee compared to a healthy knee?

Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging (MRI) of both knees. Subjective exams with different scores (Tegner score, Lysholm score..) were also done. The same exam protocol for participant was used again after two years and fifteen years since surgery. conditions: Anterior Cruciate Ligament Reconstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: ACL reconstruction single bundle name: ACL reconstruction double bundle measure: IKDC SUBJECTIVE SCORE measure: TEGNER SCORE measure: LYSHOLM SCORE measure: OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS measure: OBJECTIVE PARAMETER: AP TRANSLATION (anterior-posterior) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Clinical Center Maribor city: Maribor zip: 2000 country: Slovenia lat: 46.55472 lon: 15.64667 hasResults: False

 nctId: NCT06303713 id: 23-693 briefTitle: LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-07-19 date: 2026-07-19 date: 2024-03-12 date: 2024-03-12 name: Dana-Farber Cancer Institute class: OTHER name: Novartis briefSummary: The purpose of this study is to see whether the combination of a chemotherapy drug, carboplatin, along with the radioligand treatment, 177Lu-PSMA-617, is safe in treating prostate cancer and whether the combination is effective in shrinking or preventing growth of prostate cancer.

The names of the study drugs used in this research study are:

* Carboplatin (A type of chemotherapy)
* 177Lu-PSMA-617 (A type of radioligand therapy) conditions: Prostate Cancer conditions: Metastatic Prostate Cancer conditions: Metastatic Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Carboplatin name: 177Lu-PSMA-617 measure: Maximum tolerated dose (MTD) or the Recommended Phase 2 dose (RP2D) of carboplatin administered in combination with 177Lu-PSMA-617 measure: PSA response rate (PSA reduction by ≥50% from baseline). measure: Overall Response Rate (ORR) measure: Radiographic Progression-Free Survival (rPFS) measure: Overall Survival (OS) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center city: Boston state: Massachusetts zip: 02215 country: United States name: Daniel Fein, MD role: CONTACT phone: 617-667-2100 email: dfein@bidmc.harvard.edu name: Daniel Fein, 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: Praful Ravi, MB BCHir, MRCP role: CONTACT phone: 617-632-3466 email: Praful_Ravi@DFCI.HARVARD.EDU name: Praful Ravi, MB BCHir, MRCP role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Praful Ravi, MB BChir, MRCP role: CONTACT phone: 617-632-3466 email: praful_ravi@dfci.harvard.edu name: Praful Ravi, MB BCHir, MRCP role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06303700 id: Quality of life briefTitle: Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups overallStatus: COMPLETED date: 2022-05-10 date: 2024-01-31 date: 2024-01-31 date: 2024-03-12 date: 2024-03-12 name: Amira Hussin Hussin Mohammed class: OTHER briefSummary: To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics. conditions: Public Health studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 604 type: ACTUAL measure: the severity of dyspnea measure: the level of fear of falling through daily life activities measure: quality of life and public health sex: ALL minimumAge: 12 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Amira Hussin Mohammed city: Gamasa zip: 35712 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False

 nctId: NCT06303687 id: STUDY00003496 briefTitle: VR-PAT and fNIRS to Identify CNS Biomarkers of Pain overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-12 name: Nationwide Children's Hospital class: OTHER briefSummary: This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR). conditions: Acute Pain conditions: Pediatric ALL conditions: Procedural Pain conditions: Burns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomly assigned to either the intervention (fNIRS and VR-PAT) or the control (fNIRS and standard of care) at the first research dressing change and will then crossover to the alternative group for the second laser procedure. primaryPurpose: DIAGNOSTIC masking: NONE count: 4 type: ESTIMATED name: VR-PAT measure: Change in brain activity measure: Procedural pain during burn dressing changes measure: Change in procedural anxiety measure: Self-reported VR experience sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43205 country: United States lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06303674 id: 301CER22 id: PID2021-123357OA-I00 type: OTHER_GRANT domain: Ministry of Science and Innovation - Spanish State Research Agency - European Regional Development Fund briefTitle: Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-27 date: 2024-07 date: 2025-09 date: 2024-03-12 date: 2024-03-12 name: University of the Balearic Islands class: OTHER name: Ministry of Science and Innovation name: European Regional Development Fund name: Spanish State Research Agency briefSummary: Advancement in teaching methods, together with the frenetic change in the lifestyles of the school population, provides a unique opportunity to advance scientific knowledge. The current project, called "The Break4Brain Project", aims to examine the acute (transient) effects of physical activity on brain function, cognition, and academic performance in children with and without Attention Deficit Hyperactivity Disorder (ADHD). Specifically, a total of 60 children between 10 and 12 years old will be included with (n=30) and without (n=30) ADHD. The study will use an intra-subject design of isolated conditions with four measurement moments where the children will perform three different experimental conditions lasting 10 minutes, which will be randomized in a counterbalanced manner. These experimental conditions will be based on physical activity engaging cognitively, physical activity without engaging cognitively, and cognitively engaging control condition. This project could have a significant impact in the educational field, since, if brain function, cognition, and academic performance prove to be favorably stimulated, acutely, by physical activity through active breaks, these could be prescribed as an effective teaching strategy for children with and without ADHD in the school setting. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The design of the study is a within-participants crossover pretest-posttest comparison design under laboratory settings will be used. In this design, all participants will engage in all experimental conditions (on separate days), with the order of the experimental conditions being counterbalanced across participants and outcomes assessed following each experimental condition. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Physical activity with engaging cognitively name: Physical activity without engaging cognitively measure: Academic achievement measure: Inhibition measure: Working memory measure: Sustained attention measure: Brain function measure: Physical fitness and body composition measure: Physical activity levels and sleep measure: Self-reported sedentary patterns measure: Motor proficiency measure: Biological maturation measure: ADHD symptoms measure: IQ measure: Socioeconomic levels measure: Educational levels sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD facility: University of the Balearic Islands city: Palma state: Balearic Islands zip: 07122 country: Spain lat: 39.56939 lon: 2.65024 hasResults: False

 nctId: NCT06303661 id: 74001323.3.0000.5544 briefTitle: Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease overallStatus: RECRUITING date: 2024-01-08 date: 2025-12 date: 2026-06 date: 2024-03-12 date: 2024-03-12 name: Centro de Atenção ao Assoalho Pélvico class: OTHER briefSummary: The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question\[s\] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy. conditions: Peyronie Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Combination of two therapies with conservative devices is proposed. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Non-ablative Radiofrequency name: Low-intensity Shock Wave Therapy measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function. measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to pain. measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to penile erection. measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on quality of life and psycho-emotional aspects of anxiety and depression. measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on psycho-emotional aspects of anxiety and depression. sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Atenção ao Assoalho Pelvico status: RECRUITING city: Salvador state: Ba zip: 40.290-000 country: Brazil name: Patricia V Lordelo, Phd role: CONTACT phone: +5571988592400 email: pvslordelo@hotmail.com name: Carlos Mamede, Phd role: SUB_INVESTIGATOR name: Patricia V Lordelo, Phd role: PRINCIPAL_INVESTIGATOR lat: -12.97111 lon: -38.51083 hasResults: False

 nctId: NCT06303648 id: TSND201-PK-101 briefTitle: A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects overallStatus: RECRUITING date: 2024-03-20 date: 2024-05-04 date: 2024-05-11 date: 2024-03-12 date: 2024-04-16 name: Transcend Therapeutics class: INDUSTRY briefSummary: This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects. conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1. primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Methylone measure: Cmax: Maximum Observed Plasma Concentration for methylone measure: AUC: Area under the plasma concentration-time curve for methylone measure: Incidence and frequency of adverse events measure: Change overtime in Visual Analog Scales sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: CMAX Clinical Research status: RECRUITING city: Adelaide state: South Australia zip: 5000 country: Australia name: Research Team role: CONTACT lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06303635 id: UFRJvac-1 briefTitle: Safety of UFRJvac, Trivalent COVID-19 Vaccine acronym: UFRJvac-1 overallStatus: NOT_YET_RECRUITING date: 2024-06-24 date: 2025-10-16 date: 2025-11-25 date: 2024-03-12 date: 2024-03-12 name: Azidus Brasil class: INDUSTRY name: Universidade Federal do Rio de Janeiro briefSummary: Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine. conditions: Healthy People studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 156 type: ESTIMATED measure: Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster measure: Evaluate the safety and reactogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 measure: Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 measure: Evaluate the humoral immunogenicity of the vaccine booster the trivalent UFRJvac COVID-19 measure: Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac measure: Evaluate the humoral immunogenicity of the vaccine booster trivalent UFRJvac measure: Evaluate the cellular immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303622 id: CRE-2023.610 briefTitle: Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-31 date: 2027-03-31 date: 2024-03-12 date: 2024-04-10 name: Chinese University of Hong Kong class: OTHER briefSummary: This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1250 type: ESTIMATED name: MRI-USG fusion approach name: Cognitive-guided approach measure: Proportion of men with clinically significant Prostate cancer(csPCa) measure: Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm measure: Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m measure: The proportion of men with a diagnosis of csPCa only in targeted biopsy measure: Proportion of men with a diagnosis of csPCa only in systemic biopsy measure: Proportion of men with a diagnosis of clinically insignificant PCa, measure: Procedure time measure: Pain score on a scale of 0-10 taken after biopsy measure: Proportion of men with post-biopsy adverse events within 30 days after biopsy sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06303609 id: 61102222.5.0000.5544 briefTitle: Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder acronym: Pelvic Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-06-20 date: 2026-07-20 date: 2024-03-12 date: 2024-03-18 name: Centro de Atenção ao Assoalho Pélvico class: OTHER briefSummary: The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress. conditions: Pelvic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 56 type: ESTIMATED name: nonablative radiofrequency name: Vaginal dilator name: Sham nonablative radiofrequency measure: Penetration capacity with reduced vaginal pain measure: Sexual function measure: Quality of sexual life measure: Stress perception sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06303596 id: Hippotherapy in Schizophrenia briefTitle: Hippotherapy in Patients With Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-08-01 date: 2024-10-01 date: 2024-03-12 date: 2024-03-12 name: Erzurum Technical University class: OTHER briefSummary: This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention. conditions: Equine-Assisted Therapy conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The evaluator who collects the data is blinded to the allocation of groups. whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Hippotherapy name: Standard psychiatric treatment measure: The Positive and Negative Syndrome Scale (PANSS) measure: State-Trait Anxiety Inventory (STAI) measure: The Quality of Life Scale (QLS) measure: UCLA Loneliness Scale sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erzurum Technical University, Erzurum Community Mental Health Center city: Erzurum zip: 25010 country: Turkey name: Musa Eymir, Ph.D., PT, Assist. Prof. role: CONTACT phone: +904424445388-2733 email: musa.eymir@erzurum.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06303583 id: IRB- 2022-213 briefTitle: Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma acronym: CRIS overallStatus: ENROLLING_BY_INVITATION date: 2022-06-01 date: 2024-08-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Qiu Guoqin class: OTHER briefSummary: The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: paclitaxel name: carboplatin name: tislelizumab name: radiotherapy measure: Complete pathological response rate measure: R0 resection rate measure: 2-year Disease-free survival rate measure: 2-year overall survival rate measure: Safety will be analyzed through the incidence of adverse events, serious adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06303570 id: CBL-0202DD briefTitle: A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2025-05-23 date: 2025-05-23 date: 2024-03-12 date: 2024-03-12 name: Caliway Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas. conditions: Dercum's Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: CBL-514 injection name: 0.9% Sodium chloride measure: To estimate the treatment effect, as measured by Complete Response (CR), between CBL-514 and placebo at Week 12 in participants with Dercum's disease (DD). measure: To estimate the treatment effect, as measured by pain, between CBL-514 and placebo at Week 12 in participants with DD. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To evaluate the treatment effect, as measured by change in volume, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To evaluate the incidence of adverse events of special interests (AESI) as defined in the protocol. measure: To evaluate the incidence of clinically significant abnormal findings as defined in the protocol as defined in the protocol. sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False

 nctId: NCT06303557 id: AEŞH-EK1-2023-797 briefTitle: Effect of ESPB on Intraoperative Remifentanil Consumption overallStatus: RECRUITING date: 2024-01-31 date: 2024-11-30 date: 2024-12-30 date: 2024-03-12 date: 2024-03-12 name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital class: OTHER briefSummary: In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.

General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifantanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.

As a result of all these; it was aimed to compare the intraoperative remifantanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB. conditions: Lumbar Spine Surgery conditions: Erector Spinae Plane Block conditions: Remifentanil Consumption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Preoperative Erector Spinae Plane Block name: Postperative Erector Spinae Plane Block measure: Intraoperative remifentanil consumption measure: Mean arterial pressure measure: Heart rate measure: Pain scores sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Etlik City Hospital status: RECRUITING city: Yenimahalle state: Ankara zip: 06170 country: Turkey name: Musa Zengin, Associate Professor role: CONTACT phone: 00905307716235 email: musazengin@gmail.com name: Deniz Çolak, MD role: CONTACT phone: 00905386519710 email: doctordenizcolak@outlook.com hasResults: False

 nctId: NCT06303544 id: R01HL168853 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL168853 briefTitle: More Outside Your Door: A Diet/Physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers acronym: MOYD overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-06-30 date: 2028-05-30 date: 2024-03-12 date: 2024-03-12 name: Alaska Native Tribal Health Consortium class: OTHER name: Washington State University name: University of Alaska Anchorage briefSummary: The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention. conditions: Child Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Wedge design using repeated cross sectional samples of Head Start preschool students primaryPurpose: OTHER masking: NONE count: 450 type: ESTIMATED name: Wedge 1 measure: BMI measure: Physical activity measure: Outdoor time measure: Sleep quality measure: Fingernail nitrogen & carbon stable isotope ratios sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD facility: Alaska Native Tribal Health Consortium city: Anchorage state: Alaska zip: 99508 country: United States lat: 61.21806 lon: -149.90028 hasResults: False

 nctId: NCT06303531 id: Efficacious Iron briefTitle: Efficacious Iron for Iron Deficiency Anemia in Adults Aged ≥18 Years overallStatus: ENROLLING_BY_INVITATION date: 2024-02-24 date: 2025-02 date: 2025-02 date: 2024-03-12 date: 2024-03-25 name: Dr. Anil K. Gupta Medicine Professional Corporation class: NETWORK briefSummary: Iron deficiency anemia (IDA) is a widespread condition affecting many people globally. Despite the many cases of IDA, there are few studies that compare the effectiveness of different types of iron supplements with a greater emphasis on the cost of supplements and their tolerability. This study aims to conduct a comparison between different iron supplements to determine the superiority of the iron supplements Ferrous Ascorbate (EBMfer) and Ferrous Fumarate (Eurofer) over polysaccharide iron (FeraMax). This comparison will be conducted by determining the change in hemoglobin levels for participants in this trial over a 3-month period. conditions: Iron Deficiency Anemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 111 type: ESTIMATED name: Ferrous Fumarate name: Polysaccharide Iron name: Ferrous Ascorbate measure: Change in Hemoglobin Levels measure: Change in Serum Ferritin measure: Tolerability of Study Medication - Discontinuation Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Albion Finch Medical Centre city: Etobicoke state: Ontario zip: M9V 4B4 country: Canada lat: 43.65421 lon: -79.56711 hasResults: False

 nctId: NCT06303518 id: H23-03546 briefTitle: End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: University of British Columbia class: OTHER briefSummary: Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children.

During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are.

The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment. conditions: Anesthesia conditions: Hypercapnia conditions: Hypocapnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The investigators plan to conduct a randomized, prospective, crossover trial. The six arms will be as below:

1. Normal ETCO2 -\> High Normal ETCO2 -\> Low Normal ETCO2
2. Normal ETCO2 -\> Low Normal ETCO2 -\> High Normal ETCO2
3. High Normal ETCO2 -\> Low Normal ETCO2 -\> Normal ETCO2
4. High Normal ETCO2 -\> Normal ETCO2 -\> Low Normal ETCO2
5. Low Normal ETCO2 -\> High Normal ETCO2 -\> Normal ETCO2
6. Low Normal ETCO2 -\> Normal ETCO2 -\> High Normal ETCO2 primaryPurpose: OTHER masking: SINGLE maskingDescription: The anesthesiologist will be blinded to the BIS reading and will continue to provide anesthesia according to the protocol. The BIS numerical value in the OR will be covered, but the waveform will be visible to assess signal quality. The anesthesiologist providing care to the patient will not be involved in data collection or analysis whoMasked: CARE_PROVIDER count: 100 type: ESTIMATED name: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) name: Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) name: Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) measure: To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS. measure: Patient movement as detected clinically by the surgical or anesthetic team. sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD hasResults: False

 nctId: NCT06303505 id: NAPISTAR 1-01 id: 2024-511074-80 type: EUDRACT_NUMBER briefTitle: FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC acronym: NAPISTAR1-01 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-01 date: 2027-01 date: 2024-03-12 date: 2024-03-12 name: Tubulis GmbH class: INDUSTRY briefSummary: The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients.

TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects. conditions: Ovarian Cancer conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: TUB-040 measure: Determination of MTD measure: Maximum plasma/serum concentration (Cmax) measure: Through plasma/serum concentration (Cmin) measure: The time taken to reach the maximum concentration (Tmax) measure: Area Under Curve (AUC) measure: Half life (T1/2) measure: Determination of immunogenicity measure: Determination of efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Christ Hospital city: Cincinnati state: Ohio zip: 45219 country: United States name: Alexander Starodub role: CONTACT name: Alexander Starodub, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06303492 id: CTO 4096 briefTitle: Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-04 date: 2024-03-12 date: 2024-03-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries. conditions: Pulmonary Aspiration conditions: Emergency Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 142 type: ESTIMATED name: GUS measure: Proportion of change in Anesthetic Plan measure: Percentage change in the three-category risk assessment before and after GUS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303479 id: Voldyne_Tele briefTitle: The Effect of Telerehabilitation-Based Respiratory Exercise Programs on Lung Capacity overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-09-29 date: 2024-03-12 date: 2024-03-12 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason;

* Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities,
* It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment.

In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly.

Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants.

Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated. conditions: Breathing Exercises conditions: Telerehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 26 type: ESTIMATED name: Non-Instrumental breathing exercise group name: Instrumental breathing exercise group measure: Pulmonary Function Test for FEV1 measure: Pulmonary Function Test for PEF measure: Pulmonary Function Test for FEV1/FVC measure: Pulmonary Function Test for FVC measure: International Physical Activity Questionnaire-Short Form (IPAQ-SF) sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Health Sciences city: Istanbul country: Turkey name: Esra PEHLİVAN, Assoc. Dr. role: CONTACT phone: +90 212 409 02 00 email: esra.pehlivan@sbu.edu.tr name: Esra PEHLİVAN, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR name: Fatma Nur AYYILDIZ, Student role: SUB_INVESTIGATOR name: Beyzanur YEŞİLYURT, Student role: SUB_INVESTIGATOR name: Mustafa ÇÖRTÜK, Prof. Dr. role: SUB_INVESTIGATOR name: Fulya KARAAHMETOĞLU, PhD (c) role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06303466 id: R-23053109 briefTitle: Real World Evidence Study of Danish Fabry Patients acronym: RWE-FABRY overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-01 date: 2024-08-01 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Caroline Michaela Kistorp class: OTHER name: Amicus Therapeutics name: Rigshospitalet, Denmark briefSummary: Fabry is a rare X-linked metabolic lysosomal disorder caused by deficiency in the enzyme α-galactosidase A (alpha-Gal A) by mutations in the GLA gene, encoding the alpha-Gal A enzyme, which catalyses glycosphingolipids, namely globotriaosylceramide (Gb3). Reduced or absent alpha-Gal A activity leads to accumulation of Gb3 in various organs as well as cellular dysfunction and inflammation causing phsyical symptoms and eventual organ failure. Treatment has been available since 2001 for Fabry patients - first enzyme replacement therapy and since 2016, an oral chaperone therapy, Migalastat. Although the initial trials of Migalastat had some both short and extended outcome treatment comparisons, the overall evidence of clinical efficacy is based on too small numbers considering the heterogeneity of the Fabry patient population as well as the very slow progression of the disease. Though the body of real-world evidence is growing, there is a need for more publications of real-world long-term data on clinical outcomes with a focus on treatment with Migalastat.

Research Question:

Is the incidence and prevalence of Fabry associated clinical events (FACEs) (cardiac, renal, and cerebrovascular) associated with sex, genotype, phenotype at time of diagnosis, biomarkers, and Fabry specific therapy?

Objectives:

* To investigate time to first Fabry associated clinical events (FACE) (cardiac, renal, and cerebrovascular) with particular focus on Migalastat clinical outcomes and treatment outcomes preceding Migalastat therapy.
* To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment.
* To describe FACEs in accordance with different geno- and phenotypic groups.
* To investigate the incidence and time to a first fatal or non-fatal cardiac, renal, and cerebrovascular clinical event, separated by each category.

Primary outcomes - Time to first FACE (cardiac, renal, and cerebrovascular) with particular focus on Migalastat on clinical outcomes and treatment outcomes preceding Migalastat therapy.

Secondary outcomes

* To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment.
* To describe FACEs in accordance with different geno- and phenotypic groups To investigate the incidence and time to a first fatal or non-fatal cardiac, renal and cerebrovascular clinical event, separated by each category.

Exploratory outcomes

- To describe disease progression with focus on organ involvement.

The study design is a retrospective clinical and paraclinical follow-up of the Danish National Fabry cohort in the period 01.01.2001-31.12.2022. Patient followed a structured yearly monitoring program as part of routine clincal care. conditions: Fabry Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 115 type: ESTIMATED measure: Time to first individual FACE since confirmed diagnosis (Composite endpoint) measure: Time to first FACE after initiation of Migalastat treatment (Composite endpoint) measure: Time to first individual FACE since confirmed diagnosis (cardiac) measure: Time to first individual FACE after initiation of Migalastat treatment (cardiac) measure: Time to first individual FACE since confirmed diagnosis (renal) measure: Time to first individual FACE after initiation of Migalastat treatment (renal) measure: Time to first individual FACE after initiation of Migalastat treatment (cerebrovascular) measure: Time to first individual FACE since confirmed diagnosis (cerebrovascular) measure: Prevalence of FACE since confirmed diagnosis measure: Prevalence of FACE after initiation of Fabry-specific treatment measure: Incidence of FACE since confirmed diagnosis measure: Incidence of FACE after initiation of Fabry-specific treatment measure: Incidence of cardiac events since confirmed diagnosis measure: Incidence of renal events since confirmed diagnosis measure: Incidence of cerebrovascular events since confirmed diagnosis measure: Incidence of cardiac events after initiation of Fabry-specific treatment measure: Incidence of renal events after initiation of Fabry-specific treatment measure: Incidence of cerebrovascular events after initiation of Fabry-specific treatment measure: Annualized rate of change in eGFR by CKDEPI-formula since initiation of treatment measure: Annualized rate of change in eGFR by CKDEPI-formula after initiation of Fabry-specific treatment measure: Rapid renal progression of disease since confirmed diagnosis measure: Rapid renal progression of disease after initiation of Fabry-specific treatment measure: Incidence of albuminuria since confirmed diagnosis measure: Incidence of albuminuria after initiation of Fabry-specific treatment measure: Prevalence of albuminuria since confirmed diagnosis measure: Prevalence of albuminuria after initiation of Fabry-specific treatment measure: Organ-specific decline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-06-30 uploadDate: 2024-02-21T07:57 filename: Prot_000.pdf size: 1310571 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-12-13 uploadDate: 2024-01-12T12:10 filename: SAP_001.pdf size: 519985 hasResults: False

 nctId: NCT06303453 id: REC/RCR&AHS/23/0291 briefTitle: Comparative Effects of Balance and Resisted Training in Diabetic Peripheral Neuropathy. overallStatus: RECRUITING date: 2024-02-25 date: 2024-05-01 date: 2024-05-15 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy. conditions: Diabetic Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated. whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: Balance exercises name: Resisted exercises measure: Michigan neuropathy screening instrument measure: De Morton mobility index test measure: PainDETECT Tool sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Riphah International University status: RECRUITING city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: Kashif.shaffi@gmail.com name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: Kashif.shafi@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303440 id: REC/RCR&AHS/23/0288 briefTitle: Effects of Virtual Reality Training Versus Motor Imagery in Children With Cerebral Palsy overallStatus: RECRUITING date: 2024-02-25 date: 2024-05-10 date: 2024-05-25 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Routine Physical Therapy+ Balance Training name: Virtual Reality+ Routine Physical Therapy name: Motor Imagery+ Routine Physical Therapy measure: Gross Motor Function Classification System(GMFCS) measure: Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 ) measure: WeeFIM scale sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Riphah International University status: RECRUITING city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: Kashif.shaffi@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303427 id: REC/RCR & AHS/23/0292 briefTitle: Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-05-01 date: 2024-05-15 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: ERB's palsy is an injury of upper section of the brachial plexus (C5-6) leading to an internally rotated and adducted shoulder and a pronated forearm. Modified constraint-induced movement therapy improves the functionality of the affected limb, while electrical stimulation helps in the improvement of active range of motion and muscle strength in ERB's palsy patients. This study aims to investigate the effects of modified constraint-induced movement therapy with and without electrical stimulation on range of motion, muscle strength, and motor functions in patients with ERB's Palsy. conditions: Erb's Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single-blinded as the assessor of the study would be kept blind to the treatment groups to which patients will be allocated. whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: Modified constraint-induced movement therapy name: Electrical stimulation measure: Standard universal goniometer measure: Medical Research Council (MRC) Scale measure: Active Movement Scale sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: Riphah International University city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: kashif.shaffi@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303414 id: RESCO briefTitle: Revascularization for Symptomatic Non-acute Carotid Artery Occlusion acronym: RESCO overallStatus: RECRUITING date: 2016-06-17 date: 2028-12-30 date: 2028-12-30 date: 2024-03-12 date: 2024-03-12 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. The purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery. conditions: Non-acute Carotid Artery Occlusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Carotid Endarterectomy (CEA) name: Carotid Artery Stenting (CAS) name: Hybrid Surgery measure: Stroke or death whthin 30 days or recurrent ischemic stroke related of qualifying artery beyond 30 days through 12 months measure: MMSE within 30 and 90 days after procedure measure: MoCA scale within 30 and 90 days after procedure measure: Technical success rate measure: Procedural success rate measure: Any stroke within 30 days, 90 days and 12 months after procedure measure: Death within 30 days, 90 days and 12 months after procedure measure: Cranial nerve injury measure: Carotid artery or internal carotid artery reocclusion measure: Functional outcome measure: Other major complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100005 country: China name: Tao Wang, MD role: CONTACT phone: 18810302298 email: wangtao_dr@sina.com lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital, Capital Medical University. status: RECRUITING city: Beijing zip: 100053 country: China name: Liqun Jiao, Dr. role: CONTACT phone: 13911224991 email: liqunjiao@sina.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06303401 id: REC/MS-PT/01787 Gullalay briefTitle: Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises in Post Partum Low Back Pain overallStatus: RECRUITING date: 2023-09-27 date: 2024-07-31 date: 2024-08-30 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain. conditions: Low Back Pain, Post Partum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 44 type: ESTIMATED name: SI joint thrust manipulation name: pelvic stabilization exercises measure: Numeric pain rating scale (NPRS) measure: Modified Oswestry Disability Index (ODI) sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Lady Reading Hospital and Shahab Orthopedic & General Hospital status: RECRUITING city: Peshawar state: KPK zip: 25000 country: Pakistan name: Asmar Fatima, MS OMPT role: CONTACT phone: 03336195644 email: asmar.fatima@riphah.edu.pk name: Gull alay, MS OMPT* role: PRINCIPAL_INVESTIGATOR name: Asmar Fatima, MS OMPT role: SUB_INVESTIGATOR lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06303388 id: REC/MS-PT/01721 briefTitle: Effects of Bruegger's Exercises Versus Egoscue Exercise on Lower Cross Syndrome overallStatus: RECRUITING date: 2024-02-26 date: 2024-05-30 date: 2024-06-15 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: This study aims to find effects of Bruegger's Exercise versus Egoscue exercise on pain and hyperlordosis on patient with lower cross syndrome. This is interventional study which recruits 34 participants ,14 in each group. conditions: Lower Cross Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 34 type: ESTIMATED name: Bruegger,s Exercise name: Egoscue Exercise measure: Flexicurve Ruler measure: Pelvic Inclinometer measure: NPRS measure: Modified Thomas Test measure: Visual Assessment through toe touching measure: Prone Hip Extension Co-ordination Test measure: Trunk Flexion Co-ordination and Strength Test sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Pakistan Railway General Hospital status: RECRUITING city: Rawalpindi state: Federal zip: 44000 country: Pakistan name: Abdul Wasay, MS(SPT) role: CONTACT phone: 03345056564 name: Azka Batool, MS(OMPT) role: PRINCIPAL_INVESTIGATOR name: Nadia Ishtiaq, MS-OMPT role: SUB_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06303375 id: REC/MS-PT/01718 Nida Kausar briefTitle: Effect of Kinesio Taping on Pain, Posture and Function in Lower Cross Syndrome overallStatus: RECRUITING date: 2023-10-13 date: 2024-07-31 date: 2024-08-30 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: Determine the impact of Kinesio taping on pain, postural alignment and functional outcomes in individuals with lower cross syndrome. conditions: Lower Cross Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 44 type: ESTIMATED name: Kinesio taping name: Conventional physical therapy measure: Visual analog scale (VAS) measure: Anterior pelvic tilting measure: Oswestry Disability Index (ODI) measure: Muscle Length sex: FEMALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Railway hospital Rawalpindi status: RECRUITING city: Rawalpindi state: Punjab zip: 46060 country: Pakistan name: Asmar Fatima, MS OMPT role: CONTACT phone: 03336195644 email: asmar.fatima@riphah.edu.pk name: Nida Kausar, MS OMPT* role: PRINCIPAL_INVESTIGATOR name: Asmar Fatima, MS OMPT role: SUB_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06303362 id: REC/MS-PT/014258 Sumbal Nawaz briefTitle: Effects of Elastic Band Excercises on Chest Expansion overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-30 date: 2024-01-30 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: • To determine the effects of Elastic Band Exercises on Chest Expansion, Forward Head Posture and disability conditions: Forward Head Posture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 28 type: ACTUAL name: Elastic band excercise name: strengthening with conventional physical therapy measure: Cloth tape measurement measure: Neck Disability Index measure: Craniovertebral angle sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Railway hospital Rawalpindi city: Rawalpindi state: Punjab zip: 46060 country: Pakistan lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06303349 id: CHUBX 2023/45 briefTitle: Predictive Model for the Occurrence of Cerebral Vasospasm Complicating Subarachnoid Haemorrhage by Combined Analysis of the Kinetics of a Panel of Biomarkers. acronym: CVSBIODIAG overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-12 date: 2024-03-18 name: University Hospital, Bordeaux class: OTHER name: Bordeaux University briefSummary: The objective is to create a dynamic clinical prediction model that includes routinely measured care and biological biomarkers to predict cerebral vasospasm within 14 days of bleeding in patients treated in the neurosurgical intensive care unit for subarachnoid hemorrhage.

Patients admitted to intensive care will be followed for up to 14 days (D14 time horizon of interest), or until discharge from intensive care if earlier.

Blood samples will be taken from D1 to D10 to isolate the blood biomarkers of interest for each patient.

The measurement of biomarkers and cerebral vasospasm will be blinded to each other. conditions: Cerebral Vasospasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective single-centre cohort study with prognostic aim, carried out in the neuro-resuscitation unit of the Bordeaux University Hospital. primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Samples collection measure: Occurrence of cerebral vasospasm measure: Biomarkers measurements measure: WFNS (World Federation of Neurologic Surgeons) score measure: Glasgow score measure: Medical Research Council (MRC) score measure: PtiO2 (oxygen pressure in the cerebral tissue) measure: Transcranial Doppler measure: Modified Fisher score measure: Non-significant angiographic vasospasm measure: Non-significant perfusion anomaly measure: Glasgow Outcome Scale -Extended (GOS-E) measure: Cerebral ischemic lesions measure: Occurrence of symptomatic vasospasm sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Bordeaux city: Bordeaux country: France name: Grégoire CANE, Dr role: CONTACT phone: 0557821019 email: gregoire.cane@chu-bordeaux.fr name: Laure ESTEVE role: CONTACT phone: 0557821913 email: laure.esteve@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 hasResults: False

 nctId: NCT06303336 id: REC/0258 Ayesha Ashraf briefTitle: Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP overallStatus: RECRUITING date: 2023-12-30 date: 2024-05-14 date: 2024-05-14 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy conditions: Diplegic Spastic Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: participants and outcome assessors will be kept blind about the intervention which the patients will be receiving whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: NMES with Dynamic Bracing name: NMES without Dynamic Bracing name: Dynamic Bracing Only measure: Modified Ashworth Scale measure: Observable Movement Quality Scale measure: Physicians Rating Scale sex: ALL minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Children Hospital status: RECRUITING city: Faisalābad state: Punjab zip: 54000 country: Pakistan name: Ammara Abbas, tDPT role: CONTACT phone: 03214932464 email: ammara.musvi@gmail.com name: Ayesha Ashraf, MS NMPT* role: PRINCIPAL_INVESTIGATOR lat: 31.41554 lon: 73.08969 hasResults: False

 nctId: NCT06303323 id: Nawal Fatima briefTitle: Comparative Effectiveness of Qigong Exercise Versus Wu Dang Tai Chi Chuan in CVD Risk Individuals overallStatus: RECRUITING date: 2024-03-15 date: 2024-07 date: 2024-08 date: 2024-03-12 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: To compare whether the Qigong exercise or Wu Dang Tai Chi Chuan will be effective in improving exercise capacity and reducing stress in CVD-risk individuals. Based on preliminary data, Qigong and Tai-Chi may help treat anxiety and depression symptoms in patients with chronic illnesses as well as in healthy adults. Without the need for specialized equipment, Qigong and Tai-Chi are both readily adjustable mind-body exercises that may be done whenever and wherever. For this reason, Qigong and TaiChi should be extensively encouraged as ways to enhance emotional wellbeing conditions: Cardiovascular Diseases conditions: Risk Behavior, Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: Qigong Exercise name: Wu Dang Tai Chi measure: Exercise Capacity measure: Stress sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Pakistan Railway General Hospital status: RECRUITING city: Rawalpindi state: Punjab zip: 4600 country: Pakistan name: Mehwish Waseem, MSPT-CPPT role: CONTACT phone: 0331-5309015 email: mehwish.waseem@riphah.edu.pk name: Nawal Fatima, MSPT-CPPT* role: CONTACT phone: 0307 6500954 email: nawalfatima3@gmail.com lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06303310 id: REC/RCR&AHS/23/0296 briefTitle: Comparative Effects Of Gaze Stability Exercises And Optokinetic Exercises In Patients With Vestibular Hypofunction overallStatus: RECRUITING date: 2024-02-20 date: 2024-05-01 date: 2024-05-15 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Participants fulfilling the inclusion criteria will be recruited by using the convenience sampling randomly allocated into two groups by computer generator method. 20 participants will be assigned to Group A receiving gaze stability exercises and 20 to the Group B receiving optokinetic exercises, both alongside routine physical therapy. Each group will undergo 5 weekly sessions of treatment for 4 weeks.The assessment tools include Dizziness Handicap Inventory for dizziness; Mini-BESTest and modified-Clinical Test of Sensory Interaction of Balance for balance assessment while Vestibular Disorders Activities of Daily Living Scale for daily activities. conditions: Vestibular Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group A (Gaze Stability Exercises + Balance Exercises) Group B (Optokinetic Exercises + Balance Exercises) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Assessor will be blinded. Assessor will be the person having 10 years experience in neuromuscular rehabilitation. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Gaze Stability Exercises name: Optokinetic Exercises name: Routine Physical Therapy measure: Dizziness Handicap Inventory measure: Mini-Bestest measure: Modified-Clinical Test of Sensory Interaction on Balance measure: Vestibular Disorders Activities of Daily Living Scale sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Bahawal Victoria Hospital status: RECRUITING city: Bahāwalpur state: Punjab zip: 63100 country: Pakistan name: Farrukh Rashid, MBBS, MCPS role: CONTACT phone: 03336390907 email: drfarrukhrashid@yahoo.com name: Tassaduq, MBBS, MCPS role: CONTACT phone: 03068200034 lat: 29.4 lon: 71.68333 hasResults: False

 nctId: NCT06303297 id: REC/RCR&AHS/23/0576 briefTitle: Effects of Reflexology and Generalized Stretching in Postmenopausal Females. overallStatus: RECRUITING date: 2023-11-23 date: 2024-08-01 date: 2024-09-01 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females conditions: Postmenopausal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: REFLEXOLOGY name: GENERALIZED STRETCHING measure: Insomnia severity index score measure: Menopause Rating Scale measure: Menopause Specific Quality of Life sex: FEMALE minimumAge: 50 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akhtar Saeed trust hospital, status: RECRUITING city: Lahore state: Punjab zip: 05499 country: Pakistan name: imran amjad role: CONTACT phone: 03324390125 email: imran.amjad@riphah.edu.pk name: Aneela Shahid, MSPT(WH) role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303284 id: Pending briefTitle: Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2026-12-31 date: 2027-06-01 date: 2024-03-12 date: 2024-03-18 name: University of Calgary class: OTHER briefSummary: As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs.

There is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications.

The proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed.

This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population. conditions: Ankle Fractures studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: subcutaneous Teriparatide injection name: placebo measure: Participant recruitment rate measure: Incidence of composite measure of complications measure: Adverse events measure: modified Radiological Union Scale for Tibia [RUST] score), measure: Olerud Molander Score measure: EuroQol five dimensions [EQ-5D] measure: short form-12 [SF-12] measure: pain visual analogue score [VAS] measure: time-to-fracture union measure: 90 day mortality measure: Bone mineral density measure: Total cost and QALYs sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303271 id: MUHAMMAD NISAR briefTitle: Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-06-30 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: The objective of the study is to determine the effects of transcutaneous auricular vagus nerve stimulation on dizziness and balance on elderly population with unilateral vestibular hypofunction. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. Intervention Group A received Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey exercise while Group group B received Caw Thorne Cooksey exercise only. Both groups received intervention of 30 minutes daily for 4 weeks (16 sessions). Assessment was done at the baseline, after 2 weeks and after 4 weeks conditions: Vestibular Hypofunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey name: Caw Thorne Cooksey measure: The Dix-Hall pike test measure: Berg Balance Scale measure: The Dizziness Handicap Inventory (DHI) measure: Dynamic Gait Index (DGI) measure: Modified Clinical Test of sensory interaction & Balance (MCTSIB) sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ENT dept. of DHQ Mirpur AJK status: RECRUITING city: Kashmir country: Pakistan name: Nadia Azhar, NMPT role: CONTACT phone: 03335281431 email: nadia.azhar@riphah.edu.pk hasResults: False

 nctId: NCT06303258 id: RiphahIU Sharmeen Kanwar briefTitle: Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain overallStatus: RECRUITING date: 2024-03-04 date: 2024-05-01 date: 2024-06-30 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain. conditions: Low Back Pain conditions: Pelvic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single (Outcomes Assessor) whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Core Stabalization Exercises name: Generalized Antenatal Exercises measure: Visual Analogue Scale (VAS) measure: Visual Analogue Scale (VAS) measure: Pregnant women's quality of life questionnaire (QOL-GRAV) measure: Pregnant women's quality of life questionnaire (QOL-GRAV) sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Tehsil Headquarter Hospital Raiwind status: RECRUITING city: Lahore state: Punjab zip: 55150 country: Pakistan name: Sharmeen Kanwar, MS-WHPT* role: CONTACT phone: 0307-8778164 email: kanwarsharmeen@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303245 id: REC/RCR&AHS/23/0579 briefTitle: Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section overallStatus: RECRUITING date: 2023-02-23 date: 2024-08-01 date: 2024-09-01 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section conditions: Cesarean Section; Complications, Wound, Dehiscence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: ABDOMINAL BINDERS name: TENS measure: o Numeric Pain rating Scale measure: o Symptom Distress scale measure: o PAC-SYM Questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: PAF hospital status: RECRUITING city: Lahore zip: 05499 country: Pakistan name: imran amjad role: CONTACT phone: 03324390125 email: imran.amjad@riphah.edu.pk name: Mishal Jamal, MSPT(WH) role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303232 id: REC/RCR&AHS/23/0578 briefTitle: Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement overallStatus: RECRUITING date: 2023-02-23 date: 2024-08-01 date: 2024-09-01 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women. conditions: Postpartum Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 42 type: ESTIMATED name: MANUAL LYMPHATIC DRAINAGE name: THERAPEUTIC ULTRASOUND measure: Visual Analogue Scale - VAS measure: Six Point Engorgement Scale - SPE measure: Breastfeeding Self-Efficacy Scale - BSES sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Innovative Health Concepts Clinic status: RECRUITING city: Lahore zip: 05499 country: Pakistan name: hina gul gul role: CONTACT phone: 03214979172 email: hina.gul@riphah.edu.pk name: Irsa Zahid, MSPT(WH) role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303219 id: REC/RCR&AHS/23/0577 briefTitle: Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome overallStatus: RECRUITING date: 2023-11-23 date: 2024-08-01 date: 2024-09-01 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome conditions: Polycystic Ovarian Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: RADITIONAL MODERATE INTENSITY TRAINING name: HIGH INTENSITY INTERVAL TRAINING measure: Hamilton Anxiety Rating scale (HAM-A) measure: The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) measure: The Fatigue Impact Scale (FIS) sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Gynecological Department of Fatima Memorial Hospital status: RECRUITING city: Lahore zip: 05499 country: Pakistan name: hina gul gul role: CONTACT phone: 03214979172 email: hina.gul@riphah.edu.pk name: Fatima Kashif, MSPT(WH) role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303206 id: H23-00623 briefTitle: TEC4Home Blood Pressure Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-01-01 date: 2027-01-01 date: 2024-03-12 date: 2024-03-12 name: University of British Columbia class: OTHER briefSummary: The goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (HBPT) and case management (CM), relative to usual care, for improving blood pressure (BP) control among patients with high blood pressure discharged from the emergency department (ED).

The main question it aims to answer is: Does telemonitoring with case management improve BP control, relative to usual care, for people with high blood pressure discharged from the ED?

Secondary research questions will address:

1. How do these interventions (telemonitoring and case management) improve medication adherence?
2. Do these interventions reduce physician and ED visits?
3. Are these interventions safe?
4. How do these interventions influence patient experience?

Participants in the intervention group will receive training and use of a home BP telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored BP data, and adjust medications. The control group will receive usual care from their primary care physician and will receive the same home BP monitor and hypertension education. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 408 type: ESTIMATED name: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) measure: Systolic blood pressure controlled measure: Impact of intervention on other blood pressure measures sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303193 id: 10001554 id: 001554-C briefTitle: Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2030-01-01 date: 2035-01-01 date: 2024-03-12 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: Background:

Myelodysplastic syndrome (MDS) and myelodysplastic/myeloproliferative neoplasm (MDS/MPN) are blood disorders that can cause serious complications in children and adults. MDS and MDS/MPN can also progress to acute myeloid leukemia. Treatments for these disorders are risky and not always effective. Better treatments are needed.

Objective:

To test a study drug (pacritinib) in adults and children with MDS or MDS/MPN.

Eligibility:

Children (aged 12 to 17 years) and adults (aged 18 years and older) with MDS or MDS/MPN.

Design:

Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function. They may have a bone marrow biopsy: An area over the hip will be numbed; a needle will be inserted to remove a sample of soft tissue from inside the hipbone.

Pacritinib is a capsule taken by mouth. All participants will take the study drug 2 times a day, every day, in 28-day cycles. They will write down the date and time they take each capsule. Doctors will assign varying dosages of the drug to different participants.

Participants will have clinic visits each week during cycle 1; every 2 weeks during cycle 2; and gradually increasing to every 3 months after cycle 13. Treatment will continue for up to 8 years.

Bone marrow biopsies, heart tests, and other tests will be repeated at intervals throughout the study. Participants will also fill out questionnaires about their quality of life, the symptoms of their disease, and other topics. conditions: Myelodysplastic Syndromes studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: pacritinib measure: Recommended phase 2 dose of pacritinib in participants 12-17 years of age measure: Efficacy as measured by Objective Response Rate (ORR) per each risk-based cohort measure: Pharmacokinetic (PK) properties of pacritinib measure: Extended safety of pacritinib sex: ALL minimumAge: 12 Years maximumAge: 120 Years stdAges: CHILD 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: NCT06303180 id: 10001560 id: 001560-DC briefTitle: NIDCD Otolaryngology Clinical Protocol Biospecimen Bank overallStatus: RECRUITING date: 2024-03-04 date: 2033-12-30 date: 2033-12-30 date: 2024-03-12 date: 2024-04-02 name: National Institute on Deafness and Other Communication Disorders (NIDCD) class: NIH briefSummary: Background:

Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.

Objective:

To collect biological samples for a repository that will be used for research.

Eligibility:

People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.

Design:

Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.

Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.

Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.

Samples may be used for genetic testing. conditions: Hearing Loss conditions: Head and Neck Neoplasms conditions: Hearing Disorders conditions: Laryngeal Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: To create a biorepository of diseased and normal tissue specimens for research purposes. measure: To share specimens with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of sex: ALL minimumAge: 3 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center status: RECRUITING city: Bethesda state: Maryland zip: 20892 country: United States name: Marcia Mulquin, RN, MSN role: CONTACT phone: 301-496-1601 email: mmulquin@mail.nih.gov name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: (800) 411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06303167 id: NCI-2024-01150 id: NCI-2024-01150 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-E type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-E type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E) overallStatus: ACTIVE_NOT_RECRUITING date: 2015-08-06 date: 2024-05-26 date: 2024-05-26 date: 2024-03-12 date: 2024-03-12 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial evaluates the effectiveness of osimertinib (AZD9291) in treating patients with cancer that has certain genetic changes called EGFR mutations. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of mutant forms of the EGFR protein, which play a key role in tumor cell growth. Osimertinib may cause tumor cell death and inhibit tumor growth in EGFR-overexpressing tumor cells, thereby stopping or slowing the spread of tumor cells. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Hematopoietic and Lymphoid Cell Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Echocardiography name: Multigated Acquisition Scan name: Osimertinib name: Radiologic Examination measure: Objective response rate measure: Overall survival measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06303154 id: EC45 MOBIBRA id: ID-RCB type: OTHER domain: 2023-A01937-38 briefTitle: Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment acronym: MOBIBRA overallStatus: RECRUITING date: 2024-03-21 date: 2025-09 date: 2025-09 date: 2024-03-12 date: 2024-04-16 name: Thuasne class: INDUSTRY briefSummary: The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment. conditions: Breast Cancer Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, exploratory, monocentric, uncontrolled clinical study. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Mobiderm Intimate Bra group measure: Evolution of breast edema severity measure: Comparison of methods to follow changes in the severity of breast edema - TDC measurement measure: Comparison of methods to follow changes in the severity of breast edema - Clinical assessment measure: Comparison of methods to follow changes in the severity of breast edema - Ultrasound measurement measure: Time to edema onset measure: Time to edema disappearance measure: Symptoms and quality of life changes associated with breast edema measure: Breast edema hypersensitivity measure: Breast pain measure: Skin changes associated with breast edema measure: Physical activity measure: Healing time measure: Safety of the device measure: Compliance to the device measure: Patient's satisfaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP status: RECRUITING city: Paris state: Paris 14 zip: 75014 country: France name: Séverine ALRAN, Dr role: CONTACT lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06303141 id: LUC/CPGS/PGS/20230405/001 briefTitle: Comparative Effects of Neuromuscular Training and Mobilization With Movement in Professional Athletes With Ankle Sprain overallStatus: COMPLETED date: 2023-04-05 date: 2023-09-05 date: 2023-09-10 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: The study aims to compare the effects of neuromuscular training and mobilization with movement on pain, range of motion, function, and disability in professional athletes with ankle sprain. Neuromuscular training focuses on improving neuromuscular control and stability, while mobilization with movement aims to restore joint mobility and function. By investigating the outcomes of these two interventions, the study seeks to provide insights into their effectiveness for managing ankle sprains in professional athletes. conditions: Ankle Injuries conditions: Musculoskeletal Manipulations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: the assessor who take the reading is blind whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Closed Chain exercises name: Neuromuscular Training name: Mobilization with Movement measure: Numerical Pain Rating Scale for Pain measure: Goniometer for Range of Motion measure: Star balance excursion test for Balance measure: Foot and ankle ability Measure for Functional Performance measure: Cumberland Ankle Instability measure: Agility T-test measure: Speed (20m sprint test) sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Pakistan Sports Board city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06303128 id: IRB-FY2024-61 briefTitle: Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge overallStatus: RECRUITING date: 2024-02-03 date: 2024-12 date: 2025-05 date: 2024-03-12 date: 2024-03-15 name: James Tarbox, MD class: OTHER name: Texas Tech University Health Sciences Center briefSummary: The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is:

- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?

Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction. conditions: Penicillin Allergy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: - Low-risk penicillin allergic patients ("low-risk" determined by a PEN-FAST score of 2 or less) will be recruited. Clinically stable patients will be randomly assigned in a double-blinded manner to receive either a one-dose or graded two-dose direct oral challenge with amoxicillin in an outpatient setting. Those assigned to receive one dose of amoxicillin will receive a placebo in place of a second dose of amoxicillin. Both groups will receive the same cumulative dose of amoxicillin (250mg) by the end of the trial. Baseline vital signs will be obtained and tracked throughout the trial. Patients will also be monitored for development of signs of allergic reactions during the trial, with administration of appropriate treatment should the need arise. primaryPurpose: DIAGNOSTIC masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 380 type: ESTIMATED name: Amoxicillin 250 MG name: Placebo name: Amoxicillin 62.5mg name: Amoxicillin 187.5mg measure: Proportion of successfully "delabeled" subjects in one-dose versus two-dose groups measure: Analysis of adverse reactions measure: Analysis of medical and allergic history measure: Validation of penicillin allergy delabeling measure: Analysis of demographic data sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Texas Tech University Health Sciences Center status: RECRUITING city: Lubbock state: Texas zip: 79430 country: United States name: Study Coordinator role: CONTACT phone: 806-543-8994 email: clinicalresearch@ttuhsc.edu name: Joshua A Peterson, MD role: CONTACT email: josh.peterson@ttuhsc.edu name: Joshua A Peterson, MD role: SUB_INVESTIGATOR name: Nicole Welch, MD role: SUB_INVESTIGATOR name: KaKa L Adams, MD role: SUB_INVESTIGATOR name: Barbara Mora Gonzalez, MD role: SUB_INVESTIGATOR name: Sebastian Sanchez Lopez, MD role: SUB_INVESTIGATOR name: Sierra Sullivan, MD role: SUB_INVESTIGATOR name: Jacob Nichols, MD role: PRINCIPAL_INVESTIGATOR name: James A Tarbox, MD role: PRINCIPAL_INVESTIGATOR lat: 33.57786 lon: -101.85517 hasResults: False

 nctId: NCT06303115 id: CSD231005 BoE briefTitle: CSD231005 Nicotine Pouch Biomarkers of Exposure overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2024-12-15 date: 2025-01-15 date: 2024-03-12 date: 2024-03-15 name: RAI Services Company class: INDUSTRY briefSummary: This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence. conditions: Tobacco Use conditions: Smoking studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Nicotine Pouch P1312914, 4 mg nicotine name: Nicotine Pouch P1312915, 8 mg nicotine name: Nicotine Pouch P1013215, 8 mg nicotine name: Nicotine Pouch P1013218, 10 mg nicotine name: Nicotine Pouch P1012919, 12 mg nicotine name: Smoking Abstinence name: Continued UB cigarette smoking measure: 4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL] measure: 4Aminobiphenyl [4ABP] measure: 1Aminonaphthalene [1AN] measure: 2Aminonaphthalene [2AN] measure: 2Cyanoethyl mercapturic acid [CEMA] measure: 3Hydroxypropyl mercapturic acid [3HPMA] measure: 3Hydroxy1methylpropylmercapturic acid [HMPMA] measure: 3hydroxybenzo[a]pyrene [3-OH-B[a]P] measure: 1hydroxypyrene [1OHP] measure: Monohydroxybutyl mercapturic acid [MHBMA] measure: Nnitrosonornicotine [NNN] + glucuronides [Total NNN] measure: SPhenyl mercapturic acid [SPMA] measure: Total nicotine equivalents (molar sum of nicotine, cotinine, 3hydroxycotinine and their glucuronides) [TNneq] measure: Carboxyhemoglobin [COHb] measure: Nnitrosonornicotine [NNN] + glucuronides [Total NNN] sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: Pillar Bentonville city: Bentonville state: Arkansas zip: 72712 country: United States lat: 36.37285 lon: -94.20882 facility: AMR Lexington city: Lexington state: Kentucky zip: 40509 country: United States lat: 37.98869 lon: -84.47772 facility: QPS Missouri city: Springfield state: Missouri zip: 65802 country: United States lat: 37.21533 lon: -93.29824 facility: AMR Knoxville city: Knoxville state: Tennessee zip: 37920 country: United States name: William Smith, MD role: CONTACT lat: 35.96064 lon: -83.92074 facility: Pillar Richardson city: Richardson state: Texas zip: 75080 country: United States lat: 32.94818 lon: -96.72972 hasResults: False

 nctId: NCT06303102 id: REC/RCR&AHS/23/0356 briefTitle: Effects of Segmental and Pursed Lip Breathing Exercises on Upper Cross Syndrome overallStatus: COMPLETED date: 2023-05-23 date: 2024-01-30 date: 2024-02-15 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: Upper cross syndrome is relative prevalent 67% musculoskeletal disorder among general population due to increased usage of smart gadgets and poor postural habits. Upper cross syndrome is known for initiating malfunction of cervical and upper back muscles also associated with respiration. Individuals with upper cross syndrome may present with relaxed supine positioning, they may having normal respiratory mechanics but might be converted to accessory muscles activated pattern. Neck pain is the most common type of pain in non-traumatic conditions, affecting about 75.7% of people. The aim of this study is to compare the effects of segmental and pursed lip breathing exercises on pain, functional disability and quality of life in population with upper cross syndrome.

Current study will be randomized controlled trial conducted at Ismail Medicare Jhang, 40 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A (control group) will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises) while Group B (experimental group) receive conventional physical therapy treatment with segmental and pursed lip breathing exercises. Outcome measures are Pain Numeric Scale, Quality of life (SF 36) and Functional disability (neck disability index). These tools will measure neck function and neck pain intensity. Treatment time will be 4 weeks, 3 sessions per week, each session will be 45 minutes long, and measurements will be taken after 4 weeks. Data will be analyzed by SPSS version 25. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups analysis.

Key Words: Breathing Exercises, Cervical Pain, Disability, Upper Cross conditions: UPPER CROSS SYNDROME studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise name: Manual PT/Conventional PT Treatment measure: NPRS measure: Quality of Life (SF-36 questionnaire) measure: Neck Disability Index (NDI) sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: Ismail Medicare city: Jhang state: Punjab zip: 35200 country: Pakistan hasResults: False

 nctId: NCT06303089 id: zzwee-quit (CKD) 23152 briefTitle: Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-03-01 date: 2024-03-12 date: 2024-03-12 name: Sun Yat-sen University class: OTHER briefSummary: The purpose of this study is to describe the tobacco exposure and characteristics of patients with Chronic Kidney Disease (CKD) who quit smoking, to identify patients' tobacco-related knowledge, attitude, and practice (KAP) and explore the influencing factors of smoking cessation. conditions: Smoking Cessation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 554 type: ESTIMATED name: Questionnaires set measure: Prevalence of current smokers measure: Abstinence rates measure: Nicotine dependence measure: Perceptions of tobacco harm measure: knowledge of tobacco-related diseases measure: Smoking related attitudes measure: Self-efficacy level measure: Withdrawal symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: XIAW city: Guangzhou state: Guangdong zip: 510080 country: China name: Wei Xia, PhD role: CONTACT phone: 18823359471 email: xiaw23@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06303076 id: 134 briefTitle: Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2026-12 date: 2024-03-12 date: 2024-03-12 name: Sultan Qaboos University class: OTHER briefSummary: The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg/Kg/HS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout/lost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia. conditions: Depressive Disorder, Major studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Tizanidine Hcl 4Mg Tab name: Zolpidem Tartrate 10 mg measure: Pittsburgh Sleep Quality Index measure: Frequency and Severity of Side Effects sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06303063 id: SNSC-IAS-202301 briefTitle: Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms overallStatus: RECRUITING date: 2024-01-17 date: 2025-06-30 date: 2025-12-30 date: 2024-03-12 date: 2024-04-01 name: Sinomed Neurovita Technology Inc. class: INDUSTRY briefSummary: The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms. conditions: Intracranial Aneurysm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 204 type: ESTIMATED name: SINOMED IAS Stent System name: Neuroform Atlas Stent System measure: Success aneurysm occlusion at 6 month post procedure measure: Technical success measure: Success aneurysm occlusion immediately after the procedure measure: Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 6 months post procedure measure: Complete aneurysm occlusion at 6 months post procedure measure: Retreatment Rate at 6 months and 1 year post procedure measure: In-Stent Stenosis at 6 months post procedure measure: Modified Rankin Scale (mRS) at 30 days, 6 months and 1 year post procedure measure: Major ipsilateral stroke at 30 days, 6 months and 1 year post procedure measure: All-cause mortality at 30 days, 6 months and 1 year post procedure measure: Incidence of adverse events/serious adverse events during 30 days, 6 months and 1 year post procedure measure: In-stent thrombosis at 6 months post procedure measure: Rate of Device defect sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital, Capital Medical University status: RECRUITING city: Beijing country: China name: Jianxin Yang role: CONTACT phone: 010-59978595 email: yangxinjian@voiceoftiantan.org lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06303050 id: Urooj Amir briefTitle: Additional Effects of Mental Imagery Along With Task Oriented Training on Kinesiophobia in Patients With Stroke overallStatus: RECRUITING date: 2023-12-07 date: 2024-06-07 date: 2024-06-07 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: The objective of this study to determine the effect of mental imagery and task oriented training on Kinesiophobia in stroke patients. And to determine the association of Kinesiophobia with gait and balance in stroke patients. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. The experimental group will receive 20 minutes of MI training followed by 25 minutes of TOT for a total of 45 minutes, 5 days per week for 6 weeks. conditions: Stroke, Cardiovascular studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: Mental Imagery with task Oriented training group name: Task Oriented training group measure: Berg And Balance scale measure: Tempa scale for kinesiophobia measure: Ten-meter walk test measure: Dynamic gate index measure: Time Up and Go Test sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Khyber Medical University status: RECRUITING city: Peshawar state: KPK zip: 2500 country: Pakistan name: Nadia Azhar, NMPT role: CONTACT phone: 03335281431 email: nadia.azhar@riphah.edu.pk lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06303037 id: SAHoWMU-CR2024-03-105 briefTitle: Effect of Esketamine on 95% Induction Dose of Remimazolam acronym: EEIDR overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-03 date: 2024-03-12 date: 2024-03-12 name: Second Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children. conditions: Pediatric conditions: Gastroscopy conditions: ED95 conditions: Sedation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Remimazolam besylate and low-dose Esketamine name: Remimazolam besylate and Medium dose Esketamine measure: Sedation induction time measure: Modified observer's assessment of alertness#sedation#MOAA/S#scale measure: Recovery times measure: VAS(The difficulty of gastroscope insertion) measure: Number of children with adverse effects sex: ALL minimumAge: 3 Years maximumAge: 12 Years stdAges: CHILD facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06303024 id: RELIABLE Clinical Study briefTitle: Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis acronym: RELIABLE overallStatus: RECRUITING date: 2023-06-14 date: 2024-03-01 date: 2026-03-01 date: 2024-03-12 date: 2024-03-12 name: Fondazione Don Carlo Gnocchi Onlus class: OTHER name: Careggi Hospital name: Sheba Medical Center name: Uppsala University briefSummary: Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy. conditions: Multiple Sclerosis, Relapsing-Remitting studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This is a multicentric no-profit pilot study, composed by two phases. I phase: observational prospective study II phase: interventional study primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: personalized combined physical and cognitive intervention measure: Symbol Digit Modalities Test (SDMT) measure: California Verbal Learning Test second edition (CVLT-II) measure: Brief Visuo-Spatial Memory Test- Revised (BVMT-R) measure: Word list generation (WLG) measure: Stroop test measure: Test Intelligenza Breve (TIB) measure: 9 hole peg test (9HPT) measure: The Hospital Anxiety and Depression Scale (HADS) measure: Beck Depression Inventory second edition measure: The Modified Fatigue Impact Scale (MFIS) measure: The Multiple Sclerosis Walking Scale (MSWS-12) measure: Multiple Sclerosis Impact Scale (MSIS-29-V2) measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54) measure: six minutes walking test (6MWT) measure: Romberg test measure: handgrip test measure: cognitive-motor interference measure: Timed 25-foot walk measure: brain MRI scan measure: International Physical Activity Questionnaire (IPAQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Don Carlo Gnocchi ONLUS status: RECRUITING city: Firenze zip: 50143 country: Italy name: Maria Pia Amato, Prof role: CONTACT phone: 0557947836 email: mpamato@dongnocchi.it lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06303011 id: S22C14G92003 briefTitle: Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females. overallStatus: COMPLETED date: 2023-03-15 date: 2024-03-15 date: 2024-03-15 date: 2024-03-12 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 26 type: ACTUAL name: Transcutaneous Electrical Nerve Stimulator name: TENS on para sacral area with Abdominal Massage measure: PAC-SYM Questionnaire measure: PAC-QOL Questionnaire sex: FEMALE minimumAge: 14 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Jinnah Hospital city: Lahore state: Punjab zip: 44000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06302998 id: MS.111 briefTitle: Dexmedetomidine and Vasopressin in Septic Shock acronym: DecatSepsis-2 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-01 date: 2024-03-12 date: 2024-03-12 name: Mansoura University class: OTHER briefSummary: Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.

The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality. conditions: Sepsis conditions: Septic Shock studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled superiority trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor will be nurses - not invovled in the study - will be unware about the study drug. whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: DEX-PRESSIN name: Standard of Care measure: in-hospital mortality measure: survival analysis measure: Norepinephrine Equivalent Dose (NED) measure: Duration of vasopressor infusion in survivors measure: Initiation of invasive mechanical ventilation (IMV) measure: Duration of IMV measure: Early acute kidney injury (AKI) measure: Late acute kidney injury (AKI) measure: Acute Physiology and Chronic Health Evaluation (APACHE-II) measure: Simplified Acute Physiology Score (SAPS) II score measure: ICU length of stay measure: Hospital length of stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302985 id: ICG-CLMs briefTitle: Atomized Inhalation ICG for Treatment of Congenital Lung Malformations overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2050-12-31 date: 2050-12-31 date: 2024-03-12 date: 2024-03-12 name: Jiexiong Feng class: OTHER briefSummary: To investigate the safety and effectiveness of preoperative aerosol inhalation ICG solution for thoracoscopic accurate resection of congenital lung malformations in children. conditions: Pulmonary Sequestration conditions: Congenital Pulmonary Airway Malformation conditions: Indocyanine Green conditions: Thoracoscopic Surgery conditions: Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: atomized inhalation ICG before thoracoscope pneumonectomy measure: rate residual measure: peak volume ratio measure: length of hospital stay measure: peak time ratio sex: ALL minimumAge: 3 Months maximumAge: 14 Years stdAges: CHILD facility: Tongji Hospital city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06302972 id: RCRAHS-ISB/REC/MS-PT/01771 briefTitle: Effects of IASTM Along With Comprehensive Corrective Exercise Program in Upper Cross Syndrome. overallStatus: RECRUITING date: 2023-10-30 date: 2024-06-30 date: 2024-06-30 date: 2024-03-12 date: 2024-04-19 name: Riphah International University class: OTHER briefSummary: This study will see the effects of IASTM along with comprehensive corrective exercise program in upper cross syndrome through their effects on pain and cervical ranges as well as postural improvement. Our study targets both male and female population. In the reference study only male population was targeted which did not show effects of both techniques on the female population though females have high stress levels which may alter results. conditions: Upper Cross Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were randomly assigned to the experimental group or control group after a baseline assessment with sealed enveloped method. Each participant took a envelope that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants were informed that they would receive treatment either from group 1 or group 2 without indicating which group should undergo IASTM and comprehensive corrective exercise program and which group undergo only comprehensive corrective exercise program whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Traditional treatment name: IASTM and CCEP measure: Range of motion Cervical (Flexion) measure: ROM Cervical (Extension) measure: ROM Cervical (Left Lateral Flexion) measure: ROM Cervical( Right Lateral Flexion) measure: ROM Cervical ( Right Rotation) measure: ROM Cervical ( Left Rotation) measure: Numeric Pain Rating Scale (NPRS) measure: Flexicurve Ruler and Photogrammetry for posture sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Maroof international Hospital and Railway Hospital status: RECRUITING city: Islamabad state: Federal zip: 44000 country: Pakistan lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06302959 id: 36-232 ex 23/24 briefTitle: Clock Proteins as Prognostic Markers acronym: CLOCK-PM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2027-12-31 date: 2024-03-12 date: 2024-03-29 name: Medical University of Graz class: OTHER briefSummary: Asthma is a chronic inflammatory disease of the airways that follows a strong circadian rhythm: Signs of inflammation and symptoms worsen especially in the early morning hours. The molecular circadian clock, which is a complex machinery of transcriptional and translational feedback loops, seems to reflect the inflammatory environment of peripheral blood leukocytes. Therefore, in this observational study the investigators will monitor the molecular circadian clock in patients with severe eosinophilic asthma before and during mepolizumab treatment. Our major goal is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression, treatment response or remission in patients with severe eosinophilic asthma. The molecular circadian clock will be monitored in blood and sputum leukocytes from patients with severe eosinophilic asthma before mepolizumab treatment, after 4 month of mepolizumab therapy, and once they reach remission under mepolizumab treatment. Effects will be compared to healthy controls and patients with mild-moderate asthma without mepolizumab treatment. conditions: Severe Eosinophilic Asthma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Correlation between clock expression, exacerbation rate and lung function. measure: Correlation between clock expression, symptoms and quality of life. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302946 id: P.T.REC/012/005024 briefTitle: Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke overallStatus: RECRUITING date: 2024-03-15 date: 2025-05-30 date: 2025-12-30 date: 2024-03-12 date: 2024-03-12 name: Cairo University class: OTHER briefSummary: It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation , mindfulness breathing and traditional physiotherapy while the control group will stick to traditional physiotherapy only. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: neuromuscular stimulation ,mindfulness breathing and traditional physiotherapy program name: traditional physiotherapy program measure: level of physical function measure: ventilatory function measure: level of stress sex: ALL minimumAge: 50 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Cairo state: Dokki zip: 11432 country: Egypt name: marwa M elsayed, phd role: CONTACT phone: 01156033818 phoneExt: 02 email: marwadd999@gmail.com name: marwa M elsayed, ph.d role: CONTACT phone: 01156033818 phoneExt: 02 email: marwadd999@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06302933 id: ANRS 12414 PediacamNEG briefTitle: Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms acronym: PediacamNEG overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-08-30 date: 2025-08-30 date: 2024-03-12 date: 2024-03-12 name: ANRS, Emerging Infectious Diseases class: OTHER_GOV name: Centre Pasteur du Cameroun name: Centre Mère et Enfant de la Fondation Chantal Biya name: Centre Hospitalier D'essos name: Hospital General De Douala name: Centre Hospitalier Universitaire d'Orléans name: Institut Pasteur name: Hopital Universitaire Robert-Debre name: Université Paris-Sud briefSummary: The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon

The hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:

* Immunological aspect: lack of humoral response or immune activation
* Virological aspect: Reduced HIV reservoir size
* Determine the HLA phenotype in the different groups of children included and the KIR genotypes. conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Study type: a study nested in the ANRS 12225 - Pediacam III cohort, comprising two phases

* A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.
* A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 451 type: ESTIMATED name: Blood sampling measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma measure: - Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B measure: - Functional and phenotypic characterization of B and T lymphocytes measure: - Size of the HIV reservoir measure: - Residual viremia in perinatally HIV-infected adolescent measure: - Level of HIV plasma p24 measure: - HLA phenotype and the KIR genotypes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Pasteur Cameroun city: Yaounde zip: 1274 country: Cameroon name: Mathurin C Tejiokem role: CONTACT phone: +237222231803 email: tejiokem@pasteur-yaounde.org lat: 3.86667 lon: 11.51667 hasResults: False

 nctId: NCT06302920 id: 0001 briefTitle: Effect of Kinesiotaping on Pain,Edema and Kinesiophobia in Patients With Complex Regional Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-06-20 date: 2024-12-20 date: 2024-03-12 date: 2024-03-12 name: Alanya Alaaddin Keykubat University class: OTHER briefSummary: Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later. conditions: Complex Regional Pain Syndrome Type I studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Kinesiotape measure: Resting pain measure: Edema measure: Kinesiophobia sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alanya Alaaddin Keykubat University city: Antalya country: Turkey name: Deniz Bulut role: CONTACT phone: +90 05059445604 email: denizhava1988@gmail.com name: Deniz Bulut role: PRINCIPAL_INVESTIGATOR name: İsmet Aslı Topcuoğlu role: PRINCIPAL_INVESTIGATOR lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06302907 id: M/45- 14.1.2023 briefTitle: The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration overallStatus: ENROLLING_BY_INVITATION date: 2023-01-14 date: 2023-09-10 date: 2024-06-30 date: 2024-03-12 date: 2024-03-12 name: Al-Wataniya University class: OTHER briefSummary: The aim of the present study was to evaluate the pain during local anesthetic buccal infiltration for the maxillary canines after adding Sodium Bicarbonate 8.4% during local anesthesia. conditions: Local Anesthetic Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Buffered Local anaesthesia name: Unbuffered Local anaesthesia measure: Pain on injection sex: ALL minimumAge: 15 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Al Wataniya Private University city: Hama state: Hama Government zip: 00000 country: Syrian Arab Republic lat: 35.13179 lon: 36.75783 hasResults: False

 nctId: NCT06302894 id: BAIBU-SBF-EC-01 briefTitle: The Effect of the Nursing Intervention Program on Adolescent Problematic Internet Users overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2024-10-01 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Abant Izzet Baysal University class: OTHER briefSummary: In this study; The effect of the nursing intervention program (education enriched with web 2.0 tools based on the Health Belief Model) on problematic internet use, loneliness and family harmony in adolescents who use the internet with problems will be determined. conditions: Internet Addiction Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 1000 type: ESTIMATED name: Self-sufficiency measure: Internet Addiction Scale sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Bolu Abant İzzet Baysal University Faculty of Health Sciences city: Bolu zip: 14300 country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False

 nctId: NCT06302881 id: liaohongfan briefTitle: Differentiating Tumor-stroma Ratio in Pancreatic Ductal Adenocarcinoma overallStatus: ACTIVE_NOT_RECRUITING date: 2013-01 date: 2022-07 date: 2024-03 date: 2024-03-12 date: 2024-03-12 name: First Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: This study introduces a novel transfer learning-based contrastive language-image pretraining adapter (CLIP-adapter) model for predicting the tumor-stroma ratio (TSR) in pancreatic ductal adenocarcinoma (PDAC) using preoperative dual-phase CT images. The primary aim is to develop an efficient and accessible tool for risk stratification and personalized treatment planning. conditions: Pancreatic Ductal Adenocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 207 type: ACTUAL measure: The diagnostic AUC value of pancreatic ductal adenocarcinoma with deep learning algorithm. measure: The diagnostic accuracy of pancreatic ductal adenocarcinoma with deep learning algorithm. measure: The diagnostic sensitivity of pancreatic ductal adenocarcinoma with deep learning algorithm. measure: The diagnostic specificity of pancreatic ductal adenocarcinoma with deep learning algorithm. measure: The diagnostic positive predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm. measure: The diagnostic negative predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302868 id: 006215 id: R43MH129065 type: NIH link: https://reporter.nih.gov/quickSearch/R43MH129065 briefTitle: Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias overallStatus: RECRUITING date: 2023-10-03 date: 2024-08-01 date: 2024-08-01 date: 2024-03-12 date: 2024-03-12 name: University of South Florida class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity. conditions: Arachnophobia conditions: Cynophobia conditions: Ophidiophobia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Telemedicine Exposure Therapy Using Photos and Videos name: Telemedicine-Based Virtual Reality Exposure Therapy measure: Phobia symptom severity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: RECRUITING city: Tampa state: Florida zip: 33613 country: United States name: Brian Bunnell, PhD role: CONTACT name: Brian Bunnell, PhD role: PRINCIPAL_INVESTIGATOR name: Triton Ong, PhD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-21 uploadDate: 2024-01-23T13:01 filename: Prot_000.pdf size: 451422 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-11 uploadDate: 2024-01-23T12:22 filename: ICF_001.pdf size: 14053932 hasResults: False

 nctId: NCT06302855 id: 2024-00124 briefTitle: Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-09-01 date: 2024-03-12 date: 2024-03-12 name: Karim Gariani class: OTHER briefSummary: Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test).

Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it.

The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 180 type: ESTIMATED name: dental expertise measure: adherence of diabetic patients to periodontal measure: calculate the prevalence of periodontitis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302842 id: 20J201 briefTitle: Pilot Open Label Study With Commercial Supplementation in Healthy Subjects acronym: AUXNUTRIMMUN overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-01 date: 2023-10-15 date: 2024-04-30 date: 2024-03-12 date: 2024-03-19 name: Istituto Auxologico Italiano class: OTHER briefSummary: A bidirectional relationship among nutrition, infection and immunity exists: changes in one component affect the others. Various micronutrients are essential for immunocompetence, particularly vitamins A, C, D, E, B2, B6, and B12, folic acid, iron, selenium, and zinc. Micronutrient deficiencies are a recognized global public health issue, and poor nutritional status predisposes to certain infections. Immune function may be improved by restoring deficient micronutrients to recommended levels, thereby increasing resistance to infection and supporting faster recovery when infected. Diet alone may be insufficient and tailored micronutrient supplementation based on specific age-related needs is necessary.

Aim of the study is to investigate whether nutrient supplementation may affect different functional parameters of the innate and adaptive immunity. conditions: Supportive Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 15 type: ACTUAL name: Bioritmon Immuno Defend measure: Change in neutrophil chemotaxis measure: Change in neutrophil phagocytosis measure: Change in neutrophil oxidative burst measure: Change in mononuclear CD4pos69pos measure: Change in mononuclear CD56pos69pos granzymepos measure: Change in plasma cytokine levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS city: Milan zip: 20145 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06302829 id: RiphahIU Shafia Anjum briefTitle: Comparison of IMES Versus DN on ATrPs of AC overallStatus: RECRUITING date: 2024-01-21 date: 2024-06-30 date: 2024-07-30 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: The aim of our study to compare DN and IMES for pressure pain threshold, ROM and the shoulder function in active trigger points with adhesive capsulitis. This study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy. Moreover, it would add to the society as there are very limited researches done in Pakistan using needling for trigger points in adhesive capsulitis. conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: randomized whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Dry needling name: intramusuar electrical stimulation measure: Algometer (pressure pain threshold) measure: ROM Shoulder (Flexion) measure: ROM Shoulder (Abduction) measure: ROM Shoulder (External rotation) measure: ROM Shoulder (Internal Rotation) measure: ASES Questionnaire; (American shoulder and elbow surgeons scale) sex: ALL minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Railway general hopsital status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Aneela zia, MS-OMPT role: CONTACT phone: +923365869031 email: aneela.zia@riphah.edu.pk name: Shafia Anjum, MS-OMPT role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06302816 id: REC/RCR&AHS/23/0580 briefTitle: Effects of Tupler and Scoop Exercises in Diastasis Recti overallStatus: RECRUITING date: 2023-02-23 date: 2024-08-01 date: 2024-09-01 date: 2024-03-12 date: 2024-03-12 name: Riphah International University class: OTHER briefSummary: To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis. conditions: Diastasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: TUPLER exercises name: SCOOP EXERCISES measure: Digital nylon calipers for inter recti distance (IRD) measure: NPRS for low back pain measure: Manual muscle testing for intra-abdominal strength measure: Short form Pelvic Floor Distress Inventory for Urogynaecological symptoms sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Innovative Health Concepts status: RECRUITING city: Lahore zip: 05499 country: Pakistan name: hina gul gul role: CONTACT phone: 03214979172 email: hina.gul@riphah.edu.pk name: Rutaba Hussain, MSPT(WH) role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06302803 id: NFEC-2024-033 briefTitle: Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial) acronym: INTEREST-3 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-07-01 date: 2024-03-12 date: 2024-04-02 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 225 type: ESTIMATED name: Intermittent fasting plus time-restricted eating name: Calorie restriction measure: Change in body weight over 12 months measure: Change in body mass index （BMI） measure: Change in waist circumference measure: Change in body fat composition meassured by DEXA measure: Change in liver fat measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in concentration of serum triglyceride measure: Change in concentration of serum total cholesterol measure: Change in concentration of serum LDL-c measure: Change in concentration of HbA1c measure: Change in insulin sensitivity measure: Change in β cell function measure: Change in arterial stiffness measured by pulse wave velocity measure: Change in depression score measured by the Patient Health Questionnaire-9 measure: Change in quality of sleep score measured by the Pittsburgh sleep quality index measure: Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital of Southern Medical University city: Guangzhou state: Guangdong zip: 510515 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06302790 id: AcuteMolliiSuitEffects briefTitle: Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-01 date: 2024-03-12 date: 2024-03-12 name: Kırıkkale University class: OTHER name: Gazi University briefSummary: The aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy. conditions: Mollii Suit conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The statistician in the study and the physiotherapist performing the evaluation will be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Molli Suit Apply measure: Gross Motor Function Classification System (GMFCS) measure: Modified Tardiue Scale (MTS) measure: Modifiye Modified Ashworth Scale (MAS) measure: NMC Tests with Seansamove Sensbalance sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Gazi University status: RECRUITING city: Ankara country: Turkey name: Kübra Uğurlu role: CONTACT phone: +905077295353 email: kubra.ozdamar06@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06302777 id: 2023-1184 briefTitle: MAIN-IMAGE Registry acronym: MAIN-IMAGE overallStatus: RECRUITING date: 2023-09-26 date: 2028-09-26 date: 2031-09-26 date: 2024-03-12 date: 2024-03-12 name: Goethe University class: OTHER briefSummary: All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Major adverse cardiovascular Events (MACE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Frankfurt University Hospital status: RECRUITING city: Frankfurt state: Hesse zip: 60590 country: Germany name: Lena Seegers role: CONTACT phone: +496963016666 lat: 50.11552 lon: 8.68417 facility: Frankfurt University Hospital status: RECRUITING city: Frankfurt country: Germany name: Lena Seegers role: CONTACT lat: 50.11552 lon: 8.68417 hasResults: False

 nctId: NCT06302764 id: WZiKS.4.1.2023.2 id: WZiKS.4.1.2023 type: OTHER_GRANT domain: Jagiellonian University in Kraków briefTitle: Emergency Medical Staff Workload Analysis overallStatus: RECRUITING date: 2023-10-01 date: 2024-04-20 date: 2024-06-30 date: 2024-03-12 date: 2024-04-16 name: Jagiellonian University class: OTHER briefSummary: The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows:

1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms.
2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams.
3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols.
4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology.
5. Formation of an interdisciplinary international research team. conditions: Stress conditions: Work Related Stress conditions: PTSD conditions: Mental Stress conditions: Medical Emergencies studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Qualitative & Quantitative Research measure: Focused Interview measure: Posttraumatic Stress Disorder Checklist (PCL-5) measure: Patient Health Questionnaire (PHQ-9) measure: Depersonalization Mechanism Scale (DMS) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Applied Psychology, Jagiellonian University in Krakow, Poland status: RECRUITING city: Krakow state: Małopolska zip: 30-348 country: Poland name: Krystyna Golonka, Prof role: CONTACT email: krystyna.golonka@uj.edu.pl name: Katarzyna Sitnik-Warchulska, PhD role: CONTACT email: katarzyna.sitnik-warchulska@uj.edu.pl name: Krystyna Golonka, Prof role: PRINCIPAL_INVESTIGATOR name: Katarzyna Sitnik-Warchulska, PhD role: SUB_INVESTIGATOR name: Dominika Fortuna, MS role: SUB_INVESTIGATOR lat: 50.06143 lon: 19.93658 facility: University of Coimbra status: RECRUITING city: Coimbra country: Portugal name: João Ferreira, PhD role: CONTACT email: naquelepordosol@gmail.com name: João Ferreira, PhD role: SUB_INVESTIGATOR lat: 40.20564 lon: -8.41955 facility: Bogomolets National Medical University status: RECRUITING city: Kyiv country: Ukraine name: Sergii Tukaiev, PhD role: CONTACT email: tsv.serg.69@gmail.com name: Borys Palamar, Prof role: CONTACT email: palamar.bi@ukr.net name: Borys Palamar, Prof role: SUB_INVESTIGATOR name: Sergii Tukaiev, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.45466 lon: 30.5238 hasResults: False

 nctId: NCT06302751 id: 3647 briefTitle: A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer acronym: RAISe-Care overallStatus: RECRUITING date: 2024-02-26 date: 2026-02-26 date: 2026-08-31 date: 2024-03-12 date: 2024-03-15 name: Istituto Clinico Humanitas class: OTHER briefSummary: The unplanned readmission rate after colorectal cancer surgery is still high, despite the implementation of enhanced recovery programs. The use of a mobile-based application for perioperative remote monitoring may improve the postoperative outcomes and reduce the unplanned postoperative readmissions. conditions: Colorectal Cancer conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-center, prospective, interventional case-series study with a historical cohort of comparison primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 600 type: ESTIMATED name: Care 4 Today ® (Johnson and Johnson) mobile app measure: Unplanned hospital readmissions measure: Severity of postoperative complications measure: Length of hospital stay measure: Time from symptoms onset to diagnosis measure: Healthcare costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it name: Stefano De Zanet, MS role: CONTACT phone: 02 8224 4623 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06302738 id: 09C221 briefTitle: Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern acronym: INTO-DIP overallStatus: RECRUITING date: 2023-05-04 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-04-16 name: Istituto Auxologico Italiano class: OTHER briefSummary: High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention.

It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications.

The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown.

The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI\>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension. conditions: Hypertension conditions: Sleep Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 143 type: ESTIMATED name: polysomnography measure: Prevalence of sleep disorders sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari, status: RECRUITING city: Bari state: Italy, Bari zip: 70120 country: Italy name: Sebastiano Cicco, MD role: CONTACT email: sebastiano.cicco@uniba.it lat: 41.11148 lon: 16.8554 facility: Azienda Sanitaria Locale della provincia di Brindisi status: RECRUITING city: Brindisi state: Italy, Brindisi zip: 72100 country: Italy name: Luigi Vernaglione, MD role: CONTACT phone: 003908311882006 lat: 40.63215 lon: 17.93607 facility: Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara status: RECRUITING city: Novara state: Italy, Novara zip: 28100 country: Italy lat: 45.44694 lon: 8.62118 facility: Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy status: RECRUITING city: Padova state: Italy, Padova zip: 35128 country: Italy name: Maria Teresa Seccia, MD, PhD role: CONTACT phone: 00390498212263 email: teresamaria.seccia@unipd.it lat: 45.40797 lon: 11.88586 facility: Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy status: RECRUITING city: Padova state: Italy, Padova zip: 35128 country: Italy name: Giuseppe Maiolino, MD role: CONTACT phone: 00390498212872 email: giuseppe.maiolino@gmail.com lat: 45.40797 lon: 11.88586 facility: UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy. status: NOT_YET_RECRUITING city: Cittadella state: Italy, PD zip: 35013 country: Italy name: Francesca Saladini, MD role: CONTACT phone: 00390499424531 email: francesca.saladini@alss6.veneto.it lat: 45.64523 lon: 11.78453 facility: Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia- S.O.S Centro per la Cura dell'Ipertensione Arteriosa- Medicina II Cardiovascolare status: NOT_YET_RECRUITING city: Reggio Emilia state: Italy, RE zip: 42122 country: Italy name: Chiara Grasselli, MD role: CONTACT email: chiara.grasselli@ausl.re.it lat: 44.69825 lon: 10.63125 facility: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto status: NOT_YET_RECRUITING city: Rovereto state: Italy, Trento zip: 38068 country: Italy name: Francesco Dalle Vedove, MD role: CONTACT lat: 45.8904 lon: 11.04053 facility: Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica status: NOT_YET_RECRUITING city: Trieste state: Italy, Trieste zip: 34128 country: Italy name: Andrea Grillo, MD, PhD role: CONTACT phone: 00390403994619 email: andrea.grillo@asugi.sanita.fvg.it lat: 45.64953 lon: 13.77679 facility: Department of Medicine, University of Verona, Verona, Italy status: RECRUITING city: Verona state: Italy, Verona zip: 37126 country: Italy name: Cristiano Fava, MD, PhD role: CONTACT phone: 00390458124732 email: cristiano.fava@univr.it lat: 45.4299 lon: 10.98444 facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milano state: MI zip: 20149 country: Italy name: Martino Pengo, MD, PhD role: CONTACT phone: 00390261911 email: m.pengo@auxologico.it name: Elisa Nardin role: CONTACT phone: 00390261911 email: e.nardin@auxologico.it name: Gianfranco Parati, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06302725 id: APHP231514 id: 2023-A02623-42 type: OTHER domain: IDRCB briefTitle: Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases acronym: APOSY overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2027-03 date: 2024-03-12 date: 2024-03-12 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity). conditions: HPV Infection conditions: Systemic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Vaginal self sampling detecting HPV measure: prevalence of HPV infection (yes/no) after VSS proposal measure: the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population measure: The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population measure: Presence of HPV infection during follow-up (yes/no) measure: description of demographic factor measure: description of clinical factor measure: description of biological factor measure: description of treatment (corticoids, immunosuppressive treatments) measure: description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: Up-to-date cervical cancer screening rate in accordance with HAS recommendations measure: Proportion of cervical cytological abnormalities if performed (histological confirmation if available) measure: proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) measure: presence of cervical precancerous lesions and cervical cancer measure: HPV vaccination coverage rate measure: Persistence of HPV infection sex: FEMALE minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard city: Paris zip: 75018 country: France name: Tiphaine Goulenok, MD role: CONTACT phone: 00 33 1 40 25 72 89 email: tiphaine.goulenok@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06302712 id: TIIP briefTitle: Traditional Islamically Integrated Psychotherapy for Muslims With OCD in Pakistan overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-30 date: 2024-03-12 date: 2024-03-18 name: International Islamic University Malaysia class: OTHER name: Foundation University Islamabad briefSummary: The current study aims to determine the effectiveness of the first culturally adapted Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims with OCD in Pakistan along with the module effectiveness in reducing OCD symptoms with comorbidities like anxiety, depression, stress, thought control, thought-action fusion, and enhancing the spiritual quality of life of participants. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Traditional Islamically Integrated Psychotherapy measure: Yale Brown Obsessive Compulsive Scale measure: Depression, Stress, Anxiety measure: Thought Action Fusion measure: Thought Control measure: Spiritual Quality sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06302699 id: UCAD-MM-001 briefTitle: Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma overallStatus: RECRUITING date: 2023-05-01 date: 2024-05-01 date: 2026-03-01 date: 2024-03-12 date: 2024-03-12 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED measure: Detection of copy number variation measure: Serial monitoring of treatment response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302686 id: INRCA_004_2023 briefTitle: engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions acronym: engAGE overallStatus: RECRUITING date: 2023-10-09 date: 2024-06-24 date: 2024-06-24 date: 2024-03-12 date: 2024-03-12 name: Istituto Nazionale di Ricovero e Cura per Anziani class: OTHER name: European Union briefSummary: The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots. conditions: Mild Cognitive Impairment conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 78 type: ESTIMATED name: engAGE system name: Group practicing with only the support of a booklet measure: Change in perceived stability of cognitive status by the older adults measure: Change in cognitive impairment in older adults measure: Change in depression in older adults measure: Change in frailty status in older adults measure: Change in mental well being in older adults measure: Change in quality of life in older adults measure: Change in acceptability of the engAGE system in older adults measure: Change in quality of life in informal caregivers measure: Change in mental well being in informal caregivers measure: Change in caregiver burden sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: IRCCS INRCA Hospital status: RECRUITING city: Ancona zip: 60127 country: Italy name: Elvira Maranesi role: CONTACT name: Roberta Bevilacqua role: PRINCIPAL_INVESTIGATOR lat: 43.5942 lon: 13.50337 facility: Karde A/S status: RECRUITING city: Oslo country: Norway name: Terje Grimstad role: CONTACT name: Terje Grimstad role: PRINCIPAL_INVESTIGATOR lat: 59.91273 lon: 10.74609 facility: HUG status: RECRUITING city: Geneva country: Switzerland name: Christian Lovis role: CONTACT name: Christian Lovis role: PRINCIPAL_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False

 nctId: NCT06302673 id: 23081229 briefTitle: The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients overallStatus: RECRUITING date: 2023-10-09 date: 2024-10 date: 2024-10 date: 2024-03-12 date: 2024-03-12 name: Indonesia University class: OTHER briefSummary: This study to determine the effectiveness of a combination of pre-surgical laserpuncture with standard anti-emetic therapy for PONV symptoms in adult patients after strabismus surgery under general anesthesia compared to a combination of pre-surgical placebo laserpuncture with standard anti-emetic therapy. Research design using a double blinded randomized controlled trial (RCT) where research subjects and data takers who will be disguised. The research will be carried out in the Operation and Inpatient Room, Kirana Building, RSUPN Dr. Cipto Mangunkusumo (RSCM) with research subjects as adult patients undergoing strabismus surgery under general anesthesia. Assessment of nausea and vomiting using AVS ( Analog Visual Scale) consists of scoring using a score from 1-5 which indicates the severity of nausea and vomiting. conditions: Nausea and Vomiting, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blinded randomized controlled trial (RCT) primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Laserpuncture and anti emetic standar therapy name: Sham Laserpuncture and anti emetic standar therapy measure: Analog Visual Scale for nausea vomitting sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: RSUPN Dr. Cipto Mangunkusumo status: RECRUITING city: Jakarta Pusat state: Jakarta country: Indonesia name: Yossie Faudina Putri, MD role: CONTACT phone: 6281290371481 email: yossie.dina2@gmail.com lat: -6.1818 lon: 106.8223 hasResults: False

 nctId: NCT06302660 id: 22/LO/0169 briefTitle: Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors acronym: MAPLES overallStatus: RECRUITING date: 2022-03-09 date: 2024-06-01 date: 2025-06-01 date: 2024-03-12 date: 2024-04-18 name: Imperial College London class: OTHER name: Imperial College Healthcare NHS Trust name: West Hertfordshire Teaching Hospitals NHS Trust name: Barking, Havering and Redbridge University Hospitals NHS Trust briefSummary: The goal of this observational study is to learn about long term symptoms in oesophageal cancer survivors. The main question it aims to answer is are:

* Study the changes in gut bacteria by examining saliva, stool and blood.
* Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria.
* Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors.

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath, saliva, blood, urine, stool and complete validated healthy-related quality-of-life questionnaires.

Researchers will compare symptomatic and asymptomatic participants to detect the changes stated above. conditions: Oesophageal Cancer conditions: Quality of Life conditions: Bacterial Overgrowth studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Breath test name: Saliva sample name: Blood sample name: Urine sample name: Stool sample name: Health-related Quality of life questionnaires measure: Identify microbiome dysbiosis in saliva associated with long-term functional symptoms. measure: Identify microbiome dysbiosis in stool associated with long-term functional symptoms. measure: Identify underlying metabolic pathways associated with microbiome derived metabolites. measure: Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis. measure: Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors. sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barking, Havering and Redbridge University Hospitals NHS Trust status: RECRUITING city: London country: United Kingdom name: Munir Tarazi, MB BCh BAO MRCS MCh role: CONTACT phone: +44 (0)20 7594 8197 email: m.tarazi@imperial.ac.uk lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London country: United Kingdom name: Munir Tarazi, MB BCh BAO MRCS MCh role: CONTACT phone: +44 (0)20 7594 8197 email: m.tarazi@imperial.ac.uk lat: 51.50853 lon: -0.12574 facility: West Hertfordshire NHS Teaching Hospitals status: RECRUITING city: London country: United Kingdom name: Munir Tarazi, MB BCh BAO MRCS MCh role: CONTACT phone: +44 (0)20 7594 8197 email: m.tarazi@imperial.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06302647 id: PI-6022 briefTitle: Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2024-06-15 date: 2024-06-30 date: 2024-03-12 date: 2024-03-15 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER briefSummary: Study objective:

To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.

Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.

Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement. conditions: Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Questionnaires measure: percentage of each of the three groups that would find the platform useful sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302634 id: ReCO id: 2022/137 type: OTHER domain: Comité de Ética de la Investigación de Santiago-Lugo briefTitle: Cardio-Oncology Rehabilitation Care Process acronym: ReCO overallStatus: RECRUITING date: 2022-06-22 date: 2027-06-22 date: 2027-06-22 date: 2024-03-12 date: 2024-03-15 name: Hospital Clinico Universitario de Santiago class: OTHER briefSummary: The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2). conditions: Cardio-Oncology conditions: Rehabilitation conditions: Cardiovascular Diseases conditions: Exercise studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Exercise-based cardio-oncology rehabilitation measure: Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography measure: Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP) measure: Decrease in functional capacity assessed by estimated VO2peak measure: Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors. measure: Changes in fasting blood glucose measure: Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels measure: Change in haemoglobin measure: Significant cardiovascular and non-cardiovascular adverse effects during treatment. measure: Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire. measure: Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test. measure: Change in lower limb strength measured by squat dynamometry (kg). measure: Change in biceps strength by dynamometry (kg). measure: Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella measure: Changes in peak expiratory flow measure: Change in upper limb strength measured by dynamometry (kg). measure: Change in anthropometric parameters: weight in kg. measure: Change in anthropometric parameters: Body mass index (BMI) in kg/m^2 measure: Change in anthropometric parameters: abdominal circumference in cm. measure: Change in resting heart rate measured by pulse oximetry (beats per min). measure: Change in resting blood pressure (mmHg) measured by a blood pressure monitor. measure: Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ). measure: Change in cardiovascular treatment by its presence or absence. measure: Adherence and compliance to cardiac rehabilitation program (CBCORe) assessed by number of training sessions attended/number of sessions planned. measure: Compliance to home-based cardiac rehabilitation program (HBCORe) assessed by the total number of telephone calls during the Physiotherapy follow-up and the total time of telephone calls. measure: Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe). measure: Satisfaction with the CORe program measure: Follow-up of the exercise performed after participation in the CORe program measure: Presence or absence of lymphoedema. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Santiago status: RECRUITING city: Santiago de Compostela state: A Coruña zip: 15706 country: Spain name: Carlos Peña-Gil, MD, PhD role: CONTACT phone: +34 981 950 778 email: carlos.pena.gil@sergas.es name: Estíbaliz Díaz-Balboa role: CONTACT phone: +34 981950747 email: estibaliz.diaz.balboa@sergas.es lat: 42.88052 lon: -8.54569 hasResults: False

 nctId: NCT06302621 id: 21-725 briefTitle: Pemigatinib + Afatinib in Advanced Refractory Solid Tumors overallStatus: RECRUITING date: 2024-07-01 date: 2024-12-01 date: 2025-12-01 date: 2024-03-12 date: 2024-04-26 name: Massachusetts General Hospital class: OTHER name: Boehringer Ingelheim name: Incyte Corporation briefSummary: This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors.

The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects.

This research study involves the study drugs Afatinib and Pemigatinib. conditions: Advanced Solid Tumor conditions: Unresectable Solid Tumor conditions: Metastatic Solid Tumor conditions: Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Afatinib name: Pemigatinib measure: Maximum tolerated dose (MTD) measure: Objective response rate (ORR) measure: Disease Control Rate measure: Duration of Response measure: Overall Survival measure: Progression-free Survival measure: Best Overall Response measure: Time to response measure: Treatment Related Adverse Events measure: Maximum Plasma Concentration [Cmax]) and C trough of pemigatinib and afatinib measure: Molecular correlates of response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Andreas Varkaris, MD role: CONTACT phone: 617-724-4000 email: AVARKARIS@MGH.HARVARD.EDU name: Andreas Varkaris, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06302608 id: NGGT-BCD-P-2203 briefTitle: Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-08 date: 2024-05-29 date: 2028-05-29 date: 2024-03-12 date: 2024-03-12 name: Xiamen Ophthalmology Center Affiliated to Xiamen University class: OTHER briefSummary: Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD) conditions: Bietti's Crystalline Dystrophy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: NGGT001 measure: BCVA measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiuju Chen city: Xiamen state: Fujian zip: 361000 country: China lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06302595 id: 2022P001093 id: 5R44CA224853 type: NIH link: https://reporter.nih.gov/quickSearch/5R44CA224853 briefTitle: MRI Guided Prostate Biopsy overallStatus: RECRUITING date: 2023-08-24 date: 2024-05-31 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: Brigham and Women's Hospital class: OTHER name: National Cancer Institute (NCI) name: Physical Sciences Inc. briefSummary: This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template. conditions: Suspected Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 15 type: ESTIMATED name: MRI-guided prostate biopsy using the needle holder frame. measure: Accuracy of needle placement sex: MALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Kemal Tuncali, MD role: CONTACT phone: 617-732-7631 email: ktuncali@bwh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06302582 id: stress injury briefTitle: Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury overallStatus: RECRUITING date: 2024-02-29 date: 2024-11-25 date: 2024-11-25 date: 2024-03-12 date: 2024-03-12 name: Liaocheng People's Hospital class: OTHER briefSummary: This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury. conditions: Pressure Injuries - Stage 3 conditions: Pressure Injuries - Stage 4 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs) name: Control group measure: Change From Baseline in Pressure Ulcer Scale for Healing (PUSH) measure: Change from baseline in Determination of growth factor content measure: Wound healing time measure: Positive rate of bacterial culture measure: Safety evaluation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central laboratory status: RECRUITING city: Liaocheng state: Shandong zip: 252000 country: China name: changhui Zhou, postgraduate role: CONTACT phone: 13562078772 email: zhouchanghui008@163.com lat: 36.45596 lon: 115.97766 hasResults: False

 nctId: NCT06302569 id: Bellini INT 2024-511587-93-00 briefTitle: Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma acronym: REPRINT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-10 date: 2028-05 date: 2024-03-08 date: 2024-03-08 name: Giuseppe Procopio class: OTHER briefSummary: This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin.

Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.

Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin.

The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes. conditions: Bellini Carcinoma conditions: Collecting Duct Carcinoma conditions: Renal Medullary Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: Pembrolizumab + Enfortumab Vedotin measure: ORR in patients treated with Pembrolizumab plus Enfortumab Vedotin measure: Progression-free survival (PFS) in patients treated with Pembrolizumab plus Enfortumab Vedotin measure: Overall-survival (OS) in patients treated with Pembrolizumab plus Enfortumab Vedotin measure: Number of Participants treated with Pembrolizumab + Enfortumab Vedotin who experience AEs/SAEs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Irccs Istituto Dei Tumori Di Milano city: Milan zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06302556 id: 2022XJ9W4F id: G53D2300526 0006 type: OTHER_GRANT domain: Ministry of University and Research. NextGenetationUE briefTitle: The Role of Immune Checkpoints in Lung Transplant (ILTRA) acronym: ILTRA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-02 date: 2024-03-08 date: 2024-03-08 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: University of Milan name: University of Padova name: University of Turin, Italy briefSummary: The goal of this observational study is to learn about rejection in lung transplantation.

The main question it aims to answer is:

• what is the role of immune checkpoints in lung transplantation? Participants will describe pathways of rejection in lung transplantation analyzing the immune checkpoints on explanted lungs as well as trans-bronchial biopsies. conditions: Lung Transplant Rejection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 280 type: ESTIMATED name: Immune checkpoints analysis name: Gene expression analysis measure: Lung-tissue immune-checkpoint profile and bronchoalveolar immune-cells mRNA signature in acute rejection after lung transplantation. measure: Lung-tissue immune-checkpoint profile in chronic rejection after lung transplantation. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy name: Mario Nosotti, Medicine role: CONTACT phone: 3393924679 email: mario.nosotti@unimi.it name: Ilaria Righi, Medicine role: CONTACT phone: +393470556707 email: ilaria.righi78@gmail.com name: Mario Nosotti, Medicine role: PRINCIPAL_INVESTIGATOR name: Ilaria Righi, Medicine role: SUB_INVESTIGATOR name: Lorenzo Rosso, Medicine role: SUB_INVESTIGATOR name: Valentina Vaira, Biology role: SUB_INVESTIGATOR name: Mario Clerici, Medicine role: SUB_INVESTIGATOR name: Daria Trabattoni, Biology role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: University of Modena and Reggio Emilia city: Modena zip: 41121 country: Italy name: Marcello Pinti, Biology role: CONTACT phone: +390592055386 email: marcello.pinti@unimore.it lat: 44.64783 lon: 10.92539 facility: University of Padua city: Padova zip: 35131 country: Italy name: Marco Schiavon, Medicine role: CONTACT phone: +39 3475642901 email: marco.schiavon@unipd.it lat: 45.40797 lon: 11.88586 facility: University of Turin city: Torino zip: 10124 country: Italy name: Massimo Boffini, Medicine role: CONTACT phone: +39 3474267034 email: massimo.boffini@unito.it lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06302543 id: POI bone marrow briefTitle: Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells acronym: alfarah overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-10 date: 2024-10-24 date: 2024-03-08 date: 2024-03-08 name: abdulmajeed hammadi class: INDUSTRY briefSummary: investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.

Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program. conditions: Premature Ovarian Insufficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single armed interventional study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: autologous bone marrow cells injection measure: change in gonadotropin levels sex: FEMALE minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Ministry of Health status: RECRUITING city: Baghdad zip: 964 country: Iraq name: abdulmajeed Hammadi, MD role: CONTACT phone: +9647902268105 email: alzaitounhospital@gmail.com lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06302530 id: UCV/2022-2023/155 briefTitle: "Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex" acronym: EUGLGC overallStatus: RECRUITING date: 2024-03-15 date: 2024-08-30 date: 2025-03-15 date: 2024-03-08 date: 2024-04-23 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER briefSummary: This research project compares the effectiveness of different surgical techniques for lengthening the gastrocnemius-soleus system in patients with equinus deformity. The study will compare 2 techniques: gastrocnemius tendon recession (Strayer) and plantaris resection. Increased ankle range of motion, complications, operative time, recovery time, pain scales and function will be measured. The results will help determine which technique is most effective and safe for correcting equinus deformity. conditions: Gastrocnemius Equinus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: To reduce bias, the study will use double-blind blinding. Patients will not know the group to which they have been assigned. In addition, the assessors performing the ankle range of motion measurements by goniometry will be blinded to each patient's treatment group.

Randomization to each group will be performed using opaque sealed envelopes that will be opened in the operating room just prior to surgery. Neither the surgeon nor the patient will know the assignment until that time.

The statistical analysis will also be performed in a blinded manner, without the statistician knowing the intervention received by each group. Only after the analysis will the groups be unblinded.

In this way, the aim is to reduce the possibility of knowledge of the assigned treatment influencing the evaluation of the results, both on the part of the patients and of the evaluators and analysts. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: Stayer name: Plantar transection measure: Ankle range of motion measure: Visual Analog Scale. measure: American Orthopedic Foot and Ankle Score measure: Complications sex: ALL minimumAge: 10 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Podologia Avançada status: RECRUITING city: Granollers state: Barcelona zip: 08401 country: Spain name: Lluis Castillo-Sanchez, Dr role: CONTACT phone: 610143173 email: info@podologiaavanzadabcn.com name: Lluis Castillo, Dr role: SUB_INVESTIGATOR name: Cristina Razzano role: PRINCIPAL_INVESTIGATOR name: Simone Moroni role: SUB_INVESTIGATOR lat: 41.60797 lon: 2.28773 facility: Clinica Mayral foot center status: RECRUITING city: Barcelona state: Barcelon zip: 08029 country: Spain name: Jordi Mayral role: CONTACT phone: (+34) 93 339 78 41 email: barcelona@clinicamayral.com name: Jordi Mayral role: SUB_INVESTIGATOR name: Cristina Razzano role: PRINCIPAL_INVESTIGATOR name: Simone Moroni role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Clinica Pasito a pasito status: RECRUITING city: Valencia zip: 46008 country: Spain name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 963855535 email: clinicaspasitoapasito@gmail.com name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 644733882 email: javier.ferrer@ucv.es name: JAVIER Ferrer- TORREGROSA, Dr role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06302517 id: K2020097 briefTitle: Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia overallStatus: COMPLETED date: 2020-09-01 date: 2022-05-31 date: 2022-08-29 date: 2024-03-08 date: 2024-03-08 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: ①Effects of BIS Index (BIS) monitoring on delirium incidence in Post-anesthesia care unit (PACU) in patients undergoing general anesthesia

②Effects of BIS BIS Index (BIS) monitoring on the quality of nursing care in the Post-anesthesia care unit (PACU) conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 134 type: ACTUAL name: BIS-guided measure: Ricker sedation-agitation scale measure: The nursing activity score (NAS) measure: vital signs （Mean arterial pressure, heart rate, pulse oxygen saturation ） measure: Comparison of complications during the PACU period measure: The comprehensive satisfaction score sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Affiliated Hospital, School of Medicine, Zhejiang University city: Jinhua state: Zhejiang zip: 322000 country: China lat: 29.10678 lon: 119.64421 hasResults: False

 nctId: NCT06302504 id: Nature briefTitle: Nature-based Mindfulness Intervention Program for Family Carers overallStatus: RECRUITING date: 2023-04-15 date: 2024-03-31 date: 2024-03-31 date: 2024-03-08 date: 2024-03-08 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Nature-based mindfulness program measure: depression measure: anxiety measure: stress measure: family functioning measure: family conflict measure: well-being sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong zip: 852 country: Hong Kong name: Hay-ming Herman Lo, PhD role: CONTACT phone: +852-27665769 email: herman.lo@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06302491 id: AND017-BTH-205 briefTitle: A Study of Safety and Efficiency of AND017 in Patients With Transfusion Dependent and Non-transfusion Dependent β-thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-07 date: 2024-03-08 date: 2024-03-08 name: Kind Pharmaceuticals LLC class: INDUSTRY briefSummary: This is a phase II, randomized, double-blinded, placebo-controlled study to treat patients with transfusion-dependent and non-transfusion dependent β -thalassemia with AND017 and optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice. conditions: β -Thalassemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: AND017 capsules name: AND017 Placebo measure: Evaluate the safety and tolerability of different oral doses of AND017 in the treatment of β-thalassemia subjects measure: Change in mean Hb levels relative to baseline at weeks 8-12 and week 20-24 post-treatment compared to baseline (mean Hb values during the 4 weeks prior to the first dose). measure: The level of Hb and the change from baseline at each visit throughout the treatment period. measure: Proportion of patients with mean Hb elevation ≥1.0 g/dL from baseline to weeks 8-12 after dosing. measure: Levels of and changes from baseline in red blood cell count throughout the treatment period measure: Levels of and changes from baseline in reticulocyte count throughout the treatment period measure: Levels of and changes from baseline in mean corpuscular volume (MCV) throughout the treatment period measure: Levels of and changes from baseline in mean corpuscular hemoglobin (MCH) throughout the treatment period measure: Levels of and changes from baseline in mean corpuscular hemoglobin concentration (MCHC) throughout the treatment period measure: Throughout the treatment period, changes in the levels and relative baseline of transferrin will be assessed. measure: Throughout the treatment period, changes in the levels and relative baseline of transferrin saturation (TSAT) will be assessed. measure: Throughout the treatment period, changes in the levels and relative baseline of ferritin will be assessed. measure: Throughout the treatment period, changes in the levels and relative baseline of serum iron level will be assessed. measure: Throughout the treatment period, changes in the levels and relative baseline of total iron binding capacity (TIBC) will be assessed. measure: Change in transfusion load (units transfused) at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose). measure: Change in number of transfusions at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose). measure: Proportion of subjects with ≥33% reduction in transfusion load (transfusion units) relative to baseline (12 weeks prior to first dose to W0) from baseline to any consecutive 12-week period after dosing. measure: Duration (days) of maintenance below this transfusion dose after a 33% reduction in transfusion load from baseline has been achieved. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302478 id: KhonKaenU001 briefTitle: 5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders overallStatus: RECRUITING date: 2024-03-12 date: 2024-05-30 date: 2024-10-31 date: 2024-03-08 date: 2024-03-13 name: Khon Kaen University class: OTHER briefSummary: The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:

* Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?
* Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?
* Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?

Participants in the intervention group will receive the 5E program, including

* Education: health education regarding venous thromboembolism prevention
* Elevation: leg elevation of 10-20 degrees
* Exercise: ankle exercises
* Enough fluid: adequate fluid uptake
* Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission conditions: Venous Thromboembolism conditions: Spinal Cord Diseases conditions: Spinal Cord Injuries conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A quasi-experimental research (two group pretest-posttest design) primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 42 type: ESTIMATED name: 5E program measure: The rate of venous thromboembolism measure: Signs and symptoms of deep venous thrombosis and pulmonary embolism measure: Thigh and calf circumference sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chaiyaphum Hospital status: RECRUITING city: Chaiyaphum zip: 36000 country: Thailand name: Suchada Chindamart, BNS role: CONTACT phone: +66619411828 email: suchada.chi@kkumail.com lat: 15.81047 lon: 102.02881 hasResults: False

 nctId: NCT06302465 id: PKUPH-sarcoma 18 briefTitle: Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells overallStatus: RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2026-12-31 date: 2024-03-08 date: 2024-03-29 name: Peking University People's Hospital class: OTHER briefSummary: Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Control of local recurrence rate is the core objective of oncotherapy. Surgery way and boundary have a significant effect on prognosis of non- metastatic bone tumor. Narlumosbartmab, a RANKL inhibitor, can make tumor boundary clear and reduce surgical difficulty by inhibiting osteoclast. This is a prospective, randomized, controlled, two-arm, open, single-center clinical trial to compare the efficacy and safety of narlumosbartmab combined with neoadjuvant chemotherapy and neoadjuvant chemotherapy alone in bone-derived malignancies with bone lytic lesions and multinucleated giant cells. Investigators mainly observe the local recurrence rate to evaluate the survival benefit for patients with poor prognosis. conditions: Malignant Bone Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide name: doxorubicin、cisplatin、methotrexate、ifosfamide measure: local recurrence rate measure: tumor necrosis rate measure: R0 removal rate measure: Event-free survival measure: Overall survival sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100044 country: China name: Lu Xie, M.D. role: CONTACT phone: +8613401044719 email: xie.lu@hotmail.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06302452 id: IRB00433605 id: R01MD019173 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD019173 briefTitle: Adult Trauma Centers RE-AIM at Gun Safety (ACTFAST) Prevention overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-02 date: 2028-02 date: 2024-03-08 date: 2024-03-08 name: Johns Hopkins University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) name: Rhode Island Hospital briefSummary: The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are:

1. (Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states;
2. (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers. conditions: Firearm Injury conditions: Safety Issues studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The trial uses a unidirectional crossover stepped wedge design with a sequential roll-out of the intervention, ACTFAST, RE-AIM implementation framework, over several discrete time points or "steps." Each of the three trauma centers will be randomly assigned to one step that will determine when they crossover from control to implementation.

Data are collected over multiple wedges, each 4-6 months in length. During the first wedge, none of the participating trauma centers will receive ACTFAST. During the second wedge, the first trauma center completes the Adoption and Implementation period. Over the third wedge, the first center shifts to the Maintenance period, the second trauma center enters the Adoption and Implementation period, and the remaining cohort stays in the control condition. This pattern continues until all trauma centers have progressed from control condition through the active implementation period. primaryPurpose: OTHER masking: NONE count: 1776 type: ESTIMATED name: Adopting Comprehensive Training for FireArm Safety in Trauma Centers measure: Proportion of admitted injured patients receiving each element of the ACTFAST Program measure: Percentage of admitted injured patients receiving elements of the ACTFAST Program measure: Patient firearm safety attitudes and behaviors as assessed by survey measure: Clinician firearm safety knowledge and confidence as assessed by survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Bayview Medical Center city: Baltimore state: Maryland zip: 21224 country: United States lat: 39.29038 lon: -76.61219 facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06302439 id: INZ701-007 briefTitle: PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2034-05 date: 2034-05 date: 2024-03-08 date: 2024-03-18 name: Inozyme Pharma class: INDUSTRY name: GACI Global briefSummary: The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) Deficiency longitudinally. The registry will prospectively gather information about the genetic, biochemical, physiological, anatomic, radiographic, and functional manifestations (including patient reported outcomes \[PROs\]) of each disease during routine, standard-of-care visits, with the aim of developing a comprehensive understanding of the burden of illness and progressive nature of the disease. conditions: Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 Deficiency conditions: ATP-Binding Cassette Subfamily C Member 6 Deficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: No Intervention for this observational study measure: Characterization of the natural history of ENPP1 Deficiency and the infantile-onset form of ABCC6 Deficiency longitudinally measure: Assessment of Patient Functional changes through a validated Patient Reported Outcomes (PROs) tool measure: Assessment of Health-Related Quality-of-Life (HRQoL) changes through validated Patient Reported Outcomes (PROs) tools measure: Measurement of inorganic phosphate (PPi) levels in patients' venous blood sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302426 id: INI-4001-101 briefTitle: Trial of INI-4001 in Patients With Advanced Solid Tumours overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2024-08-01 date: 2026-04-30 date: 2024-03-08 date: 2024-03-08 name: Inimmune Corporation class: INDUSTRY name: Avance Clinical Pty Ltd. briefSummary: Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a Phase Ia/Ib, open-label, dose-escalation and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion). primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: INI-4001 name: Nivolumab name: Pembrolizumab name: Cemiplimab name: Avelumab name: Atezolizumab name: Durvalumab measure: Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy measure: Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses measure: Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses measure: Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses measure: Number of Participants with a Change from baseline in body weight after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses measure: Change from baseline in measurements of HR in beats per minute after multiple ascending doses measure: Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses measure: Single dose PK Parameters - maximum observed concentration (Cmax) measure: Multiple dose PK Parameters - maximum observed concentration (Cmax) measure: Single dose PK Parameters - Time to Cmax (Tmax) measure: Multiple dose PK Parameters - Time to Cmax (Tmax) measure: Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) measure: Single dose PK Parameters - Total amount excreted in urine (Ae) measure: Single dose PK Parameters - Fraction excreted in the urine (Fe) measure: Single dose PK Parameters - Renal clearance (CLr) measure: Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) measure: Single dose PK Parameters - Area under the concentration-time curve (AUC0-t) measure: Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t) measure: Single dose PK Parameters - Half-life (t1/2) measure: Multiple dose PK Parameters - Half-life (t1/2) measure: Single dose PK Parameters - Clearance (Cl) measure: Multiple dose PK Parameters - Clearance (Cl) measure: Single dose PK Parameters - Volume of distribution (Vz) measure: Multiple dose PK Parameters - Volume of distribution (Vz) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Border Cancer Hospital city: Albury state: New South Wales zip: 2640 country: Australia name: Reenu Arora role: CONTACT email: AroraReenu@ramsayhealth.com.au name: Kay Xu, Dr role: PRINCIPAL_INVESTIGATOR lat: -36.07482 lon: 146.92401 facility: Cabrini Hospital city: Malvern state: Victoria zip: 3144 country: Australia name: Prachi Bhave role: CONTACT email: PBhave@cabrini.com.au name: Prachi Bhave, Dr role: PRINCIPAL_INVESTIGATOR lat: -32.02849 lon: 151.32225 hasResults: False

 nctId: NCT06302413 id: 1805574553; Aims 9-10 id: 1R01AA029396-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AA029396-01 briefTitle: Enhancing Prospective Thinking in Early Recovery acronym: HOME overallStatus: RECRUITING date: 2024-02-15 date: 2027-07-31 date: 2027-07-31 date: 2024-03-08 date: 2024-03-08 name: Indiana University class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question\[s\] this trial aims to answer are:

Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment. whoMasked: PARTICIPANT count: 500 type: ESTIMATED name: Virtual Reality name: Virtual Reality measure: Reduced Use of Drug Using Days measure: Increased Length of Abstinence measure: Increased (overall) Abstinence measure: Future Self-identification with Future Self Continuity Questionnaire measure: Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire measure: Delayed Reward Preference with the Delayed Discounting Behavioral Task sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Indiana University School of Medicine - Goodman Hal status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: Sarah Turo, BA role: CONTACT phone: 317-963-7220 email: sturo@iu.edu name: Brandon G Oberlin, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 hasResults: False

 nctId: NCT06302400 id: RS-IC04 briefTitle: Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma acronym: RHEPaiR overallStatus: RECRUITING date: 2024-02-22 date: 2027-02 date: 2027-02 date: 2024-03-08 date: 2024-03-08 name: Imperial College London class: OTHER name: Terumo Europe N.V. briefSummary: The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are:

* What is the safety and toxicity profile of the 166-Holmium microspheres?
* Is the device effective in treating HCC?

Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including:

* A Computed Tomography (CT) scan
* A Magnetic Resonance Imaging (MRI) scan
* Blood tests
* Quality of life questionnaires

Before receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months. conditions: Carcinoma, Hepatocellular studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: 166Holmium microspheres (QuiremSpheres®) measure: The incidence of adverse and serious adverse events in patients receiving individualized treatment with 166Ho- microspheres, using National Cancer Institute CTCAE v5.0. measure: The rate of efficacy as defined as overall response rate (ORR) in patients receiving individualized treatment with 166Ho- microspheres, using modified RECIST (mRECIST) response evaluation criteria. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London zip: W12 0HS country: United Kingdom name: Rohini Sharma, Professor role: CONTACT phone: 02033133720 email: r.sharma@imperial.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06302387 id: BEC-LSMU(R)-27 briefTitle: Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability overallStatus: COMPLETED date: 2018-01-01 date: 2020-04-01 date: 2023-02-01 date: 2024-03-08 date: 2024-03-08 name: Harvard Medical School (HMS and HSDM) class: OTHER briefSummary: This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are. conditions: Soft Tissue Augmentation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double-blind, where neither the patients nor the clinicians responsible for treatment know the specific treatment modality whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ACTUAL name: Acellular Dermal Matrix name: Soft Tissue Expansion using Tenting Technique measure: Crestal Bone Levels measure: Vertical soft tissue thickness measure: PPD measure: BOP measure: PI sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VIC Clinic city: Vilnius zip: 01362 country: Lithuania lat: 54.68916 lon: 25.2798 hasResults: False

 nctId: NCT06302374 id: GR2001-001 briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults overallStatus: COMPLETED date: 2023-03-04 date: 2023-11-01 date: 2024-02-19 date: 2024-03-08 date: 2024-03-08 name: Genrix (Shanghai) Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and Immunogenicity characteristics of GR2001 and compare the anti-tetanus neutralizing antibody titers of GR2001 with human tetanus immunoglobulin (HTIG)in healthy adult subjects. conditions: Tetanus studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the phase I part of the study, a total of 94 healthy subjects will be enrolled. The 94 healthy adult subjects will be enrolled into 7 cohorts sequentially. Each participant will receive a single IM dose of GR2001 or placebo or HTIG according to the cohort in which they were enrolled. After injection (Day 0), participants will remain in the study site for observation up to Day 1. The phase I part will last for 105 days following the assessments of safety, PK, PD and ADA.

In the phase II part of the study, a total of 108 healthy subjects will be enrolled. The 108 healthy subjects will be randomly assigned to the experimental group and the control group based on a ratio of 1:1:1:2:2:2.The phase II part will last for 105 days following the assessments of safety, PK, PD and ADA. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double Blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 202 type: ACTUAL name: GR2001 name: Placebo name: HTIG name: Tetanus Toxoid measure: Incidence of AEs(Phase I) measure: Tetanus-antibody titer(Phase II) measure: Tetanus-antibody titer(Phase I/II) measure: Incidence of ADA(Phase I/II) measure: Incidence of AEs(Phase II) measure: Peak plasma concentration(Cmax) measure: Area under the plasma concentration versus time curve (AUC) measure: Time of maximum plasma concentration (Tmax) measure: Terminal half-life (T1/2) measure: Apparent total body clearance (CL/F) measure: Apparent volume of distribution (Vd/F) measure: The elimination rate constant (Kel) measure: Mean Residence Time (MRT) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Huashan Hospital affiliated of Fudan University city: Shanghai state: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06302361 id: 23/54225 briefTitle: Lymphovenous Anastomosis for Breast Cancer Lymphedema overallStatus: RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: Odense University Hospital class: OTHER name: Vejle Hospital name: Zealand University Hospital name: Herlev and Gentofte Hospital briefSummary: This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.

Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.

Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.

The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.

The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research. conditions: Lymphedema conditions: Lymphedema Arm conditions: Breast Cancer Lymphedema conditions: Lymphedema, Secondary conditions: Lymphedema; Surgical conditions: Lymphedema of Upper Limb conditions: Lymphedema, Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Multi-center cohort study primaryPurpose: TREATMENT masking: NONE count: 47 type: ESTIMATED name: Lymphovenous anastomosis (LVA) measure: Arm volume (Water Displacement) measure: Arm volume (Arm Circumferences) measure: Health-related quality of life (LYMPH-Q) measure: General quality of life (SF-36) measure: Arm and shoulder function (DASH) measure: L-Dex measure: LVA patency measure: Skin Fibrosis measure: Surgery duration measure: Body composition sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Plastic Surgery, Odense University Hospital status: RECRUITING city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark name: Caroline Lilja, MD role: CONTACT phone: +4560555340 email: caroline.lilja@rsyd.dk lat: 55.39594 lon: 10.38831 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-07 uploadDate: 2024-03-04T05:57 filename: Prot_SAP_000.pdf size: 934504 hasResults: False

 nctId: NCT06302348 id: PTC923-PKU-401 briefTitle: A Study of Sepiapterin in Participants With Phenylketonuria (PKU) acronym: EPIPHENY overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2031-02-28 date: 2031-02-28 date: 2024-03-08 date: 2024-03-08 name: PTC Therapeutics class: INDUSTRY briefSummary: The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood. conditions: Phenylketonuria studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Sepiapterin measure: Mean Change From Baseline in Full-scale Intelligence Quotient (FSIQ) Weschler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) Score measure: Mean Change From Baseline in FSIQ Weschler Intelligence Scale for Children - Fifth Edition (WISC-V) Score measure: Change From Baseline in Phenylketonuria-Quality of Life (PKU-QOL) Questionnaire Score measure: Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Score measure: Mean Change From Baseline in FSIQ (WPPSI-IV) Score measure: Mean Change From Baseline in FSIQ (WISC-V) Score measure: Change From Baseline in Mean Blood Phe Levels sex: ALL maximumAge: 12 Years stdAges: CHILD facility: Indiana University city: Indianapolis state: Indiana zip: 46202 country: United States name: Susan Romie role: CONTACT name: Melissa Lah role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 hasResults: False

 nctId: NCT06302335 id: 2022-0442 briefTitle: Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection overallStatus: RECRUITING date: 2023-01-02 date: 2027-12-31 date: 2027-12-31 date: 2024-03-08 date: 2024-03-08 name: Hospital de Clinicas de Porto Alegre class: OTHER briefSummary: Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants will not know what kind of substance will be used during the surgery. whoMasked: PARTICIPANT count: 228 type: ESTIMATED name: Povidone-iodine name: Saline solution measure: Surgical site infection measure: Intracavitary surgical infection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de Clinicas de Porto Alegre status: RECRUITING city: Porto Alegre state: RS zip: 90.035-903 country: Brazil name: Daniel C Damin role: CONTACT phone: +5551996020442 email: damin@terra.com.br lat: -30.03306 lon: -51.23 hasResults: False

 nctId: NCT06302322 id: 158200-07-512-149 briefTitle: Long-term Follow up of Mucosal Tissue Height Influence on Peri-implant Bone Levels. overallStatus: COMPLETED date: 2021-01-07 date: 2022-08-15 date: 2022-10-01 date: 2024-03-08 date: 2024-03-08 name: Harvard Medical School (HMS and HSDM) class: OTHER briefSummary: Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run. conditions: Edentulous Alveolar Ridge studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 59 type: ACTUAL name: Thin Tissues name: Thick Tissues name: Surgically augmented thin tissues measure: Crestal Bone Levels measure: PPD measure: BOP measure: PI sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VIC Clinic city: Vilnius zip: 01362 country: Lithuania lat: 54.68916 lon: 25.2798 hasResults: False

 nctId: NCT06302309 id: NL85217.091.23 briefTitle: Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease acronym: TACKLING-FOG overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2025-09 date: 2024-03-08 date: 2024-03-08 name: Radboud University Medical Center class: OTHER briefSummary: The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease. conditions: Freezing of Gait studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomization will be performed in CastorEDC, a web-based data management system for academic studies (www.castoredc.com). Breaking of the randomization code is not applicable, since researchers and trainers cannot be blinded. count: 40 type: ESTIMATED name: Psychological intervention measure: % time frozen during a personalized gait trajectory measure: subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale measure: Heart Rate Variability measure: The Parkinson Anxiety Scale (PAS) measure: Gait-Specific Attention Profile measure: he Updated Perceived Control over Falling Scale (UP-COF) measure: New Freezing of Gait Questionnaire measure: The Parkinson's Disease Questionnaire measure: The Rosenberg self-esteem score measure: Perceived Stress Scale measure: Montreal Cognitive Assessment measure: Unified Parkinson's Disease Rating Scale Part III sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302296 id: Hama University/ briefTitle: Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement overallStatus: RECRUITING date: 2024-04-20 date: 2024-05-15 date: 2025-07-15 date: 2024-03-08 date: 2024-03-08 name: Hama University class: OTHER briefSummary: One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize. conditions: Tooth Mobility conditions: Injectable Platelet-rich Fibrin studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 14 type: ESTIMATED name: injectable form of PRF name: Placebo injection measure: Leveling and alignment maxillary incisors sex: ALL minimumAge: 18 Years maximumAge: 26 Years stdAges: ADULT facility: Fadi Jnaid status: RECRUITING city: Hama country: Syrian Arab Republic name: Fadi Jnaid, Associate Professor role: CONTACT email: Drfadijnaid@gmail.com name: PhD role: CONTACT phone: 0988499015 lat: 35.13179 lon: 36.75783 hasResults: False

 nctId: NCT06302283 id: 114/23-EP briefTitle: Collateral Effects of Pandemics - Care for Informal Caregivers acronym: COLLPAN-3A overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-08 date: 2024-03-08 name: University of Bonn class: OTHER name: Wuerzburg University Hospital name: Johannes Gutenberg University Mainz name: Universitätsklinikum Hamburg-Eppendorf briefSummary: The study is a workpackage in the German research consortium COLLPAN. The study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.It will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics. conditions: Bereavement studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Survey measure: Bereavement burden measure: Anxiety measure: Depression measure: Caregiving burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bonn city: Bonn zip: 53127 country: Germany lat: 50.73438 lon: 7.09549 hasResults: False

 nctId: NCT06302270 id: K2024-0507 briefTitle: CFTR Modulators in Pregnancy and Postpartum overallStatus: RECRUITING date: 2024-03-15 date: 2034-01-31 date: 2039-01-31 date: 2024-03-08 date: 2024-03-08 name: Region Stockholm class: OTHER_GOV name: Karolinska Institutet briefSummary: Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 75 type: ESTIMATED measure: Health effects in the newborn infant sex: ALL maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Stockholm CF center status: RECRUITING city: Stockholm country: Sweden name: Terezia Pinzikova, MD, PhD role: CONTACT phone: +46 8 123 80000 email: jenny.svedenkrans@regionstockholm.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06302257 id: 0532-23-HMO briefTitle: Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine in Labor Epidural Analgesia. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-08 date: 2024-03-12 name: Hadassah Medical Organization class: OTHER briefSummary: Abstract: Background: The current "gold standard" epidural analgesia involves some undesirable side effects such as motor and sympathetic blockade. Here, the investigators suggest a new approach for inducing prolonged differential pain blockade during labor by selectively targeting local anesthetic chloroprocaine to the pain-related peripheral (nociceptive) fibers. The investigators approach involves nociceptor-selective anesthesia by selective targeting of ionized local anesthetics into nociceptive fibers via activation of nociceptor-specific TRPV1 channels. The authors demonstrated that activation of these channels by specific TRPV1-agonists (capsaicin or the local anesthetic lidocaine), allows entry of a polarized, membrane-impermeable lidocaine derivative (QX-314) specifically into nociceptive neurons, inhibiting their activity and pain blockade, without causing other neural effects. Capsaicin and QX-314 are not suitable for clinical use, as capsaicin causes severe injection pain and QX-314 is neurotoxic. Here, the investigators use lidocaine as the TRPV1 agonist, and use the high pKa chloroprocaine as the ionized local anesthetic instead of the toxic QX-314. Both drugs are in routine clinical use, but have not been described in co-administration before. The investigators preclinical results show that co-administration of chloroprocaine with TRPV1 agonists, leads to prolonged nociceptor-specific analgesia. KKK Hypothesis: The investigators hypothesize that co-administration of epidural lidocaine (to activate TRPV1 channels) and chloroprocaine (as a polarized local anesthetic which can gain preferential access to nociceptors via opened TRPV1 pores) will elicit selective nociceptive-anesthesia. Methodology: This study assess epidural local analgesia in nulliparous labor. There are 2 stages: Stage 1: Prior to direct comparison of lidocaine (Group L), chloroprocaine (Group C), and a lidocaine-chloroprocaine combination (Group L-C), the investigators first determine equipotential doses of epidural chloroprocaine and lidocaine using double-blinded up-down sequential analysis using the well-established minimum local anesthetic concentration (MLAC or ED50) design. ED50 is estimated using Dixon-Massey analysis and Wilcoxon and Litchfield probit regression. Stage 2: The main phase of the study involves a randomized double-blinded comparison between Groups L, C and L-C where all drug concentrations are based on the ED50/MLAC from the Stage 1. The primary endpoint is a composite measure of selective nociceptive analgesia (VAS pain score / modified Bromage motor score). Secondary outcomes are: 1. pain (VAS 0-100), 2. modified Bromage motor score, 3. thermal imaging of feet and hands, 4. sensory assessment to cold sensation using ice, 5. anesthesia requirement from the PCEA pump, 6. maternal blood pressure. 7. ambulation, and pushing ability in labor. Primary endpoint is assessed using repeated measures ANOVA (first 30-min) and mixed models ANOVA until first analgesic request. Implications: Positive findings will be the first evidence in humans of nociceptor-specific local anesthesia; will provide a more effective neuraxial analgesia protocol for labor, and will lead to future studies of systemic nociceptor-specific local anesthesia. conditions: Labor Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Chlorprocaine name: Lidocaine name: Lidocaine-chlorprocaine combination measure: VAS pain score / modified Bromage motor block score measure: Segmental sympathectomy measure: Sensory assessment to cold sensation measure: Anesthesia requirement. measure: Pushing ability in labor. measure: Maternal Blood pressure sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Hadassah Hebrew University Medical Center, POB 12000 city: Jerusalem zip: 91120 country: Israel lat: 31.76904 lon: 35.21633 hasResults: False

 nctId: NCT06302244 id: R-21075263 briefTitle: Multimodal Neuromonitoring in Acute Brain Injury overallStatus: ACTIVE_NOT_RECRUITING date: 2017-03-27 date: 2023-06-01 date: 2024-11-01 date: 2024-03-08 date: 2024-03-12 name: Rigshospitalet, Denmark class: OTHER briefSummary: Acute brain injury due to aneurysmal subarachnoid haemorrhage (SAH) or traumatic brain injury (TBI) is a condition with a high mortality, and surviving patients often have permanent disabilities. Multimodal neuromonitoring of intracranial pressure, brain tissue oxygen tension (PbtO2), and brain energy metabolism (measured with microdialysis (MD)) may help individualise the treatment of this patient group to protect the brain and potentially improve outcomes. However, there is still a significant lack of knowledge regarding the advantages and disadvantages of this type of monitoring.

The present study consists of four substudies with the overall aim of examining which factors are most influential for regulating commonly measured intracerebral parameters such as oxygenation, glucose, and lactate. Additionally, the influence of these of parameters on functional outcome and mortality will be explored.

The individual studies are detailed below: conditions: Acute Brain Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ACTUAL measure: Correlation between systemic glucose and microdialysis glucose measure: Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg). measure: Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure. measure: The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening measure: The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome measure: Length of hospital stay measure: Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg). measure: Functional outcome at six months measure: Mortality at six months measure: Length of stay in the ICU sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06302231 id: 16690919.5.0000.5347 briefTitle: Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-08 date: 2024-03-08 name: Federal University of Rio Grande do Sul class: OTHER briefSummary: Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.

Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.

The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity. conditions: Time Restricted Eating conditions: Obesity conditions: Intermittent Fasting conditions: Overweight and Obesity conditions: Time Restricted Feeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Dietary and Exercise Approaches name: Dietary and Exercise Approaches name: Dietary Approach measure: Insulin sensitivity (indices) measure: Insulin resistance (indices) measure: Fasting insulin levels (µIU/mL) measure: Fasting glucose levels (mg/dL) measure: Glucose tolerance measure: Fasting lipid profile levels measure: β cell function (indices) measure: Fat Mass (kg) measure: Fat Percentage (%) measure: Fat Free Mass (kg) measure: Body Weight (kg) measure: Body Weight (kg) measure: Bone Mineral Content (kg) measure: Body Mass Index (kg/m^2) measure: Fasting ketones (β-hydroxybutyrate) levels (mmol/L) measure: Resting metabolic rate (Kcal/day) measure: Substrate Oxidation (respiratory exchange ratio) measure: Absolute Peak oxygen consumption measure: Relative Peak oxygen consumption measure: Fasting Leptin Levels measure: Fasting Adiponectin Levels measure: Inflammatory Markers Levels measure: LDL-cholesterol levels measure: Non-HDL-cholesterol levels sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06302218 id: 5/2024 briefTitle: ESPB vs iPACK+ACB in Total Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-30 date: 2025-10-30 date: 2024-03-08 date: 2024-03-08 name: Poznan University of Medical Sciences class: OTHER briefSummary: Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty conditions: Knee Arthritis conditions: Knee Arthropathy conditions: Knee Osteoarthritis conditions: Knee Pain Chronic conditions: Knee Disease conditions: Knee Rheumatism studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ropivacaine 0.2% Injectable Solution name: Ropivacaine 0.2% Injectable Solution name: control group measure: Opioid consumption measure: Time to first rescue opiate analgesia measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Neutrophil-to-lymphocyte ratio measure: Neutrophil-to-lymphocyte ratio measure: Platelet-to-lymphocyte ratio measure: Platelet-to-lymphocyte ratio measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5] sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Poznan University of Medical Sciences city: Poznan state: Poznań zip: 61-701 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06302205 id: S66232 briefTitle: A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity acronym: PHOENIX-L overallStatus: RECRUITING date: 2023-03-01 date: 2026-01 date: 2026-12 date: 2024-03-08 date: 2024-04-01 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: KU Leuven briefSummary: Research demonstrated that transplant recipients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study, researchers aim to investigate the adequate intensity of rehabilitation programs after liver transplantation. Patients will be randomized into one of the three PHOENIX-Liver training groups (low, moderate, moderate to high). The six months rehabilitation program is conducted from the patient's home but supervised by a PHOENIX-investigator.

At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness.

To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase. conditions: Liver Transplantation conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two interventional groups and one control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The nature of the intervention does not allow blinding of study participants. However, outcome assessors and data investigators will be blinded to the participants' group allocation. whoMasked: OUTCOMES_ASSESSOR count: 147 type: ESTIMATED name: Physical activity name: Sham intervention measure: Cardiorespiratory fitness measure: Functional exercise capacitiy measure: Hand grip strength measure: Knee-extensor strength measure: Endothelial function measure: Arterial stiffness measure: Graft function measure: Occurence of adverse events measure: Motor fitness measure: Blood pressure measure: Blood profile 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: Hanne Van Criekinge role: CONTACT phone: +3216343162 email: hanne.vancriekinge@kuleuven.be name: Diethard Monbaliu, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06302192 id: 4302 briefTitle: Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study) acronym: RED-AKI overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-31 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: Policlinico Hospital class: OTHER briefSummary: This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:

* PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset
* SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation conditions: Acute Kidney Injury conditions: ARDS, Human studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 164 type: ESTIMATED name: ARDS+AKI measure: cumulative incidence measure: AKI14 measure: AKIstage measure: cross talk lung-kidney measure: CRRT measure: incidence of failed exam measure: CKD progression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302179 id: 140-14/24 briefTitle: Risk Factors of Venous Thromboembolism After Colorectal Cancer Surgery overallStatus: COMPLETED date: 2015-01 date: 2017-12 date: 2023-05 date: 2024-03-08 date: 2024-03-08 name: Pirogov Russian National Research Medical University class: OTHER briefSummary: Aim of our study is to find frequency and identify risk factors for venous thromboembolism development in patients who underwent surgery for colorectal cancer. There were 137 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2016 to December 2017. Compression duplex ultrasound of lower legs veins was performed in 2-14 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism. conditions: Colorectal Cancer conditions: Venous Thromboembolism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 137 type: ACTUAL measure: Venous Thromboembolism sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pirogov Russian National Research Medical University city: Moscow zip: 117997 country: Russian Federation lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06302166 id: HafsaJaved briefTitle: Effects of HICT and Intermittent Fasting on PCOS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-07-01 date: 2024-07-01 date: 2024-03-08 date: 2024-03-08 name: Riphah International University class: OTHER briefSummary: The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.

Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns. conditions: Polycystic Ovary Syndrome conditions: PCO studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 33 type: ESTIMATED name: High Intensity Circuit training (HICT) name: Intermittent Fasting (IF) name: Combination of HICT and IF measure: PCOS Morphology measure: Anthropometrics measure: Clinical Hyperandrogenism measure: Body Image concerns sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: AlMuratza Hospital city: Rawalpindi state: Punjab zip: 44000 country: Pakistan name: Sarah Ehsan, PP-DPT role: CONTACT phone: 03217770829 email: sarah.ehsaan@riphah.edu.pk name: Hafsa Javed, DPT role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06302153 id: amnashahid briefTitle: Progressive Loading Exercises and Conditioning Exercises on Calf Strain acronym: runners overallStatus: COMPLETED date: 2023-06-01 date: 2024-02-10 date: 2024-02-10 date: 2024-03-08 date: 2024-03-08 name: Riphah International University class: OTHER briefSummary: Calf pain is a common complaint among runners of all ages but is most frequent in masters athletes. The most common calf injury is a tear of the medial gastrocnemius muscle (Tennis Leg) but other structures including the lateral gastrocnemius, plantaris and soleus also may be the cause of muscular pain.There are multiple techniques for the management that involves loading the strained calf musculature through rest, taping techniques, and appropriate soft tissue massage techniques, modalities such as dry needling or western acupuncture can be popular amongst runners and may also be useful. Progressive loading is a principle of resistance training exercise program design that typically relies on increasing load to increase neuromuscular demand to facilitate further adaptations whereas Athletic performance is based on a number of skills that can be developed through a sports conditioning program. This particular program focuses on improving both muscular strength and power using a technique called post-activation potentiation (PAP), also commonly referred to as complex training. conditions: Range of Motion, Pain, Sports Injuries, Stretching, Triceps Surae studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: Progressive Loading Exercises measure: pain , range of motion, functions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jawad club, Alfatah sports complex city: Faisalābad state: Punjab zip: 38000 country: Pakistan lat: 31.41554 lon: 73.08969 facility: Riphah International University, Raiwind Campus city: Faisalābad state: Punjab zip: 5400 country: Pakistan lat: 31.41554 lon: 73.08969 hasResults: False

 nctId: NCT06302140 id: VT3996-102 briefTitle: A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers overallStatus: RECRUITING date: 2024-02-28 date: 2025-02 date: 2025-10 date: 2024-03-08 date: 2024-03-29 name: Viracta Therapeutics, Inc. class: INDUSTRY briefSummary: This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of nanatinostat (Part C) in patients with advanced cancers. conditions: Advanced Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This clinical trial is divided into 3 parts (Part A, Part B, and Part C).

Patients may begin their study participation in Part A or Part B. Part B (for patients who participate in Part A) and Part C (for patients who participate in Part A and/or Part B) are optional for patients who meet certain conditions for crossover.

In Part A, patients will be given a single dose of radiolabeled nanatinostat by mouth on Day 1. Patients may stay in the hospital up to 8 days.

In Part B, patients will receive both nanatinostat in a salt form and a non-salt form, coadministered with valganciclovir in different order across 2 treatment days. Patients will be randomly assigned to either receive the salt or the non-salt form of nanatinostat first. Patients may stay in the hospital up to 4 days.

Part C will allow patients to continue receiving nanatinostat treatment as long as they are deriving clinical benefit. This part will not require a hospital stay. primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: [14C]-Nanatinostat name: Nanatinostat (free base) tablets in combination with Valganciclovir name: Nanatinostat mesylate tablets in combination with Valganciclovir name: Single-agent Nanatinostat (free base) tablets measure: The amount of radioactivity in excreta [Part A] measure: Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part B] measure: Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part B] measure: Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part B] measure: Pharmacokinetic Parameter: Fraction of the administered dose in comparison with a standard (Frel) [Part B] measure: Incidence of adverse events and serious adverse events [Part C] measure: Incidence of adverse events and serious adverse events [Parts A and B] measure: Incidence of clinically significant changes in selected safety assessments [Parts A and B] measure: Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part A] measure: Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part A] measure: Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part A] measure: Pharmacokinetic Parameter: elimination half-life (t1/2) [Part A] measure: Pharmacokinetic Parameter: apparent total clearance (CL/F) [Part A] measure: Pharmacokinetic Parameter: apparent volume of distribution during terminal phase (Vz/F) [Part A] measure: Pharmacokinetic Parameter: elimination rate constant from the central compartment (Kel) [Part A] measure: The ratio of total radioactivity in blood relative to plasma [Part A] measure: [14C]-metabolic profile and identification of metabolites in plasma [Part A] measure: Major radioactive peak/metabolites in urine and fecal radiochromatograms as a percentage of the radioactive dose [Part A] measure: Pharmacokinetic Parameter: elimination half-life (t1/2) [Part B] measure: Pharmacokinetic Parameter: metabolite-to-parent ratio [Part B] measure: Objective Response Rate (ORR) [Part C] measure: Time to Response (TTR) [Part C] measure: Duration of Response (DOR) [Part C] measure: Disease Control Rate (DCR) [Part C] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Madrid - CIOCC - Hospital Universitario HM Sanchinarro status: RECRUITING city: Madrid zip: 28050 country: Spain role: CONTACT email: ClinicalTrials@Viracta.com lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06302127 id: CCHDS briefTitle: County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial acronym: RISIMA overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-05-20 date: 2024-03-08 date: 2024-03-08 name: Peking University class: OTHER briefSummary: The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management. conditions: Hypertension conditions: Diabetes Mellitus Type 2 conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The follow-up data collection, data entry, and data quality checks will be conducted by researchers unaware of the group assignments. The analysis of results will also be performed by statisticians unaware of the allocation. whoMasked: OUTCOMES_ASSESSOR count: 2560 type: ESTIMATED name: Team-based care name: Risk-stratified care pathway name: Strengthened health education name: Financial incentives for integration of care name: Supporting health information system measure: CVD 10-year risk measure: CVD incidence rate measure: systolic blood pressure measure: total cholesterol sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302114 id: Tubitak briefTitle: Upper Extremity Asymmetries in Overhead Athletes overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-27 date: 2024-03-30 date: 2024-03-08 date: 2024-03-26 name: Pamukkale University class: OTHER name: Tübitak briefSummary: Although overhead sports have different characteristics, the movements in the shoulder and upper extremity are similar. These sports may involve a combination of symmetrical, asymmetrical, bilateral and unilateral movements. In sports involving asymmetric movements, biomechanical changes are observed in that area due to the use of the dominant extremity. One of the reliable methods to reveal the stress effects caused by biomechanical stresses is to determine limb asymmetries. Considering the literature, limb asymmetries may be related to injury and performance. conditions: Extremity Asymmetries conditions: Injury;Sports conditions: Performance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 58 type: ESTIMATED name: Assessment of overhead athletes measure: Medicine ball forward throw measure: Y balanced test measure: Range of motion of internal and external rotation measure: Strength of Internal and External Rotator Muscles sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University status: RECRUITING city: Pamukkale state: Denizli zip: 20000 country: Turkey name: Fatma Ünver role: CONTACT email: funver@pau.edu.tr name: Erhan Kızmaz role: CONTACT phone: +905418966676 email: erhankizmaz@hotmail.com lat: 37.91644 lon: 29.11729 hasResults: False

 nctId: NCT06302101 id: Exercise in older adults briefTitle: Telerehabilitation Exercise in Older Adults overallStatus: RECRUITING date: 2024-02-21 date: 2024-04-18 date: 2024-04-30 date: 2024-03-08 date: 2024-03-08 name: Pamukkale University class: OTHER briefSummary: The aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults.

Older adults will be divided into two groups (intervention group n=16; control group n=16) . conditions: Pain conditions: Elderly conditions: Balance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: chair-based exercises name: cognitive exercises measure: Berg Balance Scale measure: Timed Up and Go Test During Dual Tasking measure: Geriatric Pain Measure measure: Older people's quality of life-brief (OPQOL-brief) measure: Hodkinson Mental Test measure: Dominant Side One Leg Stand Test measure: Timed Up and Go Test measure: chair sit and stand test measure: Geriatric Depression Scale measure: Successful Aging Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Elif Gur Kabul status: RECRUITING city: Usak state: Center zip: 64200 country: Turkey name: Elif Gur Kabul role: CONTACT lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06302088 id: STUDY00026205 briefTitle: The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals acronym: SAINTS overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2027-10 date: 2027-12 date: 2024-03-08 date: 2024-03-22 name: Oregon Health and Science University class: OTHER briefSummary: The safety integration stakeholders (saints) program to integrate worker and patient safety in Oregon rural hospitals. The rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act). conditions: Accidental Falls conditions: Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All participating clinics will take part in baseline surveys of unit staff (n=240-360) and safety stakeholders will be identified. Following surveys, hospitals will be randomized to the control arm (n=3) or the intervention arm (n=3). Both groups will engage in key informant interviews on safety culture (n=30-60). Control group hospitals will continue standard operating procedures. Intervention group hospitals will engage in social network analysis of surveys, have peer leaders identified, and engage in safety leadership training and quality improvement cycles. All hospitals regardless of arm will take part in 6-and-12-month surveys and 24-month interviews. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 240 type: ESTIMATED name: SAINTS program measure: Safety participation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302075 id: UKA-L2086 briefTitle: Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol acronym: UKA-L2086 overallStatus: RECRUITING date: 2021-11-16 date: 2024-12-31 date: 2025-12-01 date: 2024-03-08 date: 2024-03-12 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B). conditions: Gonarthrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: One Day Rehabilitation name: Fast Rehabilitation measure: Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Clinico San Siro status: RECRUITING city: Milan state: Italia country: Italy name: Elena Cittera role: CONTACT phone: 0283502224 email: direzionescientifica.iog@grupposandonato.it name: Andrea Parente, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06302062 id: FIT003-001 briefTitle: Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors acronym: TAL-T overallStatus: RECRUITING date: 2023-06-06 date: 2025-12-30 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: Guangzhou FineImmune Biotechnology Co., LTD. class: INDUSTRY briefSummary: A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.

To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others. conditions: Advanced Solid Tumor conditions: Tumor Associated Lymph Node T Cell conditions: Immunotherapy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: Tumor Associated Lymph node T cell name: cyclophosphamide name: IL-2 name: Serplulimab Injection measure: DLT measure: MDT measure: Number of participants with treatment-related adverse events as assessed by CTCAE V4.03 measure: ORR measure: PFS measure: life quality score 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: Gaungdong zip: 510700 country: China name: Xuzhi Pan role: CONTACT phone: 86-020-87343135 email: panxzh@sysucc.org.cn name: Xiaoshi Zhang, professor role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06302049 id: 12345 briefTitle: Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-03-08 date: 2024-03-08 name: Sadat City University class: OTHER briefSummary: The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters. conditions: Fatty Liver Disease conditions: Steatohepatitis, Nonalcoholic studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 46 type: ESTIMATED name: Esomeprazole name: Placebo measure: Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS) measure: Liver function improvement measure: Reduction of oxidative stress sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302036 id: 7777777 briefTitle: Emotional Freedom Techniques (EFT) on Stress, Anxiety and Depression in University Students Experiencing Earthquakes overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-04-05 date: 2024-04-28 date: 2024-03-08 date: 2024-03-08 name: Emine Yıldırım class: OTHER briefSummary: After two earthquakes in Kahramanmaraş Pazarcık in our country, the continuation of long-term aftershocks caused repetition of psychological problems and difficulties in recovery. Social and spiritual support plays a key role in the post-traumatic recovery period. It is necessary to use psychological support methods that can be applied in a short time and whose effect can be observed in a short time in the spiritual healing and healing of traumas. The emotional freedom technique (EFT) is One of the short-term psychotherapeutic techniques and ıt can also be applied online. EFT, which can be easily applied by individuals or professionals after receiving the necessary training; Cognitive therapy, acceptance and commitment therapy combine elements of acupuncture point stimulation, relying on manual stimulation of acupuncture points rather than using acupuncture needles. When we look at the literature, many scientific studies have been found in which the effectiveness of EFT on anxiety, stress and depression has been evaluated, but there has been no randomized controlled study evaluating the effectiveness of EFT online on individuals who have experienced earthquakes. With this project, it is aimed to determine the effect of online Emotional Freedom Techniques (EFT) on stress, anxiety and depression in university students who experienced earthquakes.

This study, which will be carried out as a randomized controlled experimental study, will be carried out between 16.12.2023 and 20.12.2023 by online with university students who score 17 or higher on the Beck Depression Scale. Total of 60 students with depressive symptoms will be recruited to the intervention and control groups, EFT sessions will be applied to the intervention group, and the control group will only be followed. At the beginning of the application, pre-tests (Information Form, Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Inventory) and at the end of the last session, post-tests will be applied for both groups.

With this study, a randomized controlled study will be brought to the literature on the effectiveness of a therapeutic method such as EFT, which is a method that can be used after an earthquake, which is easy to apply, has no cost, and can be accessed online in hard-to-reach areas. Our project will both contribute to the literature and provide short and long-term benefits in practice, in terms of raising awareness of students about important mental problems such as anxiety and depression, which are likely to be experienced after the earthquake, and enabling them to continue their education in a healthy way. It is aimed to present the work planned within the project as a paper in at least one national / international congress. It is aimed to publish in journals within the scope of SCI, SCI-Expanded related to the research area. The results and outputs of the research will be shared in various media (Kırklareli University and Osmaniye Korkut Ata University website and social media accounts).

By determining the stress, anxiety and depression status of university students who have experienced an earthquake, it will be possible to reduce their stress, anxiety and depression with EFT application. The fact that the application used is a short-term, effective and easy psychotherapy method will prevent the disruption of the normal education processes of the students. It will make an economic contribution by reducing the need for psychological drugs that may be needed to reduce the effects of the earthquake. conditions: Emotional Problem conditions: University Students Who Experienced an Earthquake studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: EFT will be applied and surveys will be administered to the intervention group. No application will be made to the control group and surveys will be asked. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: EFT measure: depression measure: stress, anxiety sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06302023 id: HE661462 briefTitle: Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-08 date: 2024-03-08 name: Khon Kaen University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor

The main questions it aims to answer are:

* Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?
* How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups
* Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day
* Group 2 (control) Participant will not need to take a DHA conditions: Pregnant Women Diagnosed With Threatened Preterm Labor studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Docosahexaenoic acid (DHA) 1000 mg measure: Number of Participants with preterm birth measure: Rate of low birth weight neonate measure: Rate of Neonatal Intensive care unit admission sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06302010 id: KafkasU3636 briefTitle: The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-08 date: 2024-03-08 name: Hümeyra TÜLEK DENİZ class: OTHER briefSummary: This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST. conditions: Anxiety conditions: Fetal Conditions conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 86 type: ESTIMATED name: Stress Ball Intervention measure: Anxiety measure: Fetal well-being measure: Fetal well-being measure: Fetal well-being measure: Fetal well-being measure: Fetal well-being sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06301997 id: IRCT20210218050404N5 id: IR.FUMS.REC.1400.125 type: OTHER domain: Fasaums briefTitle: A Herbal Compound for Psoriasis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-01 date: 2024-03-30 date: 2024-12-30 date: 2024-03-08 date: 2024-03-08 name: Fasa University of Medical Sciences class: OTHER name: Zarrin Avaye Kowsar Salamat (ZAX company) briefSummary: The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:

• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.

Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks. conditions: Psoriasis conditions: Inflammation conditions: Skin Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ACTUAL name: ZAX.1400.P03 name: Placebo measure: Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Fasa university of medical sciences city: Fasa state: Fars zip: 7461686688 country: Iran, Islamic Republic of lat: 28.9383 lon: 53.6482 hasResults: False

 nctId: NCT06301984 id: ANDROMEDA_01_2023_V1 briefTitle: Safety and Efficacy Evaluation of Insight GS Growing System overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-06 date: 2027-08 date: 2024-03-08 date: 2024-03-08 name: EVEREST PESQUISA E DESENVOLVIMENTO LTDA class: OTHER briefSummary: Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth.

The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).

Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study.

Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events. conditions: Early Onset Scoliosis (EOS) studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Insight GS measure: Cobb Angle measure: Adverse event measure: Trunk height measure: Pain measure: Satisfaction sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD facility: Hospital Ortopédico AACD city: São Paulo state: SP zip: 04027-000 country: Brazil name: Mariana F Goncalves role: CONTACT email: mfgoncalves@aacd.org.br name: Alexandre F Cristante role: PRINCIPAL_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06301971 id: CVL-231-HV-1011 briefTitle: A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants overallStatus: RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-08 date: 2024-03-08 name: Cerevel Therapeutics, LLC class: INDUSTRY briefSummary: The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of \[14C\]-emraclidine in healthy adult male participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Emraclidine measure: Area Under the Concentration Time Curve (AUC) from Zero to Infinity (AUCinf) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: AUC from Time 0 to last Quantifiable Concentration (AUClast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Maximum Plasma Concentration (Cmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Time to Last Measurable Concentration (Tlast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Time to Maximum Observed Concentration (Tmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Apparent Terminal Elimination Half-life (t½) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Terminal Rate Constant (λz) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Total Plasma Clearance After Oral Administration (CL/F) of Emraclidine measure: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Emraclidine measure: Ratio of Plasma AUCinf for Emraclidine to Plasma AUCinf for Total Radioactivity measure: Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Total Radioactivity measure: Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Emraclidine measure: Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma AUCinf for Total Radioactivity measure: Amount Excreted in Urine (Aeu) of Total Radioactivity measure: Cumulative Aeu of Total Radioactivity measure: Percentage Excreted in Urine (feu) of Total Radioactivity measure: Cumulative feu of Total Radioactivity measure: Amount Excreted in Feces (Aef) of Total Radioactivity measure: Cumulative Aef of Total Radioactivity measure: Percentage Excreted in Feces (fef) of Total Radioactivity measure: Cumulative fef of Total Radioactivity measure: Percentage Dose (%Dose) of Total Radioactivity Excreted in Urine Plus Feces Combined measure: Cumulative Percentage Dose of Total Radioactivity Excreted in Urine Plus Feces Combined measure: Metabolite Profile of Emraclidine in Plasma, Urine and Feces measure: Structural Identification of Emraclidine Metabolites Found in Plasma, Urine and Feces 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 Signs measure: Number of Participants with Clinically Significant Changes in Laboratory Assessments measure: Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results measure: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Austin, Texas status: RECRUITING city: Austin state: Texas zip: 78744 country: United States lat: 30.26715 lon: -97.74306 hasResults: False

 nctId: NCT06301958 id: 202102567A3 briefTitle: Dextrose Prolotherapy on Articular Cartilage overallStatus: RECRUITING date: 2023-01-21 date: 2024-08-31 date: 2024-08-31 date: 2024-03-08 date: 2024-03-08 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid.

We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions. conditions: Arthritis Knee studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Dextrose prolotherapy measure: Visual Analogue Scale (VAS) measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) measure: Interleukin 6 (IL-6) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung Memorial Hospital, Chiayi status: RECRUITING city: Chiayi City state: 嘉義市 zip: 600 country: Taiwan name: HUNG-CHIH HSU, PhD role: CONTACT phone: +886-3-3621000 phoneExt: 2601 email: dr.tonyhsu@gmail.com lat: 23.47917 lon: 120.44889 hasResults: False

 nctId: NCT06301945 id: Maastro Clinic id: 72725524 type: OTHER_GRANT domain: Hanarth Fonds briefTitle: Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors acronym: INTHYM overallStatus: RECRUITING date: 2023-08-01 date: 2027-08-01 date: 2027-08-01 date: 2024-03-08 date: 2024-03-27 name: Erasmus Medical Center class: OTHER name: Maastro Clinic, The Netherlands name: Hospices Civils de Lyon briefSummary: Thymic epithelial tumors are rare neoplasms in the anterior mediastinum. The cornerstone of the treatment is surgical resection. Administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the WHO histopathological classification.

In this classification thymoma types A, AB, B1, B2, B3, and thymic carcinoma are distinguished. Studies have shown large discordances between pathologists in subtyping these tumors. Moreover, the WHO classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses.

The investigators will develop AI models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence.

In this multicentric and international project three existing databases will be used from Rotterdam, Maastricht and Lyon. For all models one database will be used to build AI models, and the other two for external validation.

The ultimate goal of this project is to develop AI models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy. conditions: Thymic Epithelial Tumor conditions: Thymic Carcinoma conditions: Thymoma conditions: Thymoma and Thymic Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1020 type: ESTIMATED name: Artificial Intelligence Diagnostics name: Recurrence Prediction Tool measure: WP1 - Databases/Data Pre-processing measure: WP2 - Deep Learning-Model for TET Classification and Recurrence Prediction measure: WP3: Clinical Evaluation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC status: RECRUITING city: Rotterdam state: South Holland zip: 3015 GD country: Netherlands name: Anna Salut Esteve Domínguez role: CONTACT email: a.estevedominguez@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06301932 id: ANE-2562-06771 briefTitle: The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy overallStatus: COMPLETED date: 2006-01-01 date: 2018-12-31 date: 2023-12-31 date: 2024-03-08 date: 2024-03-12 name: Chiang Mai University class: OTHER briefSummary: This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.

The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA? conditions: Epidural Analgesia conditions: Patient Controlled Analgesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 654 type: ACTUAL name: Open liver resection measure: Post-operative opioid consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301919 id: IRBN042024/CHUSTE briefTitle: Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-08 date: 2024-03-12 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.

Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.

The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting. conditions: Haemostasis Embolisation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Clinical data name: Imaging data name: Biological data measure: Evaluation of technical success measure: Assessment of clinical success measure: Assessment of clinical success measure: Assessment of clinical success measure: Assessment of clinical success measure: Assessment of clinical success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Saint-Etienne status: RECRUITING city: Saint-Priest-en-Jarez zip: 42270 country: France name: Rémi Grange, MD role: CONTACT phone: (0)477828963 phoneExt: +33 email: remi.grange@chu-st-etienne.fr name: Sylvain Grange, MD role: SUB_INVESTIGATOR name: Rémi Grange, MD role: PRINCIPAL_INVESTIGATOR lat: 45.47501 lon: 4.37614 hasResults: False

 nctId: NCT06301906 id: 202301060A3 briefTitle: Red Yeast Rice for Primary Prevention of Hypercholesterolemia overallStatus: RECRUITING date: 2024-02-26 date: 2025-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Chang Gung Memorial Hospital class: OTHER briefSummary: This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35\~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota. conditions: Hypercholesterolemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: LipoCol Forte Capsule 600mg bid measure: Low Density Lipoprotein-Cholesterol (LDL-C) measure: 10-Year ASCVD Risk sex: MALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: Taoyuan branch of Chang Gung Memorial Hospital status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Yueh Hsiang Huang, PhD role: CONTACT phone: 886-975360240 email: igighuang@gmail.com lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06301893 id: US-3_Uganda (IRB#2013-4576) briefTitle: Uganda Sickle Surveillance Study (US-3) overallStatus: RECRUITING date: 2013-09-07 date: 2030-12-31 date: 2032-12-31 date: 2024-03-08 date: 2024-03-12 name: Children's Hospital Medical Center, Cincinnati class: OTHER name: Makerere University name: Ministry of Health, Uganda name: Mulago Hospital, Uganda briefSummary: It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda. conditions: Sickle Cell Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000000 type: ESTIMATED measure: Incidence of HbSS and HbA measure: Incidence of HbSS and HbA sex: ALL maximumAge: 12 Months stdAges: CHILD facility: Makerere University status: RECRUITING city: Kampala country: Uganda name: Grace Ndeezi, MBChB, MMed, PhD role: CONTACT lat: 0.31628 lon: 32.58219 facility: Minister of Health status: RECRUITING city: Kampala country: Uganda name: Jane R. Aceng, MD role: CONTACT lat: 0.31628 lon: 32.58219 facility: National Coordinator EID Program status: RECRUITING city: Kampala country: Uganda name: Charles Kiyaga, MBLSM role: CONTACT name: Charles Kiyaga, PhD role: SUB_INVESTIGATOR lat: 0.31628 lon: 32.58219 facility: Sickle Cell Clinic Department of Pediatrics & Child Health Mulago Hospital status: RECRUITING city: Kampala country: Uganda name: Deogratias Manube, MBChB, MMed role: CONTACT lat: 0.31628 lon: 32.58219 hasResults: False

 nctId: NCT06301880 id: 3200 briefTitle: Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow overallStatus: COMPLETED date: 2022-01-01 date: 2023-01-31 date: 2023-01-31 date: 2024-03-08 date: 2024-03-08 name: Damascus University class: OTHER briefSummary: Forty-six consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled. After the left IMA was harvested, free flow was measured under controlled hemodynamic conditions before any intervention (flow 1) and at a mean of 12.5 minutes after the topical application of one of three agents (milrinone, nitroglycerin or normal saline) on the IMA (flow 2). conditions: Internal Mammary Artery Syndrome conditions: Vasodilation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All surgical procedures and measurements were carried out by a single surgeon (MBI) who was blinded to the topical agent which was applied. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: The topical application of a vasodilator on the LIMA graft measure: LIMA free flow sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus University Cardiac Surgery Hospital city: Damascus country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False

 nctId: NCT06301867 id: Pro00113877 briefTitle: Preventing Failed Extubations acronym: PreFIX overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-08-31 date: 2024-03-08 date: 2024-03-21 name: Duke University class: OTHER briefSummary: More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure. conditions: Mechanical Ventilation Complication conditions: Weaning Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Plateau Pressure measure: Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility measure: Percentage of patients who were reintubated prior to hospital discharge sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University Medical Center status: RECRUITING city: Durham state: North Carolina zip: 27710 country: United States name: Elias H Pratt, MD role: CONTACT email: elias.pratt@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06301854 id: TPN171H-E302 briefTitle: Long-term Safety of TPN171H Tablet in Erectile Dysfunction. overallStatus: RECRUITING date: 2024-04-12 date: 2025-04-30 date: 2025-04-30 date: 2024-03-08 date: 2024-04-26 name: Vigonvita Life Sciences class: INDUSTRY briefSummary: This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction. conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: TPN171H measure: Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation. measure: Change From Baseline in the International Index of Erectile Function - Erectile Function. measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responses. measure: Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses. measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication. measure: Change From Baseline to the 3rd months and 6th months Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction. measure: Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd and 6th month. measure: Change From Baseline in the International Index of Erectile Function - Erectile Function. measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responses. measure: Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses. measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication. measure: Change From Baseline to the 3rd，6th，9th，12th month Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction. measure: Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd，6th，9th，12th month . sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Anhui Medical University status: RECRUITING city: Hefei state: Anhui zip: 230000 country: China name: Xiansheng Zhang role: CONTACT lat: 31.86389 lon: 117.28083 facility: Peking University First Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100032 country: China name: Hui Jiang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Kai Hong role: CONTACT lat: 39.9075 lon: 116.39723 facility: Guangzhou First People's Hospital status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Junhong Deng role: CONTACT lat: 23.11667 lon: 113.25 facility: The Fifth Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510700 country: China name: Xianhan Jiang role: CONTACT lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Geng An role: CONTACT lat: 23.11667 lon: 113.25 facility: Shantou Central Hospital status: RECRUITING city: Shantou state: Guangdong country: China name: hong huang role: CONTACT lat: 23.36814 lon: 116.71479 facility: The Second Affiliated Hospital of Shantou University Medical College status: RECRUITING city: Shantou state: Guangdong country: China name: Junhong Zheng role: CONTACT lat: 23.36814 lon: 116.71479 facility: Shenzhen Songgang People's Hospital status: RECRUITING city: Shenzhen state: Guangdong zip: 518105 country: China name: Qin Xiang role: CONTACT lat: 22.54554 lon: 114.0683 facility: The 2nd Affiliated Hospital of Guilin Medical University status: RECRUITING city: Guilin state: Guangxi country: China name: Li Gao role: CONTACT lat: 25.28194 lon: 110.28639 facility: The Affiliated Hospital of Guizhou Medical University status: RECRUITING city: Guiyang state: Guizhou country: China name: Qiang Wang role: CONTACT lat: 26.58333 lon: 106.71667 facility: Qingyuan People's Hospital status: RECRUITING city: Qingyuan state: G country: China name: Jianwen Zeng role: CONTACT lat: 23.7 lon: 113.03333 facility: The Second Hospital of Hebei Medical Uniyersity status: RECRUITING city: Shijiazhuang state: Hebei country: China name: Yaxuan Wang role: CONTACT lat: 38.04139 lon: 114.47861 facility: Xingtai People's Hospital status: RECRUITING city: Xingtai state: Hebei country: China name: Junli Wei role: CONTACT lat: 37.06306 lon: 114.49417 facility: Henan Provincial People's Hospital status: RECRUITING city: Zhengzhou state: Henan zip: 450100 country: China name: Xiangsheng Zhang role: CONTACT lat: 34.75778 lon: 113.64861 facility: The First Affiliated Hospital of Henan University status: RECRUITING city: Zhengzhou state: Henan country: China name: Guoliang Xu role: CONTACT lat: 34.75778 lon: 113.64861 facility: The Central Hospital of Wuhan status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430014 country: China name: Yonglian Guo role: CONTACT lat: 30.58333 lon: 114.26667 facility: Wuhan Union Hospital status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Zhaohui Zhu role: CONTACT lat: 30.58333 lon: 114.26667 facility: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine status: RECRUITING city: Changsha state: Hunan country: China name: Yifeng Yuan role: CONTACT lat: 28.19874 lon: 112.97087 facility: Loudi Central Hospital status: RECRUITING city: Loudi state: Hunan country: China name: Liang Peng role: CONTACT lat: 27.73444 lon: 111.99444 facility: Yueyang People's Hospital status: RECRUITING city: Yueyang state: Hunan country: China name: Zeping Li role: CONTACT lat: 29.37455 lon: 113.09481 facility: Second Affiliated Hospital of Suzhou University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Boxin Xue role: CONTACT lat: 31.30408 lon: 120.59538 facility: Nanchang reproductive hospital status: RECRUITING city: Nanchang state: Jiangxi zip: 330001 country: China name: Wenliang Yao role: CONTACT lat: 28.68396 lon: 115.85306 facility: Yichang Central People's Hospital (Xiling Campus) status: RECRUITING city: Yichang state: Jiangxi country: China name: Junfeng Yu role: CONTACT lat: 30.71444 lon: 111.28472 facility: The First Hospital of Jilin University status: NOT_YET_RECRUITING city: Changchun state: Jilin zip: 130021 country: China name: Fubiao Li role: CONTACT lat: 43.88 lon: 125.32278 facility: The Second Hospital of Dalian Medical University status: NOT_YET_RECRUITING city: Dalian state: Liaoning zip: 116011 country: China name: Tao Jiang role: CONTACT lat: 38.91222 lon: 121.60222 facility: Chifeng Municipal Hospital status: RECRUITING city: Chifeng state: Neimenggu country: China name: Xin Chen role: CONTACT lat: 42.26833 lon: 118.96361 facility: The Affiliated Hospital of Qinghai University status: RECRUITING city: Xining state: Qinghai country: China name: Guoliang Chen role: CONTACT lat: 36.62554 lon: 101.75739 facility: Xianyang Central Hospital status: RECRUITING city: Xianyang state: Shanxi country: China name: Nan Li role: CONTACT lat: 34.33778 lon: 108.70261 facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine status: RECRUITING city: Xian state: Shanxi country: China name: Wei Zheng role: CONTACT lat: 34.25833 lon: 108.92861 facility: Nuclear Industry 416 Hospital status: RECRUITING city: Chengdu state: Sichuang country: China name: Jichun Shao role: CONTACT lat: 30.66667 lon: 104.06667 facility: The Affiliated Hospital of Chengdu University status: RECRUITING city: Chengdu state: Sichuang country: China name: Jin Yang role: CONTACT lat: 30.66667 lon: 104.06667 facility: Suining Central Hospital status: RECRUITING city: Suining state: Sichuang country: China name: Yougang Feng role: CONTACT lat: 30.50802 lon: 105.57332 facility: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine status: RECRUITING city: Urumqi state: Xinjiang country: China name: Feng Wang role: CONTACT lat: 43.80096 lon: 87.60046 hasResults: False

 nctId: NCT06301841 id: 2023-A00903-42 briefTitle: An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care acronym: BPCTréa2 overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-04-15 date: 2026-07-15 date: 2024-03-08 date: 2024-03-08 name: University Hospital, Caen class: OTHER briefSummary: Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia. conditions: To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: experimental measure: Duration of antibiotic therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Intensive Care Unit, CHU Caen city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06301828 id: KY202401 briefTitle: Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors overallStatus: RECRUITING date: 2024-02-21 date: 2025-06-21 date: 2026-02-21 date: 2024-03-08 date: 2024-03-08 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment. conditions: Gastrointestinal Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Gastrointestinal neoplasms primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Envafolimab Injection name: Endostar measure: DCR measure: ORR measure: PFS measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: wei x wei, M.D. role: CONTACT phone: 52271000 phoneExt: 025 lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06301815 id: Shaw_Stroke_REC24/YH/0010_2024 briefTitle: Feasibility of Measuring Vertical Perception in Acute Stroke overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: University of Winchester class: OTHER name: Hampshire Hospitals NHS Foundation Trust name: University Hospitals Dorset NHS Foundation Trust briefSummary: The goal of this observational study is to establish if it is feasible to identify vertical perception deficits in people with acute stroke. The primary purpose to the study is:

• To establish the feasibility of completing the Catherine Bergego Scale, Scale for Contraversive Pushing (SCP) and bucket test in a clinical environment with acute stroke patients to assist with identification of vertical perception loss.

Participants will be asked to complete the assessments with a therapist 48 hours after admission. If they are not completed for any reason attempts will be made to complete them at one, two and four weeks after admission. Some participants will have them completed again on discharge. The Catherine Bergego Scale and SCP are observational and will involve a therapist watching the participant undertake daily activities. The bucket test involves a therapist placing a bucket in front of the face of the participant and asking them to identify when a line on the bottom of the bucket is vertical. Acceptabiliy and feasibility will be further investigated using a survey of participants who complete the assessments and through focus groups with the rehabilitation professionals admininstering the assessments.

If it is feasible and acceptable to complete these assessments then further research can use them as an acceptable measure of vertical alignment in the clinical setting. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Scale for Contraversive Pushing name: Catherine Bergego Scale name: Bucket Test measure: Bucket Test to measure subjective visual vertical (SVV). measure: Catherine Bergego Scale to measure neglect. measure: Scale for Contraversive Pushing to measure lateropulsion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Hampshire County Hospital city: Winchester zip: SO22 5DG country: United Kingdom name: Amelia Shaw, MSc role: CONTACT phone: 01962 824940 email: amelia.shaw@hhft.nhs.uk lat: 51.06513 lon: -1.3187 hasResults: False

 nctId: NCT06301802 id: myelomeningocele management briefTitle: Outcomes of Proactive Management of Children With Myelomeningocele overallStatus: RECRUITING date: 2024-03-04 date: 2026-03-10 date: 2026-03-15 date: 2024-03-08 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: Spina bifida birth prevalence in Africa is 0.13%. Myelomeningocele (MMC) represents the most frequent and most severe cause of NB in children. Treatment of neuropathic bladder secondary to spina bifida is an ongoing challenge. Damage of the renal parenchyma in children with NB is preventable given adequate evaluation, follow-up and proactive management. Proactive management was defined as use of clean intermittent catheterization (CIC), and/or anticholinergics at presentation, or based on initial high-risk urodynamic findings by 1 year of age. The proactive approach to treat SB (CIC and pharmacotherapy) has contributed to decreasing chronic kidney disease (CKD). Myelomeningocele is considered a complex congenital disease. Hence, a multidisciplinary team is the best choice for management of spina bifida, involving neurosurgeons, orthopedic surgeons, urologists, physical medicine and rehabilitation specialists and pediatricians. Currently, children with spina bifida in Egypt must visit multiple different locations to access the complex care they need. Here, we review our experience with patients with spina bifida who will be followed with this team with an emphasis on patients' upper urinary tract protection and decreasing urinary incontinence. conditions: Urologic Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: CIC name: Anticholinergic measure: upper tract affection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut university hospital status: RECRUITING city: Assiut zip: 11571 country: Egypt name: Islam Mahmoud, DR role: CONTACT phone: 00201090088672 email: doctorislam672@gmail.com lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06301789 id: Quadratus lumborum block briefTitle: Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-03 date: 2024-03-08 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries. conditions: QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Effect of adding Mg sulphate as an adjuvant to bupivacaine for postoperative analgesia in cases of lower abdominal cancer surgeries primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 52 type: ESTIMATED name: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries measure: Postoperative analgesia sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301776 id: Bridge-2023-02-0A briefTitle: A Prospective, Experimental, Multicenter, Open-label, Randomized, Controlled Trial of 3-month Dual Antiplatelet Therapy Followed by Ticagrelor Versus 6-month Dual Antiplatelet Therapy Followed by Ticagrelor After Implanting Bridge overallStatus: RECRUITING date: 2023-12-05 date: 2025-12-31 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: The Fourth Affiliated Hospital of China Medical University class: OTHER briefSummary: To compare the incidence of the composite endpoints of non-fatal ischaemic stroke, transient ischaemia (TIA) and all-cause mortality at 12-month follow-up after implantation of Bridge for the treatment of symptomatic vertebral artery stenosis in subjects who had been taking different durations of dual-antiplatelet therapy (3 vs 6 months) and ticagrelor monotherapy. conditions: Brain Disease conditions: Vertebral Artery Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 560 type: ESTIMATED name: Ticagrelor measure: Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months. measure: Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months. measure: Incidence of target vessel-related stroke and neurological death at 1month measure: Incidence of stroke and neurological death at 12 month. measure: Incidence of all-cause mortality at 12 month. measure: Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up). sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Fourth Affiliated Hospital of China Medical University status: RECRUITING city: Shenyang state: Liaoning zip: 110032 country: China name: Lianbo Gao role: CONTACT email: gaolbdoc@163.com lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06301763 id: nosencekCancer-old briefTitle: Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-25 date: 2022-12-31 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 56 type: ACTUAL name: Intermittent Oral-esophageal Tube Feeding name: nasogastric tube feeding measure: Hemoglobin Level measure: Serum albumin Level measure: Total serum protein Level measure: Serum prealbumin Level measure: Body Mass Index Level measure: Depression measure: Swallowing-Quality of Life questionnaire measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ubonratchathani Hospital city: Ubon Ratchathani country: Thailand lat: 15.23844 lon: 104.84866 hasResults: False

 nctId: NCT06301750 id: Tube-Alzheimer briefTitle: Oral Enteral Nutrition Feeding in Alzheimer's Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Conventional Care name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric tube measure: Level of Hemoglobin measure: Level of Serum albumin measure: Level of Total serum protein measure: Level of Serum prealbumin measure: Body Mass Index measure: Pulmonary Infections measure: Mini Nutritional Assessment sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301737 id: SGB-YanD briefTitle: Lidocaine Injection: A Nove Block Therapy for Stroke-related Dysphagia overallStatus: COMPLETED date: 2022-06-21 date: 2023-05-02 date: 2023-05-17 date: 2024-03-08 date: 2024-03-25 name: Muhammad class: OTHER briefSummary: This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 65 type: ACTUAL name: Comprehensive rehabilitation name: Injection name: Lidocaine Hydrochloride measure: Video fluoroscopic swallowing study measure: Rosenbek penetration-aspiration scale measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhen No.1 Hos. city: Taiwan country: China lat: 32.32812 lon: 118.76384 hasResults: False

 nctId: NCT06301724 id: SGB-PKS briefTitle: Effectiveness of Stellate Ganglion Block in Individuals With Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.

Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Injection name: Lidocaine hydrochloride measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301711 id: SGB-CVSD briefTitle: Investigation of Potential Mechanisms in Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Ahmadu Bello University Teaching Hospital class: OTHER briefSummary: This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Stellate ganglion block name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Mini-Mental State Examination measure: Swallowing duration measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301698 id: SGB-BP briefTitle: The Effectiveness of Stellate Ganglion Block in Managing Dysphagia in Patients With Medullary Infarction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Ahmadu Bello University Teaching Hospital class: OTHER briefSummary: This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. 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, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function. conditions: Bulbar Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Comprehensive rehabilitation name: Injection name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale measure: Murray secretion severity scale measure: Yale pharyngeal residue severity rating scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301685 id: SGB-AST briefTitle: Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated. conditions: Autistic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine therapy name: Injection name: Lidocaine Hydrochloride measure: Childhood Autism Rating Scale measure: Children's Communication Checklist measure: Social Interaction Assessment Scale measure: Children's Depression Inventory measure: Childhood Anxiety Sensitivity Index sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD hasResults: False

 nctId: NCT06301672 id: NecknoseCancer-Xin briefTitle: Effect of Oral Enteral Nutrition in Nasopharyngeal Carcinoma Survivors With Swallowing Disorders overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-08 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Nasogastric Tube Feeding name: Intermittent Oral-esophageal Tube Feeding name: comprehensive rehabilitation therapy measure: concentration of Hemoglobin measure: concentration of Serum albumin measure: concentration of Serum prealbumin measure: Body Mass Index measure: Depression measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale measure: Feeding amount sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301659 id: Jingxiang-Jiu briefTitle: Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke overallStatus: COMPLETED date: 2022-08-01 date: 2023-07-12 date: 2023-08-31 date: 2024-03-08 date: 2024-03-08 name: Ahmadu Bello University Teaching Hospital class: OTHER briefSummary: Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy. On day 1 and day 30, patients' Upper Limb function were compared. conditions: Hemiparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 116 type: ACTUAL name: routine rehabilitation therapy name: Modified mirror therapy measure: Fugl-Meyer Assessment-Upper Extremity measure: coordinated contraction rate-Surface electromyography measure: Visual Analog Scale measure: Anxiety measure: Depression sex: ALL minimumAge: 35 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital city: Yangon country: Myanmar lat: 16.80528 lon: 96.15611 hasResults: False

 nctId: NCT06301646 id: IOE-psy briefTitle: Oral Enteral Nutrition Tube Feeding on Stroke Survivors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-08 name: Ahmadu Bello University Teaching Hospital class: OTHER briefSummary: The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:

Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom. conditions: Cerebrovascular Accident studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Social Functioning Scale measure: Social Support Questionnaire measure: Anxiety measure: Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301633 id: IOE-STROKE briefTitle: Comparison of Oral and Nasal Tube Feeding on Stroke-related Dysphagia overallStatus: COMPLETED date: 2022-01-31 date: 2023-12-10 date: 2023-12-30 date: 2024-03-08 date: 2024-04-11 name: Muhammad class: OTHER briefSummary: This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 126 type: ACTUAL name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Penetration-Aspiration Scale measure: Body weight measure: total protein measure: albumin measure: Yale pharyngeal residue severity rating scale measure: Patient health questionnaire-9 measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The 1st afi. Hos. city: Zhenzhou country: China lat: 32.28034 lon: 119.16999 hasResults: False

 nctId: NCT06301620 id: GUANJIEQIANG briefTitle: Intra-articular Injection: A Innovational Approach for Joint Disorder overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction

The main question it aims to answer is:

• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction conditions: Temporomandibular Joint Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Routine rehabilitation treatment name: Intra-articular Injection measure: Friction Index measure: The Visual Analog Scale measure: The maximum mouth opening limit measure: Mann Assessment of Swallowing Ability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301607 id: Feedingamount briefTitle: The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube name: comprehensive rehabilitation therapy measure: Feeding Amount measure: total protein level measure: hemoglobin level measure: albumin level measure: prealbumin level measure: Body weight measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301594 id: Dys-prevent briefTitle: Impact of Neck and Facial Exercises on Swallowing Function in Elderly Individuals overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Systematic simple swallowing training measure: Swallowing-Related Quality of Life Questionnaire measure: Eating Assessment Tool-10 measure: Time consumed in eating measure: Standardized Swallowing Assessment measure: Water Swallow Test sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301581 id: ABIntl-23-42 briefTitle: Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant overallStatus: RECRUITING date: 2024-01-22 date: 2025-12 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: Advanced Bionics AG class: INDUSTRY briefSummary: This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices. conditions: Cochlear Hearing Loss studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED measure: Freiburger monosyllabic word recognition score in quiet in the implanted ear sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Medizinische Hochschule Hannover status: RECRUITING city: Hannover zip: D-30625 country: Germany name: Andreas Büchner role: CONTACT name: Andreas Büchner role: PRINCIPAL_INVESTIGATOR lat: 52.37052 lon: 9.73322 hasResults: False

 nctId: NCT06301568 id: ABIntl-23-12 briefTitle: Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation overallStatus: RECRUITING date: 2024-01-22 date: 2024-04 date: 2024-05 date: 2024-03-08 date: 2024-03-08 name: Advanced Bionics AG class: INDUSTRY briefSummary: This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks. conditions: Cochlear Hearing Loss studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED measure: Freiburger monosyllabic word recognition score in quiet measure: HSM sentence score or OlSa recognition score in quiet sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Medizinische Hochschule Hannover status: RECRUITING city: Hannover zip: D-30625 country: Germany name: Andreas Büchner role: CONTACT lat: 52.37052 lon: 9.73322 hasResults: False

 nctId: NCT06301555 id: db2023 briefTitle: Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms overallStatus: COMPLETED date: 2023-11-01 date: 2024-01-01 date: 2024-02-01 date: 2024-03-08 date: 2024-03-08 name: Adai Technology (Beijing) Co., Ltd. class: OTHER briefSummary: Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined. conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 223 type: ACTUAL name: Reinforcement learning algorithm powered cognitive and behavioral intervention name: cognitive and behavioral intervention measure: PHQ9 Response measure: GAD7 Response sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: the First Hospital of China Medical University city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06301542 id: 2020P003474 briefTitle: Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation overallStatus: RECRUITING date: 2024-02-07 date: 2024-05-01 date: 2024-05-01 date: 2024-03-08 date: 2024-03-08 name: Brigham and Women's Hospital class: OTHER name: Boston University briefSummary: The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home. conditions: Post-stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Functional electrical stimulation measure: Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients measure: Accurate motion assistance while using the functional electrical stimulation in the laboratory. measure: Accurate motion assistance while using the functional electrical stimulation in the home. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: David M Levine, MD MPH MA role: CONTACT phone: 617-732-7063 email: dmlevine@partners.org name: David M Levine, MD MPH MA role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06301529 id: ALRx008 briefTitle: The Efficacy and Tolerability of Canagliflozin in Healthy Individual overallStatus: ENROLLING_BY_INVITATION date: 2024-02-12 date: 2024-04-29 date: 2024-04-29 date: 2024-03-08 date: 2024-03-08 name: AgelessRx class: INDUSTRY briefSummary: The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals.

The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol. conditions: Healthy Aging studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Invokana Pill measure: Change in blood glucose values after taking Canagliflozin measure: Number of participants with treatment-related side effects through collected survey responses sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AgelessRx city: Ann Arbor state: Michigan zip: 48104 country: United States lat: 42.27756 lon: -83.74088 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-01-24 uploadDate: 2024-02-21T09:47 filename: Prot_SAP_ICF_000.pdf size: 1174837 hasResults: False

 nctId: NCT06301516 id: HM20027823 id: R41MH133540 type: NIH link: https://reporter.nih.gov/quickSearch/R41MH133540 briefTitle: Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD overallStatus: RECRUITING date: 2024-02-16 date: 2024-12 date: 2024-12 date: 2024-03-08 date: 2024-03-08 name: Virginia Commonwealth University class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD. conditions: Conduct Disorder conditions: Conduct Disorders in Children conditions: Conduct Disorders in Adolescence conditions: Callous-Unemotional Traits studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial of psychological intervention. Once all assessments are completed, the treatment group allocation will be disclosed to the administrating researcher, youth, and caregiver. This blinded approach to block randomization prevents any bias from occurring during the assessment phase by the researcher. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Virtual Reality name: Comparative Control measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 23298 country: United States name: Nicholas Johnson role: CONTACT phone: 804-828-6386 email: Nicholas.Thomson@VCUHealth.org lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06301503 id: 0103/UN14.2.2.VII.14/LT/2024 briefTitle: Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB) overallStatus: RECRUITING date: 2024-03-08 date: 2024-04-20 date: 2024-04-25 date: 2024-03-08 date: 2024-04-11 name: Udayana University class: OTHER briefSummary: The goal of this clinical trial is to evaluate the efficacy of lumbar plexus-sciatic nerve block (LPB-SNB) by comparing the postoperative quality of recovery as assessed by the Quality of Recovery-40 (QoR-40) questionnaire, in patients who received a combination of LPB-SNB versus patients who received the traditional intravenous opioid, after lower extremity orthopaedic surgeries with spinal anaesthesia.

The main questions it aims to answer are:

* Will there be a significant difference in QoR-40 scores between both groups?
* Will the combined LPB-SNB significantly reduces opioid consumption within the first 24 hours?
* Will the combined LPB-SNB significantly increases postoperative duration of analgesia?

Participants will:

* Receive a coded sealed opaque envelope containing their randomly allocated intervention group; first group receives a combination of lumbar plexus-sciatic nerve block, while the second group receives no block at all. This information would not be disclosed to the participants.
* Receive an explanation on how to use the patient controlled analgesia (PCA) to deliver intravenous opioid, and instructions on filling in the QoR-40 questionnaire.

Researchers will then compare the results between both groups to see if the combined lumbar plexus-sciatic nerve block successfully provides adequate analgesia and enhance postoperative quality of recovery after lower extremity orthopaedic surgeries. conditions: Lower Extremity Surgery studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One hundred participants are to be randomly assigned by a computer-generated random number table into two parallel groups and 1:1 allocation to either receive a combination of LPB-SNB or no block at all. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Numbers were prepared in sealed envelopes prepared by a third party not involved in the study to ensure allocation concealment, and handed over to the anesthetist performing the block before surgery. Participants would be blinded to the group allocation. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: USG Guided Combined LPB-SNB with Isobaric Bupivacaine name: Control measure: Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire measure: Postoperative Intravenous Opioid Consumption measure: Postoperative Analgesia Duration sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. Dr. I.G.N.G. Ngoerah General Hospital status: RECRUITING city: Denpasar state: Bali zip: 80114 country: Indonesia name: Tjokorda GA Senapathi, Professor role: CONTACT phone: +6281337711220 email: tjoksenapathi@unud.ac.id name: Tjokorda GA Senapathi, Professor role: SUB_INVESTIGATOR name: Pontisomaya Parami, Consultant role: SUB_INVESTIGATOR name: Made Wiryana, Professor role: SUB_INVESTIGATOR name: I Made G Widnyana, Doctorate role: SUB_INVESTIGATOR name: I Putu P Suarjaya, Doctorate role: SUB_INVESTIGATOR name: I Gusti NM Aribawa, Doctorate role: SUB_INVESTIGATOR name: Ida Bagus KJ Sutawan, Consultant role: SUB_INVESTIGATOR name: Georgina M Tiberias, MD role: SUB_INVESTIGATOR lat: -8.65 lon: 115.21667 hasResults: False

 nctId: NCT06301490 id: Taif university briefTitle: The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome overallStatus: COMPLETED date: 2024-01-11 date: 2024-02-15 date: 2024-03-02 date: 2024-03-08 date: 2024-04-24 name: Taif University class: OTHER briefSummary: BACKGROUND: Shoulder pain has been reported to be the third most common musculoskeletal presentation in primary care, after low back pain and knee pain. The prognosis for those presenting with musculoskeletal shoulder pain varies greatly amongst individuals, with 50% of people reporting symptoms 6 months after presenting in primary healthcare. Functional limitations, in addition to pain, are widespread and can interfere with job, hobbies, social, and sporting activities. They may also relate to psychological discomfort and a lower quality of life. Continuous computer uses without a break, awkward postures, and the duration and frequency of laptop use have all been identified as risk factors for musculoskeletal diseases. The most prevalent cause, accounting for 70% of cases, is rotator cuff dysfunction. Rotator cuff disorders are frequently associated with short and long-term impairment and discomfort, with approximately fifty percent of patients experiencing pain or functional restrictions for up to two years. The majority of shoulder pain concerns are treated in primary care by physiotherapists and general practitioners. Myofascial release is a common hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex with promising results in improving functional level.

OBJECTIVE: The purpose of this study is to investigate the effect of myofascial release in patient with rotator cuff tendinopathy.

METHOD: The design of this study is a double blinded Randomize control trail. Forty-two participants will be divided into one of two groups, group one will have strengthening exercises, range of motion exercise, and ice application, group two will perform the same exercises with ice application plus myofascial release. Patient will be followed for one month, two session per week and the session duration will be 30-45 mins. Assessment and re-assessment will be done by independent physical therapist. All patients will be assessed by using quick DASH, VAS, ROM, and Kessler psychological distress scale. conditions: Subacromial Impingement Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ACTUAL name: Myofascial Release measure: pain intensity measure: disability measure: rang of motion measure: psychological distress, and health-related quality of life (HRQoL) sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Taif University city: Taif state: Makkah zip: 11099 country: Saudi Arabia lat: 21.27028 lon: 40.41583 hasResults: False

 nctId: NCT06301477 id: 23/109X briefTitle: PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial acronym: PROMOTE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-03-01 date: 2027-03-01 date: 2024-03-08 date: 2024-03-12 name: Children's Hospital of Eastern Ontario class: OTHER briefSummary: To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes. conditions: Inflammatory Bowel Diseases conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A single-center, randomized, placebo-controlled, double-blinded, pilot trial primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: The treating physician, study participants, and research coordinators and lab researchers will not have knowledge of the randomization codes and will be blinded as to study product allocation. Unblinding will occur only if necessary to ensure study participants safety. Only Dr. Mack (Co-PI) will request to break the blind for safety reasons. Once the blind is broken by Dr. Mack the patient will be discontinued from study product. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Resistant Starch name: Placebo measure: Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis measure: Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis measure: Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis measure: Change in intensification as measured by anti-TNFa dose escalation measure: Change in intensification as measured by anti-TNFa interval shortening measure: Change in disease activity measure: Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples measure: Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples measure: Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire measure: Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire measure: Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: Children's Hospital of Eastern Ontario city: Ottawa state: Ontario zip: K1H 8L1 country: Canada name: David Mack, MD, FRCPC role: CONTACT phone: (613)737-7600 phoneExt: 2516 email: dmack@cheo.on.ca name: Ruth Singleton, RN, CCRP role: CONTACT phone: (613)737-7600 phoneExt: 4123 email: rsingleton@cheo.on.ca name: David Mack, MD, FRCPC role: PRINCIPAL_INVESTIGATOR name: Alain Stintzi, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.41117 lon: -75.69812 hasResults: False

 nctId: NCT06301464 id: B-2003-603-103 briefTitle: Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer overallStatus: ACTIVE_NOT_RECRUITING date: 2003-03-01 date: 2024-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Seoul National University Bundang Hospital class: OTHER briefSummary: The aim of this study to validate the role of pepsinogens in gastric cancer screening. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 24000 type: ESTIMATED measure: The level of serum pepsinogens sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Bundang Hospital city: Seongnam-si state: Gyeonggi-do zip: 463-707 country: Korea, Republic of lat: 37.43861 lon: 127.13778 hasResults: False

 nctId: NCT06301451 id: XD2021-1 briefTitle: Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia overallStatus: RECRUITING date: 2022-04-01 date: 2024-12-01 date: 2024-12-01 date: 2024-03-08 date: 2024-03-08 name: Sun Jia class: OTHER briefSummary: In the past 30 years, the blood lipid level of the Chinese population has gradually increased, and the prevalence of dyslipidemia patients has increased significantly. Hyperlipidemia is a disease caused by abnormal blood lipid levels, also known as abnormal lipid metabolism. Common clinical indicators include total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL) and high-density lipoprotein ( HDL).The number of patients with abnormal blood lipid levels in China accounts for as high as 40% of the total. It is estimated that between 2010 and 2030,cardiovascular disease events will increase by 9.2 million, which seriously endangers human health and becomes a high risk factor for various cardiovascular diseases, such as atherosclerosis. One of the pathological foundations of atherosclerosis is that abnormal lipid levels in the body cause a large amount of lipid to be deposited in the arterial endothelial matrix, which is phagocytosed by smooth muscle and macrophages to form foam cells.

Hydrogen, the lightest and smallest molecular gas in the atmosphere, is considered a novel antioxidant that reduces oxidative stress. Accumulating evidence from various biomedical fields in clinical studies and experimental models of many diseases suggests that hydrogen inhalation or drinking hydrogen-containing solutions can be used as a therapeutic strategy. Due to the special physical properties of hydrogen gas that is easy to diffuse, hydrogen molecules can penetrate cell membranes to reach organelles and cell nuclei. Hydrogen's moderate reducing properties make it effective in reducing cytotoxicity, protecting nuclear DNA and mitochondria, and reducing the risk of lifestyle-related diseases and cancer.

In addition, hydrogen intake can reduce oxidative stress, improve cellular function, and reduce chronic inflammation, which are associated with the pathology and etiology of hyperlipidemia and other related diseases. Molecular hydrogen can regulate important metabolic functions such as signal transduction, protein phosphorylation, miRNA expression, and autophagy. Studies have shown that intake of hydrogen water in APOE knockout mice can reduce serum total cholesterol and low-density lipoprotein levels and prevent the progression of atherosclerosis. A study by Song et al. in 2013 included 20 subjects who drank 0.9 to 1 L of hydrogen-rich water per day for 10 weeks, and the subjects' LDL-C levels decreased significantly before and after treatment. Another study showed that subjects with underlying lipid metabolism abnormalities were treated with high-concentration hydrogen water (5.5mmol/d) for up to 24 weeks, and serum total cholesterol and low-density lipoprotein levels were significantly reduced. Protein function and redox status (eg, increased serum superoxide dismutase and decreased malondialdehyde) were improved, markers of inflammation (eg, serum tumor necrosis factor-alpha) decreased and fasting blood glucose decreased. At present, the research on the treatment of hyperlipidemia with hydrogen water is very limited. The portable hydrogen water hydrogen machine used in this study has passed the registration test of the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute. In order to evaluate the use of the portable hydrogen water hydrogen machine for hyperlipidemia The efficacy and safety of adjuvant therapy in patients, this clinical trial is specially carried out. conditions: Hyperlipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is estimated that 180 subjects will be enrolled and randomly divided into the experimental group and the control group according to 2:1. During the observation period, the experimental group drink the hydrogen water prepared by the experimental equipment on the basis of the general dietary guidance, while the control group adopted the general dietary guidance. Every subject's diet and lifestyle remains largely unchanged during the treatment period. primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: General dietary guidance and hydrogen water prepared by portable hydrogen rich water machine measure: Percent change from baseline in LDL-C at 3 months of intervention. measure: Absolute change from baseline in LDL-C at 3 months of intervention. measure: Percent change from baseline in LDL-C at 1 month of intervention. measure: Absolute change from baseline in LDL-C at 1 month of intervention. measure: Percent change from baseline in LDL-C at 6 months of intervention. measure: Absolute change from baseline in LDL-C at 6 months of intervention. measure: Percent change from baseline in triglycerides at 1 month of intervention. measure: Absolute change from baseline in triglycerides at 1 month of intervention. measure: Percent change from baseline in triglycerides at 3 months of intervention. measure: Absolute change from baseline in triglycerides at 3 months of intervention. measure: Percent change from baseline in triglycerides at 6 months of intervention. measure: Absolute change from baseline in triglycerides at 6 months of intervention. measure: Percent change from baseline in total cholesterol at 1 month of intervention. measure: Absolute change from baseline in total cholesterol at 1 month of intervention. measure: Percent change from baseline in total cholesterol at 3 months of intervention. measure: Absolute change from baseline in total cholesterol at 3 months of intervention. measure: Percent change from baseline in total cholesterol at 6 months of intervention. measure: Absolute change from baseline in total cholesterol at 6 months of intervention. measure: Percent change from baseline in HDL cholesterol at 1 month of intervention. measure: Absolute change from baseline in HDL cholesterol at 1 month of intervention. measure: Percent change from baseline in HDL cholesterol at 3 months of intervention. measure: Absolute change from baseline in HDL cholesterol at 3 months of intervention. measure: Percent change from baseline in HDL cholesterol at 6 months of intervention. measure: Absolute change from baseline in HDL cholesterol at 6 months of intervention. measure: Percent change from baseline in non-HDL cholesterol at 1 month of intervention. measure: Absolute change from baseline in non-HDL cholesterol at 1 month of intervention. measure: Percent change from baseline in non-HDL cholesterol at 3 months of intervention. measure: Absolute change from baseline in non-HDL cholesterol at 3 months of intervention. measure: Percent change from baseline in non-HDL cholesterol at 6 months of intervention. measure: Absolute change from baseline in non-HDL cholesterol at 6 months of intervention. measure: Percent change from baseline in small and dense LDL at 1 month of intervention. measure: Absolute change from baseline in small and dense LDL at 1 month of intervention. measure: Percent change from baseline in small and dense LDL at 3 months of intervention. measure: Absolute change from baseline in small and dense LDL at 3 months of intervention. measure: Percent change from baseline in small and dense LDL at 6 months of intervention. measure: Absolute change from baseline in small and dense LDL at 6 months of intervention. measure: Percent change from baseline in apolipoprotein B at 1 month of intervention. measure: Absolute change from baseline in apolipoprotein B at 1 month of intervention. measure: Percent change from baseline in apolipoprotein B at 3 months of intervention. measure: Absolute change from baseline in apolipoprotein B at 3 months of intervention. measure: Percent change from baseline in apolipoprotein B at 6 months of intervention. measure: Absolute change from baseline in apolipoprotein B at 6 months of intervention. measure: Percent change from baseline in TNF-alpha at 1 month of intervention. measure: Absolute change from baseline in TNF-alpha at 1 month of intervention. measure: Percent change from baseline in TNF-alpha at 3 months of intervention. measure: Absolute change from baseline in TNF-alpha at 3 months of intervention. measure: Percent change from baseline in TNF-alpha at 6 months of intervention. measure: Absolute change from baseline in TNF-alpha at 6 months of intervention. measure: Adverse Event (AE) Frequency measure: Severe Adverse Event (SAE) Frequency measure: Device deficiency rate sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Sun Jia role: CONTACT phone: 13751822925 lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06301438 id: LY2024-022-A briefTitle: Dalpiciclib in HR+/HER2- ABC overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-12 date: 2028-12 date: 2024-03-08 date: 2024-04-16 name: RenJi Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer. conditions: Advanced Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 103 type: ESTIMATED name: dalpiciclib measure: Progression-Free Survival measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University city: Shanghai zip: 200127 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06301425 id: TROPHY-AML01 briefTitle: MRD Response-adapted Allo-HSCT for Adverse-risk AML overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-01 date: 2024-03-08 date: 2024-03-08 name: Peking University People's Hospital class: OTHER name: Ruijin Hospital name: Wuhan TongJi Hospital name: Anhui Provincial Hospital briefSummary: This TROPHY-AML01 regimen aims to identify the effectiveness and safety of MRD response-adapted allo-HSCT for adverse-risk acute myeloid leukemia in an open-label, randomized, controlled trial. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 178 type: ESTIMATED name: Intervention group name: Control group measure: Event-free survival (EFS) measure: Relapse measure: Leukemia-free survival (LFS) measure: Non-relapse mortality (NRM) measure: Overall survival (OS) measure: Acute graft-versus-host disease (aGvHD) measure: Chronic graft-versus-host disease (cGvHD) sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301412 id: COTTIS-2_Version4.0-13Nov23 briefTitle: Combination of Hypothermia and Thrombectomy in Acute Stroke acronym: COTTIS-2 overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2026-03-18 date: 2026-06-18 date: 2024-03-08 date: 2024-03-08 name: University of Freiburg class: OTHER name: European Union name: E+E CRO consulting, Vienna, Austria name: Center for Medical data science, University of Vienna, Austria briefSummary: The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion.

The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed.

Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications. conditions: Ischemic Stroke conditions: Large Vessel Occlusion conditions: Endovascular Treatment studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: hypothermia measure: functional outcome measure: infarction volume measure: increase in infarction measure: recanalization result measure: neurological improvement measure: outcome at discharge measure: shift in functional outcome measure: very good clinical outcome measure: mortality measure: Length of ventilation measure: Length of stay measure: body temperature measure: time to groin puncture measure: time to recanalization measure: Occurrence of intracerebral haemorrhage (ICH) measure: Complications associated with hypothermia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301399 id: Rituximab01 briefTitle: Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2026-12-31 date: 2024-03-08 date: 2024-03-08 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy measure: ORR measure: PFS measure: OS measure: DoR measure: DCR sex: ALL minimumAge: 17 Years maximumAge: 79 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute & Hospital city: Tianjin state: Tianjin zip: 300060 country: China lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06301386 id: EVOLUTION briefTitle: Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-05-01 date: 2026-12-01 date: 2024-03-08 date: 2024-03-08 name: Fudan University class: OTHER name: Anyang Tumor Hospital briefSummary: The goal of this clinical trial is to learn about efficacy of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Everolimus name: PD-1 measure: objective response rate (ORR) measure: progression-free survival (PFS） measure: overall survival (OS) measure: disease control rate (DCRs) measure: advert events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anyang Tumor Hospital city: Anyang state: Henan country: China name: Yanjun Wang, PhD role: CONTACT phone: +8613837266702 email: m13837266702@163.com lat: 36.096 lon: 114.38278 facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai country: China name: Dawei Li, PhD role: CONTACT phone: +8613774201693 email: li_dawei@fudan.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06301373 id: SYSKY-2023-1185-02 briefTitle: Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2030-04-01 date: 2030-04-01 date: 2024-03-08 date: 2024-03-08 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy.

This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48.

This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Methotrexate Combined With Tofacitinib name: Methotrexate measure: The proportion of subjects who achieved ACR20 measure: Changes in disease activity scores (DAS28-CRP) relative to baseline measure: Changes in disease activity scores (DAS28-ESR) relative to baseline measure: Changes in disease activity scores (SDAI) relative to baseline measure: Changes in disease activity scores (CDAI) relative to baseline measure: Proportion of subjects with low disease activity and remission (SDAI standard) at weeks 4, 8, 12, 24, 36, and 48 after treatment measure: The proportion of subjects who met ACR50 criteria at weeks 4, 8, 12, 24, 36, and 48 after treatment measure: The proportion of subjects who met ACR70 criteria at weeks 4, 8, 12, 24, 36, and 48 after treatment measure: Changes in the Disability Index (HAQ-DI) of the Health Assessment Questionnaire relative to baseline measure: Changes in EQ-5D-5L relative to baseline measure: The proportion of subjects with joint destruction progression at 48 weeks after treatment measure: The proportion of adverse events (AE) in subjects at 4, 8, 12, 24, 36, and 48 weeks after treatment measure: The proportion of severe adverse events (SAE) in subjects at 4, 8, 12, 24, 36, and 48 weeks after treatment measure: Changes in serum MMP-3 levels relative to baseline sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301360 id: KOSMOS2 2023-04956-01 briefTitle: Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support overallStatus: RECRUITING date: 2023-12-01 date: 2025-06-01 date: 2025-12-31 date: 2024-03-08 date: 2024-03-12 name: Daniel Maroti class: OTHER name: Wayne State University briefSummary: Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned.

Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT).

The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created.

The research question for this specific study is:

Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD? conditions: Functional Somatic Disorder conditions: Somatic Symptom Disorder conditions: Functional Somatic Syndromes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT with two treatment arms primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Internet based Emotional Awareness and Expression Therapy (I-EAET) measure: Patient Health Questionnaire -15 (PHQ-15) measure: Numeric Rating Scales according to EURONET-SOMA measure: Generalized Anxiety Disorder-7 (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Post traumatic stress disorder checklist-5 (PCL-5) measure: Difficulties in Emotion Regulation Scale-16 (DERS-16) measure: Sheehan Disability Scale (SDS) measure: The revised illness perception questionnaire (IPQ-R) measure: Mediational measure: DERS-16 measure: Mediational measure: PHQ-15 measure: Mediational measure: PHQ-4 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stockholm University status: RECRUITING city: Stockholm zip: 10691 country: Sweden name: Daniel Maroti, Med Dr role: CONTACT phone: +46738028474 email: daniel.maroti@su.se lat: 59.33258 lon: 18.0649 facility: Stockholm University status: RECRUITING city: Stockholm zip: 11419 country: Sweden name: Daniel Maroti role: CONTACT phone: 0738028474 email: daniel.maroti@su.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06301347 id: LTP+P briefTitle: Learning Through Play Plus for Psychosis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-30 date: 2025-12-30 date: 2024-03-08 date: 2024-03-08 name: Pakistan Institute of Living and Learning class: OTHER briefSummary: Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia. conditions: Psychosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Learning through Play Plus measure: Recruitment Rate measure: Attrition Rate measure: Intervention attendance log measure: Positive and Negative Syndrome Scale measure: Psychotic Rating Scale measure: Parenting Stress Index measure: Maternal Attachment Inventory measure: Knowledge attitude and practices of Child Development measure: Calgary Depression Scale measure: Social and Occupational Functioning Scale measure: Euro-Qol 5 Dimensions measure: Client Service Receipt Inventory measure: Ages and Stages Questionnaire measure: Manchester Assessment of Caregiver-Infant Interaction measure: Bayley Scale of infant development measure: Child Height measure: Child Weight measure: Child head circumference sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301334 id: Soh-Med-24-01-11MS briefTitle: Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-08-01 date: 2024-03-08 date: 2024-03-08 name: Sohag University class: OTHER briefSummary: A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications

Though epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy conditions: Pain Mangement of Thoracotomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Bupivacaine 0.25% Injectable Solution measure: study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy. measure: The secondary outcome is the total postoperative morphine consumption, time of first analgesic, sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301321 id: 461_2566 briefTitle: The Evaluation and Comparison of BCR-ABL p210 mRNA Transcripts (%IS Unit) Results Between Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) and QXDx™ BCR-ABL %IS Kit (Bio-Rad) in Chronic Myeloid Leukemia Patients acronym: BCR-ABL1 overallStatus: RECRUITING date: 2024-03-20 date: 2024-03-30 date: 2024-07-30 date: 2024-03-08 date: 2024-03-08 name: Siriraj Hospital class: OTHER briefSummary: Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves. conditions: Chronic Myelogenous Leukemia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: Sensitivity measure: Specificity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Siriraj hospital status: RECRUITING city: Bangkok zip: 10700 country: Thailand name: weerapat Owattanapanich, MD role: CONTACT phone: 0891081963 email: weerapato36733@gmail.com name: Wananchi Saisaard, MT role: CONTACT phone: 0817141717 email: wern.si12@gmail.com name: weerapat Owattanapanich, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06301308 id: 2022021 briefTitle: A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial overallStatus: WITHDRAWN date: 2023-10-01 date: 2024-02-29 date: 2024-02-29 date: 2024-03-08 date: 2024-04-24 name: Second Xiangya Hospital of Central South University class: OTHER briefSummary: The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be randomly divided into three different anesthesia mode groups,namely are Group A (intraurethral lidocaine gel alone), Group B (intraurethral lidocaine gel + lidocaine 2% injection), and Group C (intraurethral lidocaine gel + liquid paraffinl).Patients only need to prepare and cooperate according to routine surgical operations，which is group B or group C. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 0 type: ACTUAL name: Intraurethral lidocaine gel alone name: Intraurethral lidocaine gel + lidocaine 2% injection name: intraurethral lidocaine gel + liquid paraffinl measure: Access the pain score using the Visual Analogue Scale (VAS) measure: Postoperative complications sex: MALE maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: The second xiangya hospital city: Changsha state: Hunan zip: 410000 country: China lat: 28.19874 lon: 112.97087 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-01-01 uploadDate: 2024-03-03T08:40 filename: Prot_SAP_ICF_000.pdf size: 387410 hasResults: False

 nctId: NCT06301295 id: 2402-017-136 briefTitle: Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients Suspicious of Early-stage Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-08 date: 2024-03-08 name: Pusan National University Hospital class: OTHER briefSummary: This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Ultarthin bronchoscopy with intratumoral washing measure: Genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid measure: Concordance rate of genetic alteration with Next Generation Sequencing detection rate among intratumoral washing fluid, plasma, and tissue measure: Turn-around time measure: Genetic alteration with Next Generation Sequencing sensitivity & specificity in intratumoral washing fluid sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301282 id: 2021-02341 briefTitle: Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease acronym: Transition overallStatus: RECRUITING date: 2023-03-03 date: 2025-12 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: University Hospital, Geneva class: OTHER briefSummary: Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood.

The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation.

For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration.

This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states measure: Correlation of electroencephalographic resting-state oscillatory activity with neuropsychiatric clinical scores during the levodopa challenge measure: Correlation of electroencephalographic resting-state oscillatory activity with motor scores during the levodopa challenge sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital, Geneva status: RECRUITING city: Geneva zip: 1204 country: Switzerland name: Vanessa Fleury, MD role: CONTACT phone: +41223728337 email: Vanessa.FleuryNissen@hcuge.ch lat: 46.20222 lon: 6.14569 hasResults: False

 nctId: NCT06301269 id: 202312124RINA briefTitle: A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia overallStatus: RECRUITING date: 2024-03-10 date: 2024-05-30 date: 2024-07-30 date: 2024-03-08 date: 2024-03-08 name: National Taiwan University Hospital class: OTHER briefSummary: The goal of this observational study is to investigate the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia.

The main questions it aims to answer are:

1. What is the current status of self-compassion, depression, and quality of life among primary caregivers of persons with dementia?
2. Are there differences in self-compassion, depression, and quality of life among primary caregivers of persons with dementia based on different background variables?
3. What is the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia?

Participants will fill out the questionnaire to complete the study. conditions: Dementia studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: CROSS_SECTIONAL count: 160 type: ESTIMATED measure: Self-Compassion Scale measure: PHQ-9 Scale measure: Quality-of-Life Scale sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: wen lin YE role: CONTACT phone: +886-2312-3456 email: vovo951357@ntuh.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06301256 id: I8F-NS-I002 briefTitle: Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2025-03-11 date: 2025-03-11 date: 2024-03-08 date: 2024-03-08 name: Florida Academic Centers Research and Education, LLC class: INDUSTRY briefSummary: The purpose of this study is to determine the clinical efficacy and safety of tirzepatide in subjects with moderate to severe hidradenitis suppurativa. The study will be conducted over 24 weeks on active therapy followed by a eight-week observational follow-up visit. The total length of the study will be 32 weeks . conditions: Hidradenitis Suppurativa studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TIRZEPATIDE measure: Hidradenitis Suppurativa Clinical Response (HiSCR) 50% sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301243 id: FY24-62 briefTitle: Molecular Signature of Inactivity Induced Exercise Responsiveness overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Concordia University Wisconsin class: OTHER briefSummary: Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. What individuals do outside of the exercise bout can influence the effectiveness of exercise. One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). This is important in that exercise may not be able to fully offset these times of inactivity. However, these studies were only looking at different fats in the blood. As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). Subjects will then come in the next day to bike somewhat hard for 1 hour. The investigators will take blood samples before, during, and after exercise to measure energy sources. The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases. conditions: Metabolic Diseases conditions: Aerobic Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Inactivity measure: Circulating lipid and carbohydrate metabolism measure: Basal and post-exercise gene expression with inactivity sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Kevin J Gries status: RECRUITING city: Mequon state: Wisconsin zip: 53092 country: United States name: Kevin J Gries, PhD role: CONTACT phone: 262-243-4293 email: kevin.gries@cuw.edu lat: 43.21573 lon: -88.02962 hasResults: False

 nctId: NCT06301230 id: PLET-2022 briefTitle: Home- vs. Hospital-based Surgical Training overallStatus: COMPLETED date: 2020-09-01 date: 2021-12-31 date: 2021-12-31 date: 2024-03-08 date: 2024-03-08 name: Clarunis - Universitäres Bauchzentrum Basel class: OTHER name: University of Basel briefSummary: The purpose of this study was to assess the effect of training with a personal, portable laparoscopic endo-trainer (PLET) on residents' laparoscopic skills. All participants were randomised to either a home- or hospital-based PLET training group and surgical skill performance was assessed using five laparoscopic exercises. Endpoints consisted ofsubjective and objective assessment ratings as well as exercise time and qualitative data up to 12 weeks. The primary outcome was the difference in exercise time and secondary outcomes included performance scores as well as qualitative data. conditions: Surgical Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 24 type: ACTUAL name: Portable Laparoscopic Trainer (PLET) measure: Exercise time measure: Assessment rating measure: Qualitative feedback sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clarunis Universitäres Bauchzentrum Basel city: Basel zip: 4002 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06301217 id: NO: PT. BU. EC. 7 briefTitle: Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Neck Pain overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-17 date: 2024-03-10 date: 2024-03-20 date: 2024-03-08 date: 2024-03-08 name: Delta University for Science and Technology class: OTHER briefSummary: Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. The quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. This study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue. conditions: Neck Pain conditions: Electromyohgraph studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ACTUAL name: There is no intervention measure: Neck disability measure: Curvature angle of the cervical spine measure: root-mean-square value (RMS) of Surface electromyography for both upper trapezius and levator scapula sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Delta university for science and technology city: Gamasa state: Dakahleya zip: 7731168 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False

 nctId: NCT06301204 id: 21.06.2022-E.67046 briefTitle: Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients overallStatus: COMPLETED date: 2022-03-01 date: 2023-11-01 date: 2023-11-01 date: 2024-03-08 date: 2024-03-08 name: Bezmialem Vakif University class: OTHER briefSummary: The aim of this clinical study conducted in accordance with the information in the literature is to compare the effects of administering tranexamic acid during orthognathic surgery, at different doses. Specifically, investigators aim to compare the effects of administering 1 ampoule IV (approximately 3 mg/kg) and 2 ampoules IV (approximately 6 mg/kg), and evaluate their impact on intraoperative bleeding (ml), surgical duration (min), postoperative swelling, and intraoperative surgical field evaluation (Fromme Scale), by comparing them with control group (applying no drug administration) patient data. conditions: Tranexamic Acid conditions: Orthognathic Surgery conditions: Edema conditions: Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Tranexamic acid injection name: Saline measure: intraoperative bleeding during the surgery (ml) measure: postoperative edema calculation for the first 1-3 and 7 day (cm) measure: intraoperative surgical site evaluation (Fromme Scale) measure: Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakıf Universty city: Istanbul state: Fatih zip: 34093 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06301191 id: 133/21-02-2022 briefTitle: The Effect of Semaglutide on Cardiovascular Markers and Liver Function overallStatus: RECRUITING date: 2022-03-01 date: 2023-03-01 date: 2024-05-01 date: 2024-03-08 date: 2024-03-08 name: Attikon Hospital class: OTHER briefSummary: Fifty patients with diabetes mellitus type 2 and non-alcoholic fatty liver disease (NAFLD) will be enrolled in the study.

25 patients will treated with semaglutide and 25 patients with dipeptidyl peptidase 4 (D-PP4) inhibitors.

At baseline, at four and at 12 months will evaluate the endothelial, cardiovascular and liver function. conditions: Diabetes Type 2 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Semaglutide, 1.0 mg/mL name: Dipeptidyl Peptidase 4 inhibitor measure: Comparison of arterial stiffness markers difference among treatment groups measure: Comparison of endothelial glycocalyx thickness difference among treatment groups measure: Comparison of liver stiffness difference among treatment groups sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Attikon University General Hospital status: RECRUITING city: Athens zip: 12462 country: Greece name: Vaia Lambadiari, Professor role: CONTACT phone: 2105831148 email: vlambad@otenet.gr lat: 37.97945 lon: 23.71622 hasResults: False

 nctId: NCT06301178 id: 12548 briefTitle: Effect of Vitamin D Injection on Hypertrophic Scars and Keloids overallStatus: RECRUITING date: 2024-02-27 date: 2025-02-20 date: 2026-02-20 date: 2024-03-08 date: 2024-03-21 name: Mostafa Bahaa class: OTHER briefSummary: Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand.

The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes conditions: Dermatologic Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Cholecalciferol measure: Clinical scoring by Vancouver Scale Score sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: faculty of medicine-Fayoum university status: RECRUITING city: Fayoum zip: 63519 country: Egypt name: Marwa Kamal, PhD role: CONTACT phone: 01021365897 email: mka05@fayou.edu.eg lat: 29.30995 lon: 30.8418 hasResults: False

 nctId: NCT06301165 id: 2023-FXY-129 briefTitle: TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2024-03-19 date: 2024-12-31 date: 2028-12-31 date: 2024-03-08 date: 2024-04-09 name: Sun Yat-sen University class: OTHER briefSummary: The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 162 type: ESTIMATED name: TPC induction chemotherapy name: GP induction chemotherapy measure: Progression-free survival measure: Overall survival measure: Distant progression measure: Locoregional progression measure: Short-term response rate measure: Incidence of acute and late toxicity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Hai-Qiang Mai role: CONTACT phone: 860-020-8734 phoneExt: 86-20-8734-364 email: maihq@sysucc.org.cn name: Hai-Qiang Mai, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Affiliated cancer hospital and institute of guangzhou medical university status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Weijun Zhang role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-Sen Memorial Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Shoumin Bai role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangzhou Medical University status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Jiancong Sun role: CONTACT lat: 23.11667 lon: 113.25 facility: Dongguan people's hospital status: NOT_YET_RECRUITING city: Dongguan country: China name: Zhigang Liu role: CONTACT lat: 23.01797 lon: 113.74866 facility: Foshan First People's Hospital status: NOT_YET_RECRUITING city: Foshan country: China name: Ning Zhang role: CONTACT lat: 23.02677 lon: 113.13148 facility: Peking university shenzhen hospital status: NOT_YET_RECRUITING city: Shenzhen country: China name: Yajie Liu, MD role: CONTACT lat: 22.54554 lon: 114.0683 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: NOT_YET_RECRUITING city: Wuhan country: China name: Kunyu Yang role: CONTACT lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06301152 id: E2-22-1905 briefTitle: Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy overallStatus: COMPLETED date: 2022-09-01 date: 2022-10-01 date: 2023-05-30 date: 2024-03-08 date: 2024-03-08 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE).

Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment. conditions: Lateral Epicondylitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two different treatment modalities were applied in two groups primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: high intensive laser name: extracorporeal shock wave therapy measure: Visual analog scale measure: Quick Disability Arm, Shoulder and Hand questionary, measure: hand grip strength measure: musculoskeletal ultrasonography sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emine Esra Bilir city: Ankara state: Çankaya zip: 06800 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06301139 id: P17-004 briefTitle: Goat Milk Infant Formula Comfort Study overallStatus: COMPLETED date: 2019-05-01 date: 2021-04-01 date: 2024-02-01 date: 2024-03-08 date: 2024-03-08 name: Ausnutria Hyproca B.V. class: INDUSTRY name: HM hospitales briefSummary: In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops. conditions: Gastrointestinal Diseases conditions: Cow's Milk Intolerance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled pilot study primaryPurpose: TREATMENT masking: NONE count: 18 type: ACTUAL name: Goat milk-based infant formula name: Cow's milk-based infant formula with probiotic drops measure: Cow's Milk-related Symptoms measure: Cow's Milk-related Symptoms measure: Parental stress measure: Parental quality of life measure: Weight measure: Length measure: Weight-for-age measure: Length-for-age measure: Weight-for-length sex: ALL minimumAge: 6 Weeks maximumAge: 3 Months stdAges: CHILD facility: HM hospitales city: Madrid zip: 28015 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06301126 id: P.T.REC/012/004985 briefTitle: Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries overallStatus: RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2025-03-01 date: 2024-03-08 date: 2024-03-12 name: Cairo University class: OTHER briefSummary: After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain. conditions: Abdomen Hernia conditions: Respiratory Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Virtual reality name: conventional physical therapy exercise program measure: Forced vital capacity (FVC) measure: Forced expiratory volume in 1 second (FEV1) measure: Peak expiratory flow (PEF) measure: Respiratory muscle strength measure: diaphragmatic mobility measure: Functional capacity sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Giza zip: 12111 country: Egypt name: Nesma M Allam, PhD role: CONTACT phone: +201281968332 email: dr.nesma2011@yahoo.com lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06301113 id: IRB#: 01202023_torabiDH_CBDloz briefTitle: This Research Study Examines the Effects of Cannabidiol-infused Candy on Reducing the Bacteria Causing Tooth Decay, When Comparing it to a Sugar Free Candy on Adults. overallStatus: COMPLETED date: 2023-01-27 date: 2023-02-11 date: 2023-02-11 date: 2024-03-08 date: 2024-03-08 name: West Coast University class: OTHER briefSummary: The goal of this clinical trial is to compare the effect of CBD candy versus sugar free candy on reducing the number of bacteria causing tooth decay, in adults The main question is to see whether CBD have any effect on reducing the number of Streptococcus mutans, in the oral cavity the main bacteria causing tooth decay.

Participants will be randomly placed in a group, and assigned to take either CBD-infused lozenge (if in the experimental group) or a sugar-free candy (if in the control group) once a day for 15 days.

A sample of saliva will be collected and analyzed in a lab before and after consumption of the candy to see whether either product could reduce the harmful bacteria in the mouth. conditions: Tooth Decay studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 30 Participants were randomly assigned to groups A (experimental group)and B (Control group). primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ACTUAL name: CBD infused candy name: Sugar free Candy measure: To investigate the impact of CBD-infused lozenges on Streptococcus mutans, by employing quantitative polymerase chain reaction (qPCR) for bacterial analysis. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West Coast University city: Anaheim state: California zip: 92802 country: United States lat: 33.83529 lon: -117.9145 hasResults: False

 nctId: NCT06301100 id: E20230371 briefTitle: Single-center, Prospective Study on the Identification and Delineation of Brain and Lung Tumors and At-Risk Organs, and Functional Testing of Surrounding Tissues Based on Dual-Energy CT overallStatus: RECRUITING date: 2023-04-28 date: 2024-04-28 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study explored the feasibility of dual-energy CT in head and lung tumors. Dual-energy CT can achieve quantitative CT imaging based on traditional imaging by dual-energy spectral imaging, and enhance the clarity of head and lung tumors. In this study, we will prospectively explore the image accuracy and delineation accuracy of dual energy CT in radiotherapy to verify whether dual energy CT performs better with conventional CT. conditions: Image Quality and Contouring Accuracy of the Tumor in Radiotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Dual energy CT after routine simulation measure: DICE value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huan-Hu-Xi status: RECRUITING city: Tianjin state: Tianjin zip: 300381 country: China name: Zhiyong Yuan, Doctor role: CONTACT phone: +86 186 2222 1199 email: zyuan@tmu.edu.cn lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06301087 id: WP-2024-01 briefTitle: Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App overallStatus: COMPLETED date: 2022-05-01 date: 2024-02-08 date: 2024-02-08 date: 2024-03-08 date: 2024-03-15 name: Weprom class: OTHER name: Kelindi briefSummary: The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :

* the median age of possible neurodevelopmental disorders notification of infants
* the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data conditions: Development, Child conditions: Postnatal Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 55618 type: ACTUAL name: Web Application measure: Time to neurodevelopment desorder diagnostic measure: User's satisfaction measure: Relevance of the neurodevelopmental desorder notification measure: Rate of mothers'postnal depression measure: Time of mothers'postnatal depression sex: ALL maximumAge: 10 Years stdAges: CHILD facility: ILC city: Le Mans country: France lat: 48.0 lon: 0.2 hasResults: False

 nctId: NCT06301074 id: HS-10509-101 briefTitle: The Phase I Study of HS-10509 in Chinese Adult Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-10 date: 2024-03-08 date: 2024-03-08 name: Jiangsu Hansoh Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia.

Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part. conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: For each cohort, participants will be assigned to receive HS-10509 or placebo in parallel primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: HS-10509 name: Placebo measure: Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment. measure: Changes from baseline in lab tests measure: Changes from baseline in vital signs measure: Change from baseline in body weight measure: Change from baseline in Electrocardiogram (ECG) measure: Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS) measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS) measure: Change from baseline in Barnes Akathisia Rating Scale (BARS) measure: Change from baseline in Simpson-Angus Scale (SAS) measure: Cmax measure: Tmax measure: AUC0-t measure: AUC0-∞ measure: λz measure: t½ measure: CL/F measure: Vd/F measure: MRT measure: Css, max measure: Css, min measure: Css, av measure: Tss, max measure: AUCss measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Hospital of Jilin University city: Changchun state: Jilin country: China name: Xiaojiao Li, Dr. role: CONTACT phone: +86 13514314089 email: Xingxingsuo123456@126.com lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06301061 id: PB001 briefTitle: Focal Microvibration and Chronic Lumbosacral Radicular Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2026-04-01 date: 2024-03-08 date: 2024-03-08 name: Federico II University class: OTHER briefSummary: The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question\[s\] it aims to answer are:

* Can focal microvibration improve pain in this patient population?
* Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday.

Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy. conditions: Pain, Chronic conditions: Lumbosacral Radiculopathy conditions: Radicular; Neuropathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: Equistasi® name: Sham name: Gabapentin; Pregabalin; Duloxetine; Amitriptyline measure: Pain intensity measure: Pain interference in daily life measure: Disability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06301048 id: BFHHZS20230203 briefTitle: Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma overallStatus: COMPLETED date: 2023-11-07 date: 2023-12-07 date: 2023-12-07 date: 2024-03-08 date: 2024-03-08 name: Beijing Friendship Hospital class: OTHER briefSummary: This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates. conditions: Duodenal Adenoma conditions: Complication of Treatment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 79 type: ACTUAL name: Stent Placement in Pancreatic and Bile Ducts measure: Rate of complications measure: Rate of complete resection measure: Rate of recurrence sex: ALL minimumAge: 18 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: NCT06301035 id: 2024-01-012 briefTitle: Asymmetric High-flow Nasal Cannula (HFNC) vs Standard HFNC for Post Extubation High-risk Group overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-10-31 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: Samsung Medical Center class: OTHER name: Fisher and Paykel Healthcare briefSummary: Background The exacerbation of respiratory failure that occurs after endotracheal intubation often occurs in patients who have received mechanical ventilation therapy, and when it occurs, it emerges as an important issue to consider reintubation of endotracheal intubation. High-flow nasal cannula (HFNC) through nasal cannula is known to produce positive airway pressure and deliver a certain amount of oxygen, and recently reported clinical studies have demonstrated the effect of lowering the risk of reintubation after endotracheal intubation, which is recommended for use in recent clinical practice guidelines. However, in patients at high risk of intubation failure, the combination of high-flow oxygen therapy and non-invasive positive-pressure ventilation therapy rather than the application of high-flow oxygen therapy alone through nasal cannula is helpful in reducing the rate of reintubation of endotracheal intubation. However, an alternative to non-invasive positive-pressure ventilation therapy is needed as there is a possibility of complications such as aspiration pneumonia, maladaptation of the application device (mask), and discomfort, making it difficult to apply it in the field.

Recently, it has been reported that high flow oxygen therapy through an asymmetric nasal cannula forms sufficient positive pressure in terms of respiratory dynamics, which makes the patient feel comfortable and reduces work of breath. However, no clinical studies have yet compared physiological effects using this method in patients at high risk of extubation failure.

Goal The investigators would like to compare the physiological effects of high flow oxygen therapy through 'asymmetric nasal cannula' with high flow oxygen therapy through 'standard nasal cannula' in patients identified as high-risk groups for valvular failure.

Hypothesis 'Asymmetric nasal cannula' reduces work of breath compared to 'standard nasal cannula' in high-risk patients with valvular failure. conditions: Acute Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Asymmetric High flow nasal cannula name: Standard(symmetric) High flow nasal cannula measure: Respiratory Rate Oxygenation (ROX) Index measure: The Lowest value of SpO2 within 24 hours after extubation measure: PaO2/FiO2 measure: SpO2/FiO2 measure: changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT) measure: Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index) measure: Respiratory rate measure: work of breath (Modified Borg Scale, MBS) measure: systolic blood pressure measure: mean arterial pressure measure: heart rate measure: Rate of reintubation within 7 days measure: Length of ICU stay measure: Length of hospital stay measure: ICU Mortality measure: Hospital Mortality measure: 28 Day Mortality measure: 90 Day Mortality sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center city: Seoul country: Korea, Republic of name: Hye Rim Chung role: CONTACT phone: +82-2-3410-6399 email: hyerim37.jeong@samsung.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06301022 id: WXZ-Finerenone briefTitle: Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus overallStatus: RECRUITING date: 2022-12-15 date: 2024-10-31 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: First Affiliated Hospital of Harbin Medical University class: OTHER briefSummary: Background： This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus(DM), however, evidence based on both clinical trails and real-world data are limited.

Methods:

Patients with CKD without DM were enrolled in this study from December 2022 to December 2024. In conjunction with the established treatment regimen for chronic kidney disease (CKD), study participants were additionally administered Finerenone. To evaluate the therapeutic impact and safety profile of the intervention, three primary biomarkers were monitored: 24-hour urinary protein (UTP), estimated glomerular filtration rate (eGFR), and serum potassium (sK+). These parameters were closely measured on a monthly basis, starting from the point of enrollment and continuing for a duration of twelve months or possibly longer. conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED measure: 24 hours urinary total protein measure: estimate Gromerular filtration rate measure: serum potassium sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Aaffiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang zip: 150001 country: China name: XINGZHI WANG, PHD.,MD role: CONTACT phone: +8613904506176 email: WANG.XINGZHI@HRBMU.EDU.CN lat: 45.75 lon: 126.65 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-15 uploadDate: 2024-02-26T03:42 filename: Prot_SAP_000.pdf size: 207441 hasResults: False

 nctId: NCT06301009 id: AI-CAC-PVS briefTitle: The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray acronym: AI-CAC-PVS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2025-10-01 date: 2024-03-08 date: 2024-03-08 name: Azienda Ospedaliera Città della Salute e della Scienza di Torino class: OTHER name: Compagnia di San Paolo briefSummary: The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph. The present study will provide prospective validation of its diagnostic performance in a primary prevention population with a clinical indication for coronary artery calcium (CAC) testing. conditions: Cardiovascular Diseases conditions: Atherosclerosis conditions: Coronary Artery Calcification studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 500 type: ESTIMATED name: AI-CAC score measure: Diagnostic accuracy of the AI-CAC score to identify the presence of subclinical atherosclerosis on chest x-ray measure: Percentage of individuals with a therapeutic management change by the attending physician based on the CAC score, with concordant AI-CAC. measure: Comparison of ASCVD events occurring in patients without (AI-CAC=0) vs. with subclinical atherosclerosis (AI-CAC >0) based on the AI-CAC score, as assessed by Kaplan Meier estimates of ASCVD events occurring until study completion. sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300996 id: STUDY23110042 briefTitle: Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2029-05 date: 2024-03-08 date: 2024-04-03 name: Marco Capogrosso class: OTHER name: Roche-Genentech briefSummary: Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor deficits in people with Type 2, 3, or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 2, 3, or 4 SMA aged 16 or older that show quantifiable motor deficits of the upper body. The investigators will then implant the subjects with percutaneous, linear spinal leads near the cervical spinal cord for a period of up to 29 days. Although these leads are not optimized for motor function but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology enabling our team to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted. conditions: Spinal Muscular Atrophy conditions: Spinal Muscular Atrophy Type 3 conditions: Spinal Muscular Atrophy Type II conditions: Spinal Muscular Atrophy 4 conditions: SMA studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-arm, open-label study performed to quantify variables that are predictive of the efficacy of spinal cord stimulation to improve motor control. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads) measure: Muscle Weakness Torque measure: Number and Severity of Adverse Events measure: Muscle Weakness Muscle Activation measure: Motor Function ROM measure: Motor Function RULM measure: Motor Function Fatigue measure: Discomfort/Pain measure: Sensorimotor Network Structure Density measure: Impression measure: Sensorimotor Network Structure Integrity measure: Sensorimotor Network Function measure: Cortico-spinal Tract Integrity measure: Spinal Circuit Excitability measure: Motoneuron Firing Rates measure: Motor Firing Number sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Sydney Bader, MS role: CONTACT email: syb17@pitt.edu name: Cierra Clark, MS role: CONTACT email: cic27@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06300983 id: PR(AG)398/2022 briefTitle: Effectiveness of a Psychoeducational Intervention on Myositis Patients' Quality of Life and Well-Being acronym: HRQoL overallStatus: COMPLETED date: 2022-09-15 date: 2022-10-31 date: 2022-10-31 date: 2024-03-08 date: 2024-03-08 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Purpose. Myositis is a rare disease associated with impaired health-related quality of life. A study evaluating the effectiveness of an intervention to improve the quality of life and well-being of myositis patients is presented.

Materials and Methods. All myositis patients in a health district are contacted. Eligible patients are randomly assigned to the experimental or control group. A psychoeducational intervention of 5 100-min sessions focusing on the disease as related to daily life is conducted only in experimental patients. Several reliable tools to measure quality of life and well-being are administered twice, before and after the intervention, to both groups. conditions: Quality of Life conditions: Myositis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 34 type: ACTUAL name: Psychoeducative name: Placebo measure: Health related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona city: Barcelona zip: 08035 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06300970 id: 0900f3eb81e634a9 briefTitle: Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia overallStatus: COMPLETED date: 2022-08-09 date: 2023-08-16 date: 2023-08-16 date: 2024-03-08 date: 2024-03-08 name: Centers for Disease Control and Prevention class: FED name: Ministry of Health, Liberia briefSummary: To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia. conditions: Plasmodium Falciparum conditions: Malaria conditions: Uncomplicated Malaria studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 352 type: ACTUAL name: Amodiaquine-artesunate (ASAQ) name: Artemether+Lumefantrine (AL) measure: Number of Participants with Early Treatment Failure (ETF) measure: Number of Participants with Late Treatment Failure (LTF) measure: Number of Participants with Adequate Clinical and Parasitological Response (APCR) measure: Number of Patients with Adverse Events measure: Number of samples with confirmed Histidine-rich protein 2/3 (HRP2/3) gene deletions measure: Number of samples with molecular markers of anti-malarial resistance sex: ALL minimumAge: 6 Months maximumAge: 59 Months stdAges: CHILD facility: Sinje Health Center, Garwula District, Sinje, Grand Cape Mount County city: Sinje state: Grand Cape Mount County country: Liberia facility: Saclepea-Mahn Comprehensive Health Center Saclepea-Mahn District, Nimba County city: Saclepea state: Nimba County country: Liberia lat: 6.9625 lon: -8.84056 hasResults: False

 nctId: NCT06300957 id: IRB00023124 id: CE003310 type: OTHER_GRANT domain: CDC id: OMB NO: 0920-1301 type: OTHER domain: OMB briefTitle: Help Wanted: Evaluating a Prevention Intervention for People With Sexual Interest in Children overallStatus: RECRUITING date: 2023-10-24 date: 2026-05-31 date: 2026-10-31 date: 2024-03-08 date: 2024-03-08 name: Johns Hopkins Bloomberg School of Public Health class: OTHER name: Barry University name: University of Massachusetts, Lowell briefSummary: This project aims to evaluate the Help Wanted Prevention Intervention, an online program to provide people with a sexual attraction to children the skills and resources to support their commitment to keep children safe and to improve the participants well-being. In phase one, ten men with a sexual attraction to children who have never had a contact offense with a child will be asked to go through an abbreviated version of the participant procedures that will be used in study phase two (described next). Specifically, the ten participants will complete one of the online surveys, review the Help Wanted program, and participate in a 30-60 minute anonymous audio call with a member of the study team to provide feedback on the study procedures and materials (e.g., consent form, recruitment form). Feedback from phase one will inform changes to study procedures for phase two. Phase two consists of a large-scale evaluation of the Help Wanted program. Three hundred men with a sexual attraction to children who have never had a contact offense with a child or accessed the Help Wanted Program will be randomly selected to be part of one of two groups: the program group (N = 200) or the control group (N = 100). Both groups will be asked to complete an online survey before reviewing the Help Wanted Program, provide feedback on the program over a one-month period, and complete another online survey immediately after reviewing the program and three months after reviewing the program. Participants in the control group will have a one month waiting period after the first online survey, during which the participants will receive alternative resources and supports for mental health and sexual attraction to children. After the one month waiting period, participants in the control group will complete one additional online survey before reviewing the Help Wanted program and completing the two final online surveys (one immediately after reviewing the program, one three months after reviewing the program). Survey questions will ask about participants thoughts, feelings, and behaviors, including questions about the participants overall well-being and sexual attraction to children. All study materials and resources are in English. Resources provided to participants are also in English, but provide services in over 30 countries to include participants who may reside in countries outside of the United States. Participation is anonymous and all data will be kept confidential. conditions: Program Evaluation conditions: Child Sexual Abuse conditions: Perpetration of Child Sexual Abuse conditions: Prevention Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In Phase one investigators will recruit 10 participants to test out the study protocols. All 10 participants will go through the same study procedures.

In Phase two, investigators will recruit 300 participants to take part in the RCT, 200 in the HW group and 100 in the WL group. After consenting to participate and completing the first online survey, participants will be randomized to either an intervention condition (N =200) or wait-list control condition (N =100) using a 2:1 allocation. The intervention group will gain access to Help Wanted for 1 month after which the participants will complete a post-intervention survey and then a three-month follow up survey. Participants in the control group will receive alternative resources for one month, then complete a one-month post-waitlist survey before being granted access to Help Wanted for a one-month period. The control group participants will then complete a one-month post-intervention survey and three-month follow-up survey. primaryPurpose: PREVENTION masking: NONE count: 310 type: ESTIMATED name: Help Wanted Prevention Intervention name: Waitlist Control measure: Sexual Behavior Involving Minors Scale (SBIMS). measure: Sexual Child Molestation Risk Assessment (SChiMRA) score measure: Depression, Anxiety and Stress Scale-21 (DASS-21) measure: Suicidal Ideation Attributes Scale (SIDAS) measure: General Self-Efficacy Scale - Short Form (GSE-6). measure: Revised University of California, Los Angeles (UCLA) Loneliness Scale measure: Self-Efficacy Scale Related to Minors (SESM) measure: Hypersexual Behavior Inventory-19 score measure: Sexual Attraction to Children measure: Cognitions of internet sexual offending score measure: Cognitions that condone and support sexual offending against children scale - short form measure: Emotional Congruence with Children score measure: Brief Aggression Questionnaire score measure: Short Self-Regulation Questionnaire score measure: Alcohol Use Disorders Identification Test (AUDIT) score measure: Recent Alcohol & Cannabis Use score measure: Demographic characteristics as assessed by survey developed by study team measure: Number of Sexual Health Services Used measure: Sexual Offence Self-Report Risk Scale (SOSRS): measure: Minor Attraction Outness Scale measure: Revised Adverse Childhood Experiences Scale measure: Balanced Inventory of Desirable Responding - Impression Management Subscale (BIDR-Version 6-Form 40 - IMS). measure: Impact of Research Participation as assessed by survey sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Bloomberg School of Public Health status: RECRUITING city: Baltimore state: Maryland zip: 21231 country: United States name: Elizabeth J Letourneau, PhD role: CONTACT phone: 843-343-6865 email: elizabethletourneau@jhu.edu name: Amanda E Ruzicka, MA role: CONTACT phone: 7172699886 email: aruzicka@jhu.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06300944 id: Ran Gao-2023-12 briefTitle: The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery overallStatus: RECRUITING date: 2023-12-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-08 date: 2024-03-08 name: General Hospital of Ningxia Medical University class: OTHER briefSummary: The purpose of this study is to investigate whether continuous intraoperative infusion of esketamine combined with the addition of esketamine to postoperative PCIA can improve postoperative pain and sleep quality in patients undergoing laparoscopic uterine surgery under general anesthesia. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 108 type: ESTIMATED name: saline name: Esketamine measure: Moderate to severe pain measure: Incidence of adverse reactions including nausea, vomiting and dizziness measure: Sleep quality measure: Remifentanil dosage measure: Additional post-operative analgesics measure: Postoperative exhaust time of patients sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Hospital of Ningxia Medical University status: RECRUITING city: Yinchuan state: Ningxia country: China name: Ma Hanxiang role: CONTACT phone: 86-13519591508 email: mahanxiang@hotmail.com lat: 38.46806 lon: 106.27306 hasResults: False

 nctId: NCT06300931 id: KAPSDFE0948 briefTitle: KAP for Use of SDF Among Dental Interns Before vs After Educational Intervention overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-10 date: 2024-03-08 date: 2024-03-08 name: Cairo University class: OTHER briefSummary: This study is a KAP questionnaire to assess Egyptian intern dentists' knowledge, attitudes and practices regarding use of SDF before and after an educational intervention. conditions: SDF studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: OTHER count: 449 type: ESTIMATED name: educational lecture measure: Assessment of knowledge levels and attitude regarding SDF use before educational intervention measure: Assessment of knowledge levels and attitude regarding SDF use after educational intervention Correlation between demographic data and use of SDF. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300918 id: 2024-KY76 briefTitle: A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA overallStatus: RECRUITING date: 2024-03-08 date: 2025-08-01 date: 2025-08-01 date: 2024-03-08 date: 2024-03-19 name: Jie Li class: OTHER briefSummary: The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.

Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points. conditions: The Condition of Fundus Neovascularization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Time measure: The number of fundus neovascularization seen in FFA. measure: The area of fundus neovascularization seen in FFA (using PD size as measurement). measure: The intensity of neovascularization fluorescein leakage sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial status: RECRUITING city: Chendu state: Sichuan zip: 610014 country: China name: Jie Li, doctor role: CONTACT phone: +86 13908094675 email: lijieyk@med.uestc.edu.cn hasResults: False

 nctId: NCT06300905 id: CRO-2023-05-OMO-SNA-YPZ briefTitle: Clinical Study on Malodor overallStatus: COMPLETED date: 2023-06-01 date: 2023-07-02 date: 2023-07-02 date: 2024-03-08 date: 2024-03-08 name: Colgate Palmolive class: INDUSTRY briefSummary: This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use. conditions: Oral Malodor studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ACTUAL name: test product name: Control product measure: Organoleptic Oral Malodor Evaluations sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Dental Institute of Chengdu city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06300892 id: SURG-2023-31841 briefTitle: Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2025-12-01 date: 2024-03-08 date: 2024-03-08 name: University of Minnesota class: OTHER briefSummary: This is a prospective, observational study of patients undergoing open GI surgery. At the time of operation, samples will be collected from the incision site and GI tract. The study will follow patients up to 30 days postoperatively, monitoring for signs of SSI. Samples will be taken from all patients who develop SSI. Sequencing will be performed on a subset of samples based on our specific aims.

* Aim 1: conduct a case-control study of patients with SSI and age-, sex-, diagnosis-, and wound class-matched control patients without SSI, comparing microbiome alpha diversity and community composition with 16S RNA sequencing to determine the association with SSI.
* Aim 2: identify the strain of bacteria isolated from SSIs using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation. conditions: Open GI Surgery studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: No intervention measure: alpha diversity composition measure: microbial community composition measure: pathogenic strain of bacteria sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300879 id: 2023-1058 briefTitle: A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: Huashan Hospital class: OTHER briefSummary: This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).

The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22. conditions: Gastric Cancer conditions: Adenocarcinoma of Esophagogastric Junction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients included in this group will receive totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique measure: Assess intraoperative Perioperative Safety by Duration of surgery. measure: Assess intraoperative Perioperative Safety by Duration of anastomosis. measure: Assess intraoperative Perioperative Safety by blood loss . measure: Postoperative recovery course measure: Postoperative TNM staging by Pathological findings . measure: The incidence of postoperative reflux esophagitis measure: The incidence of postoperative anastomotic stenosis measure: Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30 measure: Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huashan Hospital, Fudan University status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China name: Hankun Hao, doctor role: CONTACT phone: +86 18121186328 email: haohankun@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06300866 id: CRO-2020-04-PGN-LLU-YPZ briefTitle: Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste overallStatus: COMPLETED date: 2020-08-18 date: 2021-03-08 date: 2021-03-08 date: 2024-03-08 date: 2024-03-08 name: Colgate Palmolive class: INDUSTRY briefSummary: The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use. conditions: Gingivitis conditions: Plaque, Dental studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Test name: Control measure: Whole-Mouth Gingivitis Measurement measure: Whole-Mouth Dental Plaque Measurement sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Loma Linda University School of Dentistry city: Loma Linda state: California zip: 92350 country: United States lat: 34.04835 lon: -117.26115 hasResults: False

 nctId: NCT06300853 id: 2023-07 briefTitle: Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups. acronym: COVaxFragile overallStatus: RECRUITING date: 2023-11-14 date: 2025-11 date: 2025-11 date: 2024-03-08 date: 2024-03-08 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is an experimental study without drug and device, non-profit, single-center.

The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. This study will be relevant to frail populations who are the main targets of repeated vaccinations. Our project will benefit from the availability of a highly cohort characterized of vaccinated people, including cancer patients and elderly people, with prospective collection of samples for an in-depth evaluation of the evolution of the immune response with repeated exposure to doses of infection or vaccine. As part of the study, analyzes will be carried out on samples of patients enrolled in a manner prospective at the oncology departments of the IRCCS (Medical Oncology, Department of Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing in retirement homes of the IRCCS. Patients will also be asked for consent to store any residual samples in the Tropica DITM Biobank. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 350 type: ESTIMATED name: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses measure: Cellular response evaluation: flow cytometry profiles (proportions of cells) measure: Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD) measure: Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD) measure: Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml) measure: Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml) measure: Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml). measure: Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml) measure: Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml) measure: Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml). measure: Neutralization assays against different human Coronavirus (hCoV). measure: Whole genome sequencing analysis results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Chiara Piubelli role: CONTACT phone: +390456013706 email: chiara.piubelli@sacrocuore.it name: Chiara Piubelli role: PRINCIPAL_INVESTIGATOR name: Stefania Gori role: SUB_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06300840 id: 2023_49 id: NL84562.075.23 type: OTHER domain: METC ISALA briefTitle: Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH) acronym: VIBE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-04 date: 2024-03-08 date: 2024-03-08 name: Hanna van Eijsden class: OTHER briefSummary: The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance, (fear of) falling, fatigue and overall functioning in participants with chronic disabling unilateral vestibular hypofunction.

The main questions it aims to answer are: • does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility, fear of falling, fatigue and overall functioning • does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing.

Participants will goes through different phases in an randomized order; a baseline phase, a sham phase (i.e., wearing the BalanceBelt while it is switched off) and an intervention phase (i.e., wearing the BalanceBelt while it is switched on).

It is expected that, just as with patients with bilateral loss of the balance organ, patients with a unilateral loss will also benefit from the BalanceBelt. conditions: Vestibular Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single-case-experiment (SCE) with a reversal design and with randomization of phases. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Data-analyst and test-observer are masked whoMasked: OUTCOMES_ASSESSOR count: 8 type: ESTIMATED name: BalanceBelt measure: Mobility and Balance Score (MBS) measure: General functioning measure: physical activity_NRS measure: physical activity_steps measure: Fear of falling measure: fatigue measure: falls measure: structured interview on compliance on wearing the Balancebelt(R) measure: Questionnaire: vestibular activity avoiding instrument (VAAI) measure: Questionnaire: Dizziness handicap inventory (DHI) measure: modified Clinical Test of Sensory Interaction on Balance (mCTSIB) measure: Dynamic Gait Index (DGI) measure: Timed up and Go test (TUG) measure: age measure: time since onset of the vestibular hypofunction measure: cause of vestibular hypofunction measure: Structured interview on vestibular rehabilitation measure: outcome of the vestibular function tests measure: Structured interview on participating in the research measure: Structured interview on the overall experience with the Balancebelt(R) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gelre Hospitals city: Apeldoorn state: Gelderland zip: 7334 DZ country: Netherlands lat: 52.21 lon: 5.96944 hasResults: False

 nctId: NCT06300827 id: 2023 - 1302 briefTitle: The Effect of Structured Digital-Based Education Given to Nursing Students overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-12-01 date: 2024-03-08 date: 2024-03-08 name: Gazi University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: Turkey is a risky country in terms of disasters. Preparedness and awareness for all disasters affecting the whole world gain value. Disaster literacy is an important approach to evaluating disaster preparedness and awareness processes. Disaster literacy is defined as the ability of an individual to access, read, understand, and use the information necessary to make informed decisions and follow instructions in the context of mitigation, preparation, response, and recovery during a disaster Disaster literacy needs to be increased to raise awareness among individuals and minimize disaster risk. Along with the awareness studies, it is also important to identify the disaster preparedness belief in order to encourage individuals to change potentially harmful behavior. Belief in disaster preparedness; It may vary according to the perception of experiencing a disaster, the perceived severity of the disaster, the benefits of being prepared for a disaster, the perceived barriers to being prepared for a disaster, being prepared, and the individual's belief in his or her ability to cope with a disaster. It may be useful to determine both disaster preparedness beliefs and disaster literacy levels of individuals at the social level. It is predicted that when multiple interventions are brought together in the learning process, there will be a faster and more lasting effect. In this study, which aims to use education and information technology together, a structured digital-based educational intervention is planned. The intervention program was structured by taking advantage of both the advantages of the digital world and active learning methods in order to keep the student active. The program is eight weeks and consists of seven dimensions and the purpose of the program is based on accessing information, understanding, information, making decisions, and applying information. The planned study aimed to determine the effect of structured digital-based education given to university students studying in the nursing department on their disaster literacy and disaster preparedness belief levels. conditions: 18 Years and Over studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental Group: Structured digital-based training will be implemented. Control Group: The nursing student will be expected to continue their daily life.

Nursing students who meet the inclusion criteria will be randomly assigned to the experimental group by a statistician. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Research data/output measurements are made by a research assistant not involved in the research. whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Structured digital-based training measure: Disaster Literacy Scale measure: General Disaster Preparedness Belief Scale Using the Health Belief sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University status: RECRUITING city: Ankara country: Turkey name: Aysun Erdal, Ph. D. (c) role: CONTACT phone: +905367655107 email: aysunmutlu25@gmail.com lat: 39.91987 lon: 32.85427 facility: Necmettin Erbakan University status: RECRUITING city: Konya country: Turkey name: Fatma Zehra Genç, Ph. D. role: CONTACT phone: +905063216816 email: fatmazehragnc@gmail.com lat: 37.87135 lon: 32.48464 facility: Tokat Gaziosmanpaşa University status: RECRUITING city: Tokat country: Turkey name: Suzan Yıldız, Ph. D. role: CONTACT phone: +905444794647 email: suzanmola@hotmail.com lat: 40.31389 lon: 36.55444 hasResults: False

 nctId: NCT06300814 id: ERU-HEM-EU-01 briefTitle: The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy overallStatus: RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-12-01 date: 2024-03-08 date: 2024-03-08 name: TC Erciyes University class: OTHER briefSummary: This study was planned as a randomized controlled experimental study with a pretest-posttest design to determine the effect of parental supervision and video-guided progressive relaxation exercise (PRE) and music recital on sleep, quality of life and emotional states in children with epilepsy aged 9-16 years. The main questions it aims to answer are as follows:

According to the evaluation of children with epilepsy, does the progressive relaxation exercise applied to children have an effect on sleep, quality of life and emotional states? According to the evaluation of children with epilepsy, does music recital applied to children have an effect on sleep quality of life and emotional states? The study consisted of 45 children (15 children in the progressive relaxation exercise group, 15 children in the music recital group and 15 children in the control group). Ethics committee approval, permission from the institutions and informed consent of the children were obtained for the conduct of the study. A value of p\<0.05 was considered statistically significant in data analysis. conditions: Epilepsy in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: Progressive relaxation exercise group name: Music recital group measure: The Children's Sleep Habits Questionnaire (CSHQ) measure: The Pediatric Quality of Life Inventory (PedsQL) measure: The Me and My School Questionnaire (M&MS) sex: ALL minimumAge: 9 Years maximumAge: 16 Years stdAges: CHILD facility: Erciyes University status: RECRUITING city: Kayseri country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06300801 id: 2023-48 briefTitle: Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy acronym: popf overallStatus: NO_LONGER_AVAILABLE date: 2024-03-08 date: 2024-03-08 name: Erol Olcok Corum Training and Research Hospital class: OTHER briefSummary: Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to predict pancreatic fistula using the C-reactive protein-albumin ratio (CAR). The total number of participants expected to be included in this research comprises patients who underwent PD between 2017 and 2023 and developed pancreatic fistula. The participants invitation is based on the detection of a pancreatic fistula. This study is conducted for research purposes and participation is voluntary. No interventions will be performed on the participants as part of this study; however, we have prepared this form to obtain participant permission to gather certain information. If the participants consent to the use of information for scientific purposes with the guarantee of confidentiality, they will be asked to sign a consent form. conditions: Pancreatic Fistula After Pancreaticoduodenectomy conditions: C-Reactive Protein conditions: Albumin studyType: EXPANDED_ACCESS sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300788 id: 23-AOI-02 briefTitle: Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease acronym: PPi-DIA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-08 date: 2024-03-08 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: The investigator aim to identify the role of inorganic pyrophosphate and other anti-calcifying molecules in vascular disease in children with chronic kidney disease, with a view to developing therapeutic approaches aimed at limiting the onset of vasculopathy. conditions: Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, Control studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: PPI and T50 dosing measure: Plasma pyrophosphate concentration [PPi]pl in children with CKD measure: Plasma pyrophosphate [PPi]pl concentration in children with renal transplantation measure: Markers of phosphocalcic metabolism measure: Urinary PPi concentration measure: Markers of vascular damage in CKD sex: ALL minimumAge: 0 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: CHU Nice - Hôpital de l'Archet 2 city: Nice state: Alpes-Mritimes zip: 06300 country: France name: Julie BERNARDOR role: CONTACT phone: 04.92.03.63.65 phoneExt: +33 email: bernardor.j@chu-nice.fr lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06300775 id: 123789 briefTitle: Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Posterior Cross Bite overallStatus: RECRUITING date: 2024-06-01 date: 2025-05-01 date: 2025-06-01 date: 2024-03-08 date: 2024-03-08 name: Cairo University class: OTHER briefSummary: This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition conditions: Posterior Cross Bite studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Modified Hyrax Versus Quad Helix primaryPurpose: TREATMENT masking: NONE maskingDescription: no Masking count: 10 type: ESTIMATED name: modified hyrax name: quad helix measure: Chewing difficulty sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Cairo univeristry status: RECRUITING city: Cairo country: Egypt name: ola mostafa, prof role: CONTACT phone: 01006030036 email: ola.omar@dentistry.cu.edu.eg name: rasha adel, lecture role: CONTACT phone: 01007505888 email: rasha.adel@dentistry.cu.edu.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06300762 id: C3079 briefTitle: RCT Exudate Management Cutimed Sorbion Product Range overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-08 date: 2024-03-08 name: BSN Medical GmbH class: INDUSTRY briefSummary: The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care.

As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated. conditions: Venous Leg Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Two assessors are blinded to evaluate some outcomes whoMasked: OUTCOMES_ASSESSOR count: 152 type: ESTIMATED name: Superabsorbent dressing application measure: Exudate management performance measure: Dressing change frequency measure: Moisture-associated skin damages measure: Occurrence clinical relevant peri-wound skin changes measure: Changes in wound tissue and general wound pain measure: Need for debridement after product removal measure: Patient satisfaction with treatment and product measure: HCP satisfaction with treatment and product measure: Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Niels Stensen Klinik, Christliches-Klinikum-Melle city: Melle state: Niedersachsten zip: 49624 country: Germany name: Jan Heggemann role: CONTACT name: Sabine Guth role: CONTACT lat: 52.20197 lon: 8.33826 hasResults: False

 nctId: NCT06300749 id: LE-CCM briefTitle: Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis overallStatus: COMPLETED date: 2018-10-30 date: 2019-01-03 date: 2019-01-03 date: 2024-03-08 date: 2024-03-08 name: Mesut Arslan class: OTHER briefSummary: İt is aimed to examine the effect of chiropractic cervical manipulation on pain, functionality and grip strength in patients with lateral epicondylitis and whether it is preferable to placebo. conditions: Lateral Epicondylitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ACTUAL name: Chiropractic Cervical Manipulation name: Sham Technique Practice measure: Numerical Pain Scale (NPS) measure: Grip Strength measure: Patient Rated Tennis Elbow Evaluation (PRTEE) sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Bitlis Eren University city: Bitlis zip: 13000 country: Turkey lat: 38.40115 lon: 42.10784 hasResults: False

 nctId: NCT06300736 id: 2023PI247 briefTitle: Design of a Predictive Score for Contamination of Pediatric Blood Cultures acronym: HEPIC overallStatus: ACTIVE_NOT_RECRUITING date: 2022-01-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-08 date: 2024-03-08 name: Central Hospital, Nancy, France class: OTHER briefSummary: The contamination rate for blood cultures is high in pediatrics, due to different sampling techniques and the difficulty of sampling small-weight children, thus favoring contamination of the devices at the time of sampling. It is also more difficult to distinguish contamination from true bacteremia in children at an early stage, notably due to the limited number of vials that can be taken at any one time.

On a daily basis, clinicians are faced with the choice of whether or not to initiate probabilistic antibiotic therapy when faced with the result of a positive blood culture, particularly when identification is not yet available, but only direct examination.

Contamination has major consequences for patient management. Studies in adults have shown that contamination increases hospital length of stay by 4 to 5 days, laboratory costs by +20% and recourse to intravenous antibiotic therapy by +39%. In children, studies came to the same conclusion, with greater prescription of antibiotics, particularly intravenous antibiotics, in patients with contaminated blood cultures than in patients with sterile blood cultures. It also showed that 26% of patients with contaminated blood cultures were initially hospitalized because of the positivity of this test.

The aim of this research is to determine the factors associated with contamination, in order to create a predictive score that would help clinicians in their decision-making when receiving the blood culture result as "positive". conditions: Bacteremia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED measure: Blood culture diagnosis measure: Score performance sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: CHRU Nancy city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06300723 id: 2024-BRL-101-SCD-01 briefTitle: Clinical Study of BRL-101 in Severe SCD overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-03-20 date: 2026-06-15 date: 2024-03-08 date: 2024-03-22 name: Bioray Laboratories class: INDUSTRY name: First Affiliated Hospital of Guangxi Medical University briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101). conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ESTIMATED name: BRL-101 measure: Proportion of stem cell engrafted subjects measure: Time to neutrophil engraftment measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi zip: 530021 country: China name: Yongrong Lai, phD role: CONTACT email: laiyongrong@hotmail.com lat: 22.81667 lon: 108.31667 hasResults: False

 nctId: NCT06300710 id: CPR in PICU briefTitle: Outcomes and Risk Factors of CPR in PICU overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-02-01 date: 2025-03-01 date: 2024-03-08 date: 2024-03-18 name: Assiut University class: OTHER briefSummary: 1. To detect the frequency and the underlying causes of cardiopulmonary arrest .
2. To detect outcome of CPR
3. To identify the associated risk factors for the different outcomes after CPR among those patients conditions: Cardio Respiratory Arrest studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED measure: incidence of cardiac arrest and survival to discharge from the PICU (dead versus alive) measure: Rate of risk factors associated with outcome of CPR sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06300697 id: HUM00235532 briefTitle: Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project overallStatus: RECRUITING date: 2024-02-15 date: 2027-03 date: 2027-03 date: 2024-03-08 date: 2024-04-11 name: University of Michigan class: OTHER briefSummary: This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.

This is a mechanistic study consisting of obtaining blood and skin samples from participants at baseline. Individuals may also undergo a clinically indicated oral food challenge and have blood and skin samples collected at various times during the oral food challenge. This study will create a molecular map of the pathology of atopic dermatitis and food allergy. This information will be deployed to evaluate the hypothesis that atopic dermatitis and food allergy share unique genetic transcriptional signals in which the study team can then further analyze pathological pathways and cell types. conditions: Atopic Dermatitis conditions: Food Allergy conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: Data and biospecimen collection name: Skin biopsies name: Oral Food Challenge (OFC) procedures measure: Anaphylaxis occurrence rates in each group measure: Anaphylaxis severity in each group measure: Reaction rates in each group measure: Anaphylaxis likelihood in each group based on the Brighton score sex: ALL minimumAge: 10 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Bridgette Kaul, RN role: CONTACT phone: 734-963-5634 email: bbeaupre@umich.edu name: Chase Schuler, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06300684 id: SBS-2022-0085 briefTitle: Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition overallStatus: RECRUITING date: 2022-11-11 date: 2024-12 date: 2025-01 date: 2024-03-08 date: 2024-03-12 name: American University of Beirut Medical Center class: OTHER briefSummary: This study aims to investigate the effects of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleep patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are intricately linked, with dysregulated sleep associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can affect hormonal balance and circadian rhythm. Insomnia and obesity are interrelated public health concerns, with CBTi showing efficacy in improving sleep. This study will recruit participants with insomnia and randomly assign them to receive either CBTi or basic sleep hygiene education. Baseline assessments will include validated questionnaires about insomnia, dietary habits, and physical activity and a 7-day 24-hour diet recall sheets, as well as actigraphy for sleep parameters, and physical activity assessments. The intervention will last for four weeks, with post-intervention assessments conducted similarly to baseline. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This parallel-design interventional study randomly assigns participants to receive either Cognitive Behavioral Therapy for Insomnia (CBTi) or basic sleep hygiene education over four weeks. CBTi aims to enhance sleep quality, while the control group receives sleep hygiene education. Pre- and post-intervention assessments will measure sleep parameters and dietary habits, comparing outcomes between groups. Randomization ensures unbiased assignment. Statistical analysis evaluates CBTi's effectiveness in improving sleep patterns and diet, exploring the potential indirect impact of improved sleep on diet. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be blinded to the specific type of intervention they will receive, whether it is Cognitive Behavioral Therapy for Insomnia (CBTi) or basic sleep hygiene education. whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia (CBT-i) measure: Change in Bed Time measure: Change in Get Up Time measure: Change in Time in Bed measure: Change in Sleep Onset Latency (in minutes). measure: Change in Sleep Efficiency measure: Change in Wake After Sleep Onset measure: Change in Late-Night Eating Occasions number measure: Change in Eating Window Duration and Fasting Window Duration measure: Change in Number of Meals sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lebanese American University status: ACTIVE_NOT_RECRUITING city: Jbaïl state: Keserwan-Jbeil Governorate zip: 1102-2801 country: Lebanon lat: 34.12111 lon: 35.64806 facility: American University of Beirut Medical Center status: RECRUITING city: Beirut zip: 1100 country: Lebanon name: Chadi Antoun, MD role: CONTACT phone: +961 81 524 015 email: CA116@aub.edu.lb name: Farid Talih, MD role: PRINCIPAL_INVESTIGATOR name: Chadi Antoun, MD role: SUB_INVESTIGATOR name: Ismat Annan, MSc role: SUB_INVESTIGATOR lat: 33.88894 lon: 35.49442 hasResults: False

 nctId: NCT06300671 id: PNSÖ-Subtalar pronation briefTitle: The Effect of Subtalar Joint Pronation Amount on Lower Extremity Alignment and Performance overallStatus: RECRUITING date: 2023-12-15 date: 2024-04-30 date: 2024-05-30 date: 2024-03-08 date: 2024-03-08 name: Bahçeşehir University class: OTHER briefSummary: The lower extremity consists of segments that can be affected by the relative position of each other. Deviation of one segment from its normal alignment in the lower extremity also affects the alignment of other segments. The hip joint can affect the frontal plane alignment from proximal to distal, while the foot and ankle complex can also affect it from distal to proximal. Increased subtalar joint pronation in the kinetic chain from distal to proximal; is associated with decreased dorsiflexion angle and increased frontal plane projection angle. It has been shown that ankle dorsiflexion limitation causes changes in the biomechanics and kinematics of landing after jumping, but no study examining the effect of foot pronation on jump tests has been found in the literature. Since the foot is located at the most distal point and acts as a support base for the kinematic chain, the smallest dynamic change in the foot affects the balance of the whole body. Due to foot pronation, changes in the sole contact surface may make it difficult for the foot to adapt to the ground, balance and postural stabilization may be adversely affected, and an increase in the workload of the muscles around the joint may be observed. In another study, it is mentioned that there is limited evidence about the effect of foot posture on postural stability. Although there are studies in the literature examining the effects of subtalar joint pronation on lower extremity alignment and postural stability, studies need to examine the effects of different subtalar joint pronation amounts on lower extremity alignment, jumping performance, and postural stability. Our study will contribute to the literature with this aspect. conditions: Balance Disorders conditions: Foot Injury conditions: Lower Extremity Problem studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 48 healthy individuals between the ages of 18-40 constitute the population of the study. Participants randomized into neutral, pronation, and hyperpronation groups. primaryPurpose: SCREENING masking: NONE count: 48 type: ESTIMATED name: Foot Posture Index-6 measure: Postural Stability measure: Frontal Plane Projection Angle measure: Foot and Ankle Ability Measurement measure: Navicular Drop Test measure: Weight bearing lunge test measure: Countermovement jump test without arm swing sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Bahcesehir University status: RECRUITING city: Besiktas state: Istanbul zip: 34353 country: Turkey name: Pelin Pişirici, PT, PhD role: CONTACT phone: 05055016076 email: pelinpisirici@gmail.com name: Ozlem Feyzioglu, PT, PhD role: CONTACT phone: 05353529794 email: fztozlemfeyzioglu@gmail.com hasResults: False

 nctId: NCT06300658 id: 900/2/24 briefTitle: Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery overallStatus: RECRUITING date: 2024-03-09 date: 2024-09-01 date: 2024-09-01 date: 2024-03-08 date: 2024-03-12 name: Aswan University class: OTHER briefSummary: The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery. conditions: Stellate Ganglion Block conditions: Arteriovenous Fistula conditions: Hemodialysis conditions: Major Lower Limb Orthopedic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Stellate ganglion block measure: Fistula flow rate measure: Peak systolic velocity (PSV) measure: End diastolic velocity (EDV) measure: Incidence of failure measure: Adverse effects sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81528 country: Egypt name: Ayman M Eldemrdash, MD role: CONTACT phone: 00201001296116 email: ayman.mohamady@aswu.edu.eg name: Soudy S Hammad, MD role: SUB_INVESTIGATOR name: Tarek S Hemaida, MD role: SUB_INVESTIGATOR name: Taha T Dardeer, MD role: SUB_INVESTIGATOR name: Ahmed A Mohsen, MD role: SUB_INVESTIGATOR name: Ahmed K Fathy, MD role: SUB_INVESTIGATOR name: Gamal H Shams, MD role: SUB_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False

 nctId: NCT06300645 id: SPLATTvsTATT in recurrent CTEV briefTitle: SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform acronym: Recurrent CTEV overallStatus: ENROLLING_BY_INVITATION date: 2024-01-17 date: 2025-03-01 date: 2026-03-01 date: 2024-03-08 date: 2024-03-12 name: Assiut University class: OTHER briefSummary: Congenital talipes equinovarus, is a common congenital foot deformity involving hindfoot equinus and varus, along with mid-/forefoot adduction and cavus. Currently, the Ponseti method is the preferred initial treatment for idiopathic clubfoot1

. Despite the initial phase's remarkable efficacy in correcting clubfeet, there remains a notable recurrence rate after Ponseti treatment2

* Numerous studies demonstrate a very high success rate during early follow-ups, ranging from 92% to 100%3
* Nonetheless, recurrence remains a challenge for orthopedic surgeons. A common trigger for recurrence is the dynamic supination of the foot, which results from excessive activation of the tibialis anterior muscle during ankle dorsiflexion4

Multiple studies indicate that tibialis anterior tendon transfer (TATT) is an effective tool for management of clubfoot recurrence, particularly dynamic supination5

* The widely used technique involves transferring the entire tendon through a drill hole in the lateral cuneiform and anchoring it on the plantar aspect of the foot using a sewing button and felt pad6
* While effective, this procedure raises the risk of pressure sores due to button placement on the sole7

Split anterior tibialis tendon transfer (SPLATT) to peroneus brevis is a well-described treatment strategy of varus foot deformities in patients with neuromuscular disorders8

* The technique has been reported to achieve successful deformity correction while avoiding skin problems associated with external button placement on the sole of the foot in tendon-to-bone transfers8

The present study aims to assess the outcome of utilizing SPLATT to peroneus brevis procedure in the treatment of recurrent CTEV in comparison to the original total TATT to the lateral cuneiform conditions: Recurrent Congenital Talipes Equinovarus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 25 type: ESTIMATED name: SPLATT measure: Correction of recurrent congenital talipes sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: Assiut university hospital city: Assiut zip: 71515 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06300632 id: Geriatric Locomotive Syndrome briefTitle: Geriatric Locomotive Syndrome and Related Factors in Older Adults overallStatus: RECRUITING date: 2024-04-15 date: 2024-06-01 date: 2024-07-01 date: 2024-03-08 date: 2024-04-16 name: Kırıkkale University class: OTHER briefSummary: It has been stated that the results of physical function and physical performance affecting locomotive syndrome in elderly individuals are controversial and studies are still needed. However, no studies have been found examining its relationship with the decrease in physical activity level, decline in cognitive functions, kinesiophobia (fear of movement) and fatigue seen in old age. Early detection of locomotive syndrome risk factors in elderly individuals will help prevent this condition, detect the risk of falling in elderly individuals and increase their quality of life. Based on these deficiencies, it is aimed to examine the relationship between locomotive syndrome and kinesiophobia, physical activity level, physical performance, fatigue and cognitive functions in elderly individuals. conditions: Locomotive Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 97 type: ESTIMATED name: geriatric locomotive syndrome measure: Geriatric Locomotive Function Scale measure: Two Step Test measure: Stand Up Test measure: Tampa Kinesiophobia Scale measure: Physical Activity Scale for the Elderly (PASE) measure: Short Physical Performance Battery measure: Fatigue Severity Scale measure: Montreal Cognitive Assessment Scale (MoCA) sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Ayşe Abit Kocaman status: RECRUITING city: Kırıkkale country: Turkey name: Ayşe Abit Kocaman, Asst. Prof. role: CONTACT phone: +90318-357 37 38 / 4700 email: ayseabit@gmail.com lat: 39.84528 lon: 33.50639 hasResults: False

 nctId: NCT06300619 id: 2022-066 briefTitle: Pilates+4MS: Pilates Intervention for Multiple Sclerosis acronym: P+4MS overallStatus: COMPLETED date: 2022-04-05 date: 2022-08-25 date: 2022-08-25 date: 2024-03-08 date: 2024-03-08 name: University of Colorado, Colorado Springs class: OTHER name: University of Illinois at Urbana-Champaign briefSummary: The goal of this clinical trial is to test the physical health benefits of seated Pilates in the multiple sclerosis (MS) population. The main questions it aims to answer are: 1) is it feasible to deliver a seated Pilates class for 12 weeks, twice weekly over Zoom in a group format among participants with mild, moderate, and severe multiple sclerosis? 2) what are the mobility, balance, and symptom benefits of a 12-week seated Pilates class? 3) Does incorporating hip and shoulder stabilization augment the benefits compared to a standard seated Pilates protocol? 4) Are there benefits to physical activity participation? Participants will be screened over the phone for eligibility criteria and then scheduled for in-person data collection. In person data collection will involve: 1) completing the Timed 25-Foot Walk a total of 4 times, 2) the Timed Up and Go a total of 4 times, 3) the Berg Balance Scale a total of 2 times, and 4) a set of 8 questionnaires about multiple sclerosis symptoms and impact, and physical activity behavior. Participants will receive a FitBit and then will be randomized into the Pilates only group or the Pilates+4-Quadrant stability group for the intervention. The intervention is 12 weeks long, both groups meet twice weekly on Zoom for 60 minutes with 1 of 2 instructors and other class participants (12 per group). They wear the FitBit for all 12 weeks and then return for testing to repeat testing items 1-4 above. Researchers will compare the functional outcomes between the Pilates only group and the Pilates+4-Quadrant Stability group to see if there are differences in mobility, balance and physical activity outcomes. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants know that there are 2 Pilates groups, but not which group is under investigation vs. the comparison group. whoMasked: PARTICIPANT count: 22 type: ACTUAL name: Pilates+4 name: Pilates measure: Timed 25 Foot Walk measure: Timed Up and Go measure: Berg Balance Scale measure: Triaxial Accelerometer (FitBit) Physical Activity Data (minutes of wear time in sedentary time and light, moderate and vigorous physical activity) measure: The Godin-Shepherd Leisure Time Exercise Questionnaire measure: Late-Life Function and Disability Instrument Short Form measure: Leeds Multiple Sclerosis Quality of Life Scale measure: Modified Fatigue Impact Scale measure: Multiple Sclerosis Impact Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hybl Sports Medicine and Performance Center city: Colorado Springs state: Colorado zip: 80918 country: United States lat: 38.83388 lon: -104.82136 hasResults: False

 nctId: NCT06300606 id: NOL1 and RA briefTitle: Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia acronym: NOL and LRA overallStatus: RECRUITING date: 2024-03-05 date: 2024-04-15 date: 2024-04-15 date: 2024-03-08 date: 2024-03-08 name: American Hospital of Paris class: OTHER name: Nataliya KARASHCHUK name: Briana LUI name: Thierry GUENOUN name: Stephane ROMANO briefSummary: This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb. We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. The locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Intraoperative pain is assessed using NOL index monitoring, ALGISCORE and Numerical Scale, and second point study is the midazolam and propofol requirement. conditions: Regional Anesthesia conditions: Pain conditions: Intraoperative Monitoring studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: NOL monitoring measure: pain score measure: pain score measure: sedative requirement measure: anxiolytic requirement measure: failure of regional anesthesia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gilles BOCCARA status: RECRUITING city: Neuilly-sur-Seine zip: 92200 country: France name: Gilles BOCCARA role: CONTACT phone: +33662382833 email: gilles.boccara@ahparis.org name: thierry GUENOUN role: CONTACT phone: +33146412691 email: thierry.guenoun@ahparis.org lat: 48.8846 lon: 2.26965 hasResults: False

 nctId: NCT06300593 id: 1072.6120.292.2022-1 briefTitle: Activity of Chronic Inflammation in PCOS overallStatus: RECRUITING date: 2024-01-15 date: 2024-06-01 date: 2024-06-30 date: 2024-03-08 date: 2024-03-08 name: Jagiellonian University class: OTHER briefSummary: Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes. conditions: Polycystic Ovary Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D name: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters measure: Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes measure: Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes measure: Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes measure: Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes measure: Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes measure: Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes measure: Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes measure: Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes measure: Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes measure: Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes measure: Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes measure: Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes measure: Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes measure: Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes measure: Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes measure: Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes measure: Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes measure: Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes measure: Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes measure: Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes measure: Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes measure: Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes measure: Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes measure: Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes measure: Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes measure: Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes measure: Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Jagiellonian University Medical College status: RECRUITING city: Krakow zip: 31-501 country: Poland name: Iwona Gawron, PhD, MD role: CONTACT phone: +48 124248570 email: iwona.gawron@uj.edu.pl name: Robert Jach, Prof. role: CONTACT phone: +48 124248571 email: jach@uj-cm.krakow.pl lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06300580 id: M23-991 briefTitle: Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-10-30 date: 2024-10-30 date: 2024-03-08 date: 2024-04-04 name: AbbVie class: INDUSTRY briefSummary: The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer \[11C\]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects.

ABBV-932 is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom.

Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days.

Participants will be confined for approximately 15 days. Participants will receive 3 \[11C\]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: ABBV-932 measure: Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET) measure: Number of Participants with Adverse Events (AEs) sex: ALL minimumAge: 23 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06300567 id: CFTR-RD misdiagnosis briefTitle: Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-02 date: 2026-11-02 date: 2024-03-08 date: 2024-03-12 name: Hôpital Necker-Enfants Malades class: OTHER briefSummary: Assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis conditions: CFTR-RD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: data collection measure: lung Imaging measure: lung infection measure: pancreatic function sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300554 id: 2023-1653 id: A171600 type: OTHER domain: UW Madison id: Version 1/26/2024 type: OTHER domain: UW Madison briefTitle: 10th Mountain Healthy Minds Program App Study overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-04-25 name: University of Wisconsin, Madison class: OTHER briefSummary: The purpose of the study is to evaluate the acceptability, feasibility, and preliminary effects of the Healthy Minds Program (HMP) App in approximately 150 active duty military members. conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: Healthy Minds Program App measure: System Usability Scale Score measure: Acceptability of Intervention Measure (AIM) measure: Intervention Appropriateness Measure (IAM) measure: Feasibility of Intervention Measure (FIM) measure: HMP App Usage: Did you use the Healthy Minds Program App (Yes or No) measure: HMP App Usage: Did you download the Healthy Minds Program App (Yes or No) measure: Change in Perceived Stress Score measure: Change in WHO-5 Well-Being Score measure: Change in PROMIS Depression Score measure: Change in PROMIS Anxiety Score measure: Change in Meaning of Life Questionnaire - Presence Subscale Score measure: Change in NIH Toolbox Loneliness Score measure: Change in Suicide Cognitions Scale Score measure: HMP App Usage: How many times did you use the HMP App measure: HMP App Usage: Reasons for not downloading the HMP App measure: HMP App Usage: Reasons for not opening the HMP App sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06300541 id: 940730 briefTitle: Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease overallStatus: RECRUITING date: 2021-04-01 date: 2027-05-01 date: 2027-12-01 date: 2024-03-08 date: 2024-03-08 name: Sahlgrenska University Hospital, Sweden class: OTHER name: Ersta Hospital, Sweden briefSummary: Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality.

The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course.

The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function. conditions: Inflammatory Bowel Diseases conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Colectomy measure: Number of participants with increase in muscle mass as assessed by DEXA scan. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sahlgrenska University Hospital status: RECRUITING city: Gothenburg zip: 41345 country: Sweden name: Jonas Varkey, MD, PhD role: CONTACT phone: 0046764030388 email: jonas.varkey@vgregion.se lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06300528 id: OSU-23423 id: NCI-2024-01530 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Pemigatinib for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma or Marginal Zone Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Narendranath Epperla class: OTHER briefSummary: This phase II trial tests how well pemigatinib works in treating patients with mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Pemigatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. conditions: Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue conditions: Recurrent Mantle Cell Lymphoma conditions: Recurrent Marginal Zone Lymphoma conditions: Recurrent Nodal Marginal Zone Lymphoma conditions: Recurrent Splenic Marginal Zone Lymphoma conditions: Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue conditions: Refractory Mantle Cell Lymphoma conditions: Refractory Marginal Zone Lymphoma conditions: Refractory Nodal Marginal Zone Lymphoma conditions: Refractory Splenic Marginal Zone Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Computed Tomography name: Pemigatinib name: Positron Emission Tomography measure: Overall response rate (ORR) measure: Complete response (CR) rate 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: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Narendranath Epperla, MD, MS role: CONTACT phone: 614-393-3196 name: Narendranath Epperla, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06300515 id: PI23/00396 briefTitle: Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation acronym: HENKO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-30 date: 2026-12-31 date: 2024-03-08 date: 2024-03-08 name: Alejandro Lucia class: OTHER name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain name: Hospital General Universitario Gregorio Marañon name: Hospital Universitario La Paz name: Hospital Universitario 12 de Octubre briefSummary: Thanks to medical advances, survival rates \>5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on physical-functional, behavioral, psycho-cognitive and clinical outcomes, and blood biomarkers. The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the feasibility of implementing the proposed intervention in a real clinical situation in 3 different pediatric HSCT units. conditions: Hematopoietic System--Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The staff in charge of outcome assessment will be blinded to the group assigned to each participant. whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Control Group (Active Comparator) name: Intervention Group measure: Change in objectively-assessed cardiorespiratory fitness (CRF) from baseline to follow-up measure: Change in estimated cardiorespiratory fitness (CRF) from baseline to follow-up measure: Change in isometric leg muscle strength from baseline to follow-up measure: Change in dynamic lower-limb muscle strength from baseline to follow-up measure: Change in upper-limb muscle strength from baseline to follow-up measure: Change in respiratory muscle strength from baseline to follow-up measure: Change in the 'ventilatory threshold' (VT) from baseline to follow-up measure: Change in left ventricle (LV) ejection fraction from baseline to follow-up measure: Change in left ventricle (LV) fractional shortening from baseline to follow-up measure: Change in left ventricle (LV) global longitudinal strain (GLS) from baseline to follow-up measure: Change in total cardiac mass from baseline to follow-up measure: Change in functional mobility (stairs test) from baseline to follow-uo measure: Change in functional mobility (chair rising) from baseline to follow-up measure: Change in functional mobility (Quick Function test) from baseline to follow-up measure: Change in body mass index (BMI) from baseline to follow-up measure: Change in adiposity index from baseline to follow-up measure: Change in dual-energy X-ray absorptiometry (DXA) measures of total lean mass from baseline to follow-up measure: Change in dual-energy X-ray absorptiometry (DXA) measures of total fat mass from baseline to follow-up measure: Change in dual-energy X-ray absorptiometry (DXA) measures of bone health from baseline to follow-up measure: Change in physical activity (PA) from baseline to end of treatment measure: Change in ankle-dorsiflexion from baseline to end of treatment measure: Change in psychological status (health-related quality of life) from baseline to follow-up measure: Change in psychological status (fatigue) from baseline to follow-up measure: Change in lymphocyte subpopulations from baseline to follow-up measure: Change in immune phenotype from baseline to follow-up measure: Change in survival from baseline to follow-up measure: Change in treatment tolerability from baseline to follow-up measure: Change in treatment toxicities from baseline to follow-up measure: Change in the 'acute' molecular response to a single exercise session from baseline to 8 weeks after hospital discharge measure: Change in the 'chronic' (resting conditions) transcriptome from baseline to 8 weeks after hospital discharge measure: Change in the 'acute' transcriptome response to a single exercise session from baseline to 8 weeks after hospital discharge measure: Change in the 'acute' transcriptome response from baseline to 8 weeks after hospital discharge sex: ALL minimumAge: 4 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Hospital 12 de Octubre city: Madrid zip: 28041 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06300502 id: 2023P003620 briefTitle: Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: Massachusetts General Hospital class: OTHER name: Johns Hopkins University briefSummary: This study will evaluate the tolerability and effectiveness of four FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and Kybella and Polidocanol injections. Each patient will have a treatment and a control site.

This study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. If there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. Three treatment visits with the crossover treatment will then take place. conditions: Neurofibromas, Cutaneous conditions: Neurofibromatosis 1 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Kybella name: Asclera name: 755nm Alexandrite Laser name: 1064nm Nd:YAG Laser measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Numeric Rating Scale (NRS-11)/Patient Satisfaction measure: Skindex 16 measure: Patient Reported Outcomes measure: Clinician Reported Outcomes measure: Rate of healing measure: cNF appearance (volume) measure: cNF appearance (height) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wellman Center for Photomedicine city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06300489 id: CARTOnG-2401 briefTitle: Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer overallStatus: RECRUITING date: 2024-03-03 date: 2025-01-31 date: 2025-10-31 date: 2024-03-08 date: 2024-03-08 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This study is a multicenter, open, and phase I dose increasing clinical study. Based on the UGT1A1 \* 28 and \* 6 genotypes of patients with locally advanced rectal cancer, determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase II clinical study，and explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the same time，Preliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy. conditions: Rectal Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: irinotecan liposomes+capecitabine measure: DLT（dose-limiting toxicity） measure: MTD（maximum tolerable dose） sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Ji Zhu role: CONTACT phone: 0571-88128152 email: leo.zhu@126.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06300476 id: 2023-1511 briefTitle: Safety and Efficacy of a Single Subretinal Injection of JWK006 Gene Therapy in Subjects With Stargardt Disease(STGD1) overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-20 date: 2026-12-30 date: 2029-12-30 date: 2024-03-08 date: 2024-03-08 name: West China Hospital class: OTHER briefSummary: The purpose of the study is to assess the safety and efficacy of JWK006 in Stargardt Disease(STGD1).

JWK006 is packed by adeno-associated virus vector that expressing ABCA4 gene. conditions: Stargardt Disease 1 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 9 type: ESTIMATED name: JWK006 measure: Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events) measure: Visual acuity measure: Ophthalmoscope Measurement measure: Qualitative and quantitative assessments of autofluorescence pattern (FAF) measure: multifocal electroretinogram (mfERG) sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: West China Hospital city: Chengdu state: Sichuan zip: 610044 country: China lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06300463 id: 23-06026214 briefTitle: Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases overallStatus: RECRUITING date: 2024-03-26 date: 2025-09 date: 2027-03 date: 2024-03-08 date: 2024-04-12 name: Weill Medical College of Cornell University class: OTHER name: Agenus Inc. briefSummary: The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:

* whether these combinations of immunotherapy change the tumor microenvironment in the liver
* whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases

Participants will be randomly assigned to one of the following:

* Botensilimab and balstilimab
* Botensilimab, balstilimab, and AGEN1423
* Botensilimab, balstilimab, and radiation

Participants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years. conditions: Colorectal Cancer Metastatic conditions: Liver Metastases conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Botensilimab name: Balstilimab name: AGEN1423 name: Radiation measure: Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm measure: Number of Treatment-Related Adverse Events (TRAEs) as assessed by CTCAE v5.0 per treatment arm measure: Pathological Response Rate Per Arm measure: Radiographic Response Rate Per Arm measure: Number of Participants Per Arm with ctDNA Clearance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine/NewYork-Presbyterian Hospital status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Casey Owens role: CONTACT phone: 646-962-8189 email: cdo4001@med.cornell.edu name: Myriam Elizaire-Williams role: CONTACT email: mye4001@med.cornell.edu lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06300450 id: 2022P002171 briefTitle: Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy acronym: PAD-ALERT overallStatus: RECRUITING date: 2023-03-01 date: 2025-02-28 date: 2025-07-30 date: 2024-03-08 date: 2024-03-08 name: Brigham and Women's Hospital class: OTHER name: Esperion Therapeutics, Inc. briefSummary: This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy. conditions: Peripheral Artery Disease conditions: Peripheral Vascular Diseases conditions: Dyslipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this patient- and provider-facing alert-based CDS (EPIC BPA) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants, investigators and outcomes assessors will be blinded to the assignment of the clinician to the computer alert or control (non-alert) group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Computer Alert measure: Frequency of prescription of oral LDL-C-lowering therapy measure: Change in LDL-C level measure: Frequency of all-cause mortality measure: Frequency of major adverse cardiovascular events measure: Frequency of major adverse limb events measure: Frequency of all-cause hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Gregory Piazza, MD, MS role: CONTACT phone: 617-732-6984 email: gpiazza@bwh.harvard.edu role: CONTACT phoneExt: Piazza email: gpiazza@bwh.harvard.edu name: Gregory Piazza, MD, MS role: PRINCIPAL_INVESTIGATOR name: Samuel Goldhaber, MD role: SUB_INVESTIGATOR name: Ron Blankstein, MD role: SUB_INVESTIGATOR name: Jorge Plutzky, MD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06300437 id: MS-372-2023 briefTitle: The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program overallStatus: RECRUITING date: 2024-03-03 date: 2024-08-01 date: 2024-08-01 date: 2024-03-08 date: 2024-03-12 name: Kasr El Aini Hospital class: OTHER briefSummary: In this study, the authors aim to investigate the effect of adding jaw thrust maneuver on time to successful orotracheal fiberoptic intubation of pediatrics during resident training program. conditions: Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this study, children undergoing elective surgery under general anesthesia will be randomized into 2 groups.

* Group (J): will include the children who will receive jaw thrusting during fiberoptic intubation.
* Group (C): will include the children who will not receive jaw thrusting (just sub laxed open mouth) primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: jaw thrust name: control (sub laxed jaw) measure: time to successful endotracheal tube insertion measure: Number of attempts to successful intubation measure: Complication sex: ALL minimumAge: 1 Year maximumAge: 15 Years stdAges: CHILD facility: Cairo university hospitals status: RECRUITING city: Cairo country: Egypt name: Khaled Sarhan role: CONTACT phone: +201020067816 email: khaled.sarhan@kasralainy.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06300424 id: KY2024-162 briefTitle: Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC acronym: NEOVADE overallStatus: RECRUITING date: 2024-04 date: 2026-03 date: 2027-09 date: 2024-03-08 date: 2024-04-17 name: Guangdong Provincial People's Hospital class: OTHER briefSummary: Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions. conditions: Non Small Cell Lung Cancer conditions: EGFR Gene Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: almonertinib name: Carboplatin name: Nab paclitaxel measure: Major Pathological Response (MPR) measure: Pathological Complete Response (pCR) measure: Objective Response Rate (ORR) measure: Overall Survival (OS) measure: Event Free Survival (EFS) measure: Incidence of Adverse Events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences status: RECRUITING city: Guangzhou state: Guangdong zip: 510080 country: China name: Wen-zhao Zhong, PhD role: CONTACT phone: +86 20 83827812 phoneExt: 51221 email: syzhongwenzhao@scut.edu.cn name: Jun-Tao Lin, PhD role: CONTACT email: 237801160@qq.com name: Wen-zhao Zhong, PhD role: PRINCIPAL_INVESTIGATOR name: Jun-Tao Lin, PhD role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06300411 id: SRG-514-01 briefTitle: SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-09 date: 2024-03-08 date: 2024-03-08 name: SURGE Therapeutics class: INDUSTRY briefSummary: This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 18 type: ESTIMATED name: SRG-514 measure: Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Pharmacokinetics of SRG-514 measure: Pharmacokinetics of SRG-514 measure: Pharmacodynamics of SRG-514 measure: Wound healing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300398 id: ECS_IAMA23_0101 briefTitle: IAMA-6 Oral Dose Study in Healthy Adults overallStatus: RECRUITING date: 2024-01-08 date: 2024-09 date: 2024-09 date: 2024-03-08 date: 2024-03-12 name: Iama Therapeutics S.r.l. class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults. conditions: Neurodevelopmental Disorders studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: IAMA-6 name: Placebo measure: Number of participants with adverse events (AEs) measure: Number of participants with serious adverse events (SAEs) measure: Number of participants with physical examination abnormalities measure: Number of participants with vital sign abnormalities measure: Number of participants with electrocardiogram (ECG) abnormalities measure: Number of participants with clinical laboratory abnormalities measure: Number of participants with hearing abnormalities measure: Cmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses measure: Tmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses measure: T1/2 pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses measure: AUC(0-t) and AUCτ pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses measure: Vd pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses measure: CL pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses measure: λz pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses measure: Urine volume measure: Na+ excretion measure: K+ excretion measure: Sleep assessment sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Centro Ricerche Cliniche Di Verona S.r.l. status: RECRUITING city: Verona country: Italy name: Stefano Milleri, MD role: CONTACT phone: +39 0458126618 email: stefano.milleri@crc.vr.it lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06300385 id: IstanbulBUFC5 briefTitle: Effect of EMS and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-08 date: 2024-04-04 name: Istanbul Bilgi University class: OTHER briefSummary: Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Physiotherapy often employs strength exercises, including electromyostimulation. However, there's little research on their effectiveness for motocross athletes. This study aims to compare electromyostimulation combined with strength training versus strength training alone in relieving pain, fatigue, and improving strength in motocross athletes. conditions: Sports Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 parallel groups randomized controlled study primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Electromyostimulation name: Strengthening exercises measure: Visual analog scale measure: Strength measurement measure: Fatigue assessment measure: Grip strength assessment sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Istanbul Bilgi University status: RECRUITING city: Istanbul zip: 34440 country: Turkey name: Hulya Sisli, PhD role: CONTACT phone: 2123115303 phoneExt: +90 email: hulya.sisli@bilgi.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06300372 id: Medipol Hospital 2 briefTitle: Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors overallStatus: RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-08-01 date: 2024-03-08 date: 2024-04-02 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery. conditions: Liver Failure conditions: Acute Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Fifty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II, scheduled for living liver donation surgery for liver transplantation will be included in the study. Patients will be randomly divided into two groups (Group A=M-TAPA block group, Group B = control group) including 25 patients each, before entering the operating room. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Outcomes assessor and participants will be blinded to the study whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: M-TAPA plane block name: Postoperative pain management measure: Opioid consumption (Fentanyl PCA) measure: Pain scores (Numerical rating scale-NRS measure: Need for rescue analgesia (meperidine) measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University Mega Hospital Complex status: RECRUITING city: Istanbul state: Bagcilar country: Turkey name: Ayse Ince, Assist Prof, MD role: CONTACT phone: +905366774988 email: drayseince@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06300359 id: Prognostic indicators of GBS briefTitle: Prognostic Indicators of Gullian-Barre Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-06 date: 2024-03-08 date: 2024-03-15 name: Assiut University class: OTHER briefSummary: Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments. conditions: Guillain-Barre Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Prognostic indicators of Gullian-Barre syndrome sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06300346 id: Soh-Med-23-12-02MS briefTitle: Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-18 date: 2024-08-18 date: 2024-03-08 date: 2024-03-08 name: Sohag University class: OTHER briefSummary: Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.

Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia conditions: Emetic Attacks During Caesarean Delivery With Spinal Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Propofol measure: Incidence of nausea and vomiting with spinal anesthesia measure: Measurement of hemodynamics postoperative sex: FEMALE minimumAge: 21 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06300333 id: Ectopic tubal pregnancy briefTitle: Treatment of Ectopic Pregnancy by Low Dose of Methotrexate overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-08 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy conditions: Ectopic Pregnancy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Methotrexate measure: descriptive measurements of the results of using low dose methotrexate regimen in treatment of tubal undisturbed ectopic pregnancy sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06300320 id: TQ05105-II-06 briefTitle: A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2026-04 date: 2024-03-08 date: 2024-03-08 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease conditions: Chronic Graft Versus Host Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: TQ05105 tablets measure: Objective response rate (ORR) at 24 weeks measure: Best objective response rate (BOR) measure: Duration of response (DOR) measure: Failure-free survival (FFS) measure: Incidence rate of malignancy relapse or recurrence measure: Non relapse mortality measure: Overall Survival (OS) measure: Adverse event rate measure: Severity of adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital city: Hefei state: Anhui zip: 230001 country: China name: Lianxin Liu, PhD role: CONTACT phone: 15255456091 email: xiaoyuz@ustc.edu.cn lat: 31.86389 lon: 117.28083 facility: The 940th hospital of joint logistics support force of Chinese people's liberation army city: Lanzhou state: Gansu zip: 730050 country: China name: Tao Wu, PhD role: CONTACT phone: 13919939297 email: wutaozhen@yeah.net lat: 36.05701 lon: 103.83987 facility: Guangzhou First People's Hospital city: Guangzhou state: Guangdong zip: 510180 country: China name: Shunqing Wang, PhD role: CONTACT phone: 13437801998 email: drwangshq@medmail.com.cn lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi zip: 530021 country: China name: Zhongming Zhang, Master role: CONTACT phone: 15807801369 email: zzmmissyou@126.com lat: 22.81667 lon: 108.31667 facility: The Second Hospital of Hebei Medical University city: Shijiazhuang state: Hebei zip: 050000 country: China name: Xuejun Zhang, PhD role: CONTACT phone: 13722781112 email: zhxjhbmu@126.com lat: 38.04139 lon: 114.47861 facility: Xiangyang Central Hospital city: Xiangyang state: Hubei zip: 441021 country: China name: Guolin Yuan, PhD role: CONTACT phone: 18696231603 email: yuanguo1973@163.com lat: 32.0422 lon: 112.14479 facility: Tai'an Central Hospital city: Taian state: Shangdong country: China name: Guanchen Bai, Bachelor role: CONTACT phone: 18653819776 email: bgcbgc1@163.com lat: 36.18528 lon: 117.12 facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai zip: 200025 country: China name: Xiaoxia Hu, PhD role: CONTACT phone: 13795437259 email: hu_xiaoxia@126.com lat: 31.22222 lon: 121.45806 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xian state: Shannxi zip: 710299 country: China name: Aili He, PhD role: CONTACT phone: 13891939962 email: heaili@xiju.edu.cn lat: 34.25833 lon: 108.92861 facility: Hematology Hospital of the Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Er lie Jiang, PhD role: CONTACT phone: 022-23909180 email: jiangerlie@ihcams.ac.cn lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310000 country: China name: He Huang, PhD role: CONTACT phone: 13605714822 email: hehuangyu@126.com lat: 30.29365 lon: 120.16142 facility: The Affiliated People's Hospital of Ningbo University city: Ningbo state: Zhejiang zip: 315040 country: China name: Ying Lu, Master role: CONTACT phone: 13486090834 email: rmluying@nbu.edu.cn lat: 29.87819 lon: 121.54945 hasResults: False

 nctId: NCT06300307 id: CT-ATX-01-DM1-1.1 briefTitle: Study of ATX-01 in Participants With DM1 acronym: ArthemiR overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: ARTHEx Biotech S.L. class: INDUSTRY briefSummary: The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo.

There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo.

ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b. conditions: Myotonic Dystrophy 1 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: ATX-01 name: Placebo measure: Incidence of adverse events measure: Incidence of clinically significant changes in laboratory assessments, electrocardiograms (ECGs), vital signs, suicidal ideation and behavior measure: Maximum observed plasma concentration (Cmax) of ATX-01 measure: Area under the plasma concentration-time curve (AUC) of ATX-01 measure: Video hand opening time measure: Change from baseline in ankle dorsiflexion strength by quantitative myometry measure: Change from baseline in Impact on Activities of Daily Living questionnaire item scores sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False

 nctId: NCT06300294 id: AIBU-SBF-AYN-3 briefTitle: Acute Coronary Syndrome and Acupressure overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-15 date: 2025-01-31 date: 2024-03-08 date: 2024-03-28 name: Abant Izzet Baysal University class: OTHER briefSummary: This study aims to examine the effect of acupressure on physiological parameters and anxiety levels in individuals diagnosed with Acute Coronary Syndrome (ACS).

H1-1: Acupressure applied to individuals diagnosed with ACS has an effect on the level of anxiety.

H1-2: Acupressure applied to individuals diagnosed with ACS has an effect on blood pressure.

H1-3: Acupressure applied to individuals diagnosed with ACS has an effect on heart rate.

H1-4: Acupressure applied to individuals diagnosed with ACS has an effect on respiratory rate.

H1-5: Acupressure applied to individuals diagnosed with ACS has an effect on the pain level.

H1-6: Acupressure applied to individuals diagnosed with ACS has an effect on cortisol levels. conditions: Acute Coronary Syndrome conditions: Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: experimental and control primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Since block randomization will be used in the study, the research director and the individuals who meet the study inclusion criteria will not know which group they will be in during the preliminary evaluation process of the study. However, the person analyzing the data will not know which group the data belongs to. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 38 type: ESTIMATED name: acupressure measure: means of blood pressure measure: means of hear rate measure: means of respiratory rate measure: means of cortisol. measure: means of subjective anxiety scores. measure: means of subjective pain scores. measure: electrocardiography evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300281 id: NEAEGeriatircs briefTitle: Comparison of Neuromuscular and Aquatic Exercise Programs on Fall Risk and Physical Function in Geriatrics acronym: NE-AEinGR overallStatus: NOT_YET_RECRUITING date: 2024-05-04 date: 2024-06-15 date: 2024-10-30 date: 2024-03-08 date: 2024-03-08 name: Alanya Alaaddin Keykubat University class: OTHER name: Pamukkale University briefSummary: Objective: The aim of this study is to compare neuromuscular and aquatic Exercise programs on fall risk and physical function in geriatrics.

Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (NE Group) and Group 2 (AE Group) (Randomizer.org). NE (Neuromuscular Exercise) group will participate in a 12-week exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization, balance training, muscle strength, breathing, and functional movement patterns.AE (Aqıuatic Exercise) Group will participate in an aquatic exercise program, which includes warm-up, mobility and strength, stretching, and cooling exercises in a 140 cm deep pool with a water temperature of 32 °. Data will be collected using the International Physical Activity Survey Short Form (IPAQ-SF), Montreal Cognitive Assessment Scale (MoCA), Geriatric Pain Measure, Optojump-next (Microgate, Bolzano, Italy), 6-minute Walk Test, 30-second-Sit-to-Stand Test, Four Step Square Test, Berg Balance Scale, Fear of Falling Avoidance Behavior Questionnaire.

Practice Implications: This current study will contribute to the understanding of how neuromuscular exercises affect falls and physical function in geriatrics. conditions: Geriatrics conditions: Exercise Therapy conditions: Fall conditions: Physical Functional Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be divided into two parallel groups: The neuromuscular exercise group and the Aquatic exercise group. Both groups will participate in exercise programs for 12 weeks. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 36 type: ESTIMATED name: Neuromuscular Exercise name: Aquatic Exercise measure: Change in Pain measure: Change in walking and reaction time measure: Change in aerobic capacity measure: Change in muscular fitness measure: Change in s balance measure: Change in dynamic balance measure: Change in fear of falling measure: Physical activity level measure: Level of cognition sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300268 id: CSPL/PL/2023/004 briefTitle: Advapro Coronary Stent System in Coronary Artery Diseased Patients. acronym: RESTORE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-12 date: 2024-03-08 date: 2024-03-08 name: Advanced MedTech Solutions Pvt. Ltd. class: OTHER briefSummary: A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population.

To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.

Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit.

A QCA Analysis will be performed on minimum 48 patients in Indian population only.

Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14. conditions: Coronary Artery Disease conditions: De Novo Stenosis Lesion conditions: Coronary Stent Implantation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot Study (Open Label) primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: AdvaPro Sirolimus Eluting Coronary Stent System measure: Composite Endpoint measure: Incidence of DOCE measure: Incidence of POCE measure: Incidence of MACE measure: Target vessel failure (TVF) measure: Non-Target Vessel related Myocardial Infarction measure: Stent thrombosis measure: Device success measure: Procedural Success measure: Acute Device Success measure: For QCA Group measure: For QCA Group measure: For QCA Group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300255 id: IRB 00166616 briefTitle: Evaluation of the H.O.O.V.E.S. Healing Intensives Program overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2029-02-01 date: 2029-02-01 date: 2024-03-08 date: 2024-03-08 name: VA Salt Lake City Health Care System class: FED briefSummary: The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention. conditions: Anxiety conditions: PTSD conditions: Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: H.O.O.V.E.S. Healing Intensives measure: Mean Difference in AAQII pre- to post-session and pre- to post-intervention measure: Mean Difference in PANAS pre- to post-session and pre- to post-intervention measure: Mean Difference in STAI pre- to post-session and pre- to post-intervention measure: Mean Difference in PCL pre- to post-session and pre- to post-intervention measure: Mean Difference in BDI pre- to post-session and pre- to post-intervention measure: Mean Difference in PTGI pre- to post-session and pre- to post-intervention measure: Mean Difference in B-SCS pre- to post-session and pre- to post-intervention measure: Mean Difference in AAQII pre- to post-session measure: Mean Difference in PANAS pre- to post-session measure: Mean Difference in STAI pre- to post-session sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: George E. Wahlen Department of Veterans Affairs Medical Center city: Salt Lake City state: Utah zip: 84148 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06300242 id: UP-23-00859 briefTitle: Incentives for Influenza Vaccination overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-17 date: 2024-01-24 date: 2024-02-29 date: 2024-03-08 date: 2024-03-08 name: University of Southern California class: OTHER name: J-PAL North America briefSummary: In this work, we are assessing the impact of messaging with or without a $50 financial incentive on influenza vaccination rates in a county health system. Our main hypothesis is that a message with a $50 financial incentive will increase vaccination rates relative to a control/"treatment as usual" group. We further hypothesize that the financial incentive will increase vaccination rates relative to the message only arm. conditions: Influenza Vaccination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 66000 type: ESTIMATED name: Reminders name: Financial Incentive name: Placebo measure: Vaccination status at 1 week measure: Vaccination status at 2 weeks measure: Vaccination status at 1 month sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Contra Costa Health Services city: Martinez state: California zip: 94553 country: United States lat: 38.01937 lon: -122.13413 hasResults: False

 nctId: NCT06300229 id: 2023-508325-27-00 briefTitle: NAPO - Novel Approach for Oligospermia acronym: NAPO overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2025-12 date: 2024-03-08 date: 2024-03-13 name: Martin Blomberg Jensen class: OTHER briefSummary: This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL). conditions: Infertility, Male 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: 42 type: ESTIMATED name: Denosumab name: sodium chloride measure: The difference in sperm concentration (million pr. mL) on day 80 measure: The difference in semen quality (total sperm count, motile sperm, progressive motile sperm and morphologically normal sperm) between baseline and two semen samples delivered at day 80 and day 83 after inclusion measure: The change/differences in number of pregnancies achieved before day 180 measure: The difference in the number of miscarriages throughout the trial before day 180 measure: The change/difference in serum levels of follicle stimulating hormone (FSH) on day 80 measure: The change/difference in serum levels of reproductive hormone luteinizing hormone (LH) on day 80 measure: The change/difference in serum levels of reproductive hormone AMH on day 80 measure: The change/difference in serum levels of reproductive hormone Inhibin B on day 80 measure: The change/difference in CatSper expression on day 80 measure: The change/difference in RANKL expression on day 80 sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine city: Copenhagen country: Denmark name: Sam Kafai Yahyavi, MD role: CONTACT phone: +45 35456360 email: sam.kafai.yahyavi.01@regionh.dk name: Mads Joon Jorsal, MD role: CONTACT phone: +45 38683868 email: mads.joon.jorsal@regionh.dk name: Sam Kafai Yahyavi, MD role: PRINCIPAL_INVESTIGATOR name: Mads Joon Jorsal, MD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06300216 id: KYLL-202401-034-1 briefTitle: A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2027-11-26 date: 2028-05-26 date: 2024-03-08 date: 2024-03-08 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The aim of this multicenter, open-label, observational study is to evaluate the safety and efficacy of octreotide microspheres in the treatment of advanced neuroendocrine tumors in real clinical practice, especially to evaluate the treatment of octreotide microspheres in various subgroups of neuroendocrine tumor patients. conditions: Neuroendocrine Tumors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Octreotide microspheres measure: Treatment Emergent Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital of Shandong University city: Jinan state: Shandong zip: 250012 country: China name: Jian Wang, Dr. role: CONTACT phone: 8618560088226 email: wang.jian@sdu.edu.cn lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06300203 id: CM310_IIS_SAR07 briefTitle: Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis acronym: MEGREZ overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2025-05-30 date: 2024-03-08 date: 2024-03-08 name: Beijing Tongren Hospital class: OTHER briefSummary: Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease. conditions: Seasonal Allergic Rhinitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Interleukin-4 receptor responders name: Placebo measure: Average change from baseline in daily retrospective total nasal symptom score (rTNSS) at week 2. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tongren Hospital, Capital Medical University city: Beijing state: Beijing zip: 100000 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06300190 id: Treatment SLAP type IV lesion briefTitle: Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-07 date: 2024-03-08 date: 2024-03-12 name: Assiut University class: OTHER briefSummary: Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV conditions: SLAP Lesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 parallel groups selected by Randomisation primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Aim of this study is comparing outcome results of Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Biceps tenodesis alone name: Biceps tenodesis and labrum repair measure: Clinical outcome by American shoulder elbow score sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06300177 id: D1553-III-01 briefTitle: D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure overallStatus: RECRUITING date: 2024-03-28 date: 2026-10 date: 2027-12 date: 2024-03-08 date: 2024-04-26 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 522 type: ESTIMATED name: D-1553 Tablet name: Docetaxel injection measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective mitigation rate (ORR) measure: Duration of Response (DOR) measure: Disease control rate (DCR) measure: Time to response (TTR) measure: Patient-reported outcome (PRO) measure: Abnormal laboratory test indicators measure: Adverse event rate measure: Time to Maximum Plasma Concentration (Tmax) measure: Half life (t1/2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Province Hospital status: NOT_YET_RECRUITING city: Hefei state: Anhui zip: 230002 country: China name: Minghong Bao, Master role: CONTACT phone: 15255187155 email: baomh2015@163.com lat: 31.86389 lon: 117.28083 facility: Cancer Hospital Chinese Academy of Medical Sciences status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Yan Wang, Doctor role: CONTACT phone: 13911793771 email: wangyanyifu@163.com lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital Capital Medical University status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Yi Zhang, Doctor role: CONTACT phone: 13141370703 email: steven9130@sina.com lat: 39.9075 lon: 116.39723 facility: Beijing Cancer Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100142 country: China name: Jian Fang, Bachelor role: CONTACT phone: 13701224460 email: fangjian5555@yeah.net lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Baoshan Cao, Doctor role: CONTACT phone: 13641093518 email: caobaoshan0711@aliyun.com lat: 39.9075 lon: 116.39723 facility: Beijing Chest Hospital,Capital Medical University status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 101149 country: China name: Tongmei Zhang, Doctor role: CONTACT phone: 13683016715 email: tongmeibj@163.com lat: 39.9075 lon: 116.39723 facility: The Fifth medical center of Chinese PLA General Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 222002 country: China name: Junxun Ma, Doctor role: CONTACT phone: 13699262799 email: majunxun74@126.com lat: 39.9075 lon: 116.39723 facility: The Second Affiliated Hospital of Chongqing Medical University status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Zhenzhou Yang, Doctor role: CONTACT phone: 13883270881 email: yangzz1970@163.com lat: 29.56278 lon: 106.55278 facility: Chongqing Cancer Hospital status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400032 country: China name: Jianlin Long, Doctor role: CONTACT phone: 17830326836 email: ga.longjianlin@163.com lat: 29.56278 lon: 106.55278 facility: The Southwest hospital of AMU status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400038 country: China name: Jianjun Li, Doctor role: CONTACT phone: 13608319428 email: leejjun2007@163.com lat: 29.56278 lon: 106.55278 facility: Army Medical Center status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400042 country: China name: Mengxia Li, Doctor role: CONTACT phone: 18580408265 email: 707849603@qq.com lat: 29.56278 lon: 106.55278 facility: Chongqing University Three Gorges Hospital status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 404100 country: China name: Wei Wang, Master role: CONTACT phone: 13635324483 email: 19574605@qq.com lat: 29.56278 lon: 106.55278 facility: Fujian Medical University Union Hospital status: NOT_YET_RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Peifeng Hou, Doctor role: CONTACT phone: 13799987620 email: 717217167@qq.com lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital Of Fujian Medical University status: NOT_YET_RECRUITING city: Fuzhou state: Fujian zip: 350005 country: China name: Rixiong Wang, Doctor role: CONTACT phone: 13960758357 email: 13960758357@163.com lat: 26.06139 lon: 119.30611 facility: Fujian Cancer Hospital status: NOT_YET_RECRUITING city: Fuzhou state: Fujian zip: 350500 country: China name: Jing Zhang, Master role: CONTACT phone: 13809557405 email: cfcy813@sina.com lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital of Xiamen University status: NOT_YET_RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Feng Ye, Doctor role: CONTACT phone: 13860458889 email: yefengdoctor@sina.com lat: 24.47979 lon: 118.08187 facility: Lanzhou University Second Hospital status: NOT_YET_RECRUITING city: Lanzhou state: Gansu zip: 730030 country: China name: Junnian Shi, Master role: CONTACT phone: 13919778675 email: ldeyyzbgs@lzu.edu.cn lat: 36.05701 lon: 103.83987 facility: Gansu Provincial Cancer Hospital status: NOT_YET_RECRUITING city: Lanzhou state: Gansu zip: 730050 country: China name: Xiting Liu, Bachelor role: CONTACT phone: 13893296929 email: LXT-0421@163.com lat: 36.05701 lon: 103.83987 facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510399 country: China name: Minghui Wang, Doctor role: CONTACT phone: 13826276828 email: wmingh@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangdong Pharmaceutical University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 528405 country: China name: Xintian Qin, Master role: CONTACT phone: 13660558820 email: xintianqin@126.com lat: 23.11667 lon: 113.25 facility: The Affiliated Hospital of Guangdong Medical University status: NOT_YET_RECRUITING city: Zhanjiang state: Guangdong zip: 524001 country: China name: Shujun Li, Master role: CONTACT phone: 13726913133 email: lishujun072@163.com lat: 21.28145 lon: 110.34271 facility: The Second Affiliated Hospital of Guilin Medical College status: NOT_YET_RECRUITING city: Guilin state: Guangxi zip: 541199 country: China name: Bihui Li, Master role: CONTACT phone: 18378316283 email: lbihui0202@163.com lat: 25.28194 lon: 110.28639 facility: The First Affiliated Hospital of Guangxi Medical University status: NOT_YET_RECRUITING city: Nanning state: Guangxi zip: 530020 country: China name: Qing Bu, Doctor role: CONTACT phone: 18277133566 email: 1332271797@qq.com lat: 22.81667 lon: 108.31667 facility: Yulin First People's Hospital status: NOT_YET_RECRUITING city: Yulin state: Guangxi zip: 537000 country: China name: Haizhen Yi, Master role: CONTACT phone: 15807851995 email: yhz228815@168.com lat: 22.63333 lon: 110.15 facility: Guizhou Provincial People's Hospital status: NOT_YET_RECRUITING city: Guiyang state: Guizhou zip: 550002 country: China name: Yu Zhang, Doctor role: CONTACT phone: 18885146684 email: 248634489@qq.com lat: 26.58333 lon: 106.71667 facility: The Second Affiliated Hospital of Zunyi Medical University status: NOT_YET_RECRUITING city: Zunyi state: Guizhou zip: 563000 country: China name: Yuju Bai, Master role: CONTACT phone: 13984535566 email: byj6618@163.com lat: 27.68667 lon: 106.90722 facility: Hainan Provincial People's Hospital status: NOT_YET_RECRUITING city: Haikou state: Hainan zip: 570311 country: China name: Yongxing Chen, Master role: CONTACT phone: 13876825536 email: chen13876825536@163.com lat: 20.04583 lon: 110.34167 facility: Affiliated Hospital of Hebei University status: NOT_YET_RECRUITING city: Baoding state: Hebei zip: 050031 country: China name: Zizheng Song, Master role: CONTACT phone: 13932268911 email: 13932268911@163.com lat: 38.85111 lon: 115.49028 facility: The Affiliated Hospital of Chengde Medical College status: NOT_YET_RECRUITING city: Chengde state: Hebei zip: 067028 country: China name: Qingshan Li, Bachelor role: CONTACT phone: 15633142750 email: libing200865@126.com lat: 40.9519 lon: 117.95883 facility: The Fourth Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijiazhuang state: Hebei zip: 050011 country: China name: Yudong Wang, Doctor role: CONTACT phone: 15931166600 email: wyd_999@hebmu.edu.cn lat: 38.04139 lon: 114.47861 facility: Tangshan People's Hospital status: NOT_YET_RECRUITING city: Tangshan state: Hebei zip: 063001 country: China name: Junquan Yang, Doctor role: CONTACT phone: 19131829092 email: 13313059092@163.com lat: 39.63333 lon: 118.18333 facility: Affiliated Cancer Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Baogang Liu, Doctor role: CONTACT phone: 13804552752 email: liubaogang1962@sina.com lat: 45.75 lon: 126.65 facility: The Second Affiliated Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Tao Xin, Doctor role: CONTACT phone: 13633655999 email: xintao1234@263.net lat: 45.75 lon: 126.65 facility: Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital) status: NOT_YET_RECRUITING city: Jiamusi state: Heilongjiang zip: 154000 country: China name: Hongmei Sun, Bachelor role: CONTACT phone: 15344540000 email: SHM1357@163.com lat: 46.79927 lon: 130.31633 facility: Anyang Tumor Hospital status: NOT_YET_RECRUITING city: Anyang state: Henan zip: 455001 country: China name: Yuanyuan Ji, Master role: CONTACT phone: 13460856657 email: jiyuanyuan666@126.com lat: 36.096 lon: 114.38278 facility: The First Affiliated Hospital of Henan University of Science and Technology status: NOT_YET_RECRUITING city: Luoyang state: Henan zip: 471003 country: China name: Zhiye Zhang, Master role: CONTACT phone: 13783100985 email: 13783100985@163.com lat: 34.68361 lon: 112.45361 facility: Nanyang second general hospital status: NOT_YET_RECRUITING city: Nanyang state: Henan zip: 473000 country: China name: Qichuan Wang, Master role: CONTACT phone: 13838709208 email: chuan12616@126.com lat: 32.99472 lon: 112.53278 facility: The First affiliated Hospital of Nanyang Medical College status: NOT_YET_RECRUITING city: Nanyang state: Henan zip: 473007 country: China name: Peng Cheng, Master role: CONTACT phone: 13782042723 email: oncologist@163.com lat: 32.99472 lon: 112.53278 facility: The First Affiliated Hospital Of Xinxiang Medical Unerversity status: NOT_YET_RECRUITING city: Xinxiang state: Henan zip: 453100 country: China name: Weiwei Li, Master role: CONTACT phone: 13837384916 email: 13837384916@163.com lat: 35.19033 lon: 113.80151 facility: Xuchang Central Hospital status: NOT_YET_RECRUITING city: Xuchang state: Henan zip: 461000 country: China name: Pengyuan Wang, Master role: CONTACT phone: 13837440693 email: wangpengyuan@126.com lat: 34.03189 lon: 113.86299 facility: Henan Cancer Hospital status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450008 country: China name: Yanqiu Zhao, Master role: CONTACT phone: 13938252350 email: 13938252350@163.com lat: 34.75778 lon: 113.64861 facility: The First Affiliated Hospital Zhejiang University School of Medicine status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China name: Xingya Li, Doctor role: CONTACT phone: 13838253946 email: lixingyavip@163.com lat: 34.75778 lon: 113.64861 facility: Henan Provincial People's Hospita status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 463599 country: China name: Shundong Cang, Doctor role: CONTACT phone: 13592675836 email: cangshundong@163.com lat: 34.75778 lon: 113.64861 facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Qian Chu, Doctor role: CONTACT phone: 13212760751 email: qianchu@tjh.tjmu.edu.cn lat: 30.58333 lon: 114.26667 facility: Zhongnan hospital of Wuhan University status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Junhong Zhang, Bachelor role: CONTACT phone: 13638679004 email: Zjhzhongnan@163.com lat: 30.58333 lon: 114.26667 facility: The Second Xiangya Hospital Of Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410011 country: China name: Fang Ma, Doctor role: CONTACT phone: 13975806788 email: dr_fma@126.com lat: 28.19874 lon: 112.97087 facility: The Third Xiangya Hospital of Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410013 country: China name: Xuewen Liu, Doctor role: CONTACT phone: 18711033808 email: aveinliu@163.com lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410031 country: China name: Bolin Chen, Doctor role: CONTACT phone: 13787101898 email: chenbolin@hnca.org.cn lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410031 country: China name: Yongzhong Luo, Bachelor role: CONTACT phone: 13607443876 email: luoyongzhong@hnca.org.cn lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410119 country: China name: Rongrong Zhou, Doctor role: CONTACT phone: 13875898127 email: 664990095@qq.com lat: 28.19874 lon: 112.97087 facility: The first people's hospital of Changzhou status: NOT_YET_RECRUITING city: Changzhou state: Jiangsu zip: 213004 country: China name: Mei Ji, Doctor role: CONTACT phone: 0519-68871123 email: jimei@163.com lat: 31.77359 lon: 119.95401 facility: General Hospital of eastern theater command status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210007 country: China name: Yong Song, Doctor role: CONTACT phone: 13851761392 email: song_yong6310@126.com lat: 32.06167 lon: 118.77778 facility: Jiangsu Cancer Hospital status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Guohao Xia, Doctor role: CONTACT phone: 13913976000 email: 13913976000@163.com lat: 32.06167 lon: 118.77778 facility: Nantong Tumor Hospital status: NOT_YET_RECRUITING city: Nantong state: Jiangsu zip: 226006 country: China name: Junguo Liu, Bachelor role: CONTACT phone: 13814603295 email: jsntzlyy@126.com lat: 32.03028 lon: 120.87472 facility: Wuxi People's Hospital status: NOT_YET_RECRUITING city: Wuxi state: Jiangsu zip: 214023 country: China name: Tao Bian, Doctor role: CONTACT phone: 13358119859 email: biantaophd@126.com lat: 31.56887 lon: 120.28857 facility: Jiangyin People's Hospital status: NOT_YET_RECRUITING city: Wuxi state: Jiangsu zip: 214400 country: China name: Dong Shen, Doctor role: CONTACT phone: 15961663515 email: shendong@ntu.edu.cn lat: 31.56887 lon: 120.28857 facility: The Affiliated Hospital Of XuZhou Medical University status: NOT_YET_RECRUITING city: Xuzhou state: Jiangsu zip: 221004 country: China name: Zhengxiang Han, Doctor role: CONTACT phone: 18052268612 email: cnhzxyq@163.com lat: 34.18045 lon: 117.15707 facility: Xuzhou Central Hospital status: NOT_YET_RECRUITING city: Xuzhou state: Jiangsu zip: 221009 country: China name: Xiang Wang, Master role: CONTACT phone: 18912007930 email: wangxiang7726@163.com lat: 34.18045 lon: 117.15707 facility: Jiangxi Provincial People's Hospital status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China name: Weirong Yao, Doctor role: CONTACT phone: 13907002901 email: 13907002901@126.com lat: 28.68396 lon: 115.85306 facility: The First Affiliated Hospital Of Nanchang University status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China name: Longhua Sun, Doctor role: CONTACT phone: 18279110112 email: 48570887@qq.com lat: 28.68396 lon: 115.85306 facility: Jiangxi Cancer Hospital status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330029 country: China name: Zhenntian Liu, Master role: CONTACT phone: 15070083853 email: 345588506@qq.com lat: 28.68396 lon: 115.85306 facility: Jilin Cancer Hospital status: NOT_YET_RECRUITING city: Changchun state: Jilin zip: 130000 country: China name: Ying Cheng, Doctor role: CONTACT phone: 0431-80596003 email: jl.cheng@163.com lat: 43.88 lon: 125.32278 facility: The First Affiliated Hospital of China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110002 country: China name: Yunpeng Liu, Doctor role: CONTACT phone: 13898865122 email: cmu_trial@163.com lat: 41.79222 lon: 123.43278 facility: Shengjing hospital of China medical university status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110022 country: China name: Caigang Liu, Doctor role: CONTACT phone: 18940254967 email: liucg@sj-hospital.org lat: 41.79222 lon: 123.43278 facility: Shandong Cancer Hospitai status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250117 country: China name: Hui Zhu, Doctor role: CONTACT phone: 15805310022 email: drzhuhui@163.com lat: 36.66833 lon: 116.99722 facility: Jining First People's Hospital status: NOT_YET_RECRUITING city: Jining state: Shandong zip: 272011 country: China name: Jie Li, Doctor role: CONTACT phone: 13964921790 email: 13964921790@139.com lat: 35.405 lon: 116.58139 facility: Qingdao Municipal Hospital status: NOT_YET_RECRUITING city: Qingdao state: Shandong zip: 266011 country: China name: Mi Zhou, Master role: CONTACT phone: 18561858073 email: mi_zhou1978@163.com lat: 36.06488 lon: 120.38042 facility: The Second Affiliated Hospital of Shandong First Medical University status: NOT_YET_RECRUITING city: Tai'an state: Shandong zip: 271000 country: China name: Haiyan Liu, Master role: CONTACT phone: 18505387037 email: fylhy1998@163.com lat: 36.18528 lon: 117.12 facility: Weifang people's Hospital status: NOT_YET_RECRUITING city: Weifang state: Shandong zip: 261000 country: China name: Wei Tan, Master role: CONTACT phone: 13863659099 email: 13863659099@126.com lat: 36.71 lon: 119.10194 facility: Weihai Municipal Hospital status: NOT_YET_RECRUITING city: Weihai state: Shandong zip: 264299 country: China name: Fujun Yang, Doctor role: CONTACT phone: 18660377195 email: 58500775@qq.com lat: 37.50914 lon: 122.11356 facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200025 country: China name: Min Zhou, Doctor role: CONTACT phone: 13681779624 email: doctor_zhou_99@163.com lat: 31.22222 lon: 121.45806 facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200030 country: China name: Shun Lu, Doctor role: CONTACT phone: 13601813062 email: shun_lu@hotmail.com lat: 31.22222 lon: 121.45806 facility: Changzhi People's Hospital status: NOT_YET_RECRUITING city: Changzhi state: Shanxi zip: 046000 country: China name: Jun Zhao, Doctor role: CONTACT phone: 13835578500 email: zhaojun380@163.com name: Xianping Zhao, Bachelor role: CONTACT phone: 13453503966 email: ZXP13453503966@126.com lat: 35.20889 lon: 111.73861 facility: Shanxi Provincial Cancer Hospital status: NOT_YET_RECRUITING city: Taiyuan state: Shanxi zip: 030013 country: China name: Wei Guo, Master role: CONTACT phone: 13834563396 email: guowei812@126.com lat: 37.86944 lon: 112.56028 facility: The First Affiliated Hospital of Xi'An JiaoTong University status: NOT_YET_RECRUITING city: Xi'an state: Shanxi zip: 710061 country: China name: Xiaomin Dang, Doctor role: CONTACT phone: 18991232795 email: dxming112@163.com lat: 34.25833 lon: 108.92861 facility: The Second Affiliated Hospital of Air Force Medical University status: NOT_YET_RECRUITING city: Xian state: Shanxi zip: 710032 country: China name: Haichuan Su, Doctor role: CONTACT phone: 18629190366 email: cntdgcp@163.com lat: 34.25833 lon: 108.92861 facility: Sichuan Provincial People's Hospital status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610072 country: China name: Haitao Lan, Doctor role: CONTACT phone: 18981838376 email: lanht@sina.com lat: 30.66667 lon: 104.06667 facility: The Affiliated Hospital Of Southwest Medical Unerversity status: NOT_YET_RECRUITING city: Luzhou state: Sichuan zip: 646000 country: China name: Peirong Ren, Master role: CONTACT phone: 15883037066 email: 1097802221@qq.com facility: Mianyang Central Hospital status: NOT_YET_RECRUITING city: Mianyang state: Sichuan zip: 621099 country: China name: Gang Feng, Doctor role: CONTACT phone: 18141380968 email: 15520828768@163.com lat: 31.46784 lon: 104.68168 facility: The second people's hospital of neijiang status: NOT_YET_RECRUITING city: Neijiang state: Sichuan zip: 641000 country: China name: Yu Liu, Master role: CONTACT phone: 13698308655 email: 13278258@qq.com lat: 29.58354 lon: 105.06216 facility: Tianjin medical University cancer status: NOT_YET_RECRUITING city: Tianjin state: Tianjin zip: 300181 country: China name: Xiubao Ren, Doctor role: CONTACT phone: 18622221235 email: rwziyi@163.com lat: 39.14222 lon: 117.17667 facility: The Affiliated Tumor Hospital of Xinjiang Medical University status: NOT_YET_RECRUITING city: Urumqi state: Xinjiang zip: 830054 country: China name: Chunling Liu, Master role: CONTACT phone: 13899931987 email: liudeyouxiang66@163.com lat: 43.80096 lon: 87.60046 facility: Yunnan Cancer Hospital status: NOT_YET_RECRUITING city: Kunming state: Yunnan zip: 650118 country: China name: Runxiang Yang, Master role: CONTACT phone: 13888876721 email: 13888876721@163.com lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital Zhejiang University School of Medicine status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China name: Yina Wang, Doctor role: CONTACT phone: 15957109041 email: sinead555@163.com lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital Zhejiang University School of Medicine status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China name: Pingli Wang, Doctor role: CONTACT phone: 13516808409 email: W_pl77@163.com lat: 30.29365 lon: 120.16142 facility: The First Affiliated Hospital of Wenzhou Medical University status: NOT_YET_RECRUITING city: Wenzhou state: Zhejiang zip: 325000 country: China name: Yanfan Chen, Doctor role: CONTACT phone: 13600666600 email: chenyf2605@163.com lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06300164 id: Unripecarobinceliac briefTitle: The Effect of Unripe Carob Fruit in Celiac Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-07-01 date: 2024-03-08 date: 2024-03-08 name: Toros University class: OTHER briefSummary: The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction. conditions: Celiac Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will conduct by using a prospective randomized double-blind clinical trial model. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants will not know which type of cookies to eat. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 30 type: ESTIMATED name: Unripre Carob measure: Examination of between group differences regarding serum Total Antioxidant Capacity (TAC) measure: Examination of between group differences regarding serum Malondialdehyde (MDA) measure: Examination of between group differences regarding serum zonulin measure: Comparison of between group differences regarding serum Total Antioxidant Capacity (TAC) measure: Comparison of between group differences regarding serum Malondialdehyde (MDA) measure: Comparison of between group differences regarding serum zonulin sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT hasResults: False

 nctId: NCT06300151 id: Ultrasound Real-time Guidance briefTitle: The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Zongxun Lin class: OTHER briefSummary: Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers. conditions: Labor Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia name: Dural Puncture Epidural Labor Analgesia measure: Analgesic effect（onset time） measure: Analgesic effect（block level） measure: Analgesic effect（block effect） measure: Analgesic effect（Visual Analogue Scale） measure: Analgesic effect（number of Patient controlled analgesia） measure: Analgesic effect（time of Patient controlled analgesia） measure: Uterine contraction indicators（Frequency） measure: Uterine contraction indicators（duration） measure: Uterine contraction indicators（Number of pregnant women with Tachysystole） measure: Uterine contraction indicators（Number of pregnant women with hypertonus） measure: Fetal heart indicators（Fetal heart rate） measure: Fetal heart indicators（NICHD classification） measure: Fetal heart indicators（Fetal Heart Rate decelerations） measure: Fetal heart indicators（Fetal Heart Rate Variability） measure: Apgar score measure: Sacral sensory block of pregnant women measure: modified bromage score measure: Operation evaluation（Time） measure: Operation evaluation（number of times） measure: Operation evaluation（side effects and Complications） measure: Delivery mode measure: Concentration of Interleukin 6 measure: Concentration of hypersensitive C-reactive protein measure: Concentration of cortisol measure: Maternal rehabilitation indicators（Postpartum hospital stay） measure: Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale） measure: Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40）） measure: Number of pregnant women with adjust the treatment plan and adjustment method measure: Drug consumption measure: Effect of stages of labor（time） measure: body temperature changes measure: Number of pregnant women with Infection during labor measure: Side effects and complications of labor analgesia measure: The reasons and number of pregnant women with conversion of natural labor to Caesarean section measure: Self-Rating Anxiety Scale measure: Delivery fear score（numerical rating scale） measure: Delivery satisfaction survey sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Fujian Provincial Hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Zongxun Lin, Master role: CONTACT phone: +8613763820916 email: 13763820916@189.cn lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06300138 id: 2023-631-2 briefTitle: Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-03-08 date: 2024-03-08 name: First Hospital of China Medical University class: OTHER briefSummary: Sporotrichosis is a chronic granulomatous mycosis caused by sporothrix complex. The course of sporotrichosis is always prolonged and even life-threatening, the treatment of this disease in an important scientific problem to be solved. The investigators previously found the predominance of subtype M2 macrophage which play an anti-inflammatory role in the lesions of sporotrichosis, the predominance of M2 macrophage may be responsible for the persistence of sporotrichosis; the investigators also found that local hyperthermia is effective in the treatment of sporotrichosis and hyperthermia treatment can activate the CRAC calcium channel in macrophages which triggers pro-inflammatory type M1 polarization and subsequent killing of sporothrix, however, the mechanism still calls for further investigation. The investigators hypothesize that hyperthermia leads to the activation of CRAC channels resulting in profound Ca2+ influx and Ca2+ upregulates NLRP3 inflammasome expression through inducing Nrf2 activation, then NLRP3 overexpression triggers M1 polarization and subsequent killing of sporothrix. Furthermore, the activation of Nrf2 upregulates STIM1 expression which forms a positive feedback for M1 type polarization of macrophages and further subsequent killing of sporothrix. The purpose of this project is to identify the hypothesis that hyperthermia could treat sporotrichosis by promoting pro-inflammatory type M1 polarization in macrophages, the mechanism by which hyperthermia could treat sporotrichosis is local hyperthermia could led to STIM1/CRAC calcium channel activation mediated calcium ions/Nrf2/NLRP3 induced M1 macrophages polarization and subsequent killing of sporothrix. The hypothesis will be identified at the cellular level, at the animal model level and at the clinical specimens level. The investigators believe that the project will guide the application of hyperthermia in the treatment of sporotrichosis and provide a new basis of theory and practice after the investigators achieving these goals. conditions: Sporotrichosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Itraconazole name: Infrared thermotherapy apparatus name: Itraconazole and Infrared thermotherapy apparatus measure: the overall clinical clearance rate of skin lesions measure: Overall clinical clearance rate and recurrence rate measure: adverse reactions and incidence measure: the clearance rate of target skin lesions measure: overall lesion clearance rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06300125 id: R1881/23 - L2-015 briefTitle: Percutaneous Cryoablation of Low-risk Early Breast Cancer acronym: PRECICE overallStatus: RECRUITING date: 2024-04-15 date: 2026-12-31 date: 2031-03-01 date: 2024-03-08 date: 2024-04-03 name: European Institute of Oncology class: OTHER name: Fondazione Umberto Veronesi name: IceCure Medical Ltd. briefSummary: Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 234 type: ESTIMATED name: Cryoablation measure: Procedure failure rate measure: Assessment of subject's quality of life in terms of evaluation of sources of distress measure: Assessment of subject's satisfaction measure: Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable) measure: Ipsilateral breast tumor recurrence measure: Distant metastasis sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Franco Orsi role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06300112 id: Amasya Univ_emine.akca briefTitle: Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-05-31 date: 2024-06-30 date: 2024-03-08 date: 2024-03-12 name: Amasya University class: OTHER briefSummary: The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns. conditions: Stress conditions: Sexuality conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized-controlled trial with pretest-posttest control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: YOGA measure: Perceived stress level measure: Sexual Quality of Life measure: Sleep patterns sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Amasya University city: Amasya zip: 05100 country: Turkey name: Emine İbici Akça, Ph.D role: CONTACT phone: 03582115005-4723 email: emine.akca@amasya.edu.tr lat: 40.65333 lon: 35.83306 hasResults: False

 nctId: NCT06300099 id: AZAST/Research/52/20-Jan-2024 briefTitle: Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-08 date: 2024-03-12 name: Al-Azhar University class: OTHER briefSummary: Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.

The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Dexamethasone name: Dexmedetomidine measure: postoperative visual assessment scale for pain. sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06300086 id: NUDGE-CKD briefTitle: Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease acronym: NUDGE-CKD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2034-10-01 date: 2024-03-08 date: 2024-03-08 name: Tor Biering-Sørensen class: OTHER briefSummary: Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.

This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters. conditions: Chronic Kidney Diseases conditions: Behavior and Behavior Mechanisms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 factorial design primaryPurpose: OTHER masking: NONE count: 35000 type: ESTIMATED name: Electronically delivered nudging letters to patients with CKD name: Electronically delivered nudging letter to associated GPs of patients with CKD measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Number of participants with any prescription of renin-angiotensin system inhibition measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of renin-angiotensin system inhibition measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition measure: Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors measure: Number of participants with an increase in baseline daily RASi dosage measure: Number of participants with any prescription of mineralocorticoid receptor antagonists measure: Number of participants with any prescription of non-steroid mineralocorticoid receptor antagonists measure: Number of participants with any prescription of cholesterol-lowering medication measure: Number of participants with any prescription of glucagon-like peptide-1 analogue measure: Number of participants with any prescription of antidiabetic medication besides SGLT2i measure: Number of participants with any prescription of antidiabetic medication measure: Number of participants with any prescription of antihypertensive medication besides renin-angiotensin system inhibition measure: Number of participants with any prescription of antihypertensive medication measure: Number of participants with a new prescription of mineralocorticoid receptor antagonists measure: Number of participants with a new prescription of non-steroid mineralocorticoid receptor antagonists measure: Number of participants with a new prescription of cholesterol-lowering medication measure: Number of participants with a new prescription of glucagon-like peptide-1 analogue measure: Number of participants with a new prescription of antidiabetic medication besides sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of antidiabetic medication measure: Number of participants with a new prescription of antihypertensive medication besides renin-angiotensin system inhibition measure: Number of participants with a new prescription of antihypertensive medication measure: Change in number of antihypertensive medications measure: Number of participants referred to nephrology outpatient clinics measure: Number of participants with an assessment of urine albumine to creatine ratio measure: Number of participants with an assessment of plasma-creatinine. measure: Number of participants with an assessment of estimated glomerular filtration rate by creatinine measure: Number of participants with an assessment of hemoglobin A1c measure: Number of participants with an assessment of lipids measure: Number of participants recipient of influenza vaccination measure: Number of participants recipient of COVID-19 vaccination measure: Total number of visits to general practitioners measure: Time to first phone contact to a general practice measure: Time to first visit with a general practitioner measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Number of participants with any prescription of renin-angiotensin system inhibition measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of renin-angiotensin system inhibition measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors measure: Time from intervention delivery to prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Time from randomization to prescription of renin-angiotensin system inhibition measure: Time from randomization to prescription of sodium-glucose cotransporter 2 inhibitors measure: Number of participants who have discontinued renin-angiotensin system inhibition treatment. measure: Number of participants who have discontinued sodium-glucose cotransporter 2 inhibition treatment. measure: Rate of change in estimated glomerular filtration rate measure: Rate of change in urine albumine to creatinine ratio measure: Number of participants with any hospitalization measure: Total number of all-cause hospitalizations measure: All-cause mortality measure: Number of participants with kidney failure defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence and kidney transplantation measure: Number of participants with kidney failure (alternative definition #1) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation and renal death measure: Number of participants with kidney failure (alternative definition #2) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation, renal death, and cardiovascular death. measure: Number of participants with acute dialysis measure: Number of participants with acute kidney insufficiency measure: Number of participants with incident heart failure, heart failure hospitalization, or cardiovascular death measure: Number of participants with major adverse cardiovascular events defined as a composite of myocardial infarction, stroke, and cardiovascular death. measure: Number of participants with major adverse cardiovascular events (alternative definition) defined as a composite of myocardial infarction, revascularization, stroke, and cardiovascular death. measure: Number of participants with individual components of the renal/cardiovascular composite outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte city: Hellerup state: Hovedstaden zip: 2900 country: Denmark lat: 55.73204 lon: 12.57093 hasResults: False

 nctId: NCT06300073 id: AB-360-001-2022 briefTitle: Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children overallStatus: COMPLETED date: 2023-02-14 date: 2023-02-17 date: 2023-02-17 date: 2024-03-08 date: 2024-03-08 name: Lander Enterprises, LLC class: INDUSTRY briefSummary: The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush. conditions: Dental Plaque studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: single-use, randomized, two-period, cross-over study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Examiner and data recorder will not have access to the room for test materials dispensing and instructions. whoMasked: OUTCOMES_ASSESSOR count: 22 type: ACTUAL name: Experimental: U-shaped Power Toothbrush name: Placebo Comparator: Soft Manual Toothbrush measure: Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all tooth surfaces of the whole mouth. sex: ALL minimumAge: 5 Years maximumAge: 8 Years stdAges: CHILD facility: Salus Research, Inc city: Fort Wayne state: Indiana zip: 46825 country: United States lat: 41.1306 lon: -85.12886 hasResults: False

 nctId: NCT06300060 id: REB23-1161 briefTitle: Synbiotic Supplementation in Cyclists overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-01 date: 2025-02-01 date: 2024-03-08 date: 2024-03-08 name: University of Calgary class: OTHER name: Lallemand Health Solutions briefSummary: The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.

The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health. conditions: Exercise Endurance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel arm. Single-site, double-blinded, placebo-controlled trial. primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE maskingDescription: The synbiotic and placebo are both powders identical in taste and appearance and are equally dissolvable in cold water. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Synbiotic name: Placebo measure: Change in endurance exercise performance measured during a 20km cycling distance trial measure: Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test measure: Change in peak power output (PPO) measured during a Step-Ramp-Step Test measure: Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP) measure: Change in time to exhaustion measured during a cycling session at 85% of the peak power output measure: Change in fat and carbohydrate oxidation measured during exercise sessions measure: Change in blood lactate concentration measured via pinprick capillary blood test measure: Change in body composition measured by dual energy X-ray absorptiometry (DXA) measure: Change in intestinal permeability markers measured in serum measure: Change in cytokines measure: Change in gastrointestinal symptoms measured by self-report measure: Change in fecal SCFA concentration measured by gas chromatography measure: Synbiotic strains quantification measured by qPCR in fecal matter measure: Change in fecal microbiota composition measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of Calgary city: Calgary state: Alberta zip: T2N 1N4 country: Canada name: Raylene A Reimer, PhD, RD role: CONTACT phone: 403-220-8218 email: reimer@ucalgary.ca lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06300047 id: REB23-0679 briefTitle: Diabetes Transition Coordinator Study overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2028-12-31 date: 2028-12-31 date: 2024-03-08 date: 2024-03-08 name: University of Calgary class: OTHER name: Juvenile Diabetes Research Foundation name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis.

The 3 main aims are:

1. To assess the effects of our transition intervention on clinical and patient-reported outcomes.
2. To implement the transition intervention and evaluate the implementation outcomes.
3. To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.

Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 324 type: ESTIMATED name: Non-Medical Transition Coordinator measure: Lost to Followup measure: Patient Reported Outcome Survey 1 measure: Patient Reported Outcome Survey 2 measure: Patient Reported Outcome Survey 3 measure: Clinical Outcome 1 measure: Clinical Outcome 2 measure: Clinical outcome 3 measure: Clinical outcome 4 measure: Clinical Outcome 5 measure: Clinical Outcome 6 sex: ALL minimumAge: 17 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta country: Canada lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06300034 id: bagattoni2 briefTitle: Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy acronym: SDF overallStatus: COMPLETED date: 2020-09-01 date: 2022-02-01 date: 2022-03-01 date: 2024-03-08 date: 2024-03-08 name: University of Bologna class: OTHER briefSummary: Parental perceptions on staining due to Silver Diamine Fluoride (SDF) could affect its implementation in pediatric dentistry. This study represents the second part of a wider project focused on SDF aesthetic acceptability among Italian parents. conditions: Perceptions conditions: Acceptability conditions: SDF studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 234 type: ACTUAL measure: Parental overall acceptance of SDF staining on anterior and posterior teeth measure: Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior measure: Parental overall acceptability of SDF staining according to demographic background sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile city: Bologna country: Italy lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06300021 id: PEC19242 id: 2021-A00317-34 type: OTHER domain: ID-RCB briefTitle: Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices overallStatus: COMPLETED date: 2021-09-14 date: 2022-05-20 date: 2022-05-20 date: 2024-03-08 date: 2024-03-08 name: Givaudan France Naturals class: INDUSTRY name: BioFortis briefSummary: The goal of this clinical trial is to learn about the extent to which turmeric compounds in different food matrices becomes available to the body in healthy volunteers. The main question it aims to answer is:

* Is the availability to the body of a turmeric dietary supplement altered when consumed in fruit nectar, oat milk, yogurt drink, or gummies in comparison to a dietary supplement capsule?

Participants will ingest a turmeric dietary supplement as a capsule or in different food matrices on six testing days (separated by at least one week). The day before testing day, a standardized dinner will be provided to the participants in the evening and participants will be instructed to not consume any foods or beverages (except water) and to arrive fasted (12 hours) at the investigation site. Participants will ingest turmeric dietary supplement formulations one by one in random order in the morning of testing days. Regular blood and urine samples will be collected before and up to 24 hours after the turmeric dietary supplement ingestion. Standardized meals will be provided during the entire testing day (lunch, mid-afternoon snack, dinner). conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Monocentric, randomized, cross-over, open-label, pharmacokinetic study primaryPurpose: BASIC_SCIENCE masking: NONE count: 35 type: ACTUAL name: TPG capsule name: TPG ready to drink name: TPG dairy analog name: TPG probiotic drink name: TPG gummies name: TPG sport bar measure: Dose-normalized AUC0-24h of total curcuminoids measure: Dose-normalized AUC0-24h of curcuminoid compounds and of their metabolites measure: Dose-normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites measure: Dose-normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites measure: AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites measure: AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites measure: AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites measure: Relative bioavailability for normalized AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites measure: Relative bioavailability for normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites measure: Relative bioavailability for normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites measure: Cmax of total curcuminoids, curcuminoid compounds and of their metabolites measure: Dose-normalized Cmax of total curcuminoids, curcuminoid compounds and of their metabolites measure: Half-life of total curcuminoids, curcuminoid compounds and of their metabolites measure: Tmax of total curcuminoids, curcuminoid compounds and of their metabolites sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Biofortis city: Saint-Herblain zip: 44800 country: France lat: 47.21765 lon: -1.64841 hasResults: False

 nctId: NCT06300008 id: OrthoTU13 briefTitle: Cetylated Fatty Acid for Reducing Pain After TKA overallStatus: RECRUITING date: 2024-02-12 date: 2024-09 date: 2024-12 date: 2024-03-08 date: 2024-03-08 name: Thammasat University class: OTHER briefSummary: To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA. conditions: Postoperative Pain conditions: Postoperative Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: cetylated fatty acid name: Placebo measure: Visual analog scale measure: Visual analog scale measure: Visual analog scale measure: Visual analog scale measure: inflammatory marker measure: inflammatory marker measure: inflammatory marker measure: inflammatory marker measure: Knee skin temperature measure: Knee skin temperature measure: Knee skin temperature measure: Knee skin temperature measure: Knee circumference (cm) measure: Knee circumference (cm) measure: Knee circumference (cm) measure: Knee circumference (cm) measure: Knee Range of Motion measure: Knee Range of Motion measure: Knee Range of Motion measure: Knee Range of Motion measure: Modified WOMAC measure: Modified WOMAC measure: Modified WOMAC measure: Thai forgotten joint score measure: Thai forgotten joint score measure: Thai forgotten joint score sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university status: RECRUITING city: Khlong Luang state: Pathumthani zip: 066 country: Thailand name: supakit kanitnate role: CONTACT phone: 6629260000 email: naypeng@hotmail.com name: Nattapol Tammachote, M.D. role: PRINCIPAL_INVESTIGATOR name: Supakit Kanitnate, M.D. role: SUB_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False

 nctId: NCT06299995 id: MFSP briefTitle: Phenotype and Burden of a Midfacial Segment Pain overallStatus: ENROLLING_BY_INVITATION date: 2024-02-24 date: 2025-03-31 date: 2025-03-31 date: 2024-03-08 date: 2024-03-19 name: Swiat Zdrowia class: OTHER briefSummary: The purpose of this study is to describe midfacial segment pain phenotype, burden and comorbidities in a multicentre and multidisciplinary setting. The ultimate goal is a comprehensive description of this type of pain allowing for its implementation in future classifications.

This cross-sectional study is designed to describe midfacial segment pain in a clinical setting. Patients from rhinologic, headache and facial pain or oral medicine/dentistry secondary care centres will be recruited during a one year period. Individuals with other facial pain according to current classification such as sinonasal disorders, neoplasms, local infections, history of significant trauma associated with pain onset will be excluded. Data will be collected through a structured questionnaire covering pain characteristics, coexisting diagnoses, pain-related burden and consequences, physical examination and paranasal sinuses imaging. conditions: Facial Pain studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: Pain characteristics measure: Coexisting diagnoses measure: Pain-related burden and consequences sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Otolaryngology, University of Malta city: Imsida country: Malta lat: 35.8925 lon: 14.48278 facility: Athleticomed - Pain&Headache Treatment Centre city: Bydgoszcz country: Poland lat: 53.1235 lon: 18.00762 facility: Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology city: Bydgoszcz country: Poland lat: 53.1235 lon: 18.00762 facility: Department of Neurology, Jagiellonian University Medical College city: Kraków country: Poland lat: 50.06143 lon: 19.93658 facility: Świat Zdrowia city: Orzyny zip: 12-120 country: Poland lat: 53.67846 lon: 21.06617 facility: Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak city: Oświęcim country: Poland lat: 50.03437 lon: 19.21037 facility: 4. Department of Otorhinolaryngology, National Institute of Medicine of the Ministry of the Interior and Administration city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: 5. Department of Otolaryngology, Centre of Postgraduate Medical Education city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Experimental Dentistry, Wroclaw Medical University city: Wrocław country: Poland lat: 51.1 lon: 17.03333 facility: Department of Neurology, Wroclaw Medical University city: Wrocław country: Poland lat: 51.1 lon: 17.03333 facility: MIGRE Polish Migraine Center city: Wrocław country: Poland lat: 51.1 lon: 17.03333 facility: Pain Medicine, Liverpool University Hospitals NHS Foundation Trust city: Liverpool country: United Kingdom lat: 53.41058 lon: -2.97794 facility: Department of Otorhinolaryngology, Nottingham University Hospital city: Nottingham country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06299982 id: SSGJ-608-PsO-III-02 briefTitle: An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-01-30 date: 2025-03-20 date: 2024-03-08 date: 2024-03-08 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis. conditions: Plaque Psoriasis Patients studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 750 type: ESTIMATED name: 608 Q2W name: 608 Q4W measure: Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement measure: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) measure: Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100) measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) measure: Adverse events (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299969 id: StBernwardH briefTitle: Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest acronym: FITT-OHCA overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: St.Bernward Hospital class: OTHER name: University Medical Center Goettingen briefSummary: The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA). conditions: Out-Of-Hospital Cardiac Arrest studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: In-hospital mortality measure: CPC score measure: MRS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Bernward Hospital status: RECRUITING city: Hildesheim state: Niedersachsen zip: 31134 country: Germany name: Karl H Scholz, MD role: CONTACT phone: +4955139 phoneExt: 64940 email: k.scholz@fitt-stemi.de name: Sebastian Riedel role: CONTACT phone: +4955139 phoneExt: 64940 email: s.riedel@bernward-khs.de lat: 52.15077 lon: 9.95112 hasResults: False

 nctId: NCT06299956 id: 2023-SFHHB-IC-001 briefTitle: Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark acronym: StRiDE overallStatus: RECRUITING date: 2023-09-01 date: 2029-01 date: 2029-01 date: 2024-03-08 date: 2024-03-21 name: Slagelse Hospital class: OTHER name: Region Zealand name: Vordingborg Municipality name: Kalundborg municipality name: Køge Municipality name: Næstved municipality name: Solrød Municipality briefSummary: The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.

The objective of this project is to describe:

1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.
2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.
3. Outcomes available for assessment of benefits and harms from the SET intervention.

Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking. conditions: Intermittent Claudication studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 600 type: ESTIMATED name: Supervised exercise therapy measure: Maximal Walking Distance measure: Pain-free walking distance measure: Vascular Quality of Life Questionnaire-6 (VASCUQoL-6) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PROgrez status: RECRUITING city: Slagelse zip: 4700 country: Denmark name: Helle Bøgard role: CONTACT email: hboga@regionsjaelland.dk name: Lars Tang role: CONTACT email: larta@reggionsjaelland.dk lat: 55.40276 lon: 11.35459 hasResults: False

 nctId: NCT06299943 id: BiofeedbackTargetGaitTraining briefTitle: Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke acronym: TargetGait overallStatus: RECRUITING date: 2022-01-24 date: 2025-12-30 date: 2025-12-30 date: 2024-03-08 date: 2024-03-12 name: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health class: OTHER briefSummary: Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults. conditions: Stroke conditions: Biofeedback conditions: Gait, Hemiplegic conditions: Gait Training conditions: Hemiparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel-group, single-blinded controlled clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Clinicians involved in the measurements and researchers that worked with data results did not know which group each patient was in. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Biofeedback gait training by biomechanical target parameter measure: Gait cycle measure: Foot clearance measure: Speed of walking measure: Stance phase measure: Single support phase measure: Hip joint amplitude measure: Knee joint amplitude measure: Ankle joint amplitude measure: EMG amplitude of tibialis anterior muscle measure: EMG amplitude of gastrocnemus muscle measure: EMG amplitude of quadriceps femoris muscle measure: EMG amplitude of Hamstring muscle measure: Muscle strength measure: Activities of Daily Living measure: Modified Rankin Scale for Neurologic Disability measure: The Timed Up and Go Test measure: The Medical Research Council Weakness Scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FCCerebroPathStroke status: RECRUITING city: Moscow zip: 117997 country: Russian Federation name: Dmitry Skvortsov, PhD role: CONTACT phone: +79166925419 email: skvortsov.biom@gmail.com lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06299930 id: LRR after NACT vs ACT briefTitle: Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy overallStatus: COMPLETED date: 2022-04-22 date: 2023-08-16 date: 2023-09-12 date: 2024-03-08 date: 2024-03-08 name: Seoul National University Hospital class: OTHER briefSummary: Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 10328 type: ACTUAL name: Neoadjuvant chemotherapy name: Adjuvant chemotherapy measure: Locoregional recurrence-free survival (LRR) measure: Distant metastasis-free survival sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-04-22 uploadDate: 2024-03-01T20:58 filename: Prot_SAP_000.pdf size: 151396 hasResults: False

 nctId: NCT06299917 id: CeViG id: S-20232000 - 3 type: OTHER domain: Committees on Health Research Ethics for Southern Denmark briefTitle: WORK-ON Vocational Rehabilitation for People With Inflammatory Arthritis acronym: WORK-ON overallStatus: RECRUITING date: 2024-03-01 date: 2027-09-01 date: 2027-09-01 date: 2024-03-08 date: 2024-04-17 name: The Danish Center for Expertise in Rheumatology class: OTHER name: Odense Patient Data Explorative Network name: The Danish Rheumatism Association name: Danish Association of Occupational Therapist name: Schaufuss foundation briefSummary: People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues.

Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline. conditions: Rheumatoid Arthritis conditions: Psoriatic Arthritis conditions: Axial Spondyloarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single center parallel randomized study primaryPurpose: OTHER masking: NONE maskingDescription: Statistical analyses will be blinded for group allocation count: 56 type: ESTIMATED name: WORK-ON measure: Work Ability Index (WAI) single item measure: Job loss measure: Work hours per week measure: Work Productivity and Activity Impairment questionnaire, general health (WPAI:GH) measure: Sickness absenteeism measure: Work ability in relation to demands measure: Job insecurity measure: Physical activity while at work measure: Occupational balance measure: Health related quality of life measure: VAS Pain measure: Fatigue measure: Physical activity measure: Mental well-being measure: Sleep measure: Work Ability Index (WAI) single item sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danish Hospital for Rheumatic Diseases status: RECRUITING city: Sønderborg zip: 6400 country: Denmark name: Christina MT Madsen, MSci role: CONTACT phone: +4528551373 email: cmadsen@danskgigthospital.dk name: Jette Primdahl, PhD role: CONTACT phone: +4524206692 email: jprimdahl@danskgigthospital.dk lat: 54.90896 lon: 9.78924 hasResults: False

 nctId: NCT06299904 id: stroke briefTitle: Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2024-12-01 date: 2024-03-08 date: 2024-03-08 name: The Second Affiliated Hospital of Dalian Medical University class: OTHER briefSummary: To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 42 type: ESTIMATED name: Modified Air-pulse Stimulation name: Conventional air-pulse stimulation measure: the score of Fiberoptic endoscopic examination of swallowing (FEES) measure: the score of Murray's secretion scale (MSS) measure: the score of penetration-aspiration scale (PAS) measure: the score of Clinical Pulmonary Infection Score (CPIS) sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Second Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116024 country: China name: wuyao Pan, postgraduate role: CONTACT phone: +86-18186766836 email: 331189506@qq.com lat: 38.91222 lon: 121.60222 hasResults: False

 nctId: NCT06299891 id: PhT_HypOb_Protocol_Clean_07-05 briefTitle: Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-31 date: 2026-05-31 date: 2024-03-08 date: 2024-04-16 name: Seattle Children's Hospital class: OTHER name: Children's Hospital of Philadelphia briefSummary: Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness.

Preliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 12-28-year-old individuals with HO. conditions: Hypothalamic Obesity conditions: Hypothalamic Tumor conditions: Craniopharyngioma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-center, double-blind (participant and assessor), randomized, parallel-arm placebo-controlled 28-week clinical trial, comparing changes related to active drug (Qsymia®) vs. placebo (matched capsules). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Eligible subjects will be assigned treatment using a sex-stratified permuted-block randomization (1:1) to drug vs. placebo for 27 weeks with varying block sizes constructed by the study statistician. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] name: Placebo measure: Treatment-emergent adverse events measure: Maximum tolerated dose measure: % change in BMI measure: Proportion of individuals who experience 5% decrease in BMI measure: Proportion of individuals who experience 2.5% decrease in BMI measure: Change in body fat mass measure: Change in visceral fat mass measure: Change in hunger measure: Change in energy intake sex: ALL minimumAge: 12 Years maximumAge: 28 Years stdAges: CHILD stdAges: ADULT facility: The Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: Seattle Children's city: Seattle state: Washington zip: 98101 country: United States name: Clinton Elfers role: CONTACT phone: 513-290-5710 email: clinton.elfers@seattlechildrens.org lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06299878 id: MelPRO-0322 briefTitle: MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns] acronym: CRISTINA overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-31 date: 2025-07-01 date: 2024-03-08 date: 2024-03-08 name: Russian Academy of Medical Sciences class: OTHER briefSummary: The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:

* radiological and pathological response rate to three doses of antiPD1 agents;
* do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.

After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years. conditions: Melanoma, Skin conditions: Melanoma Stage Iii studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 72 type: ESTIMATED name: Gut microbiota analysis measure: 2-year disease-free survival measure: pathological response rate measure: biomarker reproducibility sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: N.N. Blokhin Russian Cancer Research Center, skin tumor department status: RECRUITING city: Moscow zip: 115478 country: Russian Federation name: Igor V Samoylenko, MD, PhD role: CONTACT phone: +7 (499) 444-24-24 email: i.samoylenko@ronc.ru name: Angelina O Kuzmenko, MD role: CONTACT phone: +74993249024 email: angelin.kuzmenko@gmail.com name: Igor V Samoylenko, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06299865 id: YXLL-KY-2023（150） briefTitle: Comparison of Detection Rates Between Two Commonly Used Bone Density Measurement Methods overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: Xiaoqian Zhang class: OTHER briefSummary: 72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.

1. Record the patient's age, gender, height, and weight; Review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.).
2. Retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by GE Healthcare Lunar Prodigy dual energy X-ray absorptiometry from the database, and take the average (DXA bone density value). According to the diagnostic criteria of the Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
3. Identify the lumbar spine bone density values (QCT bone density values) measured by the GE Gemstone CTHD750 CT instrument from the database. According to the diagnostic criteria of the Chinese Quantitative CT (QCT) Diagnosis Guidelines for Osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
4. Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P\<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis. conditions: Osteoporosis conditions: Diagnosis conditions: Dual Energy X-ray Absorptiometry conditions: Quantitative Computed Tomography studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 72 type: ESTIMATED name: Ungrouped measure: Comparison of the difference in detection rates of osteoporosis between dual energy X-ray and quantitative CT sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Provincial Qianfoshan Hospital city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06299852 id: TK01 briefTitle: Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer overallStatus: RECRUITING date: 2022-07-01 date: 2025-09-01 date: 2025-09-01 date: 2024-03-08 date: 2024-03-08 name: N.N. Petrov National Medical Research Center of Oncology class: OTHER briefSummary: This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT.

The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT.

The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure. conditions: HER2-positive Metastatic Breast Cancer conditions: Oligometastatic Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 58 type: ESTIMATED name: Trastuzumab emtansine measure: Objective response rate (ORR) measure: Progression free survival (PFS) measure: Toxicity profile measure: Second co-primary outcome measure is quality of life sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: N.N. Petrov National Medical Research Center of Oncology status: RECRUITING city: Saint Petersburg country: Russian Federation name: Tatiana Semiglazova, DSc Med., Prof. role: CONTACT email: tsemiglazova@mail.ru name: Tatiana Kudryashova role: CONTACT phone: +79632165730 email: tatyana-kudryashova-98@mail.ru lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06299839 id: PAS-004-102 id: 2024-510900-34 type: EUDRACT_NUMBER briefTitle: PAS-004 in Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-02-29 date: 2025-12 date: 2027-02 date: 2024-03-08 date: 2024-03-08 name: Pasithea Therapeutics Corp. class: INDUSTRY briefSummary: The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. The main questions it aims to answer are:

* How well participants are able tolerate different doses of PAS-004, and
* What side effects PAS-004 might have.

Study participants will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety. Everyone participating in the study will take PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles. Participants will continue on daily PAS-004 for up to 2 years, or until:

* They decide to withdraw from the study, or
* They experience unacceptable side effects, or
* Their disease progresses, or another illness interferes with taking the study drug, or
* The sponsors stops the study. conditions: RAS Mutation conditions: NF1 Mutation conditions: RAF Mutation conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: 3+3 dose expansion primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: PAS-004 measure: Evaluation of dose limiting toxicities (DLTs) measure: Evaluation of adverse events (AEs) measure: Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004. measure: Evaluation of hematology laboratory parameters measure: Evaluation of clinical chemistry laboratory parameters measure: Apparent terminal elimination half-life (t1/2) in Plasma measure: Peak Plasma Concentration (Cmax) measure: Plasma predose or trough concentration (Ctau/Ctrough) measure: Time of maximum plasma concentration (Tmax) measure: Area under the concentration versus time curve from time zero to the last sampling time with quantifiable analyte (AUC0-t) measure: Area under the concentration versus time curve from time zero extrapolated to infinity if possible (AUC0-∞) measure: Area under the concentration versus time curve for the dosing interval, assuming steady state has been reached and duplicating the predose concentration for the 24 hour postdose concentration (AUC0-tau) measure: Apparent total plasma clearance if possible (CL/F) measure: Evaluation of the percentage of extracellular signal-regulated kinase phosphorylation (pERK) inhibition from baseline measure: Evaluation of the objective response rate (ORR) measure: Evaluation of progression-free survival (PFS) measure: Evaluation of overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology status: RECRUITING city: Austin state: Texas zip: 78758 country: United States name: Erica Torres role: CONTACT phone: 210-610-5205 email: etorres@nextoncology.com lat: 30.26715 lon: -97.74306 facility: NEXT Oncology status: RECRUITING city: Irving state: Texas zip: 75039 country: United States name: Erica Torres role: CONTACT phone: 210-610-5205 email: etorres@nextoncology.com lat: 32.81402 lon: -96.94889 facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Carmen Gonzalez role: CONTACT phone: 210-580-9521 email: cgonzalez@nextoncology.com lat: 29.42412 lon: -98.49363 facility: NEXT Oncology status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Blake Patterson role: CONTACT phone: 703-783-4505 email: BPatterson@nextoncology.com lat: 38.84622 lon: -77.30637 hasResults: False

 nctId: NCT06299826 id: D9090C00008 briefTitle: A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure acronym: LUMINARA overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2025-11-24 date: 2025-11-24 date: 2024-03-08 date: 2024-03-08 name: AstraZeneca class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF). conditions: Chronic Heart Failure studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 360 type: ESTIMATED name: AZD5462 name: Placebo measure: Cohort A and B: Change from Baseline in Ejection Fraction measure: Cohort A and B: Change from Baseline in Ejection Fraction measure: Cohorts A and B: Change from Baseline in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS) measure: Cohorts A and B: Change from Baseline in New York Heart Association Functional Class (NYHA FC) measure: Cohorts A and B: Percentage Change from Baseline in cardiac biomarkers measure: Cohorts A and B : Plasma Concentration of AZD5462 measure: Cohorts A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299813 id: 771.284 id: 2022-002955-20 type: EUDRACT_NUMBER briefTitle: Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection acronym: Adeno-beta overallStatus: RECRUITING date: 2024-03-20 date: 2025-01-15 date: 2026-04-01 date: 2024-03-08 date: 2024-03-21 name: A.O.U. Città della Salute e della Scienza class: OTHER briefSummary: The goal of this double-blind, Placebo-controlled Randomized Study is to assess if a single dose of betamethasone in children with febrile adenoviral infection works well in achieving an early fever regulation.

The experimentation is conducted to answer this question: "Can betamethasone help reduce fever more quickly in a child with viral adenovirus infection? "The secondary objective is to assess if the child's overall clinical conditions improve more rapidly (reduced sore throat, quicker return to regular eating) and a reduction in the incidence and duration of hospitalizations. conditions: Adenovirus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A double-blind, placebo-controlled randomized study primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The nurse that will prepare and administer the treatment to the patient won't be masked whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Bentelan name: Placebo measure: Proportion of patients with a sustained fever resolution at 24 hours from randomization measure: Pharyngeal-tonsillar pain level in patients younger than 36 months measure: Hospitalization measure: Duration of hospitalization (among those hospitalized), measured in days measure: Cumulative incidence of fever resolution measure: Fever duration measure: Pharyngeal-tonsillar pain level in patients older than 36 months sex: ALL minimumAge: 6 Months maximumAge: 6 Years stdAges: CHILD facility: Ospedale Infantile Regina Margherita status: RECRUITING city: Torino zip: 10126 country: Italy name: Virginia Giannone, MD role: CONTACT phone: +390113135063 email: vgiannone@cittadellasalute.to.it name: Marco Denina, MD role: CONTACT phone: +390113135064 email: mdenina@cittadellasalute.to.it name: Emanuele castagno, MD role: SUB_INVESTIGATOR name: Giannone Virginia, MD role: SUB_INVESTIGATOR name: Marco Denina, MD role: SUB_INVESTIGATOR lat: 45.07049 lon: 7.68682 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-06-12 uploadDate: 2023-12-06T05:08 filename: Prot_SAP_000.pdf size: 963093 hasResults: False

 nctId: NCT06299800 id: CE385/2023 briefTitle: Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer acronym: TCPT2023 overallStatus: RECRUITING date: 2024-02-04 date: 2025-02-04 date: 2025-02-04 date: 2024-03-08 date: 2024-03-08 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice.

Primary objective of the study:

- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus;

Secondary objectives of the study:

* description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus;
* assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes;
* assess the relationship between the characteristics of patients and the time to the onset of cancer. conditions: Diabetes Mellitus, Type 2 conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 779 type: ESTIMATED name: phenotyping of patients followed at a third-level diabetes centre with cancer measure: Smoking assessment at first visit measure: Alcool consumption at first visit measure: BMI assessment at first visit measure: Glycated assessment at first visit measure: First-line therapy characteristics assessment at first visit measure: Primary outcomes and recurrence or presence of a secondary tumor measure: Relationship between patients characteristics and the time onset of cancer considering anthropometric and biochemical data measure: Tumour characterization in the considered population, detected at the first clinical visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SCDU Endocrinology, AOU Ospedale Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Flavia Prodam role: CONTACT phone: +39 0321 660 693 email: flavia.prodam@med.uniupo.it lat: 45.44694 lon: 8.62118 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-10 uploadDate: 2024-03-01T05:46 filename: Prot_SAP_000.pdf size: 525402 hasResults: False

 nctId: NCT06299787 id: 058-2021 briefTitle: Cognitive Dysfunction in the Addictions Study - Project 4 (P4) acronym: CDiA-P4 overallStatus: RECRUITING date: 2022-02-07 date: 2024-12-31 date: 2025-07-01 date: 2024-03-08 date: 2024-03-08 name: Centre for Addiction and Mental Health class: OTHER briefSummary: The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder. conditions: Major Depressive Disorder conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: intermittent theta burst stimulation name: Sham stimulation measure: Executive Function Index - inhibition measure: Executive Function Index - working memory measure: Executive Function Index - set shifting measure: 17-Item Hamilton Depression Rating Scale (HRSD-17) measure: Columbia-Suicide Severity Rating Scale sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Centre for Addiction and Mental Health status: RECRUITING city: Toronto state: Ontario zip: M6J 1H4 country: Canada name: Daphne Voineskos, MD role: CONTACT phone: 416-535-8501 phoneExt: 30176 email: daphne.voineskos@camh.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06299774 id: 2023P003383 briefTitle: Emergency Care at Home overallStatus: RECRUITING date: 2024-02-02 date: 2025-02-02 date: 2025-03-02 date: 2024-03-08 date: 2024-03-08 name: Brigham and Women's Hospital class: OTHER briefSummary: This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department. conditions: Emergency Medical Services conditions: Emergency Department Visits studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: Emergency care at home name: Emergency care at a brick-and-mortar emergency department measure: Participant with an emergency department presentation, observation, or hospitalization within 9 days measure: Time to care initiation measure: Time spent receiving care measure: Number of days at home within 9 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: David Levine, MD, MPH, MA role: CONTACT phone: 617-732-7063 email: dmlevine@bwh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06299761 id: BBI-825-101 briefTitle: Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications acronym: STARMAP overallStatus: RECRUITING date: 2024-03-28 date: 2027-02 date: 2027-02 date: 2024-03-08 date: 2024-04-29 name: Boundless Bio class: INDUSTRY briefSummary: BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: BBI-825 single agent dose escalation primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: BBI-825 measure: Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825 measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825 measure: Maximum observed plasma concentration (Cmax) of BBI-825 measure: Trough observed plasma concentration (Ctrough) of BBI-825 measure: Time to Cmax (Tmax) of BBI-825 measure: Area under the concentration time curve (AUC) of BBI-825 measure: Anti-tumor activity of BBI-825 as determined by RECISTv1.1 sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sarcoma Oncology Research Center status: RECRUITING city: Santa Monica state: California zip: 90403 country: United States lat: 34.01945 lon: -118.49119 facility: START Midwest status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06299748 id: ARGX-113-PAC-2206 briefTitle: A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding. overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2033-12 date: 2033-12 date: 2024-03-08 date: 2024-03-08 name: argenx class: INDUSTRY briefSummary: This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported. conditions: Myasthenia Gravis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 279 type: ESTIMATED name: Efgartigimod measure: Pregnancy outcomes measure: Congenital malformations measure: The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness) measure: Maternal complications of pregnancy measure: Maternal infections measure: The number of observed fetal growth deficiency sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299735 id: AsenaIremYildiz1 briefTitle: Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-31 date: 2024-09-30 date: 2024-03-08 date: 2024-04-17 name: Ankara City Hospital Bilkent class: OTHER briefSummary: In this study, the primary aim is to compare the impact of using a double-lumen tube and bronchial blocker for single-lung ventilation in patients undergoing minimal invasive cardiac surgeries on postoperative pulmonary functions. Secondary objectives include the comparison of application duration, success in lung collapse, and the number of repositioning attempts for both techniques. conditions: Heart Valvular Disease conditions: Coronary Arteriosclerosis conditions: One-lung Ventilation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The anesthesia method applied for both patient groups is the same. However, the airway maintenance device used will vary between two different patient groups. Group BB: A bronchial blocker will be used for this patient group, Group DLT: A double-lumen tube will be used for this patient group. The parameters to be recorded for both patient groups include: preoperative smoking history, ARISCAT score, systolic arterial pressure, diastolic arterial pressure, saturation, pulse, and the duration of airway device insertion following anesthesia induction and intubation. For the assessment of postoperative pulmonary complications in both patient groups, arterial blood gas analysis, chest X-ray, respiratory sounds, and the patient's oxygen requirement will be monitored every 6 hours for 24 hours. primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 66 type: ESTIMATED name: Minimally Invasive Cardiac Surgery (airway management with double-lumen tube) name: Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker) measure: Comparison of Postoperative Pulmonary Complications in Patient Groups Undergoing Single-Lung Ventilation with Double-Lumen Tube and Bronchial Blocker measure: Duration of insertion of the double-lumen tube / bronchial blocker measure: Incidence of postoperative sore throat measure: Incidence of postoperative hoarseness measure: Impact of the success of lung collapse measure: Satisfactory lung collapse time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara bilkent city hospital status: RECRUITING city: Ankara state: Çankaya zip: 06530 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06299722 id: N-20230055 briefTitle: Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents acronym: STEEL overallStatus: RECRUITING date: 2024-03-15 date: 2025-07 date: 2025-07 date: 2024-03-08 date: 2024-03-19 name: Aalborg University class: OTHER briefSummary: We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis). conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: STEEL name: Circuit training measure: Isometric strength measure: Health-related quality of life measure: Step counts measure: Caloric expenditure measure: Maximal dynamic strength measure: Bone mineral density of the lumbar spine and body composition measure: Grip strength and rate of force development measure: Muscular strength, endurance, and rate of force development measure: Cardiorespiratory fitness and endurance measure: Exercise compliance and fidelity measure: Adverse events measure: Movement-evoked pain measure: Satisfaction with the intervention measure: Blood glucose measure: Glycated hemoglobin (Hba1c) measure: Insulin measure: Proinsulin c-peptide measure: Total cholesterol measure: High-density lipoprotein cholesterol measure: Low-density lipoprotein cholesterol measure: Very low-density lipoprotein cholesterol measure: Triglycerides measure: Glucagon measure: Homeostatic Model assessment for Insulin resistance score measure: Body Mass Index (BMI) measure: Lean body mass measure: Fat mass measure: Android/gynoid fat distribution measure: Abdominal circumference measure: Self-reported Tanner staging measure: Blood pressure sex: ALL minimumAge: 10 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen country: Denmark name: Martin K Fridh role: CONTACT email: martin.kaj.fridh@regionh.dk lat: 55.67594 lon: 12.56553 facility: Aalborg University status: RECRUITING city: Gistrup zip: 9260 country: Denmark name: Henrik Riel role: CONTACT email: hriel@dcm.aau.dk lat: 56.9943 lon: 9.99085 facility: Odense University Hospital status: RECRUITING city: Odense country: Denmark name: Mathias Rathe role: CONTACT email: mathias.rathe@rsyd.dk lat: 55.39594 lon: 10.38831 facility: Århus University Hospital status: RECRUITING city: Århus country: Denmark name: Clara Vad role: CONTACT email: claravad@live.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06299709 id: VX23-121-012 briefTitle: A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA) overallStatus: RECRUITING date: 2024-03-13 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-04-01 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: VNZ/TEZ/D-IVA name: VNZ/TEZ/D-IVA measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion, Inc. status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 hasResults: False

 nctId: NCT06299696 id: VX23-121-011 briefTitle: A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists overallStatus: ENROLLING_BY_INVITATION date: 2024-03-26 date: 2024-05 date: 2024-05 date: 2024-03-08 date: 2024-04-08 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: VNZ/TEZ/D-IVA measure: Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method sex: ALL minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 001 city: Woburn state: Massachusetts zip: 01801 country: United States lat: 42.47926 lon: -71.15228 hasResults: False

 nctId: NCT06299683 id: 230487 id: 1R01DK133415-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DK133415-01A1 briefTitle: Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-05 date: 2028-08-04 date: 2024-03-08 date: 2024-03-08 name: Vanderbilt University Medical Center class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS. conditions: Chronic Interstitial Cystitis conditions: Bladder Pain Syndrome conditions: Painful Bladder Syndrome conditions: Cystitis, Interstitial conditions: Cystitis, Chronic Interstitial conditions: Interstitial Cystitis conditions: Interstitial Cystitis, Chronic conditions: Interstitial Cystitis (Chronic) With Hematuria conditions: Interstitial Cystitis (Chronic) Without Hematuria conditions: Chronic Prostatitis conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online and another pelvic floor physical therapy. primaryPurpose: TREATMENT masking: NONE maskingDescription: Study assessors will be blinded to the study primary outcome but will be aware of study treatment conditions. count: 220 type: ESTIMATED name: Psychosocial Treatment name: Pelvic Floor Physical Therapy measure: Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale. measure: Chronic Overlapping Pain Condition-Screener (COPCS) measure: Quantitative Sensory Testing - Tolerance Average (QST-TOL) measure: Quantitative Sensory Testing - Threshold Average (QST-THR) measure: Quantitative Sensory Testing - Temporal Summation (QST-TS) measure: Urinary Nerve Growth Factor (NGF) measure: Urinary Interleukin-6 (IL6) measure: Interleukin-6, whole blood stimulated (IL6-LPS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299670 id: 939 briefTitle: Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial overallStatus: RECRUITING date: 2023-11-01 date: 2024-06-30 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh class: OTHER briefSummary: Transfusion Dependent Thalassemia (TDT) is an emerging global public health concern. Hemopoietic stem cell transplantation (HSCT) is the only curative treatment. But its adoption is limited due to lack of HLA matched donor, experienced centers and high initial cost. So, researches are going on in search of an effective, safe, easily available treatment option. Use of fetal haemoglobin inducing agents shows promising effects in treatment of TDT patients. Thalidomide an immunomodulating and anti-angiogenic drug has been shown to induce γ-globin gene expression and increase the proliferation of erythroid cells. Furthermore Hydroxyurea (HU) is known to increase haemoglobin (Hb) by HbF induction and reduction of inflammation and hypercoagulability.

Recent studies with combination of HU and Thalidomide have shown promising results in treatment of Thalassemia patients. However, most of those studies are retrospective or single arm nonrandomized trials \& The study population includes both adult and children age group . So the effectiveness of combination therapy of Thalidomide and HU needs to be established through randomized trials.

This single centered non blinded quasi randomized clinical trial will be conducted at the Department of Pediatric Hematology and Oncology in Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh for one year of period. Thirty transfusion dependent thalassemia children of 3-18 years old will be included in each group. The objective of this study is to assess the effectiveness of combination of Thalidomide and Hydroxyurea in TDT children. It will play an important role in planning a cost effective and affordable treatment option for TDT children.This study will involve minimum physical risk to the patient. Written informed consent will be taken from parents or study subjects after brief explanation of the purpose and procedure. They will also be informed about the freedom to participate or not to participate at any time. Privacy and confidentiality will be safe guarded. History regarding age, sex, height, weight of these patients will be taken. Thorough physical examinations and laboratory investigations including CBC, Hb electrophoresis, serum Ferritin, serum creatinine, SGPT will be done. Data will be collected in a predesigned questionnaire and will be kept confidential. Statistical analysis will be done using the statistical software SPSS. conditions: Transfusion-dependent Thalassemia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Thalidomide name: Hydroxy Urea name: Combinations measure: Change in Hb Level measure: Change in Blood transfusion frequency measure: Change in HbF measure: Change in Biochemicals measure: Adverse effect sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Bangabandhu Sheikh Mujib Medical University status: RECRUITING city: Dhaka zip: 1000 country: Bangladesh name: Md. Anwarul Karim, MBBS, FCPS, MD role: CONTACT phone: +880255165814 email: drkarim1990@gmail.com lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06299657 id: 2023H0286 briefTitle: Intervention for Managing Physical Reactions to Overwhelming Emotions acronym: IMPROVE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-08 date: 2024-03-08 name: Ohio State University class: OTHER briefSummary: The clinical trial aims to conduct a feasibility, acceptability, and usability clinical trial of a modular CBT-based and technologically enhanced intervention for people with an SUD and recently enrolled in IOP, probe target engagement and change in clinical outcomes, and examine attrition rates in IOP.

This study will enroll 40 adults who are currently enrolled in IOP, have a substance use disorder, and experience elevated anxiety. 20 individuals will be randomized to the experimental intervention, "Intervention for Managing Physical Reactions to Overwhelming Emotions" (IMPROVE), and 20 individuals will be randomized to the active control group, "Physical Health Education Treatment" (PHET).

Participants will be asked to complete a baseline assessment of mood, substance use, and psychophysiology. Participants will then completed ecological momentary assessments (EMA) via smartphone technology 4 times a day for \~ 28 days (the day following the baseline assessment until the 3rd intervention session). Participants will complete one 45 minute - 1 hour intervention each week for 3 weeks (either the IMPROVE or PHET intervention, pending randomization). Following the last intervention session, participants will return to the lab to complete a post-intervention assessment that mirrors the baseline assessment and then complete follow-up surveys 1- and 3-months post intervention. conditions: Anxiety conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to receive one of two possible interventions. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Raters completing the outcome assessments will be blind to condition. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: IMPROVE name: PHET measure: Intolerance of Uncertainty-12 Scale measure: Anxiety Sensitivity-3 Scale measure: PROMIS Anxiety Short Form measure: Timeline Followback measure: Desire for Drug Questionnaire measure: Penn Alcohol Craving Scale measure: Hyperkatifeia Interference Scale - Alcohol Version. measure: Clinical Institute Withdrawal Assessment Alcohol Scale Revised. measure: Hyperkatifeia Interference Scale - Opioid Version. measure: Subjective Opiate Withdrawal Scale measure: NPU Threat Task measure: Straw Breathing Avoidance Task measure: Emotion Picture Paradigm Task sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Department of Psychiatry and Behavioral Health city: Columbus state: Ohio zip: 43062 country: United States name: Nicholas P Allan, PhD role: CONTACT lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06299644 id: 2023P003282 briefTitle: Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss overallStatus: NOT_YET_RECRUITING date: 2025-05-01 date: 2026-07-01 date: 2026-12-31 date: 2024-03-08 date: 2024-03-08 name: Brigham and Women's Hospital class: OTHER name: Endo Tools Therapeutics S.A. briefSummary: The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss. conditions: Obesity conditions: Obesity, Morbid conditions: Metabolic Disease conditions: Weight, Body studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Endoscopic Sleeve Gastroplasty - Belt and Suspenders name: Endoscopic Sleeve Gastroplasty - Belt measure: Percent TWL (%TWL) measure: Adverse Events measure: Gastric Emptying measure: Number of participants with improvement in fasting glucose measure: Number of participants with improvement in Hemoglobin A1c (HgA1c %) measure: Improvement in fasting lipids profile measure: Number of participants with a change in ghrelin hormone values measure: Obesity-related comorbidities - hypertension measure: Obesity-related comorbidities - change in hypertension concomitant medications measure: Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications measure: Obesity-related comorbidities - pre-diabetes/diabetes measure: Obesity-related comorbidities - gastroesophageal reflux (GERD) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06299631 id: RECHMPL23_0187 briefTitle: Endoscopic Relapse Risks Evaluation After Ileocolic Resection for Crohn's Disease acronym: RIC-1 overallStatus: COMPLETED date: 2015-01 date: 2023-06 date: 2023-12 date: 2024-03-08 date: 2024-03-08 name: University Hospital, Montpellier class: OTHER name: Carémeau University Hospital, Nîmes briefSummary: Aim of the study:

To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents.

Methods:

From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected.

Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period.

Short and long-term outcomes were compared between the two groups.

Primary outcome:

Endoscopic recurrence (defined as \> i2 lesions according to Rutgeerts classification) 6 months after surgery conditions: Crohn's Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 133 type: ACTUAL name: Ileocolic resection measure: Endoscopic recurrence rate measure: Resection margins measure: Length of resected specimen measure: Duration of surgery measure: Intra-operative blood loss measure: Postoperative morbidity rate measure: Mortality rate measure: Myenteric plexitis measure: Number of inflammatory cells in myenteric plexuses sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montpellier University Hospital city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06299618 id: ENIGMA-I briefTitle: Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism acronym: ENIGMA-I overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: University College Cork class: OTHER name: University of Southampton name: Carol Davila University of Medicine and Pharmacy name: Microlink PC UK LTE name: Engineering Ingegneria Informatica SpA name: MEDEA SRL name: ORTHOKEY ITALIA SRL briefSummary: The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism. conditions: Autism conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Symptoms of anxiety measure: Symptoms of anxiety measure: Symptoms of depression measure: Symptoms of depression measure: Attention-Deficit/Hyperactivity measure: Sleep disturbance measure: Physical Activity measure: Symptoms of Mental Health Disorders measure: Cognitive Assessment measure: Nutritional Assessment measure: Heart Rate measure: Respiratory Rate measure: Genotype measure: DNA Methylation measure: Hormone Levels measure: Metabolomic Profile sex: ALL minimumAge: 11 Years maximumAge: 15 Years stdAges: CHILD facility: University College Cork city: Cork country: Ireland name: Deirdre Murray, PhD role: CONTACT email: enigma@ucc.ie name: Jean Conway, Masters role: CONTACT email: ethereal@ucc.ie lat: 51.89797 lon: -8.47061 facility: University of Medicine and Pharmacy Carol Davila Bucharest city: Bucharest country: Romania lat: 44.43225 lon: 26.10626 facility: University of Southampton city: Southampton country: United Kingdom name: Samuele Cortese, MD role: CONTACT name: Koushik Maharatna, PhD role: CONTACT email: km3@ecs.soton.ac.uk lat: 50.90395 lon: -1.40428 hasResults: False

 nctId: NCT06299605 id: SHARE2401 briefTitle: Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori acronym: SHARE2401 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2024-11 date: 2024-03-08 date: 2024-03-08 name: Shandong University class: OTHER name: Binzhou Maternal and Child Health Hospital name: Zibo Maternal and Child Health Hospital name: Zaozhuang Municipal Hospital name: Linyi Yizhou Hospital name: Feicheng Municipal People's Hospital briefSummary: The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated. conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 375 type: ESTIMATED name: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days name: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days name: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days measure: Eradication rate measure: Rate of adverse reactions measure: Patient compliance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299592 id: 2023-1626 id: 1RF1AG082215-01 type: NIH link: https://reporter.nih.gov/quickSearch/1RF1AG082215-01 id: A538900 type: OTHER domain: UW- Madison id: SMPH/PSYCHIATRY/PSYCHIATRY type: OTHER domain: UW- Madison id: Protocol Version 10/15/2023 type: OTHER domain: UW- Madison briefTitle: Comparison of Microglial Activation in Severe Asthma and Healthy Controls acronym: MAIA-SC overallStatus: RECRUITING date: 2024-03-06 date: 2028-08 date: 2028-08 date: 2024-03-08 date: 2024-03-27 name: University of Wisconsin, Madison class: OTHER name: National Institute on Aging (NIA) briefSummary: The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are:

* How airway inflammation in asthma affects the brain; and,
* Whether airway inflammation in asthma is related to symptoms of depression and anxiety

Over the course of 3 visits, participants will:

* Complete questionnaires
* Complete computer tasks
* Undergo allergy skin test and breathing tests
* Give two blood samples
* Give a sputum sample
* Complete brain imaging scans

Researchers will compare results between participants with asthma, and participants who do not have asthma. conditions: Asthma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: PET/MRI using [18F]FEPPA tracer measure: Binding of [18F]-FEPPA measure: How activated microglia correspond to immune biomarkers in lung and blood measure: Relationship between activated microglia and cognitive function measure: Relationship between activated microglia and psychological symptoms sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Healthy Minds status: RECRUITING city: Madison state: Wisconsin zip: 53703 country: United States name: Janelle Grogan role: CONTACT phone: 608-263-0524 email: jegrogan@medicine.wisc.edu name: Melissa Rosenkranz, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06299579 id: WG-GD11-III-01 briefTitle: GD-11 for Injection in the Treatment of Acute Ischemic Stroke overallStatus: RECRUITING date: 2024-02-29 date: 2025-02-22 date: 2025-12-31 date: 2024-03-08 date: 2024-03-15 name: Beijing Tiantan Hospital class: OTHER name: Jiangsu Wangao Pharmaceutical Co. ltd briefSummary: Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is designed as a multicenter, randomized, double-blind, placebo-parallel controlled trial using a multicenter, randomized, double-blind, placebo-parallel controlled trial design. Subjects are randomly assigned in a 1:1 ratio and random number tables are generated using SAS（Statistics Analysis System）software. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 980 type: ESTIMATED name: GD-11 for injection test group name: Placebo control group measure: Proportion of subjects with mRS score ≤1 on 90th day of treatment sex: ALL minimumAge: 18 Years maximumAge: 81 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital Capital Medical University Beijing status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Yongjun Wang role: CONTACT email: yongjunwang111@aliyun.com name: Yongjun Wang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Linfen Central Hospital status: RECRUITING city: Shangxi state: Linfen City zip: 041099 country: China name: hongguo Dai role: CONTACT email: daihongguo3199@163.com hasResults: False

 nctId: NCT06299566 id: CF NGS briefTitle: Perceptions of the CF Screening Protocol Incorporating NGS overallStatus: COMPLETED date: 2022-01-19 date: 2023-02-28 date: 2023-02-28 date: 2024-03-08 date: 2024-03-08 name: King's College London class: OTHER name: University of Warwick name: Coventry University name: Barts & The London NHS Trust name: Cystic Fibrosis Trust briefSummary: Newborn bloodspot screening (from now on referred to as screening) for cystic fibrosis (CF) became part of the national screening programme in 2007. Screening for CF is also well established internationally. The current process works well but has some disadvantages: carrier reporting - which is not the intention of CF screening in the UK (\~200 pa); need for repeat samples which can be costly and contribute to parental worry (\~300 pa.); mutation panels not fully reflecting the ethnic diversity of the birth population; identification of children designated as CF screen positive, inconclusive diagnosis (CFSPID) which can cause uncertainty (\~20-30 pa).

A trial of NGS in one centre in the UK, for one year found that it was technically feasible at reasonable cost and with an acceptable turn around time. In addition, the trial determined that using NGS could mitigate against some of the disadvantages described above.

The purpose of this piece of work was to:

1. Gather, compare and analyse the views of a range of stakeholders on the proposed CF screening protocol incorporating NGS.
2. Use the outcomes to inform discussions and decisions by the fetal, maternal and child health (FMCH) group and UK National Screening Committee (NSC) about the proposed protocol
3. Consider what generalisable information on the views of stakeholders on newborn screening could be generated from this exercise to inform other FMCH and UK NSC discussions
4. Evaluate and learn from the exercise to inform future stakeholder engagement activities by the UK NSC and screening programmes. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ACTUAL measure: Focus groups/interviews/questionnaires exploring stakeholder views of the proposed CF screening protocol incorporating NGS. measure: Focus groups/interviews/questionnaires exploring stakeholder views on equivocal, carrier, false positives/negatives results, late onset/uncertain conditions measure: Q sorts used to develop data and materials FMCH and UK NSC can use to engage stakeholders measure: Surveys to explore principles of engagement for stakeholders sex: ALL minimumAge: 10 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: King's College London city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06299553 id: INCB88888-040 PRO-MIND briefTitle: Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND) overallStatus: RECRUITING date: 2023-12-04 date: 2025-06-30 date: 2027-06-30 date: 2024-03-08 date: 2024-03-12 name: Incyte Biosciences Italy S.r.l class: INDUSTRY briefSummary: The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL. conditions: DLBCL - Diffuse Large B Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Progression free survival (PFS) measure: Baseline Characteristics measure: Overall Response Rate (ORR) measure: Duration of Response (DoR) measure: Time to next treatment (TTNT) measure: Time to response measure: Overall Survival (OS) measure: Disease Control Rate (DCR) measure: Event Free Survival (EFS) measure: Progression-Free-Survival 2 (PFS2) measure: Information of which treatment the patients will get after tafasitamab discontinuation measure: Safety of tafasitamab combined with lenalidomide measure: Safety of tafasitamab in monotherapy measure: Describe the treatment adherence of lenalidomide and dose reduction. measure: Health-Related Quality of Life (HRQoL) measure: Health-Related Quality of Life (HRQoL) measure: Health economics - Hospitalization measure: Health economics - DLBCL treatment measure: Health economics - Concomitant Treatments measure: Health economics - Monitoring activities measure: Health economics - monitoring activities performed after patients' discharge measure: Health economics - Adverse event treatment measure: Health economics - Unplanned specialist visits measure: Exploratory objectives measure: Exploratory objectives sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Incyte Biosciences Italy S.r.l status: RECRUITING city: Milan zip: 20122 country: Italy name: Nicola Battaglia role: CONTACT phone: +39 3429513636 email: NBattaglia@incyte.com name: Mario Lapecorella role: CONTACT email: MLapecorella@incyte.com name: Pier Luigi Zinzani role: PRINCIPAL_INVESTIGATOR name: Eliana Valentina Liardo role: PRINCIPAL_INVESTIGATOR name: Paolo Corradini role: PRINCIPAL_INVESTIGATOR name: Enrico Derenzini role: PRINCIPAL_INVESTIGATOR name: Francesca Gaia Rossi Dardanoni role: PRINCIPAL_INVESTIGATOR name: Andrès Ferreri role: PRINCIPAL_INVESTIGATOR name: Leonardo Flenghi role: PRINCIPAL_INVESTIGATOR name: Caterina Patti role: PRINCIPAL_INVESTIGATOR name: Maurizio Musso role: PRINCIPAL_INVESTIGATOR name: Annalisa Chiarenza role: PRINCIPAL_INVESTIGATOR name: Adalberto Ibatici role: PRINCIPAL_INVESTIGATOR name: Michele Spina role: PRINCIPAL_INVESTIGATOR name: Alice Di Rocco role: PRINCIPAL_INVESTIGATOR name: Maria Christina Cox role: PRINCIPAL_INVESTIGATOR name: Stefan Hohaus role: PRINCIPAL_INVESTIGATOR name: Andrea Bernardelli role: PRINCIPAL_INVESTIGATOR name: Francesco Piazza role: PRINCIPAL_INVESTIGATOR name: Domenico Pastore role: PRINCIPAL_INVESTIGATOR name: Giuseppe Tarantini role: PRINCIPAL_INVESTIGATOR name: Daniela Dessì role: PRINCIPAL_INVESTIGATOR name: Sofya Kovalchuk role: PRINCIPAL_INVESTIGATOR name: Alberto Fabbri role: PRINCIPAL_INVESTIGATOR name: Antonio Pinto role: PRINCIPAL_INVESTIGATOR name: Ferdinando Frigeri role: PRINCIPAL_INVESTIGATOR name: Mario Annunziata role: PRINCIPAL_INVESTIGATOR name: Elsa Pennese role: PRINCIPAL_INVESTIGATOR name: Caterina Cecilia Stelitano role: PRINCIPAL_INVESTIGATOR name: Mattia Novo role: PRINCIPAL_INVESTIGATOR name: Manuela Zanni role: PRINCIPAL_INVESTIGATOR name: Guido Gini role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06299540 id: 54179060CLL4033 id: 54179060CLL4033 type: OTHER domain: Janssen-Cilag France briefTitle: Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia acronym: QOLIBRI overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-09-30 date: 2026-09-30 date: 2024-03-08 date: 2024-04-25 name: Janssen Cilag S.A.S. class: INDUSTRY briefSummary: The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G). conditions: Leukemia, Lymphocytic, Chronic, B-Cell studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 256 type: ESTIMATED name: Individual Physical Activity Intervention (IPAI) name: Ibrutinib measure: Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5 measure: Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12 measure: Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12 measure: Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12 measure: Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12 measure: Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12 measure: Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12 measure: Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline measure: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in the Pittsburgh Sleep Quality Index (PSQI) Total Score and Sub Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Total Sleep Time Using Connected Watch measure: Change From Baseline in Total Sleep Score Using Connected Watch measure: Change From Baseline in Sleep Stages Using Connected Watch measure: Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch measure: Percentage of Participants with Treatment-related Adverse Events measure: Time to Treatment Discontinuation (TTD) measure: Reasons for Treatment Discontinuation measure: Percentage of Participants Who Still Wear the Connected Watch measure: Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch) measure: Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment measure: For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI measure: For Group 1: Percentage of Participants Who Follow the Adapted Physical Activity (APA) Sessions, the Walking Objectives and the APA Appointment as Scheduled With the APA Among Those Who Have Started IPAI measure: For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study measure: For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study measure: For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study measure: For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299527 id: 01032024 briefTitle: Telerehabilitation in Patients With Fibromyalgia overallStatus: COMPLETED date: 2023-05-27 date: 2023-11-15 date: 2024-01-27 date: 2024-03-08 date: 2024-03-13 name: Marmara University class: OTHER briefSummary: Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16). conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 66 type: ACTUAL name: Exercise Program measure: Visual Analog Scale measure: Revised Fibromyalgia Impact Questionnaire measure: Pain Catastrophizing Scale measure: Hospital Anxiety and Depression Scale measure: 6 Minute Walk Test measure: Arm Curl Test measure: Laser Cursor Assisted Angle Repetition Test (LI-RATT) measure: Short Form - 12 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences city: Istanbul state: Maltepe zip: 1464185881 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06299514 id: 4754 briefTitle: RAFT-P&A Randomized Control Trial overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2028-12-31 date: 2029-12-31 date: 2024-03-08 date: 2024-03-12 name: Lawson Health Research Institute class: OTHER briefSummary: Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.

A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy. conditions: Atrial Fibrillation conditions: Heart Failure conditions: Pacemaker conditions: Arrhythmia Atrial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1200 type: ESTIMATED name: Pace and Ablate name: Medication measure: Winratio measure: All-cause mortality measure: Cardiovascular mortality measure: Number of heart failure events measure: All-cause hospitalization measure: Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ) measure: Exercise measure: Biochemical marker sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London Health Sciences Centre - University Hospital city: London state: Ontario zip: N6A5A5 country: Canada lat: 42.98339 lon: -81.23304 facility: London Health Sciences Research city: London state: Ontario zip: N6G5A5 country: Canada name: Abbie Pardo role: CONTACT phone: 5196612111 phoneExt: 86459 email: abbie.pardo@lhsc.on.ca lat: 42.98339 lon: -81.23304 hasResults: False

 nctId: NCT06299501 id: LS 2015-1199 and 2017-24 briefTitle: How Can Child Health Services Identify and Respond to Family Violence overallStatus: COMPLETED date: 2017-08-23 date: 2019-08-31 date: 2019-08-31 date: 2024-03-07 date: 2024-03-08 name: Karolinska Institutet class: OTHER name: Jane and Dan Olsson Foundation for Scientific Purposes name: Region Stockholm briefSummary: Family violence has severe impacts on children's health and development. The Child Health Services (CHS) in Sweden reaches almost 100% of families with young children and provides a unique setting to facilitate identification of family violence. This study is a three-armed randomized controlled trial (RCT) conducted to assess the effectiveness of different approaches to identify family violence within CHS. Two different approaches are tested and compared to treatment as usual; 1) information about family violence at home visit when child is newborn, and questions posed to all mothers at the 6-8-week visit; 2) information about family violence at home visit when child is newborn, and questions posed to mothers on evidence based indication. Nurses who are randomized into any of the two intervention arms receive training and supervision. The outcomes of the study are related to knowledge, attitudes, and practices around identification and support in case of family violence and number of identified cases of family violence. conditions: Family Violence conditions: Domestic Violence conditions: Intimate-partner Violence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three-armed study, two intervention groups and one control group primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 85 type: ACTUAL name: Routine questions name: Questions on evidence based indication name: Treatment as usual measure: Knowledge, attitudes and practices measure: Number of cases of family violence sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Central Child Health Care (Centrala barnhälsovården) city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06299488 id: PS03 briefTitle: Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia acronym: Sip2Sleep overallStatus: COMPLETED date: 2023-04-05 date: 2023-06-01 date: 2023-07-01 date: 2024-03-07 date: 2024-03-07 name: Lakshmi Nutraceuticals LLC class: INDUSTRY name: People Science, Inc. briefSummary: Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf extract) on sleep. The purpose of this study is to evaluate the effects of taking this combination product on various aspects of sleep. This study is being conducted by People Science, and is sponsored by Lakshmi Nutraceuticals, LLC. The information we gather will help inform how people may use Sip2Sleep® to affect the quality of sleep.

Participants in this study will complete a number of surveys about their difficulties falling asleep and staying asleep (insomnia), their energy level during the day and health status regarding their quality of sleep.

There are no major risks associated with this study. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will complete a 5-week study consisting of screening assessments, baseline scales and surveys, objective digital measure, 2 weeks of product use (1 week on - 1 week off - 1 week on), scales and surveys, and end of study assessments and surveys. This is a remote observational study that will use the People Science app-based data collection platform Consumer Health Learning and Organizing Ecosystem (CHLOE) for study participants to report their assessments and collect objective sleep data from personal wearable devices. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study. primaryPurpose: TREATMENT masking: NONE maskingDescription: This study is not blinded. Participants consume the intervention on alternating weeks. All participants receive the intervention count: 77 type: ACTUAL name: Sip2Sleep: Montmorency Cherry and Apocynum Venetum measure: Subjective Sleep Quality measure: Insomnia Sleep Index measure: Generalized Anxiety Disorder-7 (GAD-7) measure: Subjective Alertness measure: Exploratory: Sleep Duration measure: Exploratory: Sleep Latency measure: Participant Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: People Science Inc. city: West Hollywood state: California zip: 90069 country: United States lat: 34.09001 lon: -118.36174 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-03-24 uploadDate: 2024-02-28T17:22 filename: Prot_SAP_000.pdf size: 436932 hasResults: False

 nctId: NCT06299475 id: 2023-06755-01 briefTitle: Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC acronym: LOWEC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2026-09 date: 2024-03-07 date: 2024-03-07 name: Karolinska Institutet class: OTHER name: the Swedish Pharmacy Association briefSummary: To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP). conditions: Contraception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A cluster randomized crossover trial primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 600 type: ESTIMATED name: Online counseling and invitation measure: Use of effective contraception measure: Contraceptive use measure: Incidence of pregnancy and abortion measure: Satisfaction with the intervention measure: Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups measure: Process evaluation sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299462 id: PTCy-ATG-001 briefTitle: PTCy and ATG for MSD and MUD Transplants overallStatus: NOT_YET_RECRUITING date: 2024-05-21 date: 2031-06-01 date: 2031-06-01 date: 2024-03-07 date: 2024-03-07 name: Instituto Nacional de Cancer, Brazil class: OTHER_GOV briefSummary: Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched).

Since then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch.

This is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant).

Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.

The stem cell collection target will be 5E6 CD34/kg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.

Graft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1, depending on ATG de-escalation, for matched-sibling transplants, according to prespecified criteria based on the 3+3 approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for unrelated donors. conditions: Acute Myeloid Leukemia conditions: Acute Lymphoblastic Leukemia conditions: Myelodysplastic Syndromes conditions: Hodgkin Lymphoma conditions: Non-hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with a matched sibling donor will be assigned to the PTCy+ATG2.5±1.5 arm, while patients with an matched unrelated donor will be assigned to the PTCy+ATG5.0 arm primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: ATG 5.0 name: Cyclophosphamide injection name: ATG 2.5±1.5 measure: Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria measure: Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria measure: Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949 measure: Cumulative incidence of chronic GVHD as defined by the NIH criteria measure: Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria measure: Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse measure: Cumulative incidence of relapse, defined as > 5% blasts in bone marrow or 1% blasts in peripheral blood (acute leukemias/myelodysplasia) or biopsy proven relapse or positve PET-CT (lymphoma) measure: Rate of overall survival measure: Rate of disease-free survival (death or relapse) measure: Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment) measure: Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms) measure: Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL) measure: Measuremnt of quality of life using the FACT-BMT scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-03-23 uploadDate: 2023-03-23T15:38 filename: Prot_SAP_000.pdf size: 322979 hasResults: False

 nctId: NCT06299449 id: KFSIRB200-174 briefTitle: Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement overallStatus: RECRUITING date: 2024-03-05 date: 2025-03-15 date: 2025-03-20 date: 2024-03-07 date: 2024-03-12 name: Kafrelsheikh University class: OTHER briefSummary: Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach. conditions: Implant Complication conditions: Dental Implant Failed studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: free-hand socket shield name: AI/guided socket shield measure: Stability Quotient of dental implant measure: pink esthetic score measure: Midfacial Mucosal Alterations measure: facial marginal bone level sex: ALL minimumAge: 19 Years maximumAge: 40 Years stdAges: ADULT facility: faculty of dentistry, kafrelsheikh University status: RECRUITING city: Kafr Ash Shaykh state: Kafrelsheikh zip: 214312 country: Egypt name: walid elamrousy role: CONTACT phone: +201005724781 email: Waled_Hammed@den.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06299436 id: IRB00426760 id: R01HL172830 type: OTHER domain: NHLBI/NIH briefTitle: Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure acronym: HALT-RHF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-03-31 date: 2029-03-31 date: 2024-03-07 date: 2024-03-07 name: Johns Hopkins University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH. conditions: Heart Failure With Reduced Ejection Fraction conditions: Pulmonary Hypertension conditions: Right Heart Failure Due to Left Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Diagnostic accuracy based on Area Under Curve (AUC) measure: Percentage improvement in ex vivo right ventricular tissue sample measure: Predictive capacity (based on likelihood ratio) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299423 id: 3677 briefTitle: Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients acronym: PeRseo overallStatus: RECRUITING date: 2023-11-22 date: 2025-06-30 date: 2025-11-30 date: 2024-03-07 date: 2024-03-08 name: Istituto Clinico Humanitas class: OTHER briefSummary: Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring. conditions: Inflammatory Bowel Diseases conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Single-center, interventional, case-series study with a historical cohort of comparison primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Howdy Senior® device measure: Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV) measure: Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI) measure: Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S) measure: Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery measure: 90-day postoperative complications measure: Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV) measure: Healthcare costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06299410 id: ITI-1284-008 briefTitle: PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-07 date: 2024-03-07 name: Intra-Cellular Therapies, Inc. class: INDUSTRY briefSummary: The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: ITI-1284 10 mg name: ITI-1284 20 mg measure: % Receptor occupancy measure: Pharmacokinetics: AUC0-t measure: Pharmacokinetics: Cmax measure: Pharmacokinetics: Tmax measure: Percentage of subjects with treatment-emergent adverse events measure: Change from baseline in ECG QT interval measure: Change from baseline in aspartate aminotransferase measure: Change from baseline in alanine aminotransferase sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Clinical Site 1 city: New Haven state: Connecticut zip: 06520 country: United States lat: 41.30815 lon: -72.92816 hasResults: False

 nctId: NCT06299397 id: Inonu-SBF-4 briefTitle: Breastfeeding Education and Humor-Based Practices on Breastfeeding overallStatus: COMPLETED date: 2023-06-14 date: 2023-07-14 date: 2024-02-14 date: 2024-03-07 date: 2024-03-12 name: Inonu University class: OTHER briefSummary: The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'. conditions: Humor as Topic conditions: Breast Feeding conditions: Mother-Child Relations conditions: Breastfeeding, Exclusive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants determined by the researchers before starting the study were divided into experimental and control groups by randomization method. Humor-based breastfeeding education was given to women in the experimental group for 35-45 minutes once a week for 2 weeks on specified days and hours. Breastfeeding education was given in practice. Then, humor was practiced with songs and clown costumes. An interim test was administered one month after this application and a final test was administered three months later. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: After randomization was performed by a researcher independent of the study, it was decided by lottery method which group would be the experiment and which group would be the control group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 64 type: ACTUAL name: breastfeeding - humor training name: Control Group measure: Breastfeeding Motivation Scale measure: Maternal Attachment Scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Simge OZTURK city: Bartin zip: 74100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False

 nctId: NCT06299384 id: R44MH133517 type: NIH link: https://reporter.nih.gov/quickSearch/R44MH133517 briefTitle: The Use of Voice-Based AI in 988 Crisis Counseling overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-06 date: 2026-08 date: 2024-03-07 date: 2024-03-07 name: Lyssn.io, Inc. class: INDUSTRY name: ProtoCall Services, Inc. briefSummary: Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. Our goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities. conditions: Suicide conditions: Suicide and Self-harm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: LyssnCrisis measure: Post-Call Survey measure: Call-taker crisis counseling fidelity measure: System Usability Scale (SUS) measure: Acceptability of Intervention Measure; AIM measure: Intervention Appropriateness Measure; IAM measure: Feasibility of Intervention Measure; FIM sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299371 id: MA-NSCLC-II-033 briefTitle: Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2029-04-15 date: 2024-03-07 date: 2024-03-07 name: Liaoning Tumor Hospital & Institute class: OTHER briefSummary: This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Adebrelimab name: paclitaxel for injection (albumin bound) name: Cisplatin or Carboplatin measure: Pathological complete response rate measure: Major pathologic response rate measure: R0 rate measure: Event Free Survival measure: Overall Survival measure: Objective response rate measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299358 id: KMU_MPEPE_1 briefTitle: Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-06 date: 2024-08-15 date: 2025-01-01 date: 2024-03-07 date: 2024-03-07 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Infantile colic is a developmental disorder that reduces comfort levels in infants with intense crying crises and has negative effects on the infant and family. The study is planned to measure the effect of the combination of maternal heart sound simulation, aromatic foot massage and maternal heart sound simulation and aromatic foot massage on the colic and comfort levels of infants with infantile colic. It is aimed to alleviate colic symptoms, increase comfort levels, regulate daily crying and sleep durations (increase in sleep durations, decrease in crying durations) and support the development of infants in this context by using maternal heart sound simulation, aromatic foot massage and their combined application. conditions: Nurse's Role conditions: Infantile Colic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Type and Purpose of the Study The study was designed as a randomized experimental study. Sample of the Study G\* Power 3.1.9.7. program was used to calculate the sample size (Faul et al., 2007). As a result of the analysis, the sample size was calculated as 28 people for each of the three groups, and considering the possible data losses, it was decided to take 30 people for each group.

In the study, computer-aided randomization (random.org) program was used to determine the groups. Stratified randomization was preferred to ensure group similarity. In stratification, the number of weeks of age, gender and feeding patterns of the babies were used. After stratification, block randomization was used to decide which group the babies would be in.

SPSS 22.0 package program will be used for data analysis. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: In the study, interviews will be conducted at different times so that mothers or caregivers do not encounter mothers/caregivers in other groups. In this way, participant blinding will be ensured. Since the study will be conducted with newborns, no study will be conducted on other blinding techniques and biases. In order to prevent bias in the data evaluation process, each baby will be numbered by the researcher during the application and these numbers will be used by the statistical expert in statistical evaluations. The statistical expert will not learn the identity information of the participants and will only perform statistics according to the numbering. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Foot massage name: Mother heart sound name: Foot massage and maternal heart sound measure: Changes in colic scale ratings induced by maternal heart sound measure: Changes in comfort scale ratings as a result of maternal heart sound measure: Changes in colic scale assessments induced by foot massage measure: Changes in comfort scale assessments induced by foot massage sex: ALL minimumAge: 2 Weeks maximumAge: 16 Weeks stdAges: CHILD facility: Karamanoglu Mehmetbey University city: Karaman state: Center zip: 70100 country: Turkey lat: 37.18111 lon: 33.215 hasResults: False

 nctId: NCT06299345 id: 1870394-1 briefTitle: The Effect of Motor Imagery Dosage on Motor Learning in Healthy Adults overallStatus: COMPLETED date: 2022-03-01 date: 2022-04-20 date: 2022-04-28 date: 2024-03-07 date: 2024-03-12 name: Ahmed Mahmoud Kadry class: OTHER name: Concordia University Wisconsin briefSummary: The goal of this clinical trial is to compare the effects of different durations of Motor Imagery (MI) practice and physical practice on motor performance enhancement in healthy adults. The main questions it aims to answer are:

* Does Motor Imagery (MI) practice improve motor performance?
* How do different doses of MI practice (low vs. high) compare to no MI practice in enhancing motor performance?

Participants:

* Be randomly assigned to one of three groups: no MI practice (control group), low dose MI practice (6 minutes per session), or high dose MI practice (12 minutes per session).
* Complete nine sessions over three weeks, practicing a timed mirror tracing task.
* Have their performance measured in each session by the time taken to complete the task and the number of errors made.

Compared the control group, low dose MI group, and high dose MI group to see if there are significant differences in motor performance enhancement, aiming to determine the effectiveness of MI and the optimal dose for practice. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: The participants were blinded about which group they were allocated (control or intervention) whoMasked: PARTICIPANT count: 27 type: ACTUAL name: Motor imagery training name: NO motor imagery training measure: Time measure: Errors sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Concordia University Wisconsin city: Mequon state: Wisconsin zip: 53097 country: United States lat: 43.21573 lon: -88.02962 facility: Kafrelshaikh University city: Kafr Ash Shaykh zip: 12623 country: Egypt lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06299332 id: DO611503A briefTitle: Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction overallStatus: RECRUITING date: 2023-06-23 date: 2024-05 date: 2025-05 date: 2024-03-07 date: 2024-03-07 name: InMode MD Ltd. class: INDUSTRY briefSummary: The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED). conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open-label clinical study. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Device treatment measure: Change in ED symptoms, following the RF treatment measure: Change in sexual activity leading to optimal penetration measure: Evaluate efficacy of the RF treatment for erectile function measure: Evaluate efficacy of the RF treatment for erectile function measure: Evaluate efficacy of the RF treatment for erectile function measure: Evaluate efficacy of the RF treatment for hardness of erection measure: Measuring pain level during the procedure sex: MALE minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LC Medical 140 W 58th St, Suite A New York, NY 10019 status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Lanna Cheuck role: CONTACT phone: 929-492-2052 lat: 40.71427 lon: -74.00597 facility: Washington Heights Urology status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Robert Valenzuela role: CONTACT phone: 212-781-9696 lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06299319 id: 149-2021 briefTitle: Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD acronym: PAP-OCD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-09 date: 2024-03-07 date: 2024-03-07 name: Centre for Addiction and Mental Health class: OTHER briefSummary: Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD).

The purpose of this study is to evaluate the safety, feasibility, and clinical effects of psilocybin administration in those with OCD. Ten participants with treatment-resistant OCD will receive two doses of 25mg of psilocybin under supportive conditions, two weeks apart. The investigators hypothesize that two sessions of psilocybin 25mg administered under supportive conditions to participants with treatment-resistant OCD will lead to significant reductions in OCD symptoms. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Psilocybin measure: Feasibility of administering psilocybin (25 mg) in adults with treatment-resistant OCD measure: Incidence of adverse events (Safety and Tolerability) measure: Change in the Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score from baseline measure: Proportion of participants who respond to treatment measure: Changes in Patient Health Questionnaire (PHQ-9) from Baseline to Week 3 measure: Change in the Clinical Global Impression (CGI) scale from Baseline to Week 3 measure: Change in the World Health Organization Quality of Life Short Version (WHOQOL-BREF) score from Baseline to Week 3 measure: Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) from Baseline to Week 3 measure: Change in Generalized Anxiety Disorder (GAD-7) scores from Baseline to Week 3 measure: Changes in behavioural assessments for well-being (Warwick-Edinburgh Mental Wellbeing Scale; WEMWBS) from Baseline to Week 3 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: 2023-10-20 uploadDate: 2024-02-14T17:40 filename: Prot_SAP_000.pdf size: 879497 hasResults: False

 nctId: NCT06299306 id: D3250R00116 briefTitle: REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma acronym: REACT-Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-01-31 date: 2026-01-31 date: 2024-03-07 date: 2024-03-21 name: AstraZeneca class: INDUSTRY briefSummary: This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany. conditions: Asthma, Bronchial studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1650 type: ESTIMATED measure: Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment. measure: Changes in the AIRQ® total score measure: Bi-weekly changes in the AIRQ® total score over time measure: Changes in the AIRQ® impairment domain score measure: Changes in the AIRQ® risk domain score measure: Proportion of patients with prescribed use of oral corticosteroids (OCS) measure: Proportion of patients with self-reported OCS use measure: Proportion of patients with a change in other asthma therapies measure: Treatment switches (change in prescribed therapies) over time and time on treatment. measure: Assessment of the patient satisfaction with digital and analog healthcare measure: Assessment of the patient-reported 1-year prior healthcare utilization measure: Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare measure: Assessment of the provider preferences in digital versus analog healthcare monitoring. measure: Assessment of the patient preferences towards remote monitoring and healthcare delivery. measure: Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS measure: Changes in laboratory parameter - IgE level measure: Changes in lung function parameters - Tiffenau-Index measure: Correlations between environmental factors and patients' asthma exacerbations measure: Correlation between environmental factors and changes in AIRQ® score measure: Changes in laboratory parameter - blood eosinophil measure: Changes in laboratory parameter - blood neutrophil measure: Changes in laboratory parameter - FeNO measure: Changes in laboratory parameter - C-reactive protein (CRP) level measure: Changes in lung function parameters - FEV1 % sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299293 id: 21C306 briefTitle: Facial Emotion Recognition in Anorexia Nervosa acronym: FER_AN overallStatus: COMPLETED date: 2023-02-01 date: 2024-02-01 date: 2024-02-01 date: 2024-03-07 date: 2024-03-07 name: Istituto Auxologico Italiano class: OTHER briefSummary: Altered emotional processing is reported in Anorexia Nervosa. However, this capability is generally measured through explicit measures, like self-report questionnaires and facial emotion recognition tasks. Instead, no previous research has investigated implicit emotional processing in this clinical condition. In the implicit facial emotion recognition task grounded on the implicit "redundant target effect", individuals generally respond faster when two identical targets are presented simultaneously rather than when presented alone; moreover, the competitive presence of a distractor (that is another emotion or a neutral expression) affects the correct recognition of the target. The ability to recognize and detect facial expressions is explored about two main emotions, fear and anger, because of their role in the intra- and interindividual psychological processing. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ACTUAL name: Facial Emotion Recognition Test measure: Behavioural measure relative to recognition ability measure: Behavioural measure relative to the detection ability sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe city: Piancavallo state: VCO zip: 28824 country: Italy hasResults: False

 nctId: NCT06299280 id: Igdir180 briefTitle: The Effect Of Dual-Task Training On Motor And Cognitive Performance In School-Age Children acronym: Dual-task overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-15 date: 2024-09-01 date: 2024-03-07 date: 2024-03-15 name: Igdir University class: OTHER briefSummary: The aim of the study is to investigate the effect of dual task training on performance in school-age children. Although studies on this subject in the world are limited, a comprehensive study on school-age children is needed.

MATERIAL AND METHOD:

* Evaluation will begin by applying demographic information and the Physical Activity Survey for Children.
* The evaluations to be made will primarily evaluate the child's performance on a single cognitive task in a supported sitting position on a chair, without a motor task.
* To evaluate single motor performance, a 2-minute walk test and a 30-second sit-stand test will be applied.
* Dual task evaluations will be carried out by adding a cognitive task while applying the 2-minute walk and 30-second sit-to-stand test.
* Walking speed will be evaluated with the 10m walk test.
* Balance parameter will be evaluated with functional reaching test.
* Using the Visual Analog Scale (VAS), participating children will be asked to score the difficulty of cognitive and motor performance as a number between 0 and 10.
* Walking speeds will be normalized by measuring lower extremity lengths.
* The children will be randomly divided into two groups and the study group will be given dual-task training by creating dual-task situations during the activities carried out in physical education classes.
* After 4 weeks, appropriate analyzes will be made with the data obtained as a result of the evaluations performed by the same evaluator.

As a result of this study, motor and cognitive performance in single-task conditions in typically developing children will be revealed. Additionally, changes in this performance will be detected in dual-task situations. The gains to be obtained as a result of the training will also reveal the importance of implementing dual task training in school-age children. conditions: Healthy conditions: Child, Only studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomised controlled primaryPurpose: OTHER masking: DOUBLE maskingDescription: double-blind whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: dual task training name: single task training measure: Physical Activity Questionnaire for Children (PAQ-C) measure: Physical Activity Questionnaire for Adolescent (PAQ-A) measure: Single cognitive task performance measure: 2-minute walk test measure: 30-second sit-stand test measure: 10m walk test. (single-task conditions) measure: 10m walk test. (dual-task conditions) measure: functional reaching test. measure: Visual Analog Scale (VAS) measure: lower extremity lengths assessment sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD hasResults: False

 nctId: NCT06299267 id: Igdir181 briefTitle: The Effect of Dual Task on Manual Skill Performance in Children and Adolescents acronym: Dual-task overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-15 date: 2024-07-15 date: 2024-03-07 date: 2024-03-07 name: Igdir University class: OTHER briefSummary: The aim of the study is to investigate the effect of dual-task conditions on manual dexterity performance in typically developing young people and children between the ages of 7-18.

MATERIAL AND METHOD:

* Demographic information, dominant extremity will be noted and the evaluation will begin by applying the Physical Activity Questionnaire for Children.
* The evaluations will primarily evaluate the child's performance on a single cognitive task
* The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or adolescent.
* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.
* the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.
* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the -9-Hole Test and writing a paragraph.
* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.

As a result of this study, manual dexterity performance and cognitive performance in single-task conditions in typically developing children and adolescents will be revealed. Additionally, changes in this performance will be detected in dual-task situations. conditions: Child, Only conditions: Adolescent Development studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: dual task conditions measure: single cognitive task measure: Visual Analogue Scale (VAS) measure: 9-Hole Peg Test.-Single task measure: 9-Hole Peg Test and writing a given paragraph.-Dual task measure: writing a given paragraph.-Single task measure: writing a given paragraph.-Dual task sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06299254 id: 21C305 briefTitle: Placebo Effect About Fatigue in Obesity acronym: POF overallStatus: RECRUITING date: 2023-03-01 date: 2024-02-27 date: 2025-03-01 date: 2024-03-07 date: 2024-03-07 name: Istituto Auxologico Italiano class: OTHER name: University of Turin, Italy briefSummary: Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels. conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: Placebo-Natural History measure: Behavioural outcome of fatigue measure: The individual level of perceived fatigue sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe status: RECRUITING city: Piancavallo state: VCO zip: 28824 country: Italy name: Federica Scarpina, PhD role: CONTACT phone: +39032351 phoneExt: 4003 email: f.scarpina@auxologico.it hasResults: False

 nctId: NCT06299241 id: 01C313 briefTitle: Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity acronym: PREFISAR overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-21 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-07 name: Istituto Auxologico Italiano class: OTHER briefSummary: The primary objectives of the present study are to estimate the sarcopenic proportion in a cohort of obese older subjects who have been hospitalized. The secondary objective is to individuate several clinical variables that differ between the sarcopenic obese patient and the not sarcopenic obese patient. conditions: Obesity conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED measure: Fat free mass measure: Evaluation of lower limb muscle strength measure: Senior Fitness Test (SFT) measure: Physical performance test (PPT) measure: Fat mass measure: Questionnaire SF-12 (Short Form Health Survey) measure: Oswestry Disability Index questionnaire sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano, Site Piancavallo city: Oggebbio state: Verbania zip: 28824 country: Italy lat: 45.99088 lon: 8.64663 hasResults: False

 nctId: NCT06299228 id: HSA briefTitle: Is Sensorimotor Training Effective Following a Distal Radius Fracture? overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-07 date: 2024-04-29 name: Hand Surgery Associates LLC class: OTHER name: Touro University Nevada name: Orthopaedic Specialty Group PC, Fairfield briefSummary: The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist. conditions: Distal Radius Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Experimental Group name: Control Group measure: Active Joint Position Sense (AJPS) measure: Patient Rated Wrist and Hand Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hand Surgery Associates status: RECRUITING city: Olyphant state: Pennsylvania zip: 18447 country: United States name: Nancy Naughton, OTD role: CONTACT phone: 570-780-8681 email: nancynaughton10@gmail.com name: Lori Algar, OTD role: CONTACT phone: 2034514938 email: Lori.Algar@gmail.com lat: 41.46841 lon: -75.60297 hasResults: False

 nctId: NCT06299215 id: APHP240044 briefTitle: Factors and Prognosis of Obstructive Pyelonephritis Patients acronym: PYELO-OBS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-01 date: 2026-03-01 date: 2024-03-07 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.

Most of the available data on this condition comes from small, retrospective, single-centre series.

To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.

The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients. conditions: Pyelonephritis conditions: Prognostic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function. measure: Death measure: Stage 3 Acute kidney injury (KDIGO classification) measure: failure to recover renal function measure: the incidence of acute renal failure defined by KDIGO 1 measure: the incidence of acute renal failure defined by KDIGO 2 and 3 measure: the incidence of Renal replacement therapy measure: the incidence of non-recovery of renal fuction measure: The number of days alive without Renal replacement therapy measure: The number of days alive without catecholamines measure: The number of days alive without antibiotics measure: The number of days alive without measure: Death rate sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Saint Louis city: Paris zip: 75010 country: France name: Maxime Dr COUTROT, MD role: CONTACT name: François DEPRET, MD role: CONTACT lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06299202 id: 69HCL23_0204 id: ID-RCB type: OTHER domain: 2023-A01905-40 briefTitle: Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy acronym: CERePred overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-03-07 date: 2024-03-07 name: Hospices Civils de Lyon class: OTHER briefSummary: Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment).

Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging (MRI).Tumour response to treatment is assessed on morphological size criteria.

Angiomammography (also called CESM : Contrast Enhanced Spectral Mammography) is an innovative and validated imaging technique consisting of dual energy mammography with injection of iodinated contrast medium; two images are generated, one comparable to a standard mammography and a second image highlighting the structures enhanced by the contrast medium. The characteristic neo angiogenesis of the tumour process thus allows good visualisation of the tumour compared to the underlying mammary gland.

A classical morphological analysis is therefore possible thanks to standard mammographic acquisition coupled with a quantitative functional analysis linked to the study of enhancement.

During angiomammography, several images are acquired in succession, starting with the cranio caudal view and ending with the profile view. On the same examination, these acquisitions are carried out at different injection times, making it possible to study the type of enhancement of a given area (Progressive/ Plateau/ Wash out).

Angiomammography has several advantages over breast MRI in the follow-up of chemotherapy: shorter examination time, shorter appointment time, better tolerated by the patients and without injection of Gadolinium chelates, which have recently been shown to cause definitive brain deposits during repeated injections. Currently, angiomammography is validated in the follow-up of breast cancers treated with neoadjuvant or primary chemotherapy, with an analysis of tumour response currently only morphological, as in breast MRI.

Here, the hypothesis is that the study of tumour enhancement by angiomammography may constitute a new predictive element of histological response: indeed, the performance of an initial angiomammography before treatment (baseline) and then a second angiomammography performed early in relation to the start of chemotherapy, could allow early prediction of which patients will have a complete histological response at the time of the closing surgery. This prospective study is to compare the variation in tumour enhancement, assessed on each of the two examinations using dedicated X-ray consoles, to the final histological result after closure surgery: it is hoped that the relative variation in tumour enhancement would be greater in responding patients. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Diagnostic test measure: The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM measure: RTEe according to the 3 categories of RCB score measure: The type of enhancement (TE) % sex: FEMALE minimumAge: 35 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital de la Croix Rousse city: Lyon zip: 69004 country: France name: Dorothée TACONET, MD role: CONTACT phone: 0426109185 phoneExt: +33 email: dorothee.taconet@chu-lyon.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06299189 id: 309264 briefTitle: A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care acronym: MinADHD overallStatus: RECRUITING date: 2024-01-01 date: 2027-09 date: 2027-09 date: 2024-03-07 date: 2024-03-07 name: Haukeland University Hospital class: OTHER briefSummary: The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:

i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program. conditions: ADHD conditions: ADHD - Combined Type conditions: ADHD Predominantly Inattentive Type conditions: ADHD, Predominantly Hyperactive - Impulsive studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: MinADHD measure: The Adult ADHD Self-Rating Scale measure: Adult ADHD Quality of Life Measure measure: The Patient Health Questionnaire measure: Generalized Anxiety Disorder-7 measure: Personality Disorder Severity ICD-11 measure: EuroQoL 5D-5L sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bjørgvin DPS status: RECRUITING city: Bergen country: Norway name: Gunn Elise Sæthre role: CONTACT phone: 00000000 lat: 60.39299 lon: 5.32415 hasResults: False

 nctId: NCT06299176 id: ESHF-WHRT (2024-10362) briefTitle: Whole Heart Radiotherapy for End-stage Heart Failure acronym: ESHF-WHRT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-07 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: End-stage heart failure (ESHF) causes recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard HF therapies are common as the disease progresses. Management focuses on controlling symptoms, correcting precipitants, avoiding triggers, and improving quality-of-life. The combination of recent preclinical and clinical data suggests that localized cardiac RT is relatively safe and has positive conductive and anti-proliferative effects in the "sick" heart. In this Phase 1 study, the investigators aim to assess the feasibility and safety of 5 Gy whole heart radiotherapy in six (6) ESHF participants with limited options for further medical therapy to control their disease. The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type natriuretic peptide (BNP), C-reactive protein (CRP), and troponins, while also having a very tolerable side effect profile. conditions: Heart Failure NYHA Class III conditions: Heart Failure NYHA Class IV conditions: End-stage Heart Failure conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 6 participants with end-stage heart failure (NYHA 3 or 4, LVEF \< 30%) with no other standard of care therapy options to receive whole heart radiation therapy. primaryPurpose: TREATMENT masking: NONE maskingDescription: no masking count: 6 type: ESTIMATED name: Whole Heart Radiation Therapy measure: Change in mean left ventricle ejection fraction measure: Acute adverse events definitely or probably related to radiation therapy at 30 days as per CTCAE v 5.0 measure: Overall survival measure: Hospital stays measure: Subacute adverse events measure: Late adverse events measure: Medication Changes - dose measure: Medication Changes - number measure: Quality of life CHFQOLQ-20 measure: Quality of life - SF-36 measure: Troponin changes measure: Lactate changes measure: Renal Function measure: b-natrurietic peptide sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299163 id: NB-NM032-2668-101 briefTitle: NM32-2668 in Adult Patients With Selected Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-29 date: 2027-12-31 date: 2027-12-31 date: 2024-03-07 date: 2024-03-07 name: Numab Therapeutics AG class: INDUSTRY briefSummary: This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors. conditions: Ovarian Carcinoma conditions: Fallopian Tube Carcinoma conditions: Peritoneal Carcinoma conditions: Endometrial Cancer conditions: Adenocarcinoma of Lung conditions: Triple Negative Breast Cancer conditions: Liposarcoma conditions: Leiomyosarcoma conditions: Mesothelioma, Malignant conditions: Adenocarcinoma - Gastroesophageal Junction (GEJ) conditions: Adenocarcinoma of the Stomach conditions: Melanoma, Malignant conditions: Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: NM32-2668 measure: Incidence of Dose Limiting Toxicities (DLTs) measure: Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 / ASTCT (for Cytokine Release Syndrome [CRS]) measure: Frequency of dose interruptions/reductions measure: Duration of dose interruptions/reductions measure: Assessment of the maximum observed serum concentration (Cmax) measure: Assessment of the the minimum observed serum concentration (Cmin) measure: Time from dosing at which maximum observed serum concentration is apparent (Tmax) measure: Assessment of the terminal phase (apparent elimination) rate constant (λz) measure: Assessment of the elimination half-life (t½) measure: Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]) measure: Assessment of the area under serum concentration-time curve over dosing interval (AUCtau) measure: Assessment of clearance (CL) of NM32-2668 in serum measure: Assessment of the volume of distribution (Vd) of NM32-2668 in serum measure: Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum measure: Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum measure: Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum measure: Frequency of specific anti-drug antibodies (ADAs) to NM32-2668 measure: Concentration of specific ADAs to NM32-2668 measure: Incidence of specific ADAs by category to NM32-2668 measure: Best Overall Response (BOR) according to RECIST 1.1 measure: Overall Response Rate (ORR) according to RECIST 1.1 measure: Disease Control Rate (DCR) according to RECIST 1.1 measure: Progression-free Survival (PFS) according to RECIST 1.1 measure: Time to Response (TTR) according to RECIST 1.1 measure: Duration of Response (DOR) according to RECIST 1.1 measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lifespan Cancer Institute at Rhode Island Hospital status: RECRUITING city: Providence state: Rhode Island zip: 02903 country: United States name: Benedito A. Carneiro, MD role: CONTACT name: Benedito A. Carneiro, MD role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 facility: Mary Crowley Cancer Research status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Douglas W. Orr, MD role: CONTACT name: Douglas W. Orr, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06299150 id: 2023-1 briefTitle: Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2025-02-01 date: 2024-03-07 date: 2024-03-07 name: October University for Modern Sciences and Arts class: OTHER briefSummary: Dental trauma (DT) of the incisors and their supporting tissues, which is one of the most challenging dental emergency situations, requires immediate assessment and management due to psychological and physical reasons. (8) This is especially important for young permanent teeth because of continuing development in order to minimize undesired complications. The treatment of dental trauma is sometimes neglected. (9,10) although it might lead to pain, difficulty in articulation and mastication as well as having considerable negative effects on patient's self-esteem. (11) However, aesthetics of the anterior teeth are very important aspects of human appearance and could be affected by many factors including the presence of fillings, tooth color, position, alignment, shape and number. (12)

Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. (13) According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19. (14)

As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic and time-efficient restoration is frequently demanded.(15) According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment.(16) As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color and function in a minimum amount of time. (17,18) Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. (19) Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies. (20, 21)

In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments-has become increasingly popular over the last few years. (22,23) PLVs are thin pieces of glass-matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, as for conventional laminate veneers, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. (24) Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. (25,26) Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies (27,28) and case reports (29, 30, 31), without any clinical information available at present.

Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment or partial laminate veneers) that require minimal to no preparation depends on the type of restoration will receive and doesn't require local anesthesia. conditions: Composites Resins studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: IPS e.max CAD measure: Clinical success/ survival sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06299137 id: RE2022-0000000349 id: RE2022-0000000349 type: OTHER_GRANT domain: Society of Academic Emergency Medicine briefTitle: Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-10 date: 2025-10 date: 2024-03-07 date: 2024-03-12 name: Rhode Island Hospital class: OTHER briefSummary: The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:

* Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.
* Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.

Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures. conditions: Rib Fractures conditions: Pain Acute conditions: Regional Anesthesia conditions: Opioid Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Research Assistants who collect the data will be blinded to which arm of the study the participants are in. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Serratus Anterior Plane Block name: Ropivacaine injection measure: PIC Score measure: Total oral morphine equivalents over the first 24 hours sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rhode Island Hospital city: Providence state: Rhode Island zip: 02903 country: United States name: Leland K Perice, MD role: CONTACT phone: 401-429-3441 email: lperice@lifespan.org name: Leland K Perice, MD role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 hasResults: False

 nctId: NCT06299124 id: RGT-419B-102 briefTitle: A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors overallStatus: RECRUITING date: 2023-04-17 date: 2024-12-30 date: 2025-06-30 date: 2024-03-07 date: 2024-03-08 name: Regor Pharmaceuticals Inc. class: INDUSTRY briefSummary: This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors. conditions: Breast Cancer conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: RGT-419B measure: Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level measure: Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs) measure: Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-TimeCurve to Infinity (AUC0-inf) measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2) measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax) measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion measure: Tumor Response assessed by Investigator according to RECIST v1.1 measure: QTc Interval - Changes in corrected QT interval 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: Yan Zhou role: CONTACT phone: 86-021-31168233 lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06299111 id: R9933-DVT-2308 id: 2023-508603-21-00 type: OTHER domain: EU CT Number briefTitle: A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC) acronym: ROXI-CATH overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2026-06-08 date: 2026-06-08 date: 2024-03-07 date: 2024-03-07 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in your vein, also called a 'PICC line'.

The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.

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

* What side effects may happen from taking the study drug
* How much study drug is in your blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) conditions: Venous Thromboembolism studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 195 type: ESTIMATED name: REGN9933 name: REGN7508 name: Placebo measure: Incidence of confirmed VTE per central reading center (CRC) review measure: Incidence of treatment-emergent adverse event (TEAEs) measure: Severity of TEAEs measure: Incidence of confirmed PICC associated venous thrombosis per CRC review measure: Incidence of major bleeding measure: Incidence of clinically relevant non-major (CRNM) bleeding measure: Concentrations of REGN9933 in serum measure: Concentrations of REGN7508 in serum measure: Change in activated partial thromboplastin time (aPTT) measure: Change in prothrombin time (PT) measure: Incidence of anti-drug antibody (ADA) to REGN9933 over time measure: Titer of ADA to REGN9933 over time measure: Incidence of ADA to REGN7508 over time measure: Titer of ADA to REGN7508 over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299098 id: R1033-OB-2288 briefTitle: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss acronym: COURAGE overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-13 date: 2026-06-24 date: 2026-06-24 date: 2024-03-07 date: 2024-04-01 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B of the study is to see how safe and effective the study drug is when combined with Wegovy.

Parts A and B of the study are looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 624 type: ESTIMATED name: Trevogrumab-Part A name: Trevogrumab-Part B name: Garetosmab name: Semaglutide name: Matching Placebo-Part A name: Matching Placebo-Trevogrumab name: Matching Placebo-Garetosmab measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Percent body weight change measure: Percent change in total fat mass measure: Concentrations of trevogrumab in serum over time measure: Percent body weight change measure: Percent change in total fat mass measure: Percent change in total lean mass measure: Change in waist circumference (cm) measure: Percent change in body weight measure: Percent change in total lean mass measure: Percent change in regional measurements of body composition measure: Percent change in gynoid fat mass measure: Change in total lean mass:total fat mass ratio measure: Proportion of weight loss attributable to fat mass loss measure: Percent change in android (central) fat mass measure: Percent change in thigh muscle volume (TMV) measure: Body weight reduction of ≥5% measure: Body weight reduction of ≥10% measure: Body weight reduction of ≥15% measure: Body weight reduction of ≥20% measure: Body weight reduction of ≥25% measure: Percent change in fasting serum triglycerides measure: Percent change in total cholesterol measure: Percent change in Apolipoprotein B (Apo B) measure: Percent change in low-density lipoprotein cholesterol (LDL-C) measure: Change in physical function domain (5 items) score of Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoLLite- CT) measure: Change in physical functioning domain score of SF-36 measure: Concentrations of garetosmab in serum over time measure: Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time measure: Titer of ADAs to trevogrumab after repeated doses over time measure: Incidence of ADAs to garetosmab after repeated doses over time measure: Titer of ADAs to garetosmab after repeated doses over time measure: Incidence of TEAEs measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ProSciento city: Chula Vista state: California zip: 91911 country: United States lat: 32.64005 lon: -117.0842 facility: Tandem Clinical Research city: Marrero state: Louisiana zip: 70072 country: United States lat: 29.89937 lon: -90.10035 facility: Accellacare of Wilmington city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 hasResults: False

 nctId: NCT06299085 id: OSTEO-BS (L4191) briefTitle: Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-10-31 date: 2026-03-01 date: 2024-03-07 date: 2024-03-07 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality. conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The minimum sample size was determined by considering the circulating levels of gastro-entero hormones (PYY, ghrelin, GLP-1, GIP), adipokines (leptin and adiponectin) and hormones associated with the anabolism of muscle and bone tissue (insulin). as primary endpoints; the highest calculated sample size obtained for ghrelin levels was used for the purposes of this study.

The calculation was performed using G\*Power software (v3.1.9.7) assuming a type I error (α error) of 0.05, a Power (1-β error) of 0.8, an effect size of 0.44.

The resulting minimum sample size is 42 patients. Taking into account the presence of any drop-outs, 20% more patients will be considered, for a total of 50 patients to be enrolled. primaryPurpose: SCREENING masking: NONE count: 50 type: ESTIMATED name: 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery. measure: Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery. measure: Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06299072 id: PEP-2303 briefTitle: A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast overallStatus: COMPLETED date: 2023-09-05 date: 2023-09-19 date: 2023-09-19 date: 2024-03-07 date: 2024-03-12 name: PepsiCo Global R&D class: INDUSTRY briefSummary: In this online survey conducted suing the YouGov consumer insights panel, the primary aims of this study are to provide for the first time an estimate of consumer awareness regarding wholegrains; their definitions and knowledge of potential benefits in the Saudi Arabia adult population and the he estimated consumption amongst Saudi consumers.

Secondary Objectives are to assess the breakfast habit, oat consumption \& health concerns amongst Saudi consumers; identify socio-demographic and consumer characteristics associated with breakfast consumption, the types of foods consumed at breakfast, and fill gaps in knowledge regarding breakfast eating habits, commonly consumed breakfast foods. conditions: Diet, Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 814 type: ACTUAL name: Survey measure: Consumer awareness regarding wholegrains measure: Consumer definitions of wholegrains measure: Consumer knowledge of potential benefits of wholegrains measure: Wholegrain consumption measure: Breakfast habits measure: Oat consumption measure: Health concerns measure: Socio-demographics associated with breakfast consumption measure: Consumer characteristics associated with breakfast consumption measure: Types of foods consumed at breakfast measure: Fill gaps in knowledge regarding breakfast eating habits measure: Commonly consumed breakfast foods sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Remote, no facility visits city: Riyadh country: Saudi Arabia lat: 24.68773 lon: 46.72185 hasResults: False

 nctId: NCT06299059 id: Compliance briefTitle: Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-07 date: 2024-07 date: 2024-03-07 date: 2024-03-12 name: Zeng Changhao class: OTHER briefSummary: The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Rehabilitation Treatment Compliance Questionnaire measure: Patient Health Questionnaire-9 measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299046 id: 3235 briefTitle: Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study acronym: UROBLOOD01 overallStatus: COMPLETED date: 2022-12-01 date: 2023-01-01 date: 2023-01-01 date: 2024-03-07 date: 2024-03-08 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Nowadays robot-assisted radical prostatectomy (RARP) has become the standard surgical treatment for localised prostate cancer. The robotic approach has been proven superior to open retropubic prostatectomy (ORP) in terms of surgical-related morbidity: RARP has in fact been associated with significantly lower estimated blood loos (EBL), lower transfusion rate, less length of stay, shorter catheterization time, lower risk of Clavien-Dindo grade II and III complications, lower risk of vesicourethral anastomotic stricture and less post-operative pain. The optimal anatomical visualisation and the extraordinary maneuverability, along with the tamponade effect of the pneumoperitoneum, are surely to be deemed responsible of this statistically significant differences.

However, to this day no study has ever investigated the prognostic significance of haematological parameters in terms of predicting perioperative bleeding risk in patients undergoing RARP.

Therefore, the investigators conducted a retrospective non-interventional cohort study to gather evidence concerning the impact of anemia and thrombocytopenia on bleeding risk following this surgical procedure. Furthermore, the investigators evaluated associations between demographical, pathological and surgical factors and hemorrhagic complications.

The investigators retrospectively evaluated all the patients that underwent robot-assisted radical prostatectomy in our Urology Unit from the 1st of January 2017 to the 31th of December 2020. The investigators collected demographic, clinical and pathological data from the medical records of these patients, with particular attention to other known risk-factors for RARP-associated bleeding (e.g.: volume of the prostate, body mass index, smoking status, nerve sparing technique).

Complications were analyzed according to the Clavien- Dindo classification. Bleeding was assessed by considering both the hemoglobin (Hb) drop after surgery and the fluid intraoperatively collected in the suction canister, with all the due adjustments. Moreover, post-operative haemorrhagic complications were evaluated.

The investigators included patients not younger than 18 years old, of which records of a pre-operative full blood count in the 30 days prior to the surgery along with a full blood count the day after were available.

Criteria for exclusion were a history of congenital coagulopathies and/or congenital thrombocytopenia and patients that underwent salvage radical prostatectomy after radiation therapy.

Statistics: EBL and operative time learning curve is studied. Clinical, pathological, intraoperative risk factors analysis for higher EBL is performed by linear regression modelling. Factors are evaluated independently and jointly. Association between each factor above and post-operative outcomes (i.e. post-op bleeding, need of transfusion and hematuria) is also assessed. conditions: Prostate Cancer conditions: Bleeding conditions: Prostate Adenocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 194 type: ACTUAL name: robot-assisted radical prostatectomy measure: Influence of hemoglobin value on haemorrhagic complications measure: Influence of hematocrit value on haemorrhagic complications measure: Influence of platelet count on haemorrhagic complications measure: Influence of blood group on haemorrhagic complications measure: Identification of possibile demographic and surgical predictive factors of haemorrhagic complications sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06299033 id: HPS-NP1-101 briefTitle: A Safety and Tolerability Study of Human Forebrain Neural Progenitor Cells Injection (hNPC01) in Subjects With Chronic Ischemic Stroke overallStatus: RECRUITING date: 2023-11-09 date: 2024-08-30 date: 2025-12-30 date: 2024-03-07 date: 2024-03-07 name: Hopstem Biotechnology Inc. class: INDUSTRY briefSummary: The principal aims of the clinical investigation involve assessing the safety profile and MTD of human forebrain neural progenitor cells (hNPC01) administered at escalated doses via single-dose intracerebral injection to subjects with stable chronic ischemic stroke. conditions: Chronic Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: hNPC01 measure: Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 6 months after intracerebral injection of hNPC01 measure: Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 12 months after intracerebral injection of hNPC01 measure: Number of participants with motor function improvement as assessed by rating scales of Modified Rankin Scale (mRS) during 12 months of treatment measure: Number of participants with motor function improvement as assessed by rating scales of Fugl-Meyer Motor Scale (FMMS) during 12 months of treatment measure: Number of participants with motor function improvement as assessed by rating scales of NIH Stroke Scale (NIHSS) during 12 months of treatment measure: Number of participants with motor function improvement as assessed by rating scales of Barthel Index (BI) during 12 months of treatment sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: XiangYa Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Dan Li role: CONTACT phone: 15074875481 name: Zhiquan Yang, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06299020 id: HLaRabta24 briefTitle: Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-04-20 date: 2024-12 date: 2024-03-07 date: 2024-03-07 name: Hopital La Rabta class: OTHER briefSummary: In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting). conditions: Primary Adrenal Insufficiency conditions: Intermittent Fasting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: intermittent fasting measure: hypoglycemia measure: Dehydration sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06299007 id: HYH EC 052-66-01 id: HYH EC 052-66-01 type: OTHER_GRANT domain: Hatyai Hospital Education Center briefTitle: Awareness of Iron Status Evaluation in UGIB acronym: AISE overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-07 date: 2024-03-07 name: Hat Yai Medical Education Center class: OTHER briefSummary: BACKGROUND: Data on the awareness of the need to evaluate iron status and IDA prevalence in acute UGIB are limited.

OBJECTIVES: This study aimed to investigate the rate of evaluation of iron status and prevalence of iron deficiency anemia (IDA) and the associated factors in patients with anemia hospitalized for acute upper gastrointestinal bleeding (UGIB). conditions: Upper Gastrointestinal Bleeding studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 867 type: ACTUAL measure: iron status measurement measure: Iron deficiency anemia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hatyai Hospital city: Hat Yai state: Songkhla zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 hasResults: False

 nctId: NCT06298994 id: SBA 23/391 briefTitle: Determination of Body Awareness and the Functional Movement in Patients With COPD overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2025-03-08 date: 2026-03-08 date: 2024-03-07 date: 2024-03-07 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls. conditions: Pulmonary Disease, Chronic Obstructive conditions: Postural; Defect conditions: Movement, Abnormal conditions: Pain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Evaluation of functional movement measure: Evaluation of Body Awareness measure: Functional exercise capacity measure: Respiratory muscle strength measure: Respiratory muscle endurance measure: Pain Severity measure: Pain threshold measure: Posture measure: Daily living activities measure: Severity of disease measure: Dyspnea measure: Symptoms sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Aynur Demirel city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 facility: Hacettepe University city: Ankara zip: 06100 country: Turkey name: Aynur Demirel role: CONTACT phone: +905545295057 phoneExt: 178 email: aynur.demirel@hacettepe.edu.tr name: hidaye yamikan role: CONTACT phone: +905349898724 email: hidaye.yamikan@hacettepe.edu.tr name: hidaye yamikan role: SUB_INVESTIGATOR name: cansu akkus role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06298981 id: 2301 briefTitle: Pulse Rate and Breathing Rate Accuracy overallStatus: RECRUITING date: 2024-02-12 date: 2024-06-30 date: 2024-06-30 date: 2024-03-07 date: 2024-03-22 name: Nuralogix Corporation class: INDUSTRY briefSummary: The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis. conditions: Pulse Rate and Breathing Rate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: noninvasive and investigational NuraLogix AMC-SDK measure: Breathing rate accuracy validation measure: Pulse rate accuracy validation measure: Pulse rate simulation sex: ALL minimumAge: 18 Years maximumAge: 81 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Element Materials Technology status: RECRUITING city: Louisville state: Colorado zip: 80027 country: United States name: Monica Rabanal role: CONTACT lat: 39.97776 lon: -105.13193 hasResults: False

 nctId: NCT06298968 id: NFEC-2024-074 briefTitle: Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma overallStatus: RECRUITING date: 2024-02-25 date: 2025-02-25 date: 2027-02-25 date: 2024-03-07 date: 2024-03-07 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab measure: Objective response rate (ORR) measure: The disease control rate (DCR) measure: Duration of response (DOR) measure: The median progression free survival time (mPFS) measure: The median overall survival time (mOS) measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Mengya Zang role: CONTACT phone: 86-20-62787430 email: zangmy@163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06298955 id: OMS906-PNH-003 briefTitle: Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria overallStatus: RECRUITING date: 2024-02-19 date: 2026-12 date: 2027-04 date: 2024-03-07 date: 2024-03-07 name: Omeros Corporation class: INDUSTRY briefSummary: The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH. conditions: Paroxysmal Nocturnal Hemoglobinuria studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: OMS906 study drug measure: To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients. measure: To assess efficacy measured by hemoglobin (Hgb). measure: To assess efficacy by transfusion requirements. measure: To assess efficacy by measurement of lactate dehydrogenase (LDH). measure: To assess efficacy by measurement of reticulocyte count. measure: To assess efficacy by measurement of clinical breakthrough hemolysis. measure: To assess population PK Cmax of OMS906. measure: To assess population PK AUC of OMS906. measure: To assess population PK terminal half life of OMS906. measure: To assess PD of OMS906 measure: OMS906 anti-drug antibodies (ADA). measure: Assess the change in Functional Assessment of Chronic Illness Therapy (FACIT) fatigue score. sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Omeros Investigational Site status: NOT_YET_RECRUITING city: Aachen country: Germany lat: 50.77664 lon: 6.08342 facility: Omeros Investigational Site status: NOT_YET_RECRUITING city: Ulm country: Germany lat: 48.39841 lon: 9.99155 facility: Omeros Investigational Site status: RECRUITING city: Lausanne country: Switzerland lat: 46.516 lon: 6.63282 facility: Omeros Investigational Site status: NOT_YET_RECRUITING city: Kyiv country: Ukraine lat: 50.45466 lon: 30.5238 facility: Omeros Investigational Site status: NOT_YET_RECRUITING city: Leeds country: United Kingdom lat: 53.79648 lon: -1.54785 hasResults: False

 nctId: NCT06298942 id: fac.med.24.9 briefTitle: Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-06-15 date: 2025-07-15 date: 2024-03-07 date: 2024-03-07 name: Minia University class: OTHER briefSummary: to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) conditions: Obesity, Morbid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: natural band name: silicone band measure: total cost measure: food intolerance measure: %EWL measure: complications rate measure: improvement of comorbidities sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298929 id: 36264PR427/11/23 briefTitle: Medial Rectus Fenestration vs Recession for PAET overallStatus: RECRUITING date: 2023-11-15 date: 2024-09-15 date: 2024-10-15 date: 2024-03-07 date: 2024-03-07 name: Mansoura University class: OTHER name: Tanta University briefSummary: This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.

All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration. conditions: Partially Accommodative Esotropia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: medial rectus fenestration name: medial rectus recession measure: Ocular alignment (measured in prism diopters) measure: ocular motility sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: Gharbeya country: Egypt name: Heba M Shafeik, MD role: CONTACT phone: +201227440829 email: heba.saeid@med.tanta.edu.eg lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06298916 id: FAPi-1301 briefTitle: 64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer acronym: PHANTOM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2026-04 date: 2024-03-07 date: 2024-03-07 name: Lantheus Medical Imaging class: INDUSTRY briefSummary: This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) and to compare its imaging biodistribution with FAP expression by immunohistochemistry (IHC) in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2). conditions: Metastatic Sarcoma conditions: Esophageal Cancer conditions: Gastric Cancer conditions: Pancreatic Cancer conditions: Colorectal Cancer conditions: Sarcoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Part 1: Metastatic Sarcoma Part 2: Non-metastatic sarcoma or gastrointestinal tract (GIT) cancer (esophageal, gastric, pancreatic, colorectal cancer) primaryPurpose: DIAGNOSTIC masking: NONE count: 32 type: ESTIMATED name: 64Cu-LNTH-1363S measure: Primary Part 1 Biodistribution of 64Cu-LNTH-1363S measure: Primary Part 1 - Optimal dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S measure: Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression measure: Secondary Parts 1 and 2 Safety and Tolerability measure: Secondary Part 1 FAP expression profile of 64Cu-LNTH-1363S in patients with sarcoma measure: Secondary Part 1 and Part 2 Cardiac Safety measure: Secondary Part 2 Validate optimal radioactivity in patients with sarcoma or GIT cancer measure: Exploratory Part 1 and Part 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298903 id: STUDY00002565 briefTitle: Impact of Hip Activation Compared to Hip Plus Balance Training on the Forward-Step-Down Test overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-12 date: 2024-03-25 date: 2024-08 date: 2024-03-07 date: 2024-04-29 name: Louisiana State University Health Sciences Center Shreveport class: OTHER briefSummary: The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements. conditions: Control of Frontal Plane Biomechanics conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The investigator who will analyze the data will be blinded whoMasked: INVESTIGATOR count: 34 type: ACTUAL name: Hip Activation name: Hip activation + Single leg balance measure: Forward-Step-Down Test measure: surface electromyography (sEMG) peak measure: surface electromyography (sEMG) mean measure: Unipedal Stance Test (UPST) measure: Dose-Response sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LSUHSC-Shreveport city: Shreveport state: Louisiana zip: 71103 country: United States lat: 32.52515 lon: -93.75018 hasResults: False

 nctId: NCT06298890 id: SASKAT briefTitle: The Pattern of Dry Eye Disease After Cataract Surgery overallStatus: RECRUITING date: 2024-03 date: 2026-05 date: 2027-09 date: 2024-03-07 date: 2024-03-07 name: Lithuanian University of Health Sciences class: OTHER name: Santen Oy briefSummary: This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up. conditions: Dry Eye Disease conditions: Cataract conditions: Ocular Surface Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Artificial tears (sodium hyaluronate 0.2%) measure: Assessment of ocular surface changes following cataract surgery measure: Evaluation of the cornea morphology measure: Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears measure: Evaluation of tear osmolarity measure: Evaluation of tear cytokine levels measure: Assessment of central corneal sensitivity measure: Evaluation of potential pain biomarkers in patients' saliva measure: Dry Eye Questionnaire-5 (DEQ5) 5-item measure: Ocular surface disease index (OSDI) measure: Visual function (VFQ-25) questionnaire measure: Visual acuity evaluation (LogMAR) sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lithuanian University of Health Sciences status: RECRUITING city: Kaunas zip: LT-44307 country: Lithuania name: Reda Zemaitiene role: CONTACT phone: + 370 37 327 201 email: rektoratas@lsmu.lt lat: 54.90272 lon: 23.90961 hasResults: False

 nctId: NCT06298877 id: 2023-04696-01 briefTitle: Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer acronym: FOLERO overallStatus: RECRUITING date: 2024-03-11 date: 2029-03-28 date: 2029-03-28 date: 2024-03-07 date: 2024-03-20 name: Sahar Salehi class: OTHER briefSummary: Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.

Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment.

In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are \>75 years. Despite these circumstances guidelines on patient-selection are lacking.

Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality.

The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment. conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 450 type: ESTIMATED name: Frailty and Quality of Life evaluation measure: Overall Survival measure: 1-year mortality measure: Health related quality of life (HRQoL) (QLQ-C30) measure: Health related quality of life (HRQoL) (QLQ-OV28) measure: Health related quality of life (HRQoL) (QLQ-ELD14) measure: Health related quality of life (HRQoL) (EQ-5D-5L) measure: Low anterior resection syndrome (LARS) measure: Postoperative complications measure: Readmissions measure: Length of hospital stay measure: Extent of surgery vs survival measure: Sarcopenia vs post-operative outcome measure: Standard regimen of adjuvant chemotherapy measure: Time interval to adjuvant chemotherapy measure: Total number of hospital days and readmissions within90 days after index surgery measure: Health economics measure: Recurrence or progression free survival sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska University Hospital status: RECRUITING city: Stockholm state: Solna zip: 171 76 country: Sweden name: Sahar Salehi, MD, Ass Prof role: CONTACT email: sahar.salehi@regionstockholm.se name: Daniel Hunde, MD role: CONTACT email: daniel.hunde@regionstockholm.se name: Daniel Hunde, MD role: SUB_INVESTIGATOR name: Sahar Salehi, MD, Ass Prof role: PRINCIPAL_INVESTIGATOR lat: 59.33258 lon: 18.0649 facility: Sahlgrenska University Hospital and Sahlgrenska Academy status: NOT_YET_RECRUITING city: Gothenburg zip: 41685 country: Sweden name: Pernilla Dahm-Kähler, MD, Prof. role: CONTACT phone: 0313434216 email: pernilla.dahm-kahler@gu.se name: Pernilla Dahm-Kähler, MD, Prof. role: PRINCIPAL_INVESTIGATOR name: Charlotte Palmqvist, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 facility: Linköping University Hospital status: RECRUITING city: Linköping zip: 581 85 country: Sweden name: Madelene Wedin, MD, PhD role: CONTACT email: madelene.wedin@regionostergotland.se name: Madelene Wedin, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.41086 lon: 15.62157 facility: Skåne University Hospital status: NOT_YET_RECRUITING city: Lund zip: 22185 country: Sweden name: Mihaela Asp, MD, PhD role: CONTACT email: Mihaela.Asp@skane.se name: Mihaela Asp, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Päivi Kannisto, MD, Ass Prof role: SUB_INVESTIGATOR lat: 55.70584 lon: 13.19321 hasResults: False

 nctId: NCT06298864 id: ASC-RCT 2 briefTitle: Internet-based Behavioral Intervention Following ACS acronym: ACS-CBT overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-01-31 date: 2027-01-31 date: 2024-03-07 date: 2024-03-07 name: Karolinska Institutet class: OTHER name: Karolinska University Hospital briefSummary: The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention. conditions: Acute Coronary Syndrome conditions: Online CBT Targeting Cardiac Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 260 type: ESTIMATED name: Internet-CBT name: Internet-CL measure: Cardiac anxiety questionnaire modified for weekly assessment measure: Cardiac anxiety questionnaire measure: Cardiac anxiety questionnaire measure: HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment measure: HeartQoL Health-related Quality of Life Questionnaire measure: HeartQoL Health-related Quality of Life Questionnaire measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) measure: University of Toronto Atrial fibrillation Severity Scale (AFSS) measure: University of Toronto Atrial fibrillation Severity Scale (AFSS) measure: University of Toronto Atrial fibrillation Severity Scale (AFSS) measure: Myocardial infarction behavior questionnaire measure: Myocardial infarction behavior questionnaire measure: Myocardial infarction behavior questionnaire measure: DOSE Non-Adherence questionnaire measure: DOSE Non-Adherence questionnaire measure: DOSE Non-Adherence questionnaire measure: Perceived stress scale 4-item measure: Perceived stress scale 4-item measure: Perceived stress scale 4-item measure: Short Fatigue questionnaire measure: Short Fatigue questionnaire measure: Short Fatigue questionnaire measure: Patient Health Questionnaire-9 measure: Patient Health Questionnaire-9 measure: Patient Health Questionnaire-9 measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Perceived stress scale 4-item measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity measure: Lifestyle factors: The national Board of health and Welfare questionnaire measure: Lifestyle factors: The national Board of health and Welfare questionnaire measure: Lifestyle factors: The national Board of health and Welfare questionnaire measure: Aversive cognition to medication measure: Adversive cognition to medication measure: Adversive cognition to medication measure: Adverse events measure: Adverse events measure: Adverse events measure: Adverse events measure: Accelerometer (Actigraf®) measure: Accelerometer (Actigraf®) measure: Swedish Prescribed Drug Register measure: Swedish Prescribed Drug Register measure: Swedish Prescribed Drug Register measure: Working Alliance Inventory measure: Treatment Credibility Scale measure: Client satisfaction Questionnaire measure: Follow-up questions on health changes measure: Follow-up questions on health changes measure: Follow-up questions on health changes measure: AFFS/SCL-4 measure: MI-behavior Questionnaire measure: DOSE Non-Adherence questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska University Hospital city: Stockholm zip: 11635 country: Sweden name: Josefin Särnholm, PhD role: CONTACT lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06298851 id: E-10840098-772.02-2026 briefTitle: Comparative Effects of Lower Body Quadrant Neural Mobilization and Stretching in Collegiate Football Players overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2024-03-25 date: 2024-03-31 date: 2024-03-07 date: 2024-03-07 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Neural mobilizations (NM) are defined as interventions that aim to directly or indirectly affect neural structures or surrounding tissue through manual techniques or exercise. Neural mobilizations have been studied in both patients and healthy populations. In the study, individuals in the amateur football team will be divided into three groups and will be given pre-training warm-up periods, including neural mobilization, dynamic and static stretching.After the warm-up period, its effect on flexibility and performance will be examined and compared. conditions: Sports Physical Therapy conditions: Stretch conditions: Stretch Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Neural Mobilization Group (NMG) name: Dynamic Stretching Group (DSG) name: Static Stretching Group (SSG) measure: Straight Leg Raise Test measure: Y Balance Test measure: One-Leg Forward Jump Test measure: T Test measure: BlazePod Reaction Time Determination Test sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Istanbul Medipol University city: Istanbul zip: 34820 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06298838 id: XEOS study briefTitle: High-resolution Intra-operative PSMA PET-CT in Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-07 date: 2024-03-07 name: IRCCS San Raffaele class: OTHER briefSummary: This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .

The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: AURA10® Specimen PET/CT imager measure: To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard measure: Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298825 id: KY2024-148 briefTitle: S-ADHF：Sarcopenia in Patients With ADHF acronym: S-ADHF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-06-01 date: 2024-03-07 date: 2024-03-12 name: Guangdong Provincial People's Hospital class: OTHER briefSummary: This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. conditions: Acute Decompensated Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: All-cause mortality measure: All-cause mortality measure: Cardiovascular mortality measure: All-cause hospitalisation measure: HF hospitalisation measure: The frequency and length of hospitalization of patient readmitted measure: Survival time from enrollment to death of deceased patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huan Ma city: Guangdong country: China name: Huan Ma, PhD role: CONTACT phone: +86 15078755932 email: mahuandoctor@163.com hasResults: False

 nctId: NCT06298812 id: Protocol Rev 0 11July2023 briefTitle: REFLECT Scoliosis System Post Approval Study overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2027-03-31 date: 2032-03-31 date: 2024-03-07 date: 2024-03-07 name: Globus Medical Inc class: INDUSTRY briefSummary: The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval conditions: Idiopathic Scoliosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients treated with the REFLECT Scoliosis Correction System primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: REFLECT Scoliosis Correction System measure: Primary Probable Benefit measure: Primary Safety measure: Curve progression measure: Device integrity measure: Composite endpoint analysis measure: Failure analysis measure: SRS score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Jana Robinson role: CONTACT name: Noelle Larson, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06298799 id: GEN-GE-001-IL briefTitle: GENETIC VARIABILITY TO GLP1 TREATMENT acronym: GLP1 treatment overallStatus: RECRUITING date: 2023-10-01 date: 2025-01-01 date: 2025-01-01 date: 2024-03-07 date: 2024-03-07 name: GENGE class: OTHER briefSummary: The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events.

Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit:

* Informed consent
* Study eligibility (Inclusion / Exclusion criteria)
* Collection of demographic data (age (date of birth), gender, ethnic origin)
* General and T2DM medical history review (per subject file)
* Concomitant medication review (at enrollment)
* Physical attributes (Body Weight, Height, BMI)
* Allocation to study cohort and study subgroup
* Saliva and blood collection for genetic tests
* Self-reported questionnaire for Ozempic (Semaglutide) experience conditions: Type 2 Diabetes conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study population consists of two cohorts:

A. Type 2 Diabetic participants cohort B. Healthy participants cohort primaryPurpose: OTHER masking: NONE maskingDescription: no masking count: 400 type: ESTIMATED name: DNA Sequencing and Analysis name: differential expression analysis with RNA-sequencing (RNA seq) experiments measure: Genetic variants and miRNA expressions associated with changes in BMI. measure: Genetic variants and miRNA expressions associated with changes in A1c. measure: Genetic variants and miRNA expressions associated with side effects. measure: Demographic parameters that affect GLP1 AG therapy. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambem medical center status: RECRUITING city: Haifa country: Israel name: Irit Hochberg, MD role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 hasResults: False

 nctId: NCT06298786 id: 6MIMATE012 briefTitle: Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT). acronym: F-6MMT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-09 date: 2024-03-07 date: 2024-03-13 name: Fundació Universitària del Bages class: OTHER name: Hospital Universitari Sagrat Cor name: Universitat Internacional de Catalunya name: Clinicas Dr. Emilio López Jiménez briefSummary: Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice.

The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings. conditions: Mastication Disorder conditions: Fatigue conditions: Temporomandibular Disorder conditions: Orofacial Pain conditions: Chewing Problem studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Functional 6-minute mastication test measure: Fatigue measure: Self-reported Pain measure: Pain-related TMD diagnosis measure: Self-reported daily fatigue measure: Pain pressure threshold (PPT) measure: Taste of the gum measure: Difficulty in breaking the gum at the beginning of the F-6MMT measure: Preferred side when chewing during the F-6MMT measure: Kinesiofobia related to TMD measure: Health status measure: Comorbidities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitat de Manresa city: Manresa state: Barcelona zip: 08242 country: Spain name: Jordi Padrós, Mr role: CONTACT phone: 613040826 email: jpadros@umanresa.cat name: Jordi Padros-Augé, PhDS role: PRINCIPAL_INVESTIGATOR name: Arnau Cerdà-Ribó, PT role: PRINCIPAL_INVESTIGATOR lat: 41.72815 lon: 1.82399 facility: Universitat Internacional de Catalunya city: Barcelona zip: 08017 country: Spain name: Jordi Tomás-Aliberas, PhD role: CONTACT phone: +34932541800 email: jtomas@uic.es lat: 41.38879 lon: 2.15899 facility: Hospital QuirónSalud Sagrado Corazón city: Barcelona zip: 08029 country: Spain name: Cristian Justribó, Mr role: CONTACT phone: +34672057031 email: cjustribom@uao.es name: Cristian Justribó-Manion, PhDS role: PRINCIPAL_INVESTIGATOR name: José J Bara Casaus, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Clínicas Dr. Emilio López Jiménez city: Jaén zip: 23280 country: Spain name: Emilio López-Jiménez, PhD role: CONTACT phone: 665842389 email: ddnariz@gmail.com lat: 37.76922 lon: -3.79028 hasResults: False

 nctId: NCT06298773 id: 6127 briefTitle: Spatial Profile of Tumors acronym: PROST overallStatus: NOT_YET_RECRUITING date: 2024-03-05 date: 2026-09-30 date: 2028-12-30 date: 2024-03-07 date: 2024-03-07 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The research project focuses on analyzing the spatial organization of cells within various solid tumors, utilizing advanced technologies enabling in-depth multi-parametric analysis of tumor and immune cells. The primary objective is to understand the spatial distribution of cellular subpopulations within each type of tumor, while secondary objectives include correlating these data with clinical aspects and identifying potential therapeutic targets. The study involves 1000 patients with primary or metastatic tumors and spans a duration of 5 years, from 2024 to 2028. No experimental treatments are planned; rather, only spatial imaging analyses with multiple markers will be conducted. Data analysis involves descriptive statistical methods and hypothesis testing to generate hypotheses for subsequent studies. The analyses will be performed using SPSS® version 21.0 software for Windows®. conditions: Solid Tumors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Spatial analysis of paraffin samples from solid tumors measure: Spatial analysis of cancer cells measure: Comparison of clinical data measure: Identification of therapeutic targets sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS city: Rome state: RM zip: 00168 country: Italy name: Alessandro Sgambato role: CONTACT phone: +390630154914 email: alessandro.sgambato@policlinicogemelli.it name: Alessandro Sgambato role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06298760 id: çörekotu refleksoloji briefTitle: The Effect of Reflexology and Knee Massage With Black Cumin Oil on Pain and Fatigue overallStatus: COMPLETED date: 2019-06-19 date: 2020-02-19 date: 2020-04-19 date: 2024-03-07 date: 2024-03-12 name: Erzurum Technical University class: OTHER briefSummary: In this study, black cumin extract oil was used in elderly individuals with Knee Osteoarthritis (OA). The effects of foot reflexology and knee massage on pain and fatigue symptoms. It is aimed to examine and research which of these two applications is more effective.The study, planned as a randomized controlled experimental study, included a total of 150 participants.

The data consists of participants who receive outpatient treatment in the Physical Therapy and Rehabilitation Unit at a university hospital, are over 65 years old, and have no problems with their perception after the Mini Mental Test. After randomization, participants were divided into five groups, with 30 participants in each group. Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After randomization, participants were divided into 30 participants in each group.

were divided into five groups:Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups. "Patient Information Form", "Kellgren and Lawrence", "Pain Visual Analog Scale (A-VAS)", "Fatigue Severity Scale and Western Ontario and McMaster Universities Osteoarthritis Index "WOMAC" were applied to the participants. Participants in the application groups were administered once a week for 6 weeks. The session lasted 30 minutes. The control group was allowed to continue routine treatment and care without any intervention. Data were collected by applying questionnaires to the participants in the 1st and 6th weeks. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ACTUAL name: Knee Massage With Black Cumin Oil Group: name: Foot Reflexology Group With Black Cumin Oil name: placebo group measure: Pain Score measure: fatigue severity sex: ALL minimumAge: 65 Years maximumAge: 90 Years stdAges: OLDER_ADULT facility: Ercan Bakır city: Erzurum state: Yakutiye country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06298747 id: Cervical root PRF briefTitle: Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain acronym: pulsedrf overallStatus: COMPLETED date: 2022-11-01 date: 2023-07-01 date: 2023-07-02 date: 2024-03-07 date: 2024-03-15 name: Diskapi Teaching and Research Hospital class: OTHER briefSummary: Chronic cervical pain is a common disorder with a prevalence of approximately 35% in adults. Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord, due to disc herniation or spinal stenosis. C7 and C6 are the two most commonly affected nerve roots. Various treatment modalities are available, including oral medications, physiotherapy, and epidural steroid injections. However, chronic and persistent pain that develops as a result of some patients not responding to these treatments. Ultrasound-guided selective cervical nerve root block and pulsed radiofrequency are interventional treatments used in patients with radicular cervical pain unresponsive to conservative treatments. Pulsed radiofrequency (PRF) treatment of peripheral nerves may provide long-term pain relief in patients with short-term pain relief with a local anesthetic block. Studies have shown the effectiveness of PRF therapy applied to selective cervical nerve roots in relieving cervical radicular pain. conditions: Cervical Pain studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 45 type: ACTUAL name: Selective cervical nerve root pulsed radiofrequency measure: VAS measure: Neck Disability Index (NDI) measure: Douleur Neuropathique 4 Questions (DN4) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Etlik City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06298734 id: 23-712 briefTitle: Exercise and Diet Interventions During Immunotherapy in Melanoma Patients overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-03-31 date: 2026-03-31 date: 2024-03-07 date: 2024-03-07 name: Dana-Farber Cancer Institute class: OTHER name: World Cancer Research Fund International briefSummary: The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.

The names of the groups in this research study are:

* High-Intensity Exercise (EX)
* High-fiber Diet (DT)
* Combined High-Intensity Exercise and High-Fiber Diet (COMB)
* Attention Control (AC) conditions: Melanoma (Skin) conditions: Skin Cancer conditions: Advanced Melanoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Exercise Program name: Diet Program measure: Change in Gut Microbiome Diversity measure: Change in Systemic Immune Function measure: Change in Cardiopulmonary Fitness measure: Change in Short Physical Performance Battery (SPPB) measure: Change in Percent Body Fat measure: Change in Lean mass measure: Change in Hip circumference measure: Change in Waist circumference measure: Change in Health-Related Quality of life (EORTC-QLQ C30) measure: Change in MDASI-Immunotherapy Questionnaire Score measure: Change in Anxiety (HADS) measure: Change in Depression (HADS) measure: Change in Sleep Quality (PSQI) measure: Proportion of Participants Completing the Exercise Intervention Sessions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06298721 id: 23-885 briefTitle: Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes overallStatus: RECRUITING date: 2024-03-12 date: 2027-03 date: 2027-03 date: 2024-03-07 date: 2024-04-17 name: The Cleveland Clinic class: OTHER name: American Association of Hip and Knee Surgeons briefSummary: This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care). conditions: Knee Osteoarthritis conditions: Knee Arthropathy conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Personalized outcome prediction tool + targeted interventions name: Standard of Care TKA measure: Satisfaction at 1 year sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Foundation status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Shujaa T Khan, MD role: CONTACT phone: 419-965-8274 email: khans34@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06298708 id: PED-2566-0634 briefTitle: Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents acronym: HAV-RCT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-06 date: 2024-03-07 date: 2024-03-08 name: Chiang Mai University class: OTHER name: Faculty of Medicine, Chiang Mai University briefSummary: Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years. conditions: HAV conditions: Hepatitis A conditions: Hep A conditions: Vaccine-Preventable Diseases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Mevac-A vaccine name: Havrix 720 Junior measure: Anti-HAV immunoglobulin G (IgG) seroconversion rate measure: Geometric mean concentration (GMC) of anti-HAV IgG level sex: ALL minimumAge: 18 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06298695 id: 2012939 id: 10390022210010 type: OTHER_GRANT domain: ZonMw briefTitle: Schema Therapy for Treatment-resistant Anxiety Disorders acronym: PaDoLA overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2024-09-30 date: 2030-12-31 date: 2024-03-07 date: 2024-03-07 name: Amsterdam UMC, location VUmc class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development name: ADF Stichting name: University of Amsterdam name: Maastricht University name: GGZ inGeest name: Pro Persona Mental Health Care Foundation name: Mondriaan name: GGNet name: GGZ Delfland briefSummary: The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual (TAU) in patients with treatment-resistant anxiety disorders. In a multicenter randomized controlled trial, patients will be assigned to receive individual schema therapy (maximum of 40 sessions) or treatment as usual (control group) within one year. The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy (BAI) at post treatment. Secondary outcomes include quality of life, societal costs, general mental health, remission from the anxiety disorders and/or comorbid affective disorders, positive and negative effects of psychotherapy, schemas and schema modes, and satisfaction. Measurements take place at baseline and after 1, 3, 6, 12, 24 and 36 months (follow-up of two years). conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A multicenter parallel group randomized controlled clinical intervention trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 172 type: ESTIMATED name: Individual Schema Therapy name: TAU measure: Changes in the severity of anxiety symptoms measure: Health-related quality of life measure: Mental health quality of life measure: Health care utilization and productivity losses measure: Remission from the primary anxiety disorder and from comorbid disorders measure: Screening for DSM-5 personality disorders measure: Assessment of DSM-5 personality disorders measure: Demographics measure: (Strength of) treatment preference measure: Assessment of childhood trauma measure: Assessment of autistic traits measure: Assessment of general mental health measure: Functioning and recovery in psychiatric patients measure: Early Maladaptive Schemas measure: Schema Modes measure: Positive and negative effects of psychotherapy measure: The level of satisfaction with the psychological treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298682 id: CCM1421 briefTitle: Characterization of Exosomes Platelets-released acronym: EXOPLT overallStatus: RECRUITING date: 2021-07-08 date: 2026-07-07 date: 2027-07-07 date: 2024-03-07 date: 2024-03-12 name: Centro Cardiologico Monzino class: OTHER name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico briefSummary: Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited. conditions: Platelet Thrombus studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 175 type: ESTIMATED measure: Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis measure: Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis measure: Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects. sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan country: Italy name: Daniele Prati role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06298669 id: 10652 briefTitle: Biventricular Versus Right Ventricular Pacing overallStatus: SUSPENDED date: 2023-08-09 date: 2025-02 date: 2025-02 date: 2024-03-07 date: 2024-03-07 name: Indiana University class: OTHER briefSummary: The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Biventricular Pacing name: Right Ventricular Pacing measure: 6 Minute Walk Test Performance measure: Serum NT-PRO-BNP measure: EQ-5D-3L sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indiana University Health Methodist Hospital city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 hasResults: False

 nctId: NCT06298656 id: ILBS-ACLF-17 briefTitle: Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2026-02-28 date: 2026-02-28 date: 2024-03-07 date: 2024-03-07 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: Clinically significant portal hypertension (CSPH) is defined as HVPG \>10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to \<12 mm Hg or reduction to \>20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study conditions: Acute-On-Chronic Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF measure: Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days measure: Transplant-free survival rate at 90 days measure: Correlation with evolution of AARC score by 2 week sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Liver & Biliary Sciences (ILBS) city: New Delhi state: Delhi zip: 110070 country: India name: Garvit Mundra, MD role: CONTACT phone: 01146300000 email: garvitmundrailbs@gmail.com lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06298643 id: CA056-1094 briefTitle: Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-07 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan. conditions: Lower-risk Myelodysplastic Syndromes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ACTUAL name: Red blood cell transfusion name: Red blood cell transfusion measure: Participant age measure: Participant sex measure: Participant weight measure: Participant height measure: Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method measure: Participant Eastern Cooperative Oncology Group (ECOG) score measure: Participant International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) risk category measure: Percentage of ring sideroblasts present in participants measure: Percentage of bone marrow blasts present in participants measure: Histopathology results measure: Number of red-blood cell transfusions received by participants measure: Treatment prescribed by line of therapy measure: Duration of treatment by line of therapy measure: Time between date of diagnosis and treatment measure: Time between date of treatment initiation to treatment discontinuation measure: Time between date of diagnosis to date of first red-blood cell transfusion measure: Number of participants that achieved red-blood cell transfusion independence during first-line of therapy treatment measure: Mean hemoglobin change of participants during first-line of therapy measure: Number of transfusion dependant participants achieving re-blood cell transfusion independence for ≥12 weeks with associated concurrent mean hemoglobin increase of ≥1.5 g/dL during first-line of therapy measure: Number of non-transfusion dependant participants achieving red-blood cell transfusion independence during first-line therapy for ≥24, 48 and 72 weeks measure: Time to red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy measure: Hematologic Improvement - Erythroid (HI-E) response of transfusion dependant participants receiving first line therapy measure: Modified Hematologic Improvement - Erythroid (mHI-E) of transfusion dependant participants receiving first line therapy measure: Hematologic Improvement - Erythroid (HI-E) response of non-transfusion dependant participants receiving first line therapy measure: Modified Hematologic Improvement - Erythroid (mHI-E) of non-transfusion dependant participants receiving first line therapy measure: Time to Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy measure: Duration of Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy measure: Duration of red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy measure: Number of participants diagnosed with Acute Myeloid Leukemia measure: Time to Acute Myeloid Leukemia diagnosis measure: Overall survival (OS) of participants measure: Number of red-blood cell transfusion days per participant measure: Number of red-blood cell units used per transfusion measure: Number of outpatient visits per month measure: Number of hospital admissions measure: Length of hospitalization measure: Reason for hospitalization measure: Number of emergency department visits measure: Number of Intensive care unit admissions (ICU) measure: Number of outpatient/inpatient medication claims measure: Supplemental medication use: Iron chelation use measure: Supplemental medication use: Granulocyte-colony stimulating factors (G-CSF) measure: Number of hematology tests ordered measure: Medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mebix, Inc city: Tokyo state: Minato-ku zip: 107-0052 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False

 nctId: NCT06298630 id: 2022-LTF-BRL-101 briefTitle: Long-term Follow-up Study of BRL-101 for TDT overallStatus: NOT_YET_RECRUITING date: 2024-12-08 date: 2038-08-20 date: 2038-10-15 date: 2024-03-07 date: 2024-03-22 name: Bioray Laboratories class: INDUSTRY name: First Affiliated Hospital of Guangxi Medical University name: Xiangya Hospital of Central South University name: Chinese Academy of Medical Sciences name: Nanfang Hospital, Southern Medical University name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army name: Shenzhen Children 's Hospital briefSummary: Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects. conditions: Thalassemia, Beta studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Assessments measure: Incidence of hematologic malignancies measure: Frequency, grade, and relationship of SAEs sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong zip: 510006 country: China name: Xiaoqin Feng, phD role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University city: Guangzhou state: Guangdong zip: 510006 country: China name: Jianpei Fang, phD role: CONTACT lat: 23.11667 lon: 113.25 facility: Shenzhen Children 's Hospital city: Shenzhen state: Guangdong zip: 510006 country: China name: Sixi Liu, phD role: CONTACT lat: 22.54554 lon: 114.0683 facility: No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital city: Nanning state: Guangxi zip: 530021 country: China name: Xinhua Zhang, phD role: CONTACT lat: 22.81667 lon: 108.31667 facility: Xiangya Hospital of Central South University city: Changsha state: Hunan zip: 510510 country: China name: Bin Fu, PhD role: CONTACT lat: 28.19874 lon: 112.97087 facility: Tianjin Institute of Hematology city: Tianjin state: Tianjin zip: 300000 country: China name: Jun shi, PhD role: CONTACT lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY city: Guangxi zip: 530021 country: China name: Yongrong Lai, PhD role: CONTACT hasResults: False

 nctId: NCT06298617 id: RC 27.1.2024 briefTitle: Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis overallStatus: COMPLETED date: 2023-01-01 date: 2023-07-30 date: 2023-12-25 date: 2024-03-07 date: 2024-03-12 name: Benha University class: OTHER briefSummary: Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers . conditions: Endometriosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 88 type: ACTUAL name: Diagnostic laparoscopy name: Full Blood Count (FBC) measure: Indices' ability to predict EM stage sex: FEMALE minimumAge: 25 Years maximumAge: 50 Years stdAges: ADULT facility: Benha University city: Banhā state: Al Qalyobia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False

 nctId: NCT06298604 id: IECED-12112023 briefTitle: Motorized Fine Needle Biopsy vs Standard Needles overallStatus: RECRUITING date: 2023-12-09 date: 2024-10-09 date: 2024-12-09 date: 2024-03-07 date: 2024-03-22 name: Instituto Ecuatoriano de Enfermedades Digestivas class: OTHER briefSummary: Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.

Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy. conditions: Pancreas Disease conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, diagnostic,, cross-sectional study primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Single masking, the pathologist will be blinded to the needle used for sample collection. whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: EUS-guided standard fine needle biopsy name: EUS-guided motorized fine needle biopsy measure: Endoscopic ultrasound fine needle biopsy sample quality measure: Diagnostic accuracy according to histological analysis measure: Tissue blood contamination measure: Time efficiency during tissue acquisition measure: Rate of liver specimen adequacy measure: Rate of adverse events associated with the procedure measure: Quality of cytologic sample sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED) status: RECRUITING city: Guayaquil zip: 090505 country: Ecuador name: Carlos Robles-Medranda, MD FASGE role: CONTACT phone: +593989158865 email: carlosoakm@yahoo.es name: Carlos Robles-Medranda, MD FASGE role: PRINCIPAL_INVESTIGATOR name: Raquel Del Valle, MD role: SUB_INVESTIGATOR name: Maria Egas-Izquierdo, MD role: SUB_INVESTIGATOR name: Jorge Baquerizo-Burgos, MD role: SUB_INVESTIGATOR name: Domenica Cunto, MD role: SUB_INVESTIGATOR name: Juan Alcivar-Vasquez, MD role: SUB_INVESTIGATOR name: Daniela Tabacelia, MD role: SUB_INVESTIGATOR name: Martha Arevalo-Mora, MD role: SUB_INVESTIGATOR name: Miguel Puga-Tejada, MD role: SUB_INVESTIGATOR name: Gustavo Rubio, MD role: SUB_INVESTIGATOR name: Hannah Pitanga-Lukashok, MD role: SUB_INVESTIGATOR lat: -2.20584 lon: -79.90795 hasResults: False

 nctId: NCT06298591 id: atrophic scar treatment briefTitle: The Efficacy of Combination Therapy in Atrophic Scars overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-03-15 date: 2027-03-15 date: 2024-03-07 date: 2024-03-07 name: Assiut University class: OTHER briefSummary: There are more than 100 million patients who develop scar formation caused by various factors, such as post-inflammatory acne and trauma (1). They often have physical, aesthetic, psychological, and social barriers. Scar tissue is naturally a stage of wound healing. Abnormal wound healing produces a spectrum of scar tissue types such as atrophic, hypertrophic, and keloid scars (2).

Atrophic scars are dermal depressions, which are commonly caused by the destruction of collagen following inflammatory process. This permanent disfiguring sequelae correlates with the duration of pathology, severity of lesion, and delay in therapy (3).

Treatment of atrophic acne scars remains a therapeutic challenge, yet there is no standard option as the most effective treatment (4). A range of possible options has been investigated including surgical techniques (subcision, non-ablative laser treatment, resurfacing techniques (ablative laser treatment, dermabrasion), and injection or dermal fillers or fat, and a combination of two or more modalities (5).

Ultrasound is a unique non-invasive and non-radiating medical imaging tool in the investigation of dermatological diseases by providing detailed anatomic and physiologic data of skin lesions and deeper soft tissue changes. Lesion size in three dimensions-lengths, width, and depth, morphology, the detailed anatomic information provided by sonography is useful to assessment of effect of different types of treatment modality to improve atrophic scar and avoid invasive assessment tools as punch biopsy for histopathological examination (6) conditions: Atrophic Scar studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: co2 laser measure: change of dermal thickness in sonar and Vancouver scale sex: ALL minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298578 id: Mobile Based Application briefTitle: The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-01-01 date: 2024-03-07 date: 2024-03-07 name: Assiut University class: OTHER briefSummary: The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance.

The secondary objective is to Improve quality of life and early prediction of the complications. conditions: Acetabular Fracture studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 126 type: ESTIMATED measure: percentage of missed follow up data in both groups postoperatively through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum using the Arabic validated form of (SF-36) measure: Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298565 id: ARGX-113-PASS-2208 briefTitle: A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2034-06 date: 2034-06 date: 2024-03-07 date: 2024-03-07 name: argenx class: INDUSTRY briefSummary: This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort. conditions: Myasthenia Gravis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 680 type: ESTIMATED name: efgartigimod measure: The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298552 id: ARGX-113-2308 id: 2024-511796-15-00 type: OTHER domain: CTIS number briefTitle: A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis acronym: ADAPT SERON overallStatus: RECRUITING date: 2024-04-16 date: 2025-07-25 date: 2027-07-23 date: 2024-03-07 date: 2024-04-23 name: argenx class: INDUSTRY briefSummary: The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod.

Study will consist of:

* Screening
* Part A: participants will be randomized to receive either efgartigimod IV or placebo
* Part B: participants completing part A will receive open-label efgartigimod IV conditions: Generalized Myasthenia Gravis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: Efgartigimod IV name: Placebo IV measure: Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline measure: Quantitative myasthenia gravis (QMG) total score change from baseline measure: Proportion of participants who are both MG-ADL and QMG responders sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: First Choice Neurology Boca Raton status: RECRUITING city: Boca Raton state: Florida zip: 33428 country: United States name: Brian Costell, MD role: CONTACT phone: 857-350-4834 email: clinicaltrials@argenx.com lat: 26.3669 lon: -80.13033 hasResults: False

 nctId: NCT06298539 id: 21C308 briefTitle: Auditory Sensory Attenuation in Obesity acronym: Ud_SA_OB overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-12 name: Istituto Auxologico Italiano class: OTHER name: University of Turin, Italy briefSummary: The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):

i) is observed in obesity ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.

Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\&#39;s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way. conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 36 type: ESTIMATED measure: point of subjective equality (PSE) measure: cognitive empathy measure: interpersonal pleasure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital city: Piancavallo state: VCO zip: 28824 country: Italy hasResults: False

 nctId: NCT06298526 id: 21C307 briefTitle: Auditory Sensory Attenuation in Anorexia Nervosa acronym: UdSA_AN overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-02-29 date: 2024-12-31 date: 2024-03-07 date: 2024-03-12 name: Istituto Auxologico Italiano class: OTHER briefSummary: The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):

i) is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.

Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\&#39;s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 36 type: ESTIMATED measure: point of subjective equality (PSE) measure: cognitive empathy measure: interpersonal pleasure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital city: Piancavallo state: VCO zip: 28824 country: Italy hasResults: False

 nctId: NCT06298513 id: 09C338 briefTitle: Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI acronym: RIABILITOMICA overallStatus: RECRUITING date: 2023-05-02 date: 2025-04 date: 2025-12 date: 2024-03-07 date: 2024-03-07 name: Istituto Auxologico Italiano class: OTHER briefSummary: Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine). conditions: Acute Myocardial Infarction: Rehabilitation Phase studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Cardiac rehabilitation measure: Changes in purine after rehabilitation measure: Changes in histidine after rehabilitation measure: Changes in galactose after rehabilitation sex: MALE minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20149 country: Italy name: Lia Crotti, MD PhD role: CONTACT phone: 39 0261911 phoneExt: 2903 email: lia.crotti@unimib.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06298500 id: AAG-O-H-2115 briefTitle: Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair acronym: HISTOLAP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-09 date: 2024-03-07 date: 2024-03-08 name: Aesculap AG class: INDUSTRY name: B.Braun Surgical SA briefSummary: The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified. conditions: Inguinal Hernia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 448 type: ESTIMATED name: hernia repair surgery measure: Hernia recurrence rate measure: Delayed tissue adhesive polymerization measure: Intraoperative bleeding requiring therapeutic measures measure: Organ injury measure: Hernia recurrence measure: Mesh migration measure: Adhesions measure: Erosion measure: Meshoma formation measure: Tack hernias measure: Surgical Site Infection (superficial, deep, intraabdominal) measure: Hematoma measure: Seroma measure: Hemorrhage measure: Orchitis measure: Other Adverse Event measure: Reintervention measure: Mesh repositioning or removal measure: Acute or chronic pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital San Juan de Dios city: Santa Cruz De Tenerife state: Tenerife zip: 38001 country: Spain name: José Miguel Del Pino Monzón, Dr. role: CONTACT lat: 28.46824 lon: -16.25462 hasResults: False

 nctId: NCT06298487 id: CHRD 1023 briefTitle: Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area acronym: MPSAT-ETP overallStatus: RECRUITING date: 2024-03-11 date: 2024-09 date: 2024-09 date: 2024-03-07 date: 2024-04-04 name: Hôpital NOVO class: OTHER briefSummary: The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone. conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Patient questionnaires measure: Evaluation of the overall impact of the PTE workshops offered by the MPSAT on patients' knowledge, skills, attitudes and behaviours with regard to COPD management and care measure: Measure of the impact of PTE workshops on quality of life (comparison of PTE group versus Control group) measure: Comparison of anxiety/depression levels in patients in the PTE group versus Control group measure: Comparison of levels of motivation towards physical activity during free time in the PTE group versus Control group measure: Comparison of the number of hospital admissions for COPD exacerbations in patients in the PTE group versus Control group measure: Comparison of the perception/feelings of patients in the PTE group versus Control group, concerning PTE workshops organised in a city/hospital setting sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pneumology, respiratory rehabilitation and follow-up and rehabilitation care department - Hôpital NOVO status: RECRUITING city: Pontoise zip: 95300 country: France name: Dr Bruno PHILIPPE role: CONTACT phone: +33 1 30 75 47 75 email: bruno.philippe@ght-novo.fr name: Mme Anne-Charlotte TAUVERON role: CONTACT phone: +33 6 75 08 36 60 email: anne-charlotte.tauveron@valdoise.fr lat: 49.05 lon: 2.1 hasResults: False

 nctId: NCT06298474 id: 2R44AG071105-03 type: NIH link: https://reporter.nih.gov/quickSearch/2R44AG071105-03 briefTitle: The BRAIN App (Phase 2 SBIR) overallStatus: NOT_YET_RECRUITING date: 2025-02-15 date: 2025-11-15 date: 2025-11-30 date: 2024-03-07 date: 2024-03-26 name: Hopeful Aging class: INDUSTRY briefSummary: There are currently 6.7 million Americans living with dementia and, without significant breakthroughs, this figure will double to 12.7 million by 2050. There are about 46,000 long-term care (LTC) facilities in the U.S. More than half of LTC residents have some form of dementia (Alzheimer's Association, 2018). Responsive behaviors and dysfunction of the dementia care triad-i.e., the PLWD, professional Care Partner (CP), and Family Member (FM)-are inexorably linked. The emergence of responsive behaviors can lead to disruption of the triad's function. Thus, it is imperative to maintain positive relationships and a high quality of life (QoL) within the triad to reduce BPSD. Cognitive Stimulation Therapy (CST) has demonstrated improvements in QoL and relationships for PLWD. CST is a psychosocial intervention that promotes communication and engagement in PLWD via a structured program of meaningful and enjoyable theme. While clinical trials have shown improvement in cognition and QoL, the potential large-scale impact of CST has been hampered by low adherence, with less than 40% completing trials. One likely reason for the low adherence to CST is the reliance on generic and non-digital tools (e.g., paper-based agendas, tools, DVDs, and board games) in facilitating the intervention. That is, even though CST aims to be personalized, the specific interventions used in the field tend to be generic and not tailored to each PLWD's specific interests. The use of digital technology to implement CST would offer considerable advantages to expand and personalize the range of stimulation content and provide a means for monitoring responses, optimizing protocols, and promoting adherence.

The proposed Phase II study will involve the continued development and evaluation of a multi-faceted software platform called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN Platform will be the first-ever Artificial Intelligence (AI) powered CST digital therapy platform for PLWD. The platform, which has been shown to be effective in an initial Phase I clinical trial, has three main goals: to improve the quality of life of PLWD, to reduce BPSD in PLWD, and to foster positive relationships between members of the care triad. The proposed Phase II project has the following Specific Aims: 1. Create an improved Beta version of the BRAIN Platform's eight components: (1) the Admin Management Dashboard, (2) the Annotation Dashboard, (3) the Log Viewer, (4) the Content Management System (CMS), (5) the Private CMS, (6) the Control App, (7) the Home App, and (8) the Training Dashboard. 2. Fine-tune the different classes of AI algorithms-i.e., behavioral analytics, personalized content recommendation, and personalized program generation-in the BRAIN app such that they can (a) recognize and track 12 distinct behaviors and indicators of PLWD, (b) use these behavioral traits as a basis for automatically rating the relative success of each activity, and (c) automatically recommend personalized activities that are likely to be successful for individual PLWD. 3. Conduct a Cluster Randomized Trial (CRT) of the BRAIN App to examine the app's impact on engagement/affect, quality of life, and responsive behaviors. 4. Examine satisfaction and ease of use of the app for PLWD, LTC staff, and FMs. conditions: Dementia conditions: Alzheimer Disease conditions: Vascular Dementia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Cluster Randomized Trial (CRT) will be conducted with each LTC facility being considered a cluster. All PLWD at an Experimental facility will be invited to use the intervention twice per week for 3 months, while all PLWD at a Control facility will receive standard care/programming for 3 months. Individual random assignment is not feasible, due to the high likelihood of contamination in a study involving the facilitation of activities in a LTC environment. LTC Facilities Eight (8) LTC facilities will participate in the study-i.e., 4 NHs and 4 ALFs. Half of the sites will be randomly assigned to the Experimental Group and the other half to the Control Group. So, 2 NHs and 2 ALFs will be assigned to the Experimental Group, while 2 NHs and 2 ALFs will be assigned to the Control Group. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: The BRAIN App measure: Menorah Park Engagement Scale (MPES) measure: Menorah Park Engagement Scale (MPES) measure: Engagement for Persons with Dementia Scale (EPWDS) measure: Engagement for Persons with Dementia Scale (EPWDS) measure: Dementia Related Quality of Life (DEMQOL) measure: Dementia Related Quality of Life (DEMQOL) measure: Neuropsychiatric Inventory--Nursing Home (NPI-NH) measure: Neuropsychiatric Inventory--Nursing Home (NPI-NH) measure: Quality of Carer-Patient Relationship (QCPR) measure: Quality of Carer-Patient Relationship (QCPR) measure: Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE) measure: Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Hopeful Aging city: Winchester state: Massachusetts zip: 01890 country: United States lat: 42.45232 lon: -71.137 hasResults: False

 nctId: NCT06298461 id: BowelPrep briefTitle: Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-06 date: 2024-03-07 date: 2024-03-07 name: University of Manitoba class: OTHER name: Canadian IBD Research Consortium (CIRC) briefSummary: The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis). conditions: Crohn Disease conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 418 type: ESTIMATED name: KleanLyte name: Bi-PegLyte measure: Quality of bowel cleanliness measure: Quality of bowel cleanliness measure: Volume of laxative intake measure: Endoscopic Outcomes measure: Endoscopic Outcomes measure: Endoscopic Outcomes measure: Endoscopic Outcomes measure: Patient experience data measure: Crohn's disease or ulcerative colitis flares after colonoscopy measure: Endoscopic Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298448 id: NL83176.042.23 briefTitle: eGPA and Local Inflammation Within the Ear, Nose and Throat Area overallStatus: RECRUITING date: 2024-02-14 date: 2027-12 date: 2028-12 date: 2024-03-07 date: 2024-03-07 name: University Medical Center Groningen class: OTHER name: GlaxoSmithKline briefSummary: Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed. conditions: EGPA - Eosinophilic Granulomatosis With Polyangiitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: laboratory experiments before and after mepolizumab treatment measure: The effect mepolizumab treatment has on the nasal microbiome profiles measure: Exploratory evaluation of between group differences measure: Mepolizumab effect on outcome 2 measure: s there a correlation between the disease activity, the quality of life and the microbiome and immune parameters? sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMC Groningen status: RECRUITING city: Groningen zip: 9700RB country: Netherlands name: Abraham Rutgers, MD-PhD role: CONTACT phone: +31503616161 email: a.rutgers@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06298435 id: 17536 briefTitle: Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements acronym: OPTIMVSPRIME overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-07 date: 2024-03-07 name: University Medical Center Groningen class: OTHER briefSummary: • Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings.

Main research question

* To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes
* Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex.
* Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes. conditions: Hypoxemia conditions: Hypercapnia conditions: Ventilator Associated Pneumonia conditions: Complication of Anesthesia conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ESTIMATED name: Intermittent Positive pressure ventilation measure: SpO2/FiO2 ratio measure: SpO2 measure: etCO2 measure: Blood Pressure measure: Heart Rate measure: Positive end Expiratory Pressure measure: Plateau Pressure measure: Respiration rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMCG city: Groningen zip: 9700RB country: Netherlands name: Rob Spanjersberg role: CONTACT phone: +31503616161 email: r.spanjersberg@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06298422 id: 806433 briefTitle: Oxygen Saturations Across Tones of Skin acronym: O2SATS overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-06-30 date: 2024-03-07 date: 2024-03-07 name: University of California, San Diego class: OTHER briefSummary: Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis. conditions: Generalised Melanin Pigmentation conditions: Pulse Oximetry studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Difference observed between SpO2 and SaO2. measure: Melanin Index sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCSD Health status: RECRUITING city: San Diego state: California zip: 92103 country: United States name: Pamela DeYoung role: CONTACT phone: 858-232-0343 email: pdeyoung@health.ucsd.edu lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06298409 id: EB04 briefTitle: Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan® overallStatus: RECRUITING date: 2024-02-15 date: 2024-09-15 date: 2024-12-15 date: 2024-03-07 date: 2024-03-07 name: Envivo Bio Inc class: INDUSTRY briefSummary: We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO) conditions: Small Intestinal Bacterial Overgrowth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 34 type: ESTIMATED name: CapScan collection capsule measure: Sampling of gut microbiota measure: Sampling of gut metabolome measure: Effect of rifaximin on gut microbiota measure: Effect of rifaximin on gut metabolome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Silicon Valley Gastroenterology status: RECRUITING city: Mountain View state: California zip: 94040 country: United States name: Jennifer Taufui role: CONTACT email: svgistaff@gmail.com lat: 37.38605 lon: -122.08385 hasResults: False

 nctId: NCT06298396 id: CLTD5853 briefTitle: Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients acronym: DUAL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-07 date: 2024-03-07 name: Cochlear class: INDUSTRY name: Avania briefSummary: This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients. conditions: Hearing Loss, Sensorineural studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: There is no masking in this study as all participants receive all MAPs (single group study model). The term "single-blinded" in the official title refers to the fact that participants are blinded to the order in which they receive the MAPs. count: 20 type: ESTIMATED name: Program using default MAP name: Program using low-power 1 (LP1) MAP name: Program using low-power 2 (LP2) MAP name: Program using low-power 3 (LP3) MAP measure: Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting measure: Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise measure: Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting measure: Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise measure: Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cochlear Macquarie city: Macquarie Park state: New South Wales zip: 2109 country: Australia name: Esti Nel role: CONTACT phone: +61448495008 email: Enel@cochlear.com lat: -33.7751 lon: 151.11272 hasResults: False

 nctId: NCT06298383 id: ERU1 briefTitle: The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-07-15 date: 2024-09-15 date: 2024-03-07 date: 2024-03-07 name: Cairo University class: OTHER name: Egyptian Russian University briefSummary: Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids. conditions: Symptomatic Irreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Trypsin, Bromelain and Rutoside name: Diclofenac Potassium name: Prednisolone Oral Tablet name: Placebo measure: Success of Anesthesia measure: Post-operative pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298370 id: PENG study briefTitle: The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty acronym: PENG overallStatus: RECRUITING date: 2024-03-18 date: 2024-06-08 date: 2024-07-08 date: 2024-03-07 date: 2024-03-07 name: Bezmialem Vakif University class: OTHER briefSummary: This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone. conditions: Postoperative Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, double-blind, randomized clinical trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 3 type: ESTIMATED name: Pericapsular nerve group block plus intrathecal bupivacaine name: Intrathecal bupivacaine and morphine name: Pericapsular nerve group block plus intrathecal bupivacaine and morphine measure: Morphine consumption measure: Postoperative pain scores measure: The quality of recovery score sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakif University status: RECRUITING city: Istanbul state: Fatih zip: 34093 country: Turkey lat: 41.01384 lon: 28.94966 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-01 uploadDate: 2024-02-03T12:32 filename: Prot_SAP_000.pdf size: 160574 hasResults: False

 nctId: NCT06298357 id: 300012601 id: LAIKPRI02012024 type: OTHER_GRANT domain: Kaul Pediatric Research Institute Pilot Grant briefTitle: Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2026-03-31 date: 2024-03-07 date: 2024-04-03 name: University of Alabama at Birmingham class: OTHER briefSummary: This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group). conditions: Pediatric Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There will be 2 parallel groups, immediate start group and waitlist control group. Once control participants finish the wait period (8 weeks), they will start the intervention (8 weeks). Participants in the immediate start group will start exercise and mindfulness in the hospital and continue the program for 8 weeks outside of the hospital. primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Immediate Start - Virtual Reality name: Delayed Start - Virtual Reality measure: Physical activity measure: Minutes of gameplay measure: Global Health measure: Forced Expiratory Volume in the first second (FEV1) sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Hospital of Alabama city: Birmingham state: Alabama zip: 35233 country: United States lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06298344 id: 002 briefTitle: The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-01-01 date: 2024-03-07 date: 2024-03-07 name: Universitas Sumatera Utara class: OTHER briefSummary: Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions. conditions: Congenital Heart Disease conditions: Thiamine Deficiency conditions: Patent Ductus Arteriosus conditions: Ventricular Septal Defect conditions: Atrial Septal Defect studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 88 type: ESTIMATED name: Thiamine measure: Correlation between transcatheter closure and left ventricular structure change after thiamine treatment measure: Correlation between transcatheter closure and left ventricular function change after thiamine treatment measure: Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment measure: Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment sex: ALL minimumAge: 6 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universitas Sumatera Utara city: Medan state: North Sumatera zip: 20155 country: Indonesia name: Putri Amelia role: CONTACT phone: +6285261000273 email: putri.amelia@usu.ac.id lat: 3.58333 lon: 98.66667 hasResults: False

 nctId: NCT06298331 id: KA-23073 briefTitle: Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-03-15 date: 2024-03-07 date: 2024-03-07 name: Hacettepe University class: OTHER briefSummary: The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Aerobic Exercise name: Abdominal Massage name: Patient Education measure: Weekly defecation frequency measure: Average weekly defecation time measure: Average weekly frequency of laxative use measure: Average weekly stool consistency score measure: The severity of constipation and associated discomfort measure: The severity of constipation measure: Gastrointestinal symptom level measure: Constipation-related quality of life measure: Patient perception of global change measure: Abdominal muscle strength measure: Functional exercise capacity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ceren Gursen city: Ankara zip: 06100 country: Turkey name: Serap ÖZGÜL role: CONTACT phone: +905339390803 email: serapky@yahoo.com name: Hatice Yasemin Balaban role: SUB_INVESTIGATOR name: Türkan Akbayrak role: SUB_INVESTIGATOR name: Halis Şimşek role: SUB_INVESTIGATOR name: Beyza Atay role: SUB_INVESTIGATOR name: Ege Nur Atabey Gerlegiz role: SUB_INVESTIGATOR name: İrem Gül Doğan role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06298318 id: Acute Binge Drink briefTitle: Metabolic Changes in Healthy Subjects With Acute Binge Drink acronym: MeABD overallStatus: ENROLLING_BY_INVITATION date: 2024-04-18 date: 2024-07-19 date: 2026-07-18 date: 2024-03-07 date: 2024-04-17 name: Zhejiang Chinese Medical University class: OTHER_GOV briefSummary: The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink on liver function, liver fat content and lipid metabolism in healthy young subjects. The main questions it aims to answer are:

1. if acute binge drink could alleviate liver injury and hepatic steatosis. conditions: Binge Drinking conditions: Liver Injury conditions: Hepatic Steatosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: vodka name: water measure: Hepatic fibrosis change measure: hepatic function change measure: hepatic injury change measure: Lipid metabolism change measure: Laboratory markers of inflammation measure: Fecal metabolites measure: Ethanol concentration measure: Acetaldehyde concentration measure: hangover cognition assessment tools after drinking sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Zhejiang Chinese Medical University city: Hangzhou state: Zhejiang zip: 310053 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06298305 id: QUANTIB briefTitle: Artificial Intelligence & Prostate Cancer acronym: QUANTIB overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-01 date: 2023-10-10 date: 2024-12 date: 2024-03-07 date: 2024-03-07 name: IRCCS San Raffaele class: OTHER briefSummary: This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software measure: To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI measure: To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy measure: To report time reduction in the diagnosis of suspicious PCa sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele city: Milan state: MI zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06298292 id: ZerominisCT01 briefTitle: Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies acronym: ZeroMinisMR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-06-30 date: 2024-03-07 date: 2024-03-07 name: metaX Institut fuer Diatetik GmbH class: INDUSTRY name: Birmingham Women's and Children's NHS Foundation Trust name: Great Ormond Street Hospital for Children NHS Foundation Trust briefSummary: The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years. conditions: Tyrosinemia, Type I conditions: Tyrosinemia, Type II conditions: Tyrosinemia, Type III conditions: Alkaptonuria conditions: Homocystine; Metabolic Disorder conditions: MSUD (Maple Syrup Urine Disease) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Zero minis (range of protein substitutes in tablet form) measure: Daily compliance measure: Treatment-Emergent tolerability measure: Patient Acceptability measure: Metabolic control measure: Incidence of study product emergent events. sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06298279 id: 2023-436 briefTitle: Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel overallStatus: NOT_YET_RECRUITING date: 2024-03-12 date: 2025-04-30 date: 2025-04-30 date: 2024-03-07 date: 2024-03-07 name: University of Regina class: OTHER name: Government of Canada briefSummary: This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources. conditions: Depression conditions: Anxiety conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Factor 1: Tunneled or Personalized Course Delivery Factor 2: Standard or Enhanced Social Learning Resources Participants will be randomly assigned to one of four treatment conditions (tunneled delivery of ICBT with standard resources, tunneled delivery of ICBT with enhanced social learning resources, personalized delivery ICBT with standard resources, personalized delivery of ICBT with enhanced social learning resources) primaryPurpose: TREATMENT masking: NONE maskingDescription: Participants cannot be blinded to condition because ICBT (like other psychotherapies) cannot be both provided to and concealed from a participant. However, the difference between the four conditions (i.e., presence or absence of social learning resources, tunneled versus personalized course navigation) will be concealed from all participants. Because outcomes will be assessed via self-report questionnaire measures, outcomes assessor masking is not applicable. count: 164 type: ESTIMATED name: Tunneled Delivery name: Personalized Delivery name: Standard Resources name: Enhanced Social Learning Resources name: Transdiagnostic Self-Guided ICBT measure: Generalized Anxiety Disorder 7-item (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) measure: PTSD Checklist for the DSM-5 (PCL-5) measure: Engagement measure: Work and Social Adjustment Scale (WSAS) measure: Brief Resilience Scale (BRS) measure: Healthcare Use Questionnaire measure: Case Story Questionnaire measure: Treatment Satisfaction Questionnaire measure: Digital Behavior Change Interventions Engagement Scale (DCBI) measure: Post-treatment Semi-structured interview sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Psychology, University of Regina city: Regina state: Saskatchewan zip: S4S 0A2 country: Canada name: Heather D Hadjistavropoulos, PhD role: CONTACT phone: 306-585-5133 email: heather.hadjistavropoulos@uregina.ca name: Caeleigh A Landry, MSc role: CONTACT phone: 306-337-2473 email: caeleigh.landry@uregina.ca name: Heather D Hadjistavropoulos, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.45008 lon: -104.6178 hasResults: False

 nctId: NCT06298266 id: GD2H-XYK-001 briefTitle: To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2026-05-31 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: Guangdong Second Provincial General Hospital class: OTHER briefSummary: To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma conditions: Relapsed or Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: infusion of GPRC5D-CD19 CAR T injection measure: Objective Response Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Second Provincial General Hospital city: Guangzhou state: Guangdong zip: 510317 country: China name: Qing Zhang role: CONTACT phone: +862089169186 email: zhqing@vip.163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06298253 id: 2024P000832 briefTitle: Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2 acronym: BeWell overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-06 date: 2028-06 date: 2024-03-07 date: 2024-04-09 name: Massachusetts General Hospital class: OTHER briefSummary: This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries. conditions: Food Insecurity conditions: Implementation Science conditions: Diet, Healthy conditions: Behavioral Economics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3750 type: ESTIMATED name: Behavioral economics-enhanced SWAP implementation name: Basic SWAP implementation measure: Pantry SWAP implementation measure: Percent items (by weight) ordered by pantry that are labeled green or red measure: Percent of pantry clients' selected food that is green or red measure: Client dietary quality score measure: Skin carotenoid level sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298240 id: 4R22/074 briefTitle: Implementation of Nursing Demand Management as a Factor for Improvement in a Primary Care Emergency Center. overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-01 date: 2024-01-05 date: 2024-09-01 date: 2024-03-07 date: 2024-04-15 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER briefSummary: Background: Nurse Demand Management was born in 2009 out of the need to address the growth of spontaneous acute demand in primary care. But it is not until 2013 that guidelines for the exercise of nursing actions in demand management were established in Catalonia, Spain. Nurses trained specifically to solve acute and low complexity health problems generate a quality of care comparable to that provided by family medicine doctors. On the other hand, it is worth highlighting the need to rationalise medical resources in primary care centres, primary care emergency centres or points of continuous care (different emergency facilities in the territory in terms of size and services) in order to give priority to doctors being able to dedicate more time to medium or high complexity pathology. Although nurse demand management has been implemented in primary care teams for years, it is being carried out in different intensities according to the needs or priorities of each health territory.

The promotion of the autonomous role of nursing through the implementation of nurse demand management in the urgent spontaneous demand of low complexity can be transcendent, both in the optimisation of health resources in primary care and in the management of the demand for care.

Hypothesis: The implementation of nurse demand management is a factor of improvement in the efficiency and quality of care in the Primary Care Emergency Centre of the city of Mataró (Barcelona, Spain). Objectives: The main objective of this study was to determine whether the implementation of nurse demand management is a factor in improving efficiency and quality of care in the CUAP of Mataró. Methodology: Non-randomised controlled experimental intervention study. Application of a consensual guide with 5 reasons for health consultations where demand management nursing can be applied. conditions: Nurse's Role conditions: Disease, Acute studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 312 type: ACTUAL name: nursing procedure for acute health problems of low complexity measure: Waiting time and resolution of the visit measure: Number of reconsultations measure: patient experience measure: Prescribed drugs measure: Processed labour disabilities measure: Diagnoses change sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mataró primary care emergency center city: Mataró state: Barcelona zip: 08301 country: Spain lat: 41.54211 lon: 2.4445 hasResults: False

 nctId: NCT06298227 id: Medipol Hospital 1 briefTitle: Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy overallStatus: RECRUITING date: 2024-03-11 date: 2024-07-20 date: 2024-07-30 date: 2024-03-07 date: 2024-03-15 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.

US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.

This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy. conditions: Kidney Diseases conditions: Kidney Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic nephrectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group ESPB = ESPB group, Group QLB = QLB group) including 30 patients each, before entering the operating room. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Outcomes assessor and participants will be blinded to the study whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Postoperative analgesia management with Paracerol® and IV PCA with Talinat® name: Erector spinae plane block name: Quadratus lumborum plane block measure: Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively measure: Pain scores (Numerical rating scale-NRS) measure: Need for rescue analgesia (meperidine) measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University Mega Hospital Complex status: RECRUITING city: Istanbul state: Bağcılar country: Turkey name: Ayşe İnce, Assist Prof role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06298214 id: RP-23-019 briefTitle: Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester acronym: Her Health overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-01 date: 2026-06-01 date: 2024-03-07 date: 2024-03-07 name: Elizabeth F Sutton, PhD class: OTHER name: Donaghue Medical Research Foundation briefSummary: The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.

The main question\[s\] the study aims to answer are:

* Can the Her Health program increase access to healthcare in the first year postpartum?
* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?

Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.

Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby. conditions: Postpartum conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 500 type: ESTIMATED name: Her Health Program measure: Postpartum visit attendance measure: Medical trust measure: Health literacy measure: Self-efficacy measure: Healthcare costs sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Woman's Hospital city: Baton Rouge state: Louisiana zip: 70817 country: United States lat: 30.45075 lon: -91.15455 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-05 uploadDate: 2024-02-02T12:19 filename: Prot_SAP_000.pdf size: 458232 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-06 uploadDate: 2024-02-02T12:21 filename: ICF_001.pdf size: 188057 hasResults: False

 nctId: NCT06298201 id: IMAGINE2024 briefTitle: E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity acronym: COMPACT overallStatus: RECRUITING date: 2024-04 date: 2024-11 date: 2025-07 date: 2024-03-07 date: 2024-03-07 name: University of Southern Denmark class: OTHER briefSummary: Background: Physical exercise (PE) improves symptoms and quality of life in patients with multiple sclerosis (pwMS). Comorbidity is prevalent among pwMS and may contribute to disease progression. Integrating and sustaining PE is challenging and E-based PE solutions have been proposed as a tool to support the integration of PE into daily life.

Aims: To assess the effect of e-based PE in addition to usual care in pwMS on clinical outcome and the levels of inflammatory, metabolic, and neurodegenerative mediators. Furthermore, to determine whether PE plays a role in the modification of comorbidities with a focus on vascular comorbidity and related risk factors, i.e., type 2 diabetes mellitus.

Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid.

Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial (RCT) with prospective longitudinal follow up primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the nature of the intervention, it is not feasible to blind participants or physiotherapists delivering the program. Nonetheless, to preserve the integrity of the trial, outcome assessors (researchers) will remain blinded to the allocation of treatments. whoMasked: PARTICIPANT count: 300 type: ESTIMATED name: E-Based Physical Exercise Intervention measure: 6-meters' walk test measure: "no evidence of disease activity" (NEDA-3) score measure: Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA), measure: Fatigue levels, assessed using the short-form Neuro-QOL Fatigue Scale measure: Neurofilament Light Chain (NfL) determination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southern Denmark status: ENROLLING_BY_INVITATION city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: University of Southern Denmark status: RECRUITING city: Odense zip: 5230 country: Denmark name: Nasrin Asgari, Professor role: CONTACT phone: +4530700612 email: nasgari@health.sdu.dk name: Ulrik Dalgas, Professor role: CONTACT email: dalgas@ph.au.dk lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06298188 id: RisaKids briefTitle: Risankizumab in Children With Crohn's Disease (RisaKids) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-10 date: 2026-10 date: 2024-03-07 date: 2024-03-07 name: Shaare Zedek Medical Center class: OTHER briefSummary: The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.

This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Risankizumab measure: Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06298175 id: 2021-157 briefTitle: Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions overallStatus: COMPLETED date: 2021-04-15 date: 2021-04-15 date: 2021-08-15 date: 2024-03-07 date: 2024-03-07 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The study was conducted from 15th April 2021 to 15th August 2021. It employed a pretest-posttest design with control and training groups. In this study, a pretest-posttest design including control and training groups was used. Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks. conditions: Chronic Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre-post test, randomized controlled study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ACTUAL name: Self management training measure: Self-Control Self-Management Scale (SCMS) measure: Cognitive Emotion Regulation Questionnaire (CERQ) measure: The Occupational Balance Questionnaire (OBQ) sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Saglik Bilimleri Universitesi city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06298162 id: 2018-1279 briefTitle: Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass acronym: MRI pouch overallStatus: COMPLETED date: 2019-07-25 date: 2020-02-01 date: 2020-02-01 date: 2024-03-07 date: 2024-03-07 name: Rijnstate Hospital class: OTHER briefSummary: A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL\>35%) and bad responders (TWL\<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB). conditions: Bariatric Surgery Candidate conditions: Gastric Bypass conditions: Obesity, Morbid conditions: Pouch Emptying studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10 type: ACTUAL name: 2 years after RYGB, no intervention. MRI measurement. Observational. measure: Pouch emptying rate measured with MRI measure: subjective ratings of fullness measure: subjective ratings of wellbeing sex: FEMALE minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Yonta Burgh city: Arnhem zip: 6815 AD country: Netherlands lat: 51.98 lon: 5.91111 hasResults: False

 nctId: NCT06298149 id: 2023-650-EXEMPT id: 1U54CA280812-01 type: NIH link: https://reporter.nih.gov/quickSearch/1U54CA280812-01 briefTitle: Reach Through Equitable Implementation of Turtle Island Tales overallStatus: ENROLLING_BY_INVITATION date: 2023-11-01 date: 2028-04-30 date: 2028-04-30 date: 2024-03-07 date: 2024-03-07 name: Montana State University class: OTHER name: National Institutes of Health (NIH) name: University of Utah name: National Cancer Institute (NCI) briefSummary: Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts. conditions: Obesity, Childhood conditions: Obesity conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each participating family will receive a monthly lesson targeting a healthy behavior (increase fruit/vegetable intake, decrease added sugar intake, increase physical activity, decrease sedentary/screen time, promote healthy sleep, and promote emotional regulation) over the course of one year. primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Turtle Island Tales measure: 20-item Family Nutrition and Physical Activity Survey measure: Food insecurity screener measure: Mental Health screening sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montana State University city: Bozeman state: Montana zip: 59717 country: United States lat: 45.67965 lon: -111.03856 hasResults: False

 nctId: NCT06298136 id: 15610923 briefTitle: The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder acronym: MindADHD overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: The Hong Kong Polytechnic University class: OTHER briefSummary: This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will investigate the effects of an online mindfulness-based intervention (MBI) on outcomes in children with ADHD. The effects of the MBI (arm 1) will be investigated in comparison with the effects of psychoeducation (arm 2). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The participants will be informed that an intervention (program A or program B) will be assigned to them randomly. For research team who will be in contact with participants for outcome assessment, whether the participants have been allocated to arm 1 or arm 2 will be blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 208 type: ESTIMATED name: mindfulness-based intervention name: child behavior management measure: Child ADHD symptoms measure: Parent depressive symptoms measure: Parent anxiety symptoms measure: Parent sleep quality measure: Parent well-being measure: Child executive functioning measure: Parental Stress measure: Expressed emotion sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Herman Hay Ming Lo status: RECRUITING city: Hong Kong country: Hong Kong name: Christine Wing Tung Yeung, MSsc role: CONTACT phone: +85266279904 email: wing-tung.yeung@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06298123 id: adjuvant-03 briefTitle: Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling overallStatus: COMPLETED date: 2019-02-01 date: 2023-02-01 date: 2023-02-01 date: 2024-03-07 date: 2024-03-07 name: Chen Xiaoping class: OTHER briefSummary: The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors. conditions: Hepatocellular Carcinoma conditions: Adjuvant Immunotherapy conditions: Checkpoint Inhibitor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 304 type: ACTUAL name: Anti-PD-1 monoclonal antibody measure: Recurrence-Free Survival (RFS) measure: Overall Survival (OS) measure: Imaging data (enhanced CT and MRI） and histopathology data, if available. 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 city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06298110 id: PRP in Abdominal hysterectomy briefTitle: The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-08-25 date: 2024-09-25 date: 2024-03-07 date: 2024-03-08 name: Helwan University class: OTHER briefSummary: To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy. conditions: Wound Heal conditions: Abdominal Wound conditions: PRP studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Platelets Rich plasma of the same patient measure: changes in wound healing measure: Vancouver scar scale changes measure: Visual Analog Scale changes measure: Hospital readmission measure: Infection sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298097 id: 2019.11 briefTitle: Brain Connectivity Measured With High-density Electroencephalography acronym: NEUROCONN overallStatus: RECRUITING date: 2020-06-11 date: 2025-02-02 date: 2025-02-02 date: 2024-03-07 date: 2024-03-07 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 170 type: ESTIMATED name: Connectivity measures measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: High-density electroencephalography measurements (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3) measure: Muscle strength measurement (work package 3) measure: Muscle strength measurement (work package 3) measure: Muscle strength measurement (work package 3) measure: Muscle strength measurement (work package 3) measure: Muscle strength measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Sensorimotor impairment measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Spasticity measurement (work package 3) measure: Funtional skills measurement (work package 3). measure: Funtional skills measurement (work package 3). measure: Funtional skills measurement (work package 3). measure: Funtional skills measurement (work package 3). measure: Funtional skills measurement (work package 3). measure: Activities of daily living measurement (work package 3) measure: Activities of daily living measurement (work package 3) measure: Activities of daily living measurement (work package 3) measure: Activities of daily living measurement (work package 3) measure: Activities of daily living measurement (work package 3) measure: Pain measurement (work package 3) measure: Pain measurement (work package 3) measure: Pain measurement (work package 3) measure: Pain measurement (work package 3) measure: Pain measurement (work package 3) measure: Cognitive performance measurements (work package 3) measure: Cognitive performance measurements (work package 3) measure: Cognitive performance measurements (work package 3) measure: Cognitive performance measurements (work package 3) measure: Cognitive performance measurements (work package 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Camillo Hospital status: RECRUITING city: Venice country: Italy role: CONTACT email: n.ricercaclinica@hsancamillo.it lat: 45.43713 lon: 12.33265 hasResults: False

 nctId: NCT06298084 id: 2023-505925-15-00 id: 2023/3668 type: OTHER domain: CSET number briefTitle: Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd acronym: ICARUSBREAST02 overallStatus: RECRUITING date: 2024-03-21 date: 2027-09 date: 2029-06 date: 2024-03-07 date: 2024-03-29 name: Gustave Roussy, Cancer Campus, Grand Paris class: OTHER name: Daiichi Sankyo briefSummary: ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.

The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0).

The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd.

The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months. conditions: Breast Cancer Metastatic conditions: HER2-positive Metastatic Breast Cancer conditions: HER2 Low Breast Carcinoma conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 152 type: ESTIMATED name: Patritumab deruxtecan name: Olaparib measure: DLTs (dose-limiting toxicity) for part 1a and 1b measure: Frequency of safety event for part 1a and 1b measure: Severity of safety event for part 1a and 1b measure: Proportion of treatment modification due to AEs for part 1a and 1b measure: frequency of laboratory abnormalities for part 1a and 1b measure: Severity of laboratory abnormalities for part 1a and 1b measure: radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 1a and 1b measure: ORR for part 2 measure: DOR for part 2 measure: PFS for part 2 measure: CBR for part 2 measure: ORR for part 1 measure: DOR for part 1 measure: PFS for part 1 measure: CBR for part 1 measure: PK analysis for part 1 measure: ADA analysis for part 1 measure: DLTs for part 2 measure: Frequency of safety event for part 2 measure: Severity of safety event for part 2 measure: proportion of treatment modification event for part 2 measure: frequency of laboratory abnormalities for part 2 measure: Severity of laboratory abnormalities for part 2 measure: radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 2 measure: PK analysis for part 2 measure: ADA analysis for part 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustave Roussy Institut status: RECRUITING city: Villejuif zip: 94805 country: France name: Barbara Pistilli role: CONTACT phone: +33 (0)1 42 11 61 62 email: barbara.pistilli@gustaveroussy.fr name: Fernanda Mosele role: CONTACT phone: +33 (0)1 42 11 61 43 email: Mariafernanda.MOSELE@gustaveroussy.fr lat: 48.7939 lon: 2.35992 hasResults: False

 nctId: NCT06298071 id: SIBP-R002-Ib briefTitle: A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout. overallStatus: RECRUITING date: 2023-03-03 date: 2024-12-30 date: 2025-12-30 date: 2024-03-07 date: 2024-03-07 name: Shanghai Institute Of Biological Products class: INDUSTRY name: First Affiliated Hospital Bengbu Medical College name: The First Affiliated Hospital of Henan University of Science and Technology name: Chengdu Fifth People's Hospital briefSummary: To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials. conditions: Gout studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: According to the sequence from low-dose group to high-dose group, there are 12 participants in each group, totaling 36 participants. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: SIBP-R002 name: SIBP-R002 name: SIBP-R002 name: Methotrexate measure: AE(Adverse Events) measure: SAE(Serious Adverse Events) measure: AUC(Area Under The Plasma Concentration Versus Time Curve) measure: Cmax(Peak Plasma Concentration) measure: Tmax(Peak Time) measure: T ½ (Terminal elimination half-life) measure: CL (Clearance Rate) measure: ADA (Anti-uricase Antibody, Anti-PEG Antibody, Anti-PEG-uricase Antibody) measure: NAb (Anti-PEG-uricase Neutralizing Antibody) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Bengbu Medical College status: RECRUITING city: Bengbu state: Anhui country: China name: Huan Zhou, Master role: CONTACT phone: 86-13665527160 email: zhouhuanbest@hotmail.com lat: 32.94083 lon: 117.36083 hasResults: False

 nctId: NCT06298058 id: SIBP-A13-I briefTitle: A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients. overallStatus: NOT_YET_RECRUITING date: 2024-03-12 date: 2026-04-30 date: 2026-06-30 date: 2024-03-07 date: 2024-03-07 name: Shanghai Institute Of Biological Products class: INDUSTRY name: Shanghai Pulmonary Hospital, Shanghai, China briefSummary: To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is an open, multi-dose increasing single and multiple dose study. primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: SIBP-A13 formulation for injection measure: AE (Adverse Events) measure: SAE (Serious Adverse Events) measure: AUC (Area Under The Plasma Concentration Versus Time Curve) measure: Cmax (Peak Plasma Concentration) measure: Tmax (Peak Time) measure: T ½ (Terminal elimination half-life) measure: CL (Clearance Rate) measure: ORR (Objective Response Rate) measure: DCR (Disease control rate) measure: PFS (Progression-free survival) measure: OS (overall survival) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06298045 id: DIM-06790-002 briefTitle: Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy overallStatus: RECRUITING date: 2023-07-15 date: 2025-03-31 date: 2025-03-31 date: 2024-03-07 date: 2024-03-07 name: Servier Affaires Médicales class: INDUSTRY briefSummary: The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only. conditions: Stable Angina studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Assessment of angina symptoms via the summary score of SAQ-7 measure: CCS angina grading post-inclusion measure: Tolerance ( Adverse Events) measure: Tolerance ( Serious Adverse Events) measure: Adherence to the antianginal treatment combination under evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thera Card Srl status: RECRUITING city: Braşov zip: 500091 country: Romania name: Zara Cornelia, Dr role: CONTACT phone: +40723733774 email: cornelia.zara@theracardia.ro lat: 45.64861 lon: 25.60613 hasResults: False

 nctId: NCT06298032 id: 000414 briefTitle: A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons overallStatus: RECRUITING date: 2024-02-20 date: 2024-11-12 date: 2024-11-12 date: 2024-03-07 date: 2024-03-07 name: Ferring Pharmaceuticals class: INDUSTRY briefSummary: Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases. conditions: Inflammatory Gastrointestinal Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Olamkicept Part A name: Olamkicept Part B name: Placebo measure: Number of treatment-emergent adverse events, including type, intensity, and causality measure: Change in vital signs from baseline to Day 36 after a single dose infusion measure: Change in vital signs from baseline to Day 64 after multiple dose infusions measure: Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion measure: Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions measure: Change in haematology from baseline to Day 36 after a single dose infusion measure: Change in haematology from baseline to Day 64 after multiple dose infusions measure: Change in clinical chemistry from baseline to Day 36 after a single dose infusion measure: Change in clinical chemistry from baseline to Day 64 after multiple dose infusions measure: Change in haemostasis parameters from baseline to Day 36 after a single dose infusion measure: Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions measure: Change in urinalysis parameters from baseline to Day 36 after a single dose infusion measure: Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions measure: Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf) measure: Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast) measure: Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi) measure: Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax) measure: Single-dose PK of FE 999301: Time of maximum observed concentration (tmax) measure: Single-dose PK of FE 999301: Terminal half-life (t1/2) measure: Single-dose PK of FE 999301: Mean residence time (MRT) measure: Single-dose PK of FE 999301: Total clearance (CL) measure: Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss) measure: Multiple-dose PK of FE 999301: Area under concentration-time curve from dosing up to time τ, where τ is the dosing interval (AUCτ) measure: Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast) measure: Multiple-dose PK of FE 999301: Observed accumulation index (Rac) measure: Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio) measure: Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax) measure: Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax) measure: Multiple-dose PK of FE 999301: Terminal half-life (t½) measure: Multiple-dose PK of FE 999301: Mean residence time (MRT) measure: Multiple-dose PK of FE 999301: Total clearance (CL) measure: Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss) measure: Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ferring Investigational Site status: RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06298019 id: 73464 briefTitle: Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2039-04 date: 2024-03-07 date: 2024-03-07 name: Stanford University class: OTHER briefSummary: The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called "CD19" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these "re-engineered" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease.

The main questions the study intends to answer are:

* Understanding how well patients tolerate undergoing this therapy in terms of side effects;
* Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs; conditions: Dermatomyositis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Patients will be enrolled in a sequential manner with respect to the aggressiveness of the conditioning regimen used prior to receiving the CAR T infusion therapy. The first 3 patients will undergo standard conditioning--daily cyclophosphamide (IV, 300 mg/m2) and fludarabine (30 mg/m2) x 3 days. If this regimen is found to allow sufficient engraftment of the CAR T cells, participants will be enrolled in sequential groups (of 3-5) representing milder doses or alternative medications that overall represent gentler cytoreduction, which advancement to each sequential group contingent upon satisfactory number and function of infused CAR T cells. primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: KYV-101 measure: Number of participants experiencing adverse events sex: ALL minimumAge: 25 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06298006 id: 275025 briefTitle: A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients acronym: PASC24 overallStatus: RECRUITING date: 2022-02-22 date: 2026-12-31 date: 2027-06-30 date: 2024-03-07 date: 2024-03-07 name: Region Örebro County class: OTHER name: Örebro University, Sweden name: Karolinska Institutet name: Karolinska University Hospital name: Sahlgrenska University Hospital, Sweden briefSummary: The prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after COVID-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Follow-up measure: Change in cognitive functions measured with Mindmore and change in cognitive profile in Mindmore. measure: Symptom improvement in depression measure: Self-reported symptom improvement in depression measure: Grade of self-reported mental fatigue measure: Rate of self-reported symptoms suggestive of post-traumatic stress disorder (PTSD) measure: Grade of self-reported stress measure: Grade of self-reported cognitive failures in everyday life measure: Occurence of activity limitations and changes in health-related quality of life (QoL) measure: Grade of work incapacity/sick leave and time to return to work measure: Changes in body size measure: Waist size measure: Rate of peak expiratory flow (PEF) measure: Grade of physical exercise capacity measure: Concetration of Beta-Amyloid 42 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration. measure: Beta Amyloid Ratio 42/40 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease measure: Concentration of neurogranin in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease measure: Concentration of Tau (P-Tau) protein in cerebrospinal fluid (CSF) as a CSF biomarker of cortikal damage/neurodegeneration measure: Concentration of phosphorylated Tau (P-Tau) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration/taupathy measure: Concentration of neurofilament light (NFL) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration measure: Concentration of neurofilament light (NFL) in plasma as a blood biomarker of neurodegeneration measure: Occurence of APOE4 allele as biomarker of genetic predisposition to Alzheimer's disease and susceptibility to more severe course of COVID-19 infection measure: Brain volumes and signal abnormalities in white and gray matter measure: Changes in functional and structural brain connectivity measure: Changes in gut microbiome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Geriatrics, University Hospital Örebro status: RECRUITING city: Örebro country: Sweden name: Yvonne Freund-Levi, MD, PhD role: CONTACT phone: +46 736841130 email: yvonne.freund@oru.se name: Zbigniew Dzialanski, MD role: SUB_INVESTIGATOR lat: 59.27412 lon: 15.2066 hasResults: False

 nctId: NCT06297993 id: WIND-PSC-01 briefTitle: Adult Patients With Primary Sclerosing Cholangitis acronym: WIND-PSC overallStatus: RECRUITING date: 2024-04 date: 2029-01 date: 2031-01 date: 2024-03-07 date: 2024-04-09 name: Arbor Research Collaborative for Health class: OTHER briefSummary: Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC. conditions: PSC studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 2000 type: ESTIMATED measure: Develop interventional clinical trial external control using clinical and biomarker data. measure: Identify alternative endpoints to predict clinical benefit using large clinical and biomarker data. measure: Changes in patient reported outcomes over time as assessed by Patient Reported Outcomes surveys. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schiff Center for Liver Diseases / University of Miami status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Cynthia Levy, MD role: CONTACT phone: 306-243-4615 email: clevy@med.miami.edu name: Cynthia Levy, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06297980 id: 23-1513 briefTitle: Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes acronym: MERIT overallStatus: RECRUITING date: 2024-03-15 date: 2026-10-31 date: 2026-10-31 date: 2024-03-07 date: 2024-03-07 name: University of Colorado, Denver class: OTHER name: The Leona M. and Harry B. Helmsley Charitable Trust briefSummary: The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity. conditions: Type 1 Diabetes conditions: Hypoglycemia conditions: Hyperglycaemia Due to Type 1 Diabetes Mellitus conditions: Menstruation Disturbances studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period. primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Personalized modifications to treatment to address menstrual cycle effects on glycemia measure: Glucose time in range measure: Glucose standard deviation measure: Mean glucose (mg/dL) pre-exercise measure: Mean glucose (mg/dL) while exercising measure: Mean glucose (mg/dL) over 24 hours after exercise measure: Glucose standard deviation measure: Glucose standard deviation sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: JANET K SNELL-BERGEON, PhD role: CONTACT phone: 303-724-6762 email: Janet.Snell-Bergeon@cuanschutz.edu name: Catherine Chartier-Logan, MPH role: CONTACT phone: 3037247505 email: Catherine.Chartier-Logan@cuanschutz.edu name: Sarit Polsky, MD role: SUB_INVESTIGATOR name: Cristy Geno, PhD role: SUB_INVESTIGATOR name: Bryan Bergman, PhD role: SUB_INVESTIGATOR name: Laura Pyle, PhD role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06297967 id: CSAPG-33 briefTitle: Acetic Acid 2% Solution for Skin Ulcers acronym: ECA-AA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-06 date: 2024-03-07 date: 2024-03-12 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).

Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment. conditions: Ulcer, Skin studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Acetic Acid name: Prontosan measure: Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment measure: Percentage of participants with ulcer healing at 4 weeks from the start of treatment. measure: Percentage of participants with ulcer healing at 12 weeks from the start of treatment. measure: Time (days) to ulcer healing from the start of treatment. measure: Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale. measure: Number of adverse reactions associated with the treatment, collected from the medical record. measure: The healthcare expenditure associated with each branch of the study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Consorci Sanitari Alt'Pènedes i Garraf city: Barcelona state: Cataluña zip: 08810 country: Spain name: Marta De Vicente role: CONTACT phone: +34 938931616 email: mdevicente@csapg.cat name: Noemí Casaponsa role: CONTACT phone: +34 938960025 phoneExt: 43197 email: recerca@csapg.cat name: Marta De Vicente role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06297954 id: GA22-00011 briefTitle: Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding overallStatus: RECRUITING date: 2023-03-16 date: 2024-06 date: 2024-06 date: 2024-03-07 date: 2024-03-07 name: Universidad Autonoma de Nuevo Leon class: OTHER briefSummary: A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 12 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale. conditions: Upper Gastrointestinal Bleeding studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. The sequence of treatment (metoclopramide) and placebo in which they will be distributed to patients will be determined using randomization software. A folio number will be assigned and depending on the sequence the treatment or placebo will be administered. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale primaryPurpose: DIAGNOSTIC masking: DOUBLE maskingDescription: As it is double-blind, both physician and patient will not know the treatment they are receiving and it will only be revealed later at the end of the protocol. Following the previous folios, both the treatment and the placebo will be distributed in boxes by default by the research staff, delivering them to the personnel who will apply the drug or placebo, indicating the doses and frequencies of these when administered. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Metoclopramide name: Placebo measure: To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding. measure: To determine whether the use of metoclopramide avoids repeating the endoscopic procedure. measure: To determine whether the use of metoclopramide shortens the length of hospital stay. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Dr. José Eleuterio González, UANL status: RECRUITING city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: José Luis Herrera Elizondo, Physician role: CONTACT phone: +528180182968 email: here_herrera_11@hotmail.com name: José Alberto González González, Physician role: CONTACT phone: +528183668061 email: jalbertogastro@gmail.com lat: 25.67507 lon: -100.31847 hasResults: False

 nctId: NCT06297941 id: REM-422-102 briefTitle: Study of REM-422 in Patients With AML or Higher Risk MDS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-15 date: 2027-06-15 date: 2024-03-07 date: 2024-04-23 name: Remix Therapeutics class: INDUSTRY briefSummary: The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML conditions: Myelodysplastic Syndromes conditions: Higher Risk Myelodysplastic Syndromes conditions: Acute Myeloid Leukemia conditions: Acute Myeloid Leukemia Refractory studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: REM-422 measure: Frequency and severity of Treatment Emergent Adverse Events (TEAEs) measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) measure: AML: Rate of Complete Response (remission) (CR) measure: AML: Rate of CR with partial hematologic recovery (CRh) measure: AML: Duration of CR measure: AML: Duration of CRh measure: AML: Overall response rate (ORR) (CR + CRh + CRi + PR) with incomplete hematologic recovery [CRi] + partial response [PR]) per modified IWG response criteria 2003 based on Investigator assessment measure: AML: Duration of response (DOR) measure: MDS: Rate of Compete Response (CR) measure: MDS: Duration of Complete Response (CR) measure: MDS: Overall Response Rate (ORR) measure: MDS: Duration of Response (DOR) measure: Determine pharmacokinetic profile (Cmax) of REM-422 measure: Determine pharmacokinetic profile (Cmin) of REM-422 measure: Determine pharmacokinetic profile (Tmax) of REM-422 measure: Determine pharmacokinetic profile (AUC) of REM-422 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope city: Duarte state: California zip: 91010 country: United States name: Anthony S Stein, MD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Memorial Sloan Kettering city: New York state: New York zip: 10065 country: United States name: Eytan M Stein, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Courtney D DiNardo, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06297928 id: 2023/11238/I briefTitle: Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity overallStatus: RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: Parc de Salut Mar class: OTHER briefSummary: The goal of this observational study is to investigate metabolic changes in individuals undergoing bariatric surgery, specifically focusing on those with obesity and varying metabolic health statuses. The main questions it aims to answer are:

* Can metabolic markers predict the transition from metabolically unhealthy obesity to metabolically healthy obesity after bariatric surgery?
* How do metabolic profiles change in individuals with metabolically healthy obesity after bariatric surgery?
* What are the metabolic differences between individuals with metabolically healthy and unhealthy obesity before and after bariatric surgery?

Participants will undergo routine evaluations and blood tests before and after bariatric surgery. These tests will include assessments of metabolic health markers and sampling of blood plasma for metabolomic analysis. The study will study changes in metabolic profiles between individuals who transition to metabolically healthy obesity and those who remain metabolically unhealthy after surgery. conditions: Bariatric Surgery Candidate conditions: Obesity, Morbid conditions: Obesity, Metabolically Benign studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 145 type: ESTIMATED name: baratric surgery measure: Identification of Metabolic Signatures Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Analysis Predicting Transition from Metabolically Unhealthy Obesity (MUO) to Metabolically Healthy Obesity (MHO) Status measure: Comparison of Metabolomic Changes Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) between Patients with Persistent Metabolically Unhealthy Obesity (MUO) and Those Transitioning to Metabolically Healthy Obesity (MHO) Status measure: Comparison of Baseline Metabolomic Profile and Its Evolution Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) after Surgery between Patients with Metabolically Healthy Obesity (MHO) and Metabolically Unhealthy Obesity (MUO) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hospital del Mar status: RECRUITING city: Barcelona zip: 08003 country: Spain name: David Benaiges Boix, PhD role: CONTACT phone: 0034932483902 email: dbenaiges@psmar.cat name: David Benaiges, PhD role: PRINCIPAL_INVESTIGATOR name: Joan Pedro-Botet, PhD role: SUB_INVESTIGATOR name: Albert Goday, PhD role: SUB_INVESTIGATOR name: Carme Serra role: SUB_INVESTIGATOR name: Elisenda Climent, PhD role: SUB_INVESTIGATOR name: Helena Julià, PhD role: SUB_INVESTIGATOR name: Miguel Olano, MD role: SUB_INVESTIGATOR name: Oscar Pozo, PhD role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06297915 id: 2022/08-45 briefTitle: Infusion Treatments of Chronic Peripheral Neuropathic Pain overallStatus: COMPLETED date: 2022-05-17 date: 2023-05-10 date: 2023-08-01 date: 2024-03-07 date: 2024-03-07 name: Hacettepe University class: OTHER briefSummary: This study aimed to evaluate and compare the efficacy of ketamine and lidocaine infusion in patients with chronic peripheral neuropathic pain.

Patients who received intravenous ketamine infusion and the other patient group who received intravenous lidocaine infusion were evaluated in the study. Pain scores and quality of life were assessed with scales before treatment at two weeks, two months, and six months after treatment. conditions: Neuropathic Pain studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: RETROSPECTIVE count: 102 type: ACTUAL name: Ketamine name: Lidocain measure: Neuropathic Pain Scale measure: Pain Rating Scale measure: Quality of Life Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University city: Ankara state: Cankaya zip: 06360 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06297902 id: 2023_31 briefTitle: RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3 acronym: RADPAINT-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-06 date: 2030-06 date: 2024-03-07 date: 2024-03-07 name: Oslo University Hospital class: OTHER name: Haukeland University Hospital name: St. Olavs Hospital name: Norwegian University of Life Sciences briefSummary: The objective of the RADPAINT-3 trial is to investigate whether dose painting is safe compared to standard radiotherapy. RADPAINT-3 is a randomized, non-inferiority, multi-center phase II study, initiated at the Section for Head and Neck Cancer, Department of Oncology, Oslo University Hospital, accruing from first half of 2024. The primary endpoint is frequency of grade ≥ 3 (CTCAE v5.0) mucosal ulcers one year after treatment. The expected inclusion period is three years, total study duration is six years and planned inclusion number is 100 patients. The collaborating sites are St Olav´s Hospital and Haukeland University Hospital. The patients will be randomized 1:1 to either standard radiotherapy (2 Gy x 34; total dose 68 Gy) or experimental radiotherapy (dose painting). All patients will have 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission computed tomography (FDG-PET/CT) prior to radiotherapy. In the experimental arm, we will escalate the dose to the hypermetabolic part of the tumor (maximum point dose 83.3 Gy), shown in pre-treatment FDG-PET images. Dose escalation will be applied to these regions during the first half of the fractionated treatment (17 of 34 fractions). The patients in both arms will receive concomitant nimorazole (hypoxic radiosensitizer) and concomitant cisplatin if indicated according to standard treatment. The main inclusion criterion is patients with human-papillomavirus (HPV)-unrelated head and neck cancer with poor prognosis.

The RADPAINT-3 trial includes a translational sub-study where we aim to elucidate underlying mechanisms related to the radiotherapy effect, by investigating blood samples. Analysis of cytokines in repetitive blood samples may predict both tumor response and toxicity. The data derived from this sub-study, will be further explored using artificial intelligence.

If RADPAINT-3 shows that there is no excess toxicity, we will continue the study after a new protocol has been approved. The new primary endpoint will be local control at 1 year after radiotherapy. Power analysis show that we will need in total 182 evaluable patients including the 100 patients from RADPAINT-3. The translational sub-study will then be extended to investigate genetic expression data from pre-therapy routine tumor biopsies and correlate this with the analysis of blood samples and tumor control. conditions: Head and Neck Cancer conditions: Radiotherapy Side Effect studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Dose painting measure: Late mucosal ulcer measure: Early toxicity measure: Late toxicity measure: Odynophagia measure: Health-related quality of life measure: Cytokines sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297889 id: Ma Hucheng briefTitle: Effect of Core Strength Training on the Physical Fitness and Skills of Youth Field Hockey Players in China overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-01 date: 2024-06-15 date: 2024-03-07 date: 2024-03-08 name: Universiti Putra Malaysia class: OTHER briefSummary: Hockey, tracing its origins back to 2000 BC, has undergone substantial evolutionary transformations throughout the centuries. Initially known by various names, the game transitioned to its modern form approximately 50 years ago, when matches were conducted on grass fields with wooden sticks. In contemporary international hockey, there has been a notable shift towards artificial grass, cultivating a dynamic and fast-paced game that places heightened demands on individual skills, tactical acumen, and physical fitness. This evolution reflects a continuous adaptation, seamlessly blending tradition with cutting-edge equipment and hybrid playing grounds.

Against this backdrop, modern-day hockey programs have metamorphosed into rigorous and demanding training regimes. Athletes engaged in these programs are required not only to demonstrate outstanding physical fitness but also exhibit a high level of proficiency in the nuanced skills essential for competitive play. As hockey continues its progressive trajectory, athletes partaking in these programs must meet elevated standards, underscoring the imperative integration of both exceptional fitness levels and precise skill execution.

Despite the growing emphasis on the physical and skill dimensions of hockey, a literature review uncovered a dearth of research specifically focusing on core strength training for hockey players. While core strength training has demonstrated efficacy in improving physical fitness and skill performance among athletes in other team sports, its applicability to hockey players remains underexplored. Moreover, no studies have systematically examined the impact of core strength training on the two critical variables of physical fitness and skill performance in hockey players.

To address this research gap, the present study sought to investigate the effects of core strength training on the physical fitness and skill performance of youth hockey players in Gansu Province, China. By doing so, this study not only contributes valuable insights to the existing body of literature but also furnishes theoretical support for the development of hockey sport programs. The findings are anticipated to inform targeted interventions aimed at enhancing athletes' physical fitness and skill performance, ultimately fostering the progression of hockey programs within the sporting landscape of China. conditions: Player studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: In this experiment, the experimental group engaged in the core strength training segment of the intervention specifically devised for this study, whereas the control group underwent conventional strength training activities. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: core strength training 1-6weeks name: core strength training 7-12weeks measure: Power test measure: Speed test sex: MALE minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: Ma Hucheng status: RECRUITING city: Lanzhou state: Gansu zip: 730000 country: China name: Hucheng Ma, PHD role: CONTACT phone: +8613909492013 email: 875803848@qq.com name: WEI WEI, Senior Coach role: CONTACT phone: +8618919171585 email: 3371189581@qq.com lat: 36.05701 lon: 103.83987 hasResults: False

 nctId: NCT06297876 id: H00023815 briefTitle: COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color overallStatus: RECRUITING date: 2023-05-19 date: 2024-05 date: 2025-05 date: 2024-03-07 date: 2024-03-07 name: University of Massachusetts, Worcester class: OTHER name: Merck Sharp & Dohme LLC briefSummary: Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts conditions: Vaccine Hesitancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will view either storytelling videos or learn more videos. They will not know which video they will get ahead of time nor will they know that they may get one or the other. whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Storytelling name: Learn More (Active Comparator) measure: Change in Vaccine Hesitancy measure: Vaccine Uptake sex: ALL minimumAge: 18 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Massachusetts Chan Medical School status: RECRUITING city: Worcester state: Massachusetts zip: 01605 country: United States name: Sarah Forrester, PhD role: CONTACT phone: 508-856-8338 email: sarah.forrester@umassmed.edu name: Jeroan Allison, MD role: CONTACT phone: 5088568993 email: jeroanallison@umassed.edu lat: 42.26259 lon: -71.80229 hasResults: False

 nctId: NCT06297863 id: DOWN-SUITE briefTitle: Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke acronym: DOWN-SUITE overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2026-09-30 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: University of Milano Bicocca class: OTHER name: Fondazione IRCCS San Gerardo dei Tintori name: Azienda Ospedaliero-Universitaria Careggi, Firenze name: Azienda Ospedaliera Universitaria Gaetano Martino, Messina briefSummary: The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.

This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).

The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°). conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The DOWN-SUITE trial is a prospective, multicenter, proof of concept, randomised, controlled, open label, phase 2a/b clinical trial with blinded outcome assessment, comparing cerebral collateral status in patients with acute ischemic stroke due to middle cerebral artery occlusion (M1 segment) treated with in-hospital application of HDT15 (-10° to -15°) versus usual positioning (0° to +30°), before and during mechanical thrombectomy. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A blinded central imaging core lab, whose members will be unaware of the procedure assignments, will assess all imaging outcomes, including the primary efficacy outcome (collateral status, assessed during the pretreatment diagnostic angiographic series of mechanical thrombectomy) whoMasked: OUTCOMES_ASSESSOR count: 118 type: ESTIMATED name: HEAD DOWN TILT -10° to -15° measure: Good collateral status measure: Feasibility of HDT15 measure: Delay to thrombectomy measure: Vomiting measure: Early neurological deterioration measure: Symptomatic intracranial hemorrhage measure: Aspiration pneumonia measure: Neurological disability measure: Systolic blood pressure measure: Diastolic blood pressure measure: Oxygen saturation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297850 id: WARD-Glucose Validation v.2.2 briefTitle: Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study overallStatus: RECRUITING date: 2024-04-01 date: 2024-09-30 date: 2025-05-01 date: 2024-03-07 date: 2024-04-12 name: University Hospital Bispebjerg and Frederiksberg class: OTHER name: Rigshospitalet, Denmark name: Steno Diabetes Center Copenhagen name: Zealand University Hospital briefSummary: The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.

The main questions it aims to answer are:

• Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?

Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days. conditions: Diabetes Mellitus conditions: Dysglycemia conditions: Perioperative Complication conditions: Circulatory; Complications studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) measure: Agreement between glucose measure: Agreement between glucose readings when at low glucose levels measure: Agreement between glucose readings when at normal glucose levels measure: Agreement between glucose readings when at high glucose levels measure: Adverse clinical outcomes measure: Readmission measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet status: RECRUITING city: Copenhagen state: The Capital Region Of Denmark zip: 2100 country: Denmark name: Eske K Aasvang, MD, DMSc role: CONTACT email: eske.kvanner.aasvang.01@regionh.dk lat: 55.67594 lon: 12.56553 facility: Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital status: RECRUITING city: Copenhagen state: The Capital Region Of Denmark zip: 2400 country: Denmark name: Christian S Meyhoff, MD, PhD role: CONTACT email: christian.sylvest.meyhoff@regionh.dk lat: 55.67594 lon: 12.56553 facility: Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital status: RECRUITING city: Copenhagen state: The Capital Region Of Denmark zip: 2400 country: Denmark name: Henrik Palm, MD, DMSc role: CONTACT email: henrik.palm@regionh.dk lat: 55.67594 lon: 12.56553 facility: Surgical department, Bispebjerg and Frederiksberg Hospital, status: NOT_YET_RECRUITING city: Copenhagen state: The Capital Region Of Denmark zip: 2400 country: Denmark name: Lars N Jørgensen, MD, DMSc role: CONTACT email: lars.nannestad.joergensen@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06297837 id: LHS0205 briefTitle: ADAPT-AST (Adaptive Antimicrobial Susceptibility Testing) acronym: ADAPT-AST overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-03 date: 2024-03-07 date: 2024-03-07 name: Liverpool University Hospitals NHS Foundation Trust class: OTHER_GOV briefSummary: The goal of this study is to improve the way urinary tract infections (UTIs) are tested for antibiotic resistance. The main questions it aims to answer are:

* Can the investigators use a method called Bayesian causal inference to create or check clinical prediction models that help predict if certain antibiotics will work for a urinary infection, using patient information from the National Health Service (NHS)?
* Can this new ADAPT-AST method, which uses data and a smarter approach, do a better job of testing for urinary infection than the old methods? Will it help doctors make quicker decisions and save resources by being more efficient?

Participants in this study will not be receiving treatments. The study will involve:

Using statistical methods to predict UTI test results based on patient data. Evaluating whether this new approach can provide doctors with more timely and useful information for treating UTIs.

Assessing whether it can help save money and resources in the lab and pharmacy. conditions: Urinary Tract Infections studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 500000 type: ESTIMATED measure: The number of antimicrobial susceptibility results that 'should' spur action by a clinician on measure: The number of days until a result that 'should' spur action by a clinician measure: The number of antimicrobial susceptibility results that 'could' spur action by a clinician on measure: The number of days until a result that 'could' spur action by a clinician measure: The projected health economic cost per specimen, including laboratory (e.g., consumable cost) and patient (e.g., drug toxicity, clinical failure) measures. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-10-03 uploadDate: 2023-11-16T04:00 filename: Prot_ICF_000.pdf size: 2230025 hasResults: False

 nctId: NCT06297824 id: 2023-04909-01 briefTitle: Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm acronym: ERGT-A overallStatus: RECRUITING date: 2023-10-10 date: 2024-12-31 date: 2025-06-30 date: 2024-03-07 date: 2024-03-07 name: Karolinska Institutet class: OTHER briefSummary: Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present.

A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents. conditions: Self-harm conditions: Emotion Regulation conditions: Adolescent - Emotional Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility, open trial primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: ERGT-A measure: Feasibility measure, recruitment rate measure: Feasibility measures, proportion included measure: Feasibility measures, compliance measure: Feasibility measures, attrition measure: Feasibility measures, client satisfaction measure: Feasibility measures, negative effects of treatment measure: Preliminary effect, self harm frequency EOT measure: Preliminary effect, self harm frequency 1MFU measure: Preliminary effect, emotion dysregulation EOT measure: Preliminary effect, emotion dysregulation 1MFU sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: Prima Barn och Vuxenpsykiatri Handen och Järva status: RECRUITING city: Stockholm state: Spånga zip: 16374 country: Sweden name: Dimitar Krastev, MSc role: CONTACT phone: +46735269516 email: Dimitar.Krastev@prima.se name: MaiBritt Giacobini, PhD role: CONTACT phone: +46709736662 email: Maibritt.Giacobini@prima.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06297811 id: SMA PT 001 briefTitle: Myeloprotection With Trilaciclib in Pan-cancer Population overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-30 date: 2027-12-31 date: 2024-03-07 date: 2024-03-07 name: Sun Yat-sen University class: OTHER briefSummary: The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are:

* effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy
* does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type

Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy. conditions: Non-Small Cell Lung Cancer conditions: Breast Cancer conditions: Endometrial Cancer conditions: Cervical Cancer conditions: Head And Neck Squamous Cell Carcinomas studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 132 type: ESTIMATED name: Trilaciclib Injection name: Paclitaxel name: Carboplatin measure: Occurrence of grade 3/4 neutropenia within 6 cycles sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Oncology,Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06297798 id: SakaryaAppliedSciencesUPNS briefTitle: Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2024-03-21 date: 2024-05-10 date: 2024-03-07 date: 2024-03-15 name: Sakarya Applied Sciences University class: OTHER briefSummary: This study is designed to examine the effect of telerehabilitation application on the musculoskeletal system of drivers.The study will include 40 voluntary participants who work as drivers on inter-district routes in Sakarya. The participants' sociodemographic information, musculoskeletal problems, and postures will be assessed. Participants will be divided into two groups: one group will receive tele-rehabilitation with posture and stabilization exercises, while the other group will serve as the control group. The exercises will be implemented for 10 weeks, followed by an 8-week tapering period, after which the groups will be crossed over. A re-evaluation will be conducted after 10 weeks, with follow-up assessments scheduled for 3 months later. conditions: Drive conditions: Musculoskeletal Diseases conditions: Postural; Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Telerehabilitation measure: MUSCLE SKELETAL SYSTEM ASSESSMENT measure: Posture Measures sex: MALE minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sakarya University of Applied Sciences city: Sakarya zip: 54000 country: Turkey name: Nurgul SEN, Master's degree role: CONTACT phone: 05344527440 email: pakizesen@subu.edu.tr name: Ceyhun TURKMEN, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR hasResults: False

 nctId: NCT06297785 id: 2022-03997-01 briefTitle: Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS) overallStatus: RECRUITING date: 2022-10-17 date: 2027-04 date: 2027-04 date: 2024-03-07 date: 2024-03-07 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity. conditions: IBS - Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Gut-directed hypnotherapy measure: Change in gastrointestinal symptom severity sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mag-Tarmlab, Sahlgrenska University Hospital status: RECRUITING city: Gothenburg zip: 41345 country: Sweden name: Jenny Lövdahl role: CONTACT phone: 0313428107 email: magtarmlab.su@vgregion.se lat: 57.70716 lon: 11.96679 facility: Sahlgrenska University Hospital status: RECRUITING city: Gothenburg zip: 41345 country: Sweden lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06297772 id: RJBMT-003 briefTitle: Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-01 date: 2028-05-01 date: 2024-03-07 date: 2024-03-13 name: Ruijin Hospital class: OTHER briefSummary: A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities conditions: AML, Adult studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: Decitabine name: Fludarabine Injection name: Busulfan Injection measure: disease-free survival measure: incidence of relapse rate measure: Non-recurrent mortality sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital city: Shanghai zip: 200025 country: China name: Xiaoxia Hu role: CONTACT phone: 862164370045 email: hxx12276@rjh.com.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06297759 id: ATADEK-2023/16 briefTitle: The Validity and Reliability Study of Turkish Version of the Sense of Competence in Dementia Care Staff (SCIDS) Scale overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-07 date: 2024-09 date: 2024-03-07 date: 2024-03-07 name: Yeditepe University class: OTHER name: Acibadem University briefSummary: The purpose of the study is to adapt the SCIDS into the Turkish version and validate it in the social and cultural context of Turkey to assess staff competency in dementia care in the long-term care setting. conditions: Dementia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Questionnaire measure: Sense of Competence in Dementia Care Staff (SCIDS) Scale measure: Caring Behaviors Inventory-24 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297746 id: am7mi3VB briefTitle: Subvastus vs. Medial Parapatellar Approaches in Total Knee Arthroplasty With Quadriceps Muscle Elastography overallStatus: COMPLETED date: 2023-07-10 date: 2023-12-01 date: 2023-12-01 date: 2024-03-07 date: 2024-03-08 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: ABSTRACT

INTRODUCTION

Knee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. In the SV approach, the vastus medialis muscle is preserved. Some argue that the extensor mechanism may heal earlier with the SV approach. In this study, unlike previous studies, the investigators aimed to quantitatively compare the early outcomes of MP and SV approaches, through shear wave elastography (SWE) measurements isolated over the vastus medialis and vastus lateralis muscles.

MATERIALS AND METHODS

The study included 20 patients with indications for TKA due to primary osteoarthritis, divided into MP and SV groups. SWE measurements of the vastus medialis and vastus lateralis muscles were performed preoperatively and at 3-month follow-up. Clinical scores (Knee Society Score and WOMAC) and straight leg raising time were recorded both preoperatively and postoperatively. conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Subvastus approach name: Medial Parapatellar approach measure: Shear wave values sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine city: Istanbul state: Fatih zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06297733 id: IstanbulBUFC3 briefTitle: Turkish Adaptation, Validity and Reliability of the Approaches and Study Skills Inventory in Physiotherapy Students overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-07 date: 2024-04-16 name: Istanbul Bilgi University class: OTHER briefSummary: The quality and quantity of learning are determined by the learning approach adopted by the student. When learning and studying approaches are mentioned, individual differences between learners' learning intentions during a learning situation or while studying and what types of strategies are used to achieve these intentions come to mind. These learning approaches are thought to determine the quality of learning outcomes. Many measurement tools have been developed to quantitatively measure learning and studying approaches. These developed tools are mostly applied at the higher education level. Among the purposes of using measurement tools; These include identifying low-performing students through screening, evaluating and identifying areas of difficulty that require prediction or improvement plans, evaluating before and after academic improvement programs, and raising awareness and advising students on their academic strengths and weaknesses.

When multidimensional measurement tools that evaluate students' study approaches and skills are examined, it is seen that the use of the Approaches and Study Skills Inventory for Students (ASSIST) tool has become widespread in recent years. This vehicle; It has been reported that it measures learning strategies and skills for different students and is sensitive enough to distinguish between learning types.

The Portuguese, Norwegian and Danish versions of the survey, which was developed in English and intended to be translated into Turkish as the Study Skills and Approaches Scale, have also been translated, its psychometric properties have been demonstrated and it has been observed that it is becoming widespread in the literature. conditions: Health Education studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 260 type: ESTIMATED name: Translating the Questionnaire into Turkish and Related Processes name: Validity name: Reliability measure: Approaches and Study Skills Inventory for Students measure: Participant Information Form sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Marmara University status: RECRUITING city: Istanbul zip: 34854 country: Turkey name: Ilksan Demirbuken, Prof role: CONTACT phone: 2167775701 phoneExt: +90 email: ilksan.demirbuken@marmara.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06297720 id: 2401110013 briefTitle: Early Oral Hydration After Thoracoscopic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-28 date: 2025-06-30 date: 2024-03-07 date: 2024-03-07 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer:

* the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia.
* the degree of improvement in sore throat and dry mouth after oral hydration.
* the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting.
* the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics.
* patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia.

Participants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room. conditions: Anesthesia conditions: Intubation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Oral hydration measure: sore throat level by VAS (Visual Analogue Scale) measure: Mouth dryness measure: post-operative nausea and vomiting (PONV) measure: timing of post-operative nausea and vomiting (PONV) measure: duration of post-operative nausea and vomiting (PONV) measure: management of post-operative nausea and vomiting (PONV) measure: Heart Rate in PACU (Postanesthesia Care Unit) measure: Blood pressure in PACU (Postanesthesia Care Unit) measure: Patient's satisfaction sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ChangGung MH city: Taoyuan zip: 33380 country: Taiwan name: JUN-YU CHEN role: CONTACT lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06297707 id: P.T.REC/012/005044 briefTitle: Effect of Aquatic High Intensity Resistive Training on Patients With Chronic Heart Failure overallStatus: RECRUITING date: 2024-03-05 date: 2025-03-30 date: 2025-12-30 date: 2024-03-07 date: 2024-03-07 name: Cairo University class: OTHER briefSummary: PURPOSE:

to evaluate effect of aquatic high intensity resistive training on cardiac function and exercise capacity in patients with chronic heart failure.

BACKGROUND:

Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of \>37.7 million individuals globally. HF is a shared chronic phase of cardiac functional impairment secondary to many etiologies, and patients with HF experience numerous symptoms that affect their quality of life, including dyspnea, fatigue, poor exercise tolerance, and fluid retention. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: aquatic high intensity resistive training name: usual care measure: Cardiac function measure: exercise capacity measure: physical symptoms of heart failure sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Cairo state: Dokki zip: 11432 country: Egypt name: marwa M elsayed, phd role: CONTACT phone: 01156033818 phoneExt: 02 email: marwadd999@gmail.com name: marwa M elsayed, ph.d role: CONTACT phone: 01156033818 phoneExt: 02 email: marwadd999@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06297694 id: PamukkaleU. briefTitle: Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-07 date: 2024-03-07 date: 2024-03-07 name: Pamukkale University class: OTHER briefSummary: In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis. conditions: Rheumatoid Arthritis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 156 type: ESTIMATED measure: Disease Activity Score (DAS 28) measure: Nine hole peg test measure: Hand grip strength sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297681 id: 2023-1-27-2 briefTitle: Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-01-30 date: 2025-12-31 date: 2024-03-07 date: 2024-03-07 name: Beijing Chao Yang Hospital class: OTHER name: Beijing Chuiyangliu Hospital name: Beijing Boren Hospital briefSummary: It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min). conditions: M-protein Related Cardiac Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Daratumumab + Bortezomib + Dexamethasone + Dapagliflozin measure: Objective response rate (ORR) measure: 2-year PFS rate, progression free survival (PFS) measure: 2-year OS rate, overall survival (OS) measure: Duration of Relief (DOR) measure: Next treatment time (TTNT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297668 id: D5985C00008 briefTitle: A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C). overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2024-06-13 date: 2024-06-13 date: 2024-03-07 date: 2024-03-07 name: AstraZeneca class: INDUSTRY briefSummary: This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Treatment A: BGF MDI HFA name: Treatment B: BGF MDI HFO name: Treatment C: BGF MDI HFO name: AeroChamber Plus Flow-Vu spacer measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI measure: Maximum Observed Concentration (Cmax) of BGF MDI measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) measure: Maximum Observed Concentration (Cmax) measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) measure: Time to Reach Maximum Observed Concentration (tmax) measure: Terminal Rate Constant (λz) measure: Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz) measure: Mean Residence Time of the Unchanged Drug in the Systemic Circulation from Zero to Infinity (MRTinf) measure: Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F) measure: Number of Participants with Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Research Site city: Berlin zip: 14050 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site city: Harrow zip: HA1 3UJ country: United Kingdom lat: 51.57142 lon: -0.33371 hasResults: False

 nctId: NCT06297655 id: TQG202-III-01 briefTitle: A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-07 date: 2024-03-07 name: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated. conditions: Hemophilia A studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Recombinant human activated coagulation factor VIII for injection measure: The proportion of on-demand treatment improvement for newly occurring bleeding events measure: Activity recovery measure: The proportion of effective surgical hemostasis measure: Annualized bleeding rate (ABR) measure: The incidence of Less Han Expected Thermal Effect measure: The injection times of recombinant human coagulation factor VIII measure: The dosage of recombinant human coagulation factor VIII measure: Changes of Haemophilia Joint Health Score before and after on-demand treatment measure: Changes of Quality of Life Assessment before and after on-demand treatment sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital city: Hefei state: Anhui zip: 230002 country: China name: Juan Tong, Doctor role: CONTACT phone: 13955114442 email: tongj5200@163.com lat: 31.86389 lon: 117.28083 facility: The Second Affiliated Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400010 country: China name: Shu Chen, Master role: CONTACT phone: 13983420188 email: chenshu921@163.com lat: 29.56278 lon: 106.55278 facility: The First Hospital of Lanzhou University city: Lanzhou state: Gansu zip: 730013 country: China name: Yaming Xi, Doctor role: CONTACT phone: 13919110815 email: xiyaming02@163.com lat: 36.05701 lon: 103.83987 facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong zip: 510515 country: China name: Jing Sun, Doctor role: CONTACT phone: 13316202696 email: jsun-cn@qq.com lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi zip: 530021 country: China name: Peng Cheng, Master role: CONTACT phone: 13977166448 email: 13977166448@163.com lat: 22.81667 lon: 108.31667 facility: Henan Tumor Hospital city: Zhengzhou state: Henan zip: 450003 country: China name: Hu Zhou, Doctor role: CONTACT phone: 13939068863 email: papertigerhu@163.com lat: 34.75778 lon: 113.64861 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Jie Peng, Doctor role: CONTACT phone: 13974802938 email: pengjie-0728@163.com lat: 28.19874 lon: 112.97087 facility: Nanjing Drug Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China name: Rongfu Zhou, Doctor role: CONTACT phone: 13605142342 email: rfzhoucn@163.com lat: 32.06167 lon: 118.77778 facility: Jiangxi Provincial People's Hospital city: Nanchang state: Jiangxi zip: 330006 country: China name: Chenghao Jin, Doctor role: CONTACT phone: 13699500207 email: Jinch227@aliyun.com lat: 28.68396 lon: 115.85306 facility: Hematology Hospital of Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang, Doctor role: CONTACT phone: 13502118379 email: zhanglei1@ihcams.ac.cn lat: 39.14222 lon: 117.17667 facility: The Second Affiliated Hospital of Kunming Medical University city: Kunming state: Yunnan zip: 650106 country: China name: Zeping Zhou, Doctor role: CONTACT phone: 18788571605 email: 18788571605@163.com lat: 25.03889 lon: 102.71833 hasResults: False

 nctId: NCT06297642 id: TQB2928-AK105-Ib-01 briefTitle: TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2028-03 date: 2024-03-07 date: 2024-03-19 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors. conditions: Advanced Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 114 type: ESTIMATED name: TQB2928 injection name: Penpulimab measure: Dose limiting toxicity (DLT) measure: Adverse event rate measure: Objective response rate (ORR) measure: Complete response rate (CRR) measure: Disease Control Rate measure: Duration of Response measure: Progression-free Survival measure: Overall survival (OS) measure: Incidence of Anti-Drug antibody measure: Incidence of neutralizing antibodies measure: Peak time (Tmax) measure: Peak concentration (Cmax) measure: The area under the plasma concentration time curve from zero to after 24h (AUC0-24h) measure: Steady-state apparent volume of distribution (Vz/F) measure: Minimum plasma concentration at steady state (Cmin,ss) measure: Receptor Occupancy (RO%) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Science city: Beijing state: Beijing zip: 100021 country: China name: Ning Li, Doctor role: CONTACT phone: 15601395554 email: lining@cicams.ac.cn lat: 39.9075 lon: 116.39723 facility: Gansu Provincial Cancer Hospital city: Lanzhou state: Gansu zip: 730000 country: China name: Junfeng Jiang, Master role: CONTACT phone: 13893332604 email: 13893332604@163.com name: Yuhua Liu, Bachelor role: CONTACT phone: 15682892029 email: tianlujyx@163.com lat: 36.05701 lon: 103.83987 facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510000 country: China name: Qingqing Cai, Doctor role: CONTACT phone: 18376665396 email: caiqq@sysucc.org.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06297629 id: 2021-0636 id: NCI-2024-01689 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2024-08-31 date: 2026-08-31 date: 2024-03-07 date: 2024-04-11 name: M.D. Anderson Cancer Center class: OTHER name: Astex Pharmaceuticals, Inc. briefSummary: To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant. conditions: Allogeneic Stem Cell Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: ASTX727 name: Donor Lymphocyte Infusion 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: Betul Oran, MD role: CONTACT phone: 713-745-2820 email: boran@mdanderson.org name: Betul Oran, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06297616 id: 18814 id: J3R-JE-YDAB type: OTHER domain: Eli Lilly and Company briefTitle: A Study of LY3841136 in Japanese Participants With Obesity or Overweight overallStatus: RECRUITING date: 2024-04-15 date: 2025-10-12 date: 2025-10-12 date: 2024-03-07 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to learn about the side effects of LY3841136 when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last about 28 weeks and may include up to 17 visits. conditions: Obesity conditions: Overweight studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: LY3841136 name: Placebo measure: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136 measure: PK: Maximum Observed Concentration (Cmax) of LY3841136 measure: Pharmacodynamics (PD): Change From Baseline in Body Weight sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sumida Hospital status: RECRUITING city: Sumida-ku state: Tokyo zip: 130-0004 country: Japan role: CONTACT phone: 81356087276 name: Takuma Yonemura role: PRINCIPAL_INVESTIGATOR facility: Hakata Clinic status: RECRUITING city: Fukuoka zip: 812-0025 country: Japan role: CONTACT phone: 81922837701 name: Takashi Eto role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 hasResults: False

 nctId: NCT06297603 id: 18806 id: J1I-MC-GZQA type: OTHER domain: Eli Lilly and Company briefTitle: Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3) overallStatus: RECRUITING date: 2024-03-15 date: 2026-09-11 date: 2026-10-09 date: 2024-03-07 date: 2024-04-11 name: Eli Lilly and Company class: INDUSTRY briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 320 type: ESTIMATED name: Retatrutide name: Placebo measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) measure: Percentage of Participants Achieving HbA1c <7.0% measure: Percentage of Participants Achieving HbA1c ≤6.5% measure: Change from Baseline in Fasting Serum Glucose measure: Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL measure: Percent Change from Baseline in Body Weight measure: Change from Baseline in Body Weight measure: Percentage of Participants Achieving Weight Reduction of ≥5% measure: Percentage of Participants Achieving Weight Reduction of ≥10% measure: Percentage of Participants Achieving Weight Reduction of ≥15% measure: Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction measure: Percent Change from Baseline in Non-HDL Cholesterol measure: Percent Change from Baseline in Triglycerides measure: Change from Baseline in Systolic Blood Pressure (SBP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Institute of Arizona (CRI) - Sun City West status: RECRUITING city: Sun City West state: Arizona zip: 85375 country: United States name: Jalal Abbas role: PRINCIPAL_INVESTIGATOR lat: 33.66198 lon: -112.34127 facility: Diabetes and Endocrine Associates status: NOT_YET_RECRUITING city: La Mesa state: California zip: 91942 country: United States name: Robert Lipetz role: PRINCIPAL_INVESTIGATOR lat: 32.76783 lon: -117.02308 facility: UCLA South Bay Endocrinology status: RECRUITING city: Torrance state: California zip: 90505 country: United States name: Dianne Cheung role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 facility: Northeast Research Institute (NERI) status: NOT_YET_RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States name: Senan Sultan role: PRINCIPAL_INVESTIGATOR lat: 30.0933 lon: -81.71898 facility: Care Research status: NOT_YET_RECRUITING city: Idaho Falls state: Idaho zip: 83404 country: United States name: Hira Siktel role: PRINCIPAL_INVESTIGATOR lat: 43.46658 lon: -112.03414 facility: Cotton O'Neil Clinical Research Center status: RECRUITING city: Topeka state: Kansas zip: 66606 country: United States name: Alan Wynne role: PRINCIPAL_INVESTIGATOR lat: 39.04833 lon: -95.67804 facility: Billings Clinic status: NOT_YET_RECRUITING city: Billings state: Montana zip: 59101 country: United States name: Lauren Kleess role: PRINCIPAL_INVESTIGATOR lat: 45.78329 lon: -108.50069 facility: Sierra Nevada Specialty Care status: NOT_YET_RECRUITING city: Reno state: Nevada zip: 89511 country: United States name: David Howard role: PRINCIPAL_INVESTIGATOR lat: 39.52963 lon: -119.8138 facility: Albany Medical College, Division of Community Endocrinology status: NOT_YET_RECRUITING city: Albany state: New York zip: 12203 country: United States name: Robert Busch role: PRINCIPAL_INVESTIGATOR lat: 42.65258 lon: -73.75623 facility: Research Foundation of SUNY - University of Buffalo status: NOT_YET_RECRUITING city: Buffalo state: New York zip: 14221 country: United States name: Ajay Chaudhuri role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 facility: NYC Research INC status: RECRUITING city: Long Island City state: New York zip: 11106 country: United States name: Anastasios Manessis role: PRINCIPAL_INVESTIGATOR lat: 40.74482 lon: -73.94875 facility: University of North Carolina Medical Center status: NOT_YET_RECRUITING city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Klara Klein role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 facility: Lucas Research, Inc. status: NOT_YET_RECRUITING city: Hickory state: North Carolina zip: 28601 country: United States name: Anthony Barber role: PRINCIPAL_INVESTIGATOR lat: 35.73319 lon: -81.3412 facility: Cleveland Clinic status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Willy Marcos Valencia role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: Central States Research status: RECRUITING city: Tulsa state: Oklahoma zip: 74136 country: United States name: Sarah Land role: PRINCIPAL_INVESTIGATOR lat: 36.15398 lon: -95.99277 facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair status: NOT_YET_RECRUITING city: Pittsburgh state: Pennsylvania zip: 15243 country: United States name: Daniel Austin role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: AM Diabetes & Endocrinology Center status: NOT_YET_RECRUITING city: Bartlett state: Tennessee zip: 38133 country: United States name: Kashif Latif role: PRINCIPAL_INVESTIGATOR lat: 35.20453 lon: -89.87398 facility: Dallas Diabetes Research Center status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Juno Research status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77040 country: United States name: Damaris Vega role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Endocrine Ips, Pllc status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77079 country: United States name: Prashant Koshy role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Southern Endocrinology Associates status: NOT_YET_RECRUITING city: Mesquite state: Texas zip: 75149 country: United States name: Sumana Gangi role: PRINCIPAL_INVESTIGATOR lat: 32.7668 lon: -96.59916 facility: Diabetes & Endocrine Treatment Specialists status: NOT_YET_RECRUITING city: Sandy state: Utah zip: 84093 country: United States name: Timothy Graham role: PRINCIPAL_INVESTIGATOR lat: 40.59161 lon: -111.8841 facility: CEDIC status: NOT_YET_RECRUITING city: Caba state: Buenos Aires zip: C1060ABN country: Argentina name: Elizabeth Gelersztein role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro de Investigaciones Metabólicas (CINME) status: NOT_YET_RECRUITING city: Ciudad Autónoma de Buenos Aires state: Buenos Aires zip: 1056 country: Argentina name: Federico Perez Manghi role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: CIMeL Clinical Research status: NOT_YET_RECRUITING city: Lanus state: Buenos Aires zip: B1824KAJ country: Argentina name: Mariano Chahin role: PRINCIPAL_INVESTIGATOR lat: -34.70252 lon: -58.3955 facility: Centro de Investigaciones Médicas Mar del Plata status: NOT_YET_RECRUITING city: Mar del Plata state: Buenos Aires zip: 7600 country: Argentina name: Andres Alvarisqueta role: PRINCIPAL_INVESTIGATOR lat: -38.00228 lon: -57.55754 facility: DIM Clínica Privada status: NOT_YET_RECRUITING city: Ramos Mejía state: Buenos Aires zip: B1704ETD country: Argentina name: Alejandra Camino role: PRINCIPAL_INVESTIGATOR lat: -34.6551 lon: -58.55318 facility: Investigaciones Medicas Imoba Srl status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1056ABH country: Argentina name: Silvia Orio role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Médico Viamonte status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1120AAC country: Argentina name: Diego Aizenberg role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Instituto de Investigaciones Clinicas Zarate status: NOT_YET_RECRUITING city: Rosario state: Santa Fe zip: 2000 country: Argentina name: Marisa Vico role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: Instituto de Investigaciones Clinicas Rosario status: NOT_YET_RECRUITING city: Rosario state: Santa Fe zip: S2000CVD country: Argentina name: Maximiliano Sicer role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: Centro Médico Colón status: NOT_YET_RECRUITING city: Córdoba zip: 5003 country: Argentina name: Maria Parody role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: Centro de Endocrinologia Alcantara Gonzalez status: NOT_YET_RECRUITING city: Bayamon zip: 00959 country: Puerto Rico name: Altagracia Alcantara -Gonzalez role: PRINCIPAL_INVESTIGATOR lat: 18.39856 lon: -66.15572 facility: Private Practice - Dr. Paola Mansilla-Letelier status: NOT_YET_RECRUITING city: Guaynabo zip: 00970 country: Puerto Rico name: Paola Mansilla-Letelier role: PRINCIPAL_INVESTIGATOR lat: 18.35745 lon: -66.111 facility: Endocrinologist Metabolic Clinic & Research Institute status: NOT_YET_RECRUITING city: San Juan zip: 00921 country: Puerto Rico name: Martha Gomez-Cuellar role: PRINCIPAL_INVESTIGATOR lat: 18.46633 lon: -66.10572 facility: Panthera Biopartners - Preston status: NOT_YET_RECRUITING city: Preston state: England zip: PR2 9QB country: United Kingdom name: Reem Handforth role: PRINCIPAL_INVESTIGATOR lat: 53.76282 lon: -2.70452 facility: Lister Hospital status: NOT_YET_RECRUITING city: Stevenage state: Hertfordshire zip: SG1 4AB country: United Kingdom name: Adie Viljoen role: PRINCIPAL_INVESTIGATOR lat: 51.90224 lon: -0.20256 facility: Panthera Biopartners - Manchester status: NOT_YET_RECRUITING city: Rochdale state: Manchester zip: OL11 4AU country: United Kingdom name: Krishnakumar Radhakrishnan role: PRINCIPAL_INVESTIGATOR lat: 53.61766 lon: -2.1552 facility: Panthera Biopartners - Glasgow status: NOT_YET_RECRUITING city: Glasgow state: Scotland zip: G51 4LB country: United Kingdom name: Raghavendra Madimchetty role: PRINCIPAL_INVESTIGATOR lat: 55.86515 lon: -4.25763 hasResults: False

 nctId: NCT06297590 id: 18795 id: J4T-MC-OLAA type: OTHER domain: Eli Lilly and Company id: 2024-510604-37-00 type: OTHER domain: EU Trial Number id: U1111-1302-6222 type: OTHER domain: Universal Trial Number briefTitle: A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-02 date: 2027-02 date: 2024-03-07 date: 2024-04-17 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.

The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid.

The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for Part B. If conducted, the optional bridging period for Part A participants would last up to approximately 1 year after their completion of Part A.

If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 120 weeks. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: LY3954068 name: Placebo name: Flortaucipir F18 measure: Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration measure: Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration measure: Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) measure: Optional Part B: PK: Cmax measure: Part A: PK: Area Under the Concentration Versus Time Curve (AUC) measure: Optional Part B: PK: AUC measure: Part A: PK: Cerebrospinal Fluid (CSF) concentration of LY3954068 measure: Optional Part B: PK: CSF concentration of LY3954068 measure: Part A: Pharmacodynamics (PD): Change from Baseline of CSF tau measure: Optional Part B: PD: Change from Baseline of CSF tau sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: K2 Medical Research LLC city: Maitland state: Florida zip: 32751 country: United States role: CONTACT phone: 407-500-5252 name: Brandon Lenox role: PRINCIPAL_INVESTIGATOR lat: 28.62778 lon: -81.36312 facility: Charter Research, LLC city: The Villages state: Florida zip: 32162 country: United States role: CONTACT phone: 352-775-1000 name: Jeffrey Norton role: PRINCIPAL_INVESTIGATOR lat: 28.93408 lon: -81.95994 facility: Indiana University School of Medicine - Clinical Research Center city: Indianapolis state: Indiana zip: 46202 country: United States role: CONTACT phone: 317-963-7505 name: Jared Brosch role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: Massachusetts General Hospital (MGH) city: Charlestown state: Massachusetts zip: 02129 country: United States role: CONTACT phone: 617-643-5607 name: Steven Arnold role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 facility: CenExel AMRI city: Toms River state: New Jersey zip: 08755 country: United States role: CONTACT phone: 732-341-9500 name: Sanjiv Sharma role: PRINCIPAL_INVESTIGATOR lat: 39.95373 lon: -74.19792 facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States name: Shruti Raja role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 facility: Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States role: CONTACT phone: 414-955-0650 name: Malgorzata Franczak role: PRINCIPAL_INVESTIGATOR lat: 43.0389 lon: -87.90647 facility: The University of Tokyo Hospital city: Bunkyo-ku state: Tokyo zip: 113-8655 country: Japan role: CONTACT phone: +81-33-815-5411 name: Takeshi Iwatsubo role: PRINCIPAL_INVESTIGATOR lat: 35.37517 lon: 139.92991 facility: National Hospital for Neurology and Neurosurgery (UCLH) city: London zip: WC1N 3BG country: United Kingdom role: CONTACT phone: 0203 448 3011 name: Catherine Mummery role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Royal Hallamshire Hospital city: Sheffield zip: S10 2JF country: United Kingdom name: Daniel Blackburn role: PRINCIPAL_INVESTIGATOR lat: 53.38297 lon: -1.4659 facility: University Hospital Southampton city: Southampton zip: SO16 6YD country: United Kingdom name: Christopher Kipps role: PRINCIPAL_INVESTIGATOR lat: 50.90395 lon: -1.40428 hasResults: False

 nctId: NCT06297577 id: MASH2024 briefTitle: Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-15 date: 2025-09-30 date: 2024-03-07 date: 2024-03-18 name: Cairo University class: OTHER briefSummary: Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.

The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:

will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST. conditions: Intrabony Periodontal Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the type of intervention, only the outcome assessor and the statistician will be blinded whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) name: Platelet Rich Fibrin (PRF) combined with minimally invasive surgical technique (MIST) measure: Clinical attachment level (CAL) measure: Probing Depth (PD) measure: Radiographic Linear Defect Depth (RLDD) measure: Recession Depth (RD) measure: Post-operative Pain measure: Radiographic defect fill (RDF) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06297564 id: 07/3/9-2023/4 briefTitle: Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments overallStatus: COMPLETED date: 2022-09-01 date: 2024-01-01 date: 2024-01-01 date: 2024-03-07 date: 2024-03-07 name: New Valley University class: OTHER briefSummary: The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments. conditions: Progesterone Primed Endometrial Protocol conditions: Gonadotropin Releasing Hormone Antagonist Protocol conditions: Assisted Reproductive Treatments studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Progesterone primed endometrial protocol name: Gonadotropin-releasing hormone antagonist protocol measure: The number of retrieved oocytes measure: Pregnancy rate sex: FEMALE minimumAge: 21 Years maximumAge: 40 Years stdAges: ADULT facility: New Valley University city: New Valley zip: 72511 country: Egypt hasResults: False

 nctId: NCT06297551 id: SBU-AML-LSC id: IRB2023-00528 type: OTHER domain: Stony Brook University briefTitle: Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA) overallStatus: RECRUITING date: 2024-03-05 date: 2025-05-31 date: 2025-05-31 date: 2024-03-07 date: 2024-03-07 name: Suhu Liu class: OTHER briefSummary: Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved. Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming. The research we are proposing here is to investigate whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. Our retrospective study have found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment. This pilot study will allow us to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry measure: Concordance between the relative fraction of Leukemia Stem Cells (LSC) vs Hematopoietic Stem Cells (HSC) and treatment response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stony Brook Cancer Center status: RECRUITING city: Stony Brook state: New York zip: 11794 country: United States name: Caterina Vacchi-Suzzi, PhD role: CONTACT phone: 631-728-7425 email: cancerclinicaltrials@stonybrookmedicine.edu name: Suhu Liu, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 40.92565 lon: -73.14094 hasResults: False

 nctId: NCT06297538 id: GR-2021-12372323 briefTitle: Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation overallStatus: RECRUITING date: 2023-04-29 date: 2024-10-29 date: 2026-04-29 date: 2024-03-07 date: 2024-03-07 name: Neuromed IRCCS class: OTHER name: Fondazione Policlinico Universitario Campus Bio-Medico name: I.R.C.C.S. Fondazione Santa Lucia briefSummary: Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: gamma transcranial alternating current stimulation (tACS) name: sham transcranial alternating current stimulation (tACS) measure: Changes in bradykinesia features as objectively assessed by kinematic techniques measure: Changes in motor learning performance as objectively assessed by kinematic techniques sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Neuromed status: RECRUITING city: Pozzilli country: Italy name: Giulia Paparella role: CONTACT phone: 3384780752 lat: 41.51142 lon: 14.06252 hasResults: False

 nctId: NCT06297525 id: STP938-201 briefTitle: Study of STP938 in Advanced Solid Tumours overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2027-05 date: 2024-03-07 date: 2024-03-08 name: Step Pharma, SAS class: INDUSTRY briefSummary: The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.

The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Patients will be assigned to a dose level of STP938 (Phase 1a) or an expansion cohort (Phase 1b) at the time of their enrollment. primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: STP938 measure: Safety and Tolerability measure: Area under the curve (AUC) of STP938 measure: Maximum plasma concentration (Cmax) measure: Time to reach maximum concentration (TMax) measure: Evaluation of preliminary clinical activity of STP938 measure: Evaluation of best overall response of STP938 measure: Evaluation of Duration of Response measure: Evaluation of Progression Free Survival measure: Change in serum CA125 (ovarian cancer only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297512 id: pGBM-WBRT/DOX2020 briefTitle: Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM). overallStatus: RECRUITING date: 2022-12-09 date: 2027-11-09 date: 2028-03-09 date: 2024-03-07 date: 2024-03-07 name: Iacopo Sardi class: OTHER briefSummary: Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB conditions: Glioblastoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Radiotherapy, Temozolomide, Doxorubicin measure: Evaluation prolonged Dox measure: Percentage of Withdrawal from the study rate measure: Percentage of SAEs measure: Mortality rate measure: Early discontinuation of dox treatment rate measure: Event-free survival (EFS), disease progression (PFS), and overall survival (OS) sex: ALL minimumAge: 3 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Iacopo Sardi role: CONTACT email: iacopo.sardi@meyer.it lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06297499 id: IRB-22-07-4803 briefTitle: Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08-01 date: 2024-12-01 date: 2024-03-07 date: 2024-03-12 name: Wayne State University class: OTHER briefSummary: Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration. conditions: Pruritus Caused by Drug studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized double-blinded trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Ondansetron 8mg measure: Pruritus parameters in Post anesthesia Care Unit (PACU) measure: Pruritus severity in Post anesthesia Care Unit (PACU) measure: Pruritus parameters PACU measure: Pruritus severity PACU measure: Rescue Pruritus Treatment medication measure: Nausea PACU measure: Nausea Post PACU measure: Post-operative Pain measure: Peripheral oxygen saturation- Mother measure: Peripheral oxygen saturation- Infant measure: Heart rate- Mother measure: Heart rate- Infant measure: Blood pressure Mother measure: Blood pressure- Infant measure: Electrocardiogram (ECG ) Mother measure: ECG Infant sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Detroit Medical Center- Hutzel Women's Hospital city: Detroit state: Michigan zip: 48201 country: United States name: George M McKelvey, PhD role: CONTACT phone: 313-598-6036 email: gmckelve@dmc.org name: Justin Hruska, MD role: CONTACT phone: 402-432-0985 email: justinhruska1@gmail.com lat: 42.33143 lon: -83.04575 hasResults: False

 nctId: NCT06297486 id: SPK-8011-302 id: 2023-504537-46 type: EUDRACT_NUMBER briefTitle: Study of a Gene Therapy Treatment for Hemophilia A acronym: KEYSTONE 1 overallStatus: RECRUITING date: 2024-03-13 date: 2027-05 date: 2035-09-04 date: 2024-03-07 date: 2024-04-18 name: Spark Therapeutics, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis. conditions: Hemophilia A studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned into one of three cohorts, each receiving the same study treatment. primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: SPK-8011 measure: Annualized Bleed Rate (ABR) for All Bleeds [Cohort A] measure: Median FVIII: C levels [Cohort A] measure: ABR for treated bleeds [Cohort A] measure: Percentage of Participants with ABR=0 for all bleeds; treated bleeds; treated spontaneous bleeds; and treated joint and target joint bleeds [Cohort A] measure: ABR for treated spontaneous, joint, and target joint bleeds [Cohort A] measure: Annualized FVIII dosage [Cohort A] measure: Proportion of Resolved Target Joints [Cohort A] measure: Mean Change of Total Hemophilia Joint Health Score [Cohort A] measure: FVIII:C levels over time [Cohort A] measure: Mean ABR for all bleeds and treated bleeds [Cohort C] measure: FVIII: C levels over time from Week 26 [Cohort C] measure: Proportion of Participants Who Receive IV Methylprednisolone (IVMP) Prior to Week 8 (Early IVMP) [Cohorts A, B, C] measure: Proportion of Participants Who Receive Secondary Oral Immunomodulation [Cohorts A, B, C] measure: Median Time to First Immunomodulation-related Corticosteroid Dose [Cohorts A, B, C] measure: Median Duration of Secondary Oral Immunomodulation [Cohorts A, B, C] measure: Proportion of Participants with FVIII Inhibitor Development [Cohorts A, B, C] measure: Proportion of participants with Treatment-related AEs of ALT Elevation [Cohorts A, B, C] measure: Proportion of participants with treatment-related AEs of Infusion Reaction [Cohorts A, B, C] measure: Number of participants with abnormal physical exam findings, abnormal vital signs, and abnormal selected clinical laboratory test results [Cohorts A, B, C] measure: Proportion of participants with AEs and SAEs [Cohorts A, B, C] measure: Proportion of participants with AESIs [Cohorts A, B, C] sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orthopaedic Institute for Children/Orthopaedic Hemophilia Treatment Center status: RECRUITING city: Los Angeles state: California zip: 90007 country: United States name: Doris Quon, MD, PhD role: CONTACT lat: 34.05223 lon: -118.24368 facility: Kaiser Permanente-Oakland Medical Center status: RECRUITING city: Oakland state: California zip: 94611 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 37.80437 lon: -122.2708 facility: Kaiser Permanente-Roseville Medical Center status: RECRUITING city: Roseville state: California zip: 95661 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 38.75212 lon: -121.28801 facility: Kaiser Permanente -Sacramento Medical Center status: RECRUITING city: Sacramento state: California zip: 95814 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 38.58157 lon: -121.4944 facility: Kaiser Permanente -San Francisco Medical Center status: RECRUITING city: San Francisco state: California zip: 94115 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 37.77493 lon: -122.41942 facility: University of California - San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Andrew Leavitt, MD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Kaiser Permanente- Santa Clara Medical Center status: RECRUITING city: Santa Clara state: California zip: 94115 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 37.35411 lon: -121.95524 facility: Kaiser Permanente-Vallejo Medical Center status: RECRUITING city: Vallejo state: California zip: 94589 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 38.10409 lon: -122.25664 facility: Kaiser Permanente -Walnut Creek Medical Center status: RECRUITING city: Walnut Creek state: California zip: 94596 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 37.90631 lon: -122.06496 hasResults: False

 nctId: NCT06297473 id: SJ-1050 briefTitle: Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors. acronym: PITCARE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-01-01 date: 2028-08-01 date: 2024-03-07 date: 2024-03-07 name: Zealand University Hospital class: OTHER briefSummary: The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas). conditions: Non-Functional Pituitary Adenoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized to either intervention or control primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Adverse events (primary outcome) will be established by a blinded adjudication committee.

A committé of external endocrinologist/ophthalmologist will blinded to participant ID/allocation assess all the participants admissions to hospital and assess wether it qualifies as an event whoMasked: OUTCOMES_ASSESSOR count: 812 type: ESTIMATED name: Telephone-/video follow-up name: In-person follow-up measure: Composite outcome of adverse events measure: Thyroid replacement therapy measure: Growth hormone replacement therapy measure: Desmopressin replacement therapy measure: Hormonal replacement therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297460 id: STEPPSPENITENTIARY briefTitle: Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers overallStatus: ACTIVE_NOT_RECRUITING date: 2022-01-01 date: 2024-12-01 date: 2025-12-01 date: 2024-03-07 date: 2024-03-07 name: Universitat Jaume I class: OTHER name: Centre d'Estudis i Formació Especialtzada Generalitat de Catalunya briefSummary: The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study. conditions: Self Harm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Systems Training for Emotional Predictability & Problem Solving (STEPPS) measure: Level of emotional and behavioral disregulation of patients measure: Type and levels of impulsivity of patients measure: Suicide risk of patients measure: Self-injury frequency, typology and funcionality of patients measure: Degree of hopeless of patients measure: Perceived level of feasibility by professionals measure: Perceived level of acceptability of the intervention by professionals measure: Satisfaction of the intervention by patients measure: Perceived level of adequacy by professionals measure: Barriers and facilitators detected by professionals that are influencing the implementation process - Quantitative information measure: Level of burnout of professionals measure: Barriers and facilitators detected by professionals that are influencing the implementation process - Qualitative information sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rosa city: Castellón De La Plana state: Castellón zip: 12071 country: Spain lat: 39.98567 lon: -0.04935 hasResults: False

 nctId: NCT06297447 id: N-20230073 briefTitle: Keeping it Simple Study (KISS) acronym: KISS overallStatus: RECRUITING date: 2024-03-11 date: 2025-12-31 date: 2026-12 date: 2024-03-07 date: 2024-03-13 name: Bettina Eiger class: OTHER name: University of Southern Denmark name: Aalborg University name: Central Denmark Region name: Vrije Universiteit Brussel briefSummary: Problem: The number of patients living with chronic musculoskeletal (MSK) pain has steadily increased over the past decade with costs rising equally. Long-standing pain is associated with significant maladaptive beliefs about pain, psychological characteristics and associated behaviors which involve structural and functional neurobiological characteristics which share common pathophysiological mechanisms as chronic pain. The investigators recent priority setting partnership investigated the research priorities from 1000 patients with chronic MSK pain, relatives, and clinicians. Better pain education was rated as one of the three most important research areas.

Solution: Pain science education has the potential to target maladaptive psychological and behavioral components that may contribute to the maintenance of chronic pain. The KISS project will evaluate the effect of a pain neuroscience education program (PNE4Adults) on rehabilitation outcomes in patients with chronic MSK pain. This intervention has the potential to change beliefs and behaviors surrounding pain in patients with chronic MSK pain. If this is successful in disrupting maladaptive cycles contributing to chronicity, this may improve outcomes for many thousand citizens. conditions: Musculoskeletal Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter randomized controlled, superiority trial with a 2-group parallel design. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Randomization will be stratified by cite. Block randomization in random concealed block sizes of 4 to 6 (1:1) into two parallel groups is used to avoid imbalance in the randomization between intervention groups. A person not otherwise affiliated with the study will generate the randomization sequence.The randomization will be coded (Group 1 or 2), thus the primary investigator (BE) will not know the code to the groups. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: PNE4Adults - pain science education name: Usual care measure: Musculoskeletal Health Questionnaire (MSK-HQ) measure: Mean Pain intensity measure: Pain interference measure: Concept of pain measure: Pain catastrophizing measure: Fear of movement measure: Patient specific functional limitation measure: Patient impression of change measure: Patient satisfaction with current symptom state measure: Pain Self-efficacy measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Træningsenheden, Holbæk Municipality status: RECRUITING city: Holbæk state: Region Sjælland zip: 4300 country: Denmark name: Helle B. Hansen, PT role: CONTACT phone: 72363252 email: helha@holb.dk lat: 55.71354 lon: 11.7169 facility: Træningsenheden, Køge Municipality status: RECRUITING city: Køge state: Region Sjælland zip: 4600 country: Denmark name: Annette B. Schlaikjer, PT role: CONTACT phone: +45 51 36 33 78 email: annette.schlaikjer@koege.dk lat: 55.45802 lon: 12.18214 facility: Genoptræningscenteret, Solrød Municipality status: RECRUITING city: Solrød Strand state: Region Sjælland zip: 2680 country: Denmark name: Linda M. Blæsbjerg, PT role: CONTACT phone: +4556182405 email: kolbl@solrod.dk lat: 55.53285 lon: 12.22227 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-06 uploadDate: 2024-03-06T10:23 filename: Prot_000.pdf size: 413728 hasResults: False

 nctId: NCT06297434 id: JH-221-201 briefTitle: Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH overallStatus: RECRUITING date: 2023-02-15 date: 2025-01-01 date: 2025-01-01 date: 2024-03-07 date: 2024-03-07 name: J2H Biotech class: INDUSTRY briefSummary: The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH. conditions: Non-alcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: J2H-1702 name: J2H-1702 name: J2H-1702 name: Placebo measure: Changes from baseline in results on MRI-PDFF at week12. measure: Changes from baseline in results on MRE at week12. sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: J2H Biotech status: RECRUITING city: Suwon state: Gyeonggi-do zip: 16684 country: Korea, Republic of name: Eunji Byeon role: CONTACT lat: 37.29111 lon: 127.00889 hasResults: False

 nctId: NCT06297421 id: SZYY20240229IBS-D briefTitle: Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-01 date: 2026-06 date: 2024-03-07 date: 2024-04-23 name: Shenzhen Hospital of Southern Medical University class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults. conditions: Irritable Bowel Syndrome With Diarrhea conditions: Fecal Microbiota Transplantation conditions: Mental Health Issue studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 434 type: ESTIMATED name: Fecal Microbiota Transplantation name: Placebo measure: Percentage of Patients Who Were Composite Weekly Responders measure: Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0 measure: Percentage of Patients Who Were Composite Weekly Responders measure: Percentage of Patients Who Were Abdominal Pain Weekly Responder measure: Percentage of Patients Who Were Stool Consistency Weekly Responder measure: Percentage of Patients Who Were Abdominal Bloating Weekly Responder measure: Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale measure: Change from Baseline in the Weekly Average of Worst Abdominal Pain in the Past 24 hours measure: Change from Baseline in the Number of Days per Week with at Least One Stool with Consistency of Type 6 or 7 measure: Change from Baseline in the Number of Stools of Type 6 or 7 per Week measure: Change from Baseline in the Weekly Average of Worst Abdominal Bloating in the Past 24 Hours Score measure: Change from baseline in Irritable Bowel Syndrome Severity Scale (IBS-SSS) Scores measure: Change from baseline in Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL) Total Scores sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Shenzhen Hospital of Southern Medical University city: Shenzhen state: Guangdong zip: 518000 country: China lat: 22.54554 lon: 114.0683 hasResults: False

 nctId: NCT06297408 id: JWCAR029115 briefTitle: Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2026-05 date: 2024-03-07 date: 2024-03-07 name: Shanghai Ming Ju Biotechnology Co., Ltd. class: INDUSTRY briefSummary: To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Relma-cel measure: DLT rate measure: determine RP2D measure: SELENA-SLEDAI measure: BILAG -2004 measure: PGA (physician global assessment) score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297395 id: Cervical Traumatic Inj briefTitle: Subaxial Cervical Traumatic Injuries overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-07 date: 2024-03-07 name: Assiut University class: OTHER briefSummary: The aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the Trauma Unit of Assiut University Hospital. conditions: Cervical Injury Spine studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 100 type: ESTIMATED measure: Percentage of improvement measure: Patient Outcomes measure: Complication measure: rehabilitation measure: Complication measure: rehabilitation measure: Complication measure: Complication measure: Complication sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297382 id: SBU-HEM-PSI-01 briefTitle: Impact of ChatGPT-based Nursing Process Training overallStatus: NOT_YET_RECRUITING date: 2024-03-06 date: 2024-04-24 date: 2025-04-25 date: 2024-03-07 date: 2024-03-07 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The goal of this randomized controlled study is to determine the impact of ChatGPT based nursing process training on nursing students' clinical decision-making competencies and artificial intelligence anxiety.

Population and Sample: The population of the research consists of senior students studying at Gülhane Faculty of Nursing, University of Health Sciences. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G\*Power 3.1 program. In a similar study in the relevant literature, the effect size regarding the change in clinical decision-making level was calculated as 0.898. In order to exceed the 99% value in determining the power of the study; At the 5% significance level and 0.898 effect size, 44 people, 22 people in the groups, need to be reached (df=21; t=1.721). In the research, it was aimed to reach a total of 60 people, 30 people in the groups, considering the high power of the test and the losses. conditions: Nurse-Patient Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This research will be conducted as an experimental study with pretest-posttest randomised control group design. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Experimental and control groups will be determined using https:// www.randomizer.org. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: ChatGPT Based Nursing Process Training measure: Descriptive Information Form measure: Clinical Decision Making Scale in Nursing measure: rtificial Intelligence Anxiety Scale: sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297369 id: RHDIRB2020110301 REC #250 briefTitle: Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients overallStatus: RECRUITING date: 2024-02-01 date: 2025-02-01 date: 2025-08-01 date: 2024-03-07 date: 2024-03-07 name: Ain Shams University class: OTHER briefSummary: Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients conditions: Cisplatin Adverse Reaction conditions: Cisplatin Nephrotoxicity conditions: Cisplatin Induced Peripheral Neuropathy conditions: Cancer Patients conditions: Cisplatin Ototoxicity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: N acetyl cysteine measure: The occurrence of cisplatin-induced ototoxicity in the form of hearing loss. measure: The occurrence of cisplatin-induced nephrotoxicity. measure: The occurrence of cisplatin-induced peripheral neuropathy. measure: The occurrence of cisplatin-induced peripheral neuropathy. measure: The occurrence of cisplatin-induced peripheral neuropathy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt. status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06297356 id: YCEYHAN briefTitle: The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy overallStatus: RECRUITING date: 2023-10-01 date: 2024-02-19 date: 2024-04-01 date: 2024-03-07 date: 2024-03-07 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient.

The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels.

The main questions it aims to answer are:

Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels?

For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy.

They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment. conditions: Inhalation Therapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Stress ball measure: dyspnea severity measure: anxiety levels measure: treatment duration measure: Vital signs: Respiratory rate measure: Vital signs: Pulse measure: Vital signs: Blood pressure measure: saturation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin CEYHAN status: RECRUITING city: Kırşehir state: Center zip: 40100 country: Turkey name: Yasemin CEYHAN, PhD role: CONTACT phone: +9054645898065 email: yasemin-ceyhan@hotmail.com role: CONTACT phoneExt: CEYHAN email: yasemin-ceyhan@hotmail.com name: Yasemin CEYHAN, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06297343 id: 2023-A02491-44 briefTitle: Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula acronym: MODIFVASC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-03 date: 2027-03 date: 2024-03-07 date: 2024-04-10 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation. conditions: Renal Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 544 type: ESTIMATED name: Creation of an arteriovenous fistula measure: Occurrence of ischaemia of the hand sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Privé des Peupliers city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06297330 id: PROMESS - SLEEP briefTitle: Sleep for Optimal MEdical StudentS (PROMESS) overallStatus: RECRUITING date: 2023-11-11 date: 2024-09-30 date: 2024-09-30 date: 2024-03-07 date: 2024-03-07 name: Research on Healthcare Performance Lab U1290 class: OTHER briefSummary: Medical students have been shown to have a greater prevalence of poor sleep leading to poorer quality of life than other groups of students. Among medical students, poor sleep quality and insomnia have been associated with higher level of stress, as well as poorer academic performance. Our field surveys carried out in 2022 and 2023 at the Lyon Est medical school make the same alarming observation. They revealed that 53% of students had significant sleep problems.They also showed that students presented high levels of physical and mental fatigue. It is expected that these disorders will significantly degrade their quality of life as well as their health. Indeed, lack of sleep is associated with serious health problems such as illnesses cardiovascular or immune system deficiencies.

The PROMESS - SLEEP project aims to offer solutions to students to improve their sleep during their medical studies. It responds to a demand expressed by students: our field study showed that 40% of 4th year students declared being "very interested and/or interested" in following an intervention that aimed at improving sleep. An early knowledge of sleep optimization tools would allow students to quickly acquire the tools necessary to cope with the difficult conditions encountered during their training and lives of future doctors.The objective of this study is to determine the influence of an intervention program based on sleep improvement and fatigue reduction among medical students. conditions: Health Behavior conditions: Health-Related Behavior conditions: Sleep conditions: Sleep Disorder conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All volunteers will receive an intervention program based on sleep improvement and fatigue reduction. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Sleep measure: Perceived level of sleep troubles. Evolution of the score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI). measure: Perceived level of sleep troubles. Score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI). measure: Epworth Sleepiness scale. Score obtained at the Epworth Sleepiness scale. measure: Multidimensional Fatigue. Score obtained at the Multidimensional Fatigue Inventory (MFI). measure: Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS). measure: Actimetry records. Time in Bed during the pre-intervention. measure: Actimetry records. Total sleep duration during the pre-intervention. measure: Actimetry records. Sleep efficiency during the pre-intervention. measure: Actimetry records. Sleep Onset Latency during the pre-intervention. measure: Actimetry records. Wake after Sleep Onset during the pre-intervention. measure: Actimetry records. Number of Awakenings during the pre-intervention. measure: Actimetry records. Bedtime during the pre-intervention. measure: Actimetry records. Mid-sleep point during the pre-intervention. measure: Actimetry records. Sleep Onset time during the pre-intervention. measure: Actimetry records. Sleep Inertia during the pre-intervention. measure: Actimetry records. Wake-up time during the pre-intervention. measure: Actimetry records. Sleep regularity index during the pre-intervention. measure: Multidimensional Fatigue. Evolution of the score obtained at the Multidimensional Fatigue Inventory (MFI) during the intervention. measure: Actimetry records. Evolution in Time in Bed during the intervention. measure: Actimetry records. Evolution in Total sleep duration during the intervention. measure: Actimetry records. Evolution in Sleep efficiency during the intervention. measure: Actimetry records. Evolution in Sleep Onset Latency during the intervention. measure: Actimetry records. Evolution in Wake after Sleep Onset during the intervention. measure: Actimetry records. Evolution in Number of Awakenings during the intervention. measure: Actimetry records. Evolution in Mid-sleep point during the intervention. measure: Actimetry records. Evolution in Bed time during the intervention. measure: Actimetry records. Evolution in Sleep Onset Time during the intervention. measure: Actimetry records. Evolution in Sleep Inertia during the intervention. measure: Actimetry records. Evolution in Wake-up Time during the intervention. measure: Actimetry records. Evolution in Sleep regularity index during the intervention. measure: VAS - sleep quantity: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep. measure: VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality. measure: VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue. measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RESHAPE status: RECRUITING city: Lyon zip: 69008 country: France name: Sophie Schlatter, Dr. role: CONTACT phone: 07 68 21 05 51 phoneExt: 33 email: sophie.schlatter@univ-lyon1.fr name: Angèle Métais, Dr. role: CONTACT phone: 06 77 39 89 66 phoneExt: 33 email: angele.metais@univ-lyon1.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06297317 id: Trailstiff briefTitle: Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event acronym: Trailstiff overallStatus: COMPLETED date: 2021-11-11 date: 2021-11-13 date: 2024-02-01 date: 2024-03-07 date: 2024-03-07 name: University Hospital, Caen class: OTHER briefSummary: This study aimed to assess the longitudinal changes in triceps surae muscle-tendon architecture to an ultra distance trail running. Experienced trail runners (N=55, 78% men, age: 45.2 \[13.5\] years) participated in a 156-km trail run (6000m climbing) consisting in six 26-km laps. The resting architectural properties of triceps surae muscle-tendon were measured using ultrasound imaging for Achille tendon cross-sectional area (AT CSA), medial gastrocnemius muscle pennation angle, thickness, length and fiber length. Measurements were performed the day before the race (Baseline), at 52-km (T1), at 104-km (T2), at 156-km (T3) and 12 hours after the race (H12). conditions: Achilles Tendinopathy conditions: Calf Injury conditions: Sport Injury conditions: Lower Limb Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 55 type: ACTUAL name: Ultrasound measurement of triceps surae muscle-tendon architecture measure: Achille tendon cross sectional area measure: Medial gastrocnemius thickness measure: Medial gastrocnemius pennation angle measure: Medial gastrocnemius fascicle length measure: Medial gastrocnemius muscle length measure: Finisher status measure: Average speed sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Caen Normandie city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06297304 id: PROMESS - PHYSICAL ACTIVITY briefTitle: Sedentary Behaviors Reduction and Physical Activity Promotion for Optimal Medical StudentS overallStatus: RECRUITING date: 2023-11-11 date: 2024-09-30 date: 2024-09-30 date: 2024-03-07 date: 2024-03-12 name: Research on Healthcare Performance Lab U1290 class: OTHER briefSummary: Medical students are under great competitive pressure throughout their studies. Our field surveys conducted in 2022 and 2023 at the Lyon Est Faculty of Medicine revealed that 78% of 482 students showed an excessive sedentary lifestyle compared to the threshold set by WHO. It is expected that a low level of physical activity and/or too high a sedentary lifestyle deteriorates significantly their quality of life and their health. In 2014, a British survey of 356 students in Medicine showed that lack of physical activity was an major predictor of burnout symptoms. Numerous studies show that regular physical activity improves the mental health of students and their cognitive performance.

The PROMESS - PHYSICAL ACTIVITY project aims to offer solutions to students to decrease their sedentary behavior and to improve their physical activity level during their medical studies through an intervention program. From a long term perspective, this intervention may also prevent disorders related to inadequate levels of physical activity and/or sedentary behavior. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested and/or interested" in following an intervention that aimed at improving physical activity. The objective of this study is to determine the influence of an intervention based on sedentary behavior reduction and physical activity promotion among medical students. conditions: Health Behavior conditions: Health-Related Behavior conditions: Physical Inactivity conditions: Sedentary Behavior conditions: Sedentary Time studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All volunteers will receive a physical activity and sedentary management intervention. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Sedentary and physical activity behaviors measure: Perceived level of sedentary : Evolution of the score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors. measure: Perceived level of physical activity : Score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity levels. measure: Perceived level of sedentary : Score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors. measure: Actimetry records.Total activity during the pre-intervention. measure: Actimetry records. Moderate-to-vigorous Physical Activity (MVPA) during the pre-intervention. measure: Actimetry records. Light Physical Activity during the pre-intervention. measure: Actimetry records. Steps count during the pre-intervention. measure: Actimetry records. Energy expenditure during the pre-intervention. measure: Actimetry records. Number of sedentary breaks during the pre-intervention. measure: Actimetry records. Sedentary time during the pre-intervention. measure: Actimetry records. Number of prolonged sedentary bouts during the pre-intervention. measure: Actimetry records.Vector of the dynamic body acceleration (VeDBA) during the pre-intervention. measure: Body composition markers. Body Mass Index (BMI) during the pre-intervention. measure: Body composition markers. Skeletal muscle mass measured by bioimpedancemetry during the pre-intervention. measure: Body composition markers. Fat mass measured by bioimpedancemetry during the pre-intervention. measure: Body composition markers. Total body hydration measured by bioimpedancemetry during the pre-intervention. measure: Physical Fitness markers - Strength. The force developed during a maximal isometric contraction of the quadriceps during the pre-intervention. measure: Physical Fitness markers markers - Power. Height of jump during the pre-intervention. measure: Physical Fitness markers - Power. Time of flight during the pre-intervention. measure: Physical Fitness markers - Power. Relative Power during the pre-intervention. measure: Physical Fitness markers - Endurance. Speed through the endurance test during the pre-intervention. measure: Physical Fitness markers - Endurance. VO2max through the endurance test during the pre-intervention. measure: Physical Fitness markers - Endurance. Heart rate during the endurance test during the pre-intervention. measure: Perceived level of physical activity : Evolution of the score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity level. measure: Actimetry records. Evolution in Total activity during the intervention. measure: Actimetry records. Evolution in Moderate-to-vigorous physical activity (MVPA) during the intervention. measure: Actimetry records. Evolution in Light physical activity measured in min/day during the intervention. measure: Actimetry records. Evolution in Step Count during the intervention. measure: Actimetry records. Evolution in Energy expenditure during the intervention. measure: Actimetry records. Evolution in number of sedentary breaks during the intervention. measure: Actimetry records. Evolution in Number of prolonged sedentary bouts during the intervention. measure: Actimetry records. Evolution in the vector of the dynamic body acceleration (VeDBA) during the intervention. measure: Body composition markers. Evolution in BMI during the intervention. measure: Body composition markers. Evolution in fat mass measured by bioimpedancemetry during the intervention. measure: Body composition markers: Impedance metric measures. Evolution in skeletal muscle mass measured by bioimpedancemetry during the intervention. measure: Body composition markers: Impedance metric measures. Evolution in total body hydration measured by bioimpedancemetry during the intervention. measure: VAS - physical fitness: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness. measure: VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical activity. measure: VAS - sedentary behaviours. Evolution of the scores obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviours. measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RESHAPE status: RECRUITING city: Lyon zip: 69008 country: France name: Sophie Schlatter, Dr. role: CONTACT phone: 07 68 21 05 51 phoneExt: 33 email: sophie.schlatter@univ-lyon1.fr name: Angèle Métais, Dr. role: CONTACT phone: 06 77 39 89 66 phoneExt: 33 email: angele.metais@univ-lyon1.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06297291 id: CLN0984 briefTitle: Global Paradise System US Post Approval Study acronym: US GPS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-09 date: 2031-07 date: 2024-03-07 date: 2024-03-07 name: ReCor Medical, Inc. class: INDUSTRY briefSummary: The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure. conditions: Hypertension conditions: Cardiovascular Diseases conditions: Vascular Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Paradise Ultrasound Renal Denervation Treatment measure: Co-Primary Endpoint #1: Group Mean BP reduction measure: Co-Primary Endpoint #2: Subject Responder measure: Change in mean home systolic/diastolic BP in mmHg measure: Change in mean office systolic/diastolic BP in mmHg measure: Change in home and office pulse pressure measure: Change in the number and/or dosage and/or type of antihypertensive medications taken measure: Change in patient reported outcomes measure: Percentage of patients who are controlled as measured by various cut points of home BP (control to be assessed as both < 130 mmHg systolic and <135 mmHg systolic) office BP (control to also be assessed as <130 mmHg and <140 mmHg systolic) measure: Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg measure: Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg measure: Change in home and office heart rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297278 id: IRB-23-01-5444 id: R01MH132830 type: NIH link: https://reporter.nih.gov/quickSearch/R01MH132830 briefTitle: Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids acronym: BRAINS overallStatus: RECRUITING date: 2024-05-01 date: 2028-04-30 date: 2028-04-30 date: 2024-03-07 date: 2024-04-23 name: Wayne State University class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth. conditions: Adolescence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 174 type: ESTIMATED name: Moderate Intensity Exercise measure: Skin Conductance Responding (SCR) measure: Unconditioned Stimulus (US) Expectancy Ratings measure: Fear extinction neural circuitry: Functional activation and coupling measure: Endocannabinoid (eCB) Concentrations measure: Fear Ratings measure: Approach/Avoidance Behavior measure: Amygdala response during extinction recall sex: ALL minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD facility: Tolan Park Medical Building status: RECRUITING city: Detroit state: Michigan zip: 48201 country: United States name: MacKenna Shampine role: CONTACT phone: 313-242-7464‬ email: mackenna.shampine@wayne.edu lat: 42.33143 lon: -83.04575 hasResults: False

 nctId: NCT06297265 id: 1B-23-2 id: NCI-2023-10828 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 1B-23-2 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-07 date: 2024-03-07 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer. conditions: Anatomic Stage 0 Breast Cancer AJCC v8 conditions: Anatomic Stage IA Breast Cancer AJCC v8 conditions: Localized Breast Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Lymphedema Management name: Questionnaire Administration name: Adjuvant breast radiation therapy measure: Rate of compliance of MLD breast massage sessions measure: Assess the effect of MLD breast massage breast edema measure: Assess the effect of MLD breast massage on pain measure: Assess the effect of MLD breast massage on functional status measure: Assess the effect of MLD breast massage on quality of life measure: Assess the effect of MLD breast massage on body image sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Kimberly Arieli, RN role: CONTACT phone: 323-865-0451 email: Kimberly.Arieli@med.usc.edu name: May L. Tao, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06297252 id: RECHMPL23_0189 briefTitle: Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population acronym: GROUP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-09 date: 2024-03-07 date: 2024-03-07 name: University Hospital, Montpellier class: OTHER name: Beziers Hospital briefSummary: Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs.

The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated.

The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment.

Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum. conditions: Pregnancy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 140 type: ESTIMATED name: standardized clinical psychiatric evaluations name: self-administered psychiatric questionnaire assessments name: blood sampling measure: To determine the prevalence of the presence of at least one characterized psychiatric disorder, in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment. measure: To determine the prevalence of each psychiatric disorder characterized during pregnancy at the time of the second-trimester ultrasound, based on a standardized clinical assessment. measure: Determine comorbidity profiles across all pathologies, describing whether there are patient groups based on these profiles. measure: Compare the prevalence of psychiatric disorders unknown to the obstetrics team with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. measure: Compare the prevalence of psychiatric disorders unknown to the patient with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. measure: Compare the prevalence of psychiatric disorders unknown to the general practitioner with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. measure: Assess patients' medication compliance using self-administered questionnaires (MARS). measure: Assess patients' treatment beliefs using self-administered questionnaires (BMQ). measure: Determine the sociodemographic, psychological, psychiatric, medical and obstetric factors, as well as those associated with access to care and the care pathway associated with known or unknown diagnoses during pregnancy. measure: Determine the properties (sensitivity) of screening questionnaires (EPDS) for psychiatric disorders in this population. measure: Determine the properties (specificity) of screening questionnaires (EPDS) for psychiatric disorders in this population. measure: Determine the properties (positive predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population. measure: Determine the properties (negative predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population. measure: Determine the properties (sensitivity) of screening questionnaires ( MDQ) for psychiatric disorders in this population. measure: Determine the properties (specificity) of screening questionnaires ( MDQ) for psychiatric disorders in this population. measure: Determine the properties (positive predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population. measure: Determine the properties (negative predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population. measure: Determine the properties (sensitivity) of screening questionnaires (PCL-5) for psychiatric disorders in this population. measure: Determine the properties (specificity) of screening questionnaires (PCL-5) for psychiatric disorders in this population. measure: Determine the properties (positive predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population. measure: Determine the properties (negative predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population. measure: Determine the properties (sensitivity) of screening questionnaires (EDEQ) for psychiatric disorders in this population. measure: Determine the properties (specificity) of screening questionnaires (EDEQ) for psychiatric disorders in this population. measure: Determine the properties (positive predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population. measure: Determine the properties (negative predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population. measure: Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (PAI). measure: Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (MIBS). measure: Describe how the study will be carried out, either in person or by teleconsultation, and the reasons for this choice. measure: Determine the prevalence of each psychiatric disorder at two months post-inclusion based on a standardized clinical assessment. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297239 id: UC001 briefTitle: Argentine Registry of Lp(a) acronym: GAELpa overallStatus: RECRUITING date: 2024-02-01 date: 2026-02-01 date: 2026-02-01 date: 2024-03-07 date: 2024-03-07 name: School of Medicine. National University of Cuyo class: OTHER briefSummary: The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels.

The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations.

One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation.

Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk.

The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care. conditions: Lp(A) conditions: Hypercholesterolemia conditions: Cardiovascular Diseases conditions: Diabete Type 2 conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: prevalence of high level of Lp(a) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Nacional de Cuyo status: RECRUITING city: Mendoza zip: 5500 country: Argentina name: Nicolás F Renna, PhD MD FESC role: CONTACT phone: +5492615714415 email: nicolasfede@gmail.com name: Pablo Corral, MD role: CONTACT lat: -32.89084 lon: -68.82717 hasResults: False

 nctId: NCT06297226 id: CA088-1000 briefTitle: Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma acronym: QUINTESSENTIAL overallStatus: RECRUITING date: 2024-03-21 date: 2026-10-02 date: 2030-06-04 date: 2024-03-07 date: 2024-03-29 name: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company class: INDUSTRY briefSummary: The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: BMS-986393 measure: Best overall response (BOR) measure: Best overall response (BOR) measure: BOR of partial response (PR) or better measure: BOR of complete response (CR) [including stringent complete response sCR] measure: Incidence of adverse events (AEs) measure: Incidence of serious adverse events (SAEs) measure: Incidence of adverse event of special interest (AESI) measure: Incidence of participants with clinical laboratory abnormalities measure: Minimal residual disease (MRD) negative status as determined using next generation sequencing (NGS) measure: Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC) measure: Duration of response (DOR) assessed by an IRC measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Overall response rate (ORR) assessed by an Investigator measure: Complete response rate (CRR) assessed by an Investigator measure: Time to response (TTR) assessed by an Investigator measure: Duration of response (DOR) assessed by an Investigator measure: Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator measure: Maximum observed plasma concentration (Cmax) measure: Area under the concentration-time curve (AUC) measure: Time of maximum observed plasma concentration (Tmax) measure: Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales measure: Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales measure: Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Local Institution - 0001 status: NOT_YET_RECRUITING city: Birmingham state: Alabama zip: 35294-3300 country: United States name: Site 0001 role: CONTACT lat: 33.52066 lon: -86.80249 facility: Local Institution - 0025 status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85234 country: United States name: Site 0025 role: CONTACT lat: 33.35283 lon: -111.78903 facility: Local Institution - 0037 status: NOT_YET_RECRUITING city: Little Rock state: Arkansas zip: 72205 country: United States name: Site 0037 role: CONTACT lat: 34.74648 lon: -92.28959 facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Sarah Larson, Site 0028 role: CONTACT phone: 310-829-5471 lat: 34.05223 lon: -118.24368 facility: Local Institution - 0018 status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Site 0018 role: CONTACT lat: 37.77493 lon: -122.41942 facility: Colorado Blood Cancer Institute status: RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: Tara Gregory, Site 0049 role: CONTACT phone: 720-754-4800 lat: 39.73915 lon: -104.9847 facility: Local Institution - 0045 status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33176 country: United States name: Site 0045 role: CONTACT lat: 25.77427 lon: -80.19366 facility: Local Institution - 0029 status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Site 0029 role: CONTACT lat: 27.94752 lon: -82.45843 facility: Local Institution - 0009 status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Site 0009 role: CONTACT lat: 33.749 lon: -84.38798 facility: Local Institution - 0004 status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30342 country: United States name: Site 0004 role: CONTACT lat: 33.749 lon: -84.38798 facility: Local Institution - 0005 status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Site 0005 role: CONTACT lat: 41.85003 lon: -87.65005 facility: Local Institution - 0056 status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Site 0056 role: CONTACT lat: 41.85003 lon: -87.65005 facility: Local Institution - 0019 status: NOT_YET_RECRUITING city: Iowa City state: Iowa zip: 52242 country: United States name: Site 0019 role: CONTACT lat: 41.66113 lon: -91.53017 facility: Local Institution - 0016 status: NOT_YET_RECRUITING city: Kansas City state: Kansas zip: 66160 country: United States name: Site 0016 role: CONTACT lat: 39.11417 lon: -94.62746 facility: Local Institution - 0026 status: NOT_YET_RECRUITING city: Saint Matthews state: Kentucky zip: 40207 country: United States name: Site 0026 role: CONTACT lat: 38.25285 lon: -85.65579 facility: Local Institution - 0039 status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Site 0039 role: CONTACT lat: 42.35843 lon: -71.05977 facility: Local Institution - 0036 status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Site 0036 role: CONTACT lat: 42.35843 lon: -71.05977 facility: Local Institution - 0033 status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Site 0033 role: CONTACT lat: 44.02163 lon: -92.4699 facility: Local Institution - 0010 status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Site 0010 role: CONTACT lat: 38.62727 lon: -90.19789 facility: Local Institution - 0034 status: NOT_YET_RECRUITING city: New Brunswick state: New Jersey zip: 08903 country: United States name: Site 0034 role: CONTACT lat: 40.48622 lon: -74.45182 facility: Local Institution - 0046 status: NOT_YET_RECRUITING city: Buffalo state: New York zip: 14263 country: United States name: Site 0046 role: CONTACT lat: 42.88645 lon: -78.87837 facility: Local Institution - 0002 status: NOT_YET_RECRUITING city: New York state: New York zip: 10029 country: United States name: Site 0002 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Local Institution - 0003 status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States name: Site 0003 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Local Institution - 0031 status: NOT_YET_RECRUITING city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Site 0031 role: CONTACT lat: 35.9132 lon: -79.05584 facility: Local Institution - 0054 status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Site 0054 role: CONTACT lat: 39.12713 lon: -84.51435 facility: Local Institution - 0032 status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Site 0032 role: CONTACT lat: 39.96118 lon: -82.99879 facility: Local Institution - 0038 status: NOT_YET_RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Site 0038 role: CONTACT lat: 45.52345 lon: -122.67621 facility: Local Institution - 0043 status: NOT_YET_RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Site 0043 role: CONTACT lat: 36.16589 lon: -86.78444 facility: Local Institution - 0035 status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75390-88520 country: United States name: Site 0035 role: CONTACT lat: 32.78306 lon: -96.80667 facility: Local Institution - 0027 status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Site 0027 role: CONTACT lat: 29.76328 lon: -95.36327 facility: Local Institution - 0055 status: NOT_YET_RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Site 0055 role: CONTACT lat: 29.42412 lon: -98.49363 facility: Local Institution - 0050 status: NOT_YET_RECRUITING city: Salt Lake City state: Utah zip: 84143 country: United States name: Site 0050 role: CONTACT lat: 40.76078 lon: -111.89105 facility: Local Institution - 0011 status: NOT_YET_RECRUITING city: Seattle state: Washington zip: 98109 country: United States name: Site 0011 role: CONTACT lat: 47.60621 lon: -122.33207 facility: Local Institution - 0015 status: NOT_YET_RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States name: Site 0015 role: CONTACT lat: 43.07305 lon: -89.40123 facility: Local Institution - 0020 status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2N 4N2 country: Canada name: Site 0020 role: CONTACT lat: 51.05011 lon: -114.08529 facility: Local Institution - 0021 status: NOT_YET_RECRUITING city: Montréal state: Quebec zip: H4A 3J1 country: Canada name: Site 0021 role: CONTACT lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06297213 id: R-2487-SS-01 briefTitle: R-2487 in Patients With Sjogren's Syndrome (SS) acronym: R-2487-SS-01 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-08-30 date: 2026-08-30 date: 2024-03-07 date: 2024-04-12 name: Rise Therapeutics LLC class: INDUSTRY briefSummary: The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.

Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured. conditions: Sjogren's Syndrome conditions: Sjögren conditions: Sjögren Syndrome, Unspecified studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: R-2487 measure: Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration measure: Change in disease activity through Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI) measure: Change in Patient reported general health questionnaire Short Form Health Survey-36(SF-36) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297200 id: 24-050 briefTitle: Low-Intensity Focused Ultrasound and the Complex Patient overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-03-07 date: 2024-03-07 name: Virginia Polytechnic Institute and State University class: OTHER name: Salem VA Medical Center name: Washington DC VA Medical Center briefSummary: Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population. conditions: Opioid Use Disorder conditions: Chronic Pain conditions: Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions. count: 25 type: ESTIMATED name: Low-Intensity Focused Ultrasound name: Low-Intensity Focused Ultrasound - sham measure: Incidence of Treatment-Emergent Adverse Events via a neurological examination measure: Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire measure: Changes in Heart Rate (HR) measure: Changes in Respiration Rate (RR) measure: Changes in mood via visual analog mood scale (VAMS) measure: Changes in Blood Pressure (BP) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fralin Biomedical Research Institute at VTC city: Roanoke state: Virginia zip: 24016 country: United States name: Jessica Florig, MPH role: CONTACT phone: 540-526-2261 email: jnw@vtc.vt.edu name: Wynn Legon, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.27097 lon: -79.94143 hasResults: False

 nctId: NCT06297187 id: C-CUSAWH-001 briefTitle: Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-23 date: 2024-07 date: 2024-08 date: 2024-03-07 date: 2024-03-07 name: Integra LifeSciences Corporation class: INDUSTRY briefSummary: The study is a single arm, retrospective, single-center, post market registry.

The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata. conditions: Vulvar Intraepithelial Neoplasia conditions: Condylomata Acuminata studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 75 type: ESTIMATED name: CUSA (Cavitronic Ultrasonic Surgical Aspirator) measure: Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata measure: Primary Site Recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Center for Cancer and Blood Disorders city: Dallas state: Texas zip: 76014 country: United States lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06297174 id: BE23-035 briefTitle: Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions overallStatus: NOT_YET_RECRUITING date: 2024-08-26 date: 2024-09-17 date: 2024-09-20 date: 2024-03-07 date: 2024-03-07 name: Pharma Nueva class: INDUSTRY briefSummary: Objectives:

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions

Study Design:

An open label, randomized, two-treatment, four-period, two-sequence, replicate crossover bioequivalence study in healthy Thai volunteers under fasting conditions with at least 7 days washout period between the administrations of investigational products of each period conditions: Healthy Vollunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 44 type: ESTIMATED name: Racecadotril 100 mg Capsules name: HIDRASEC® measure: Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril measure: Peak Plasma Concentration (Cmax) of Racecadotril sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06297161 id: B1871065 briefTitle: A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML). overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2029-12-31 date: 2029-12-31 date: 2024-03-07 date: 2024-03-07 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.

This study is seeking for participants who are:

* Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea.
* willing to take part in the study after being informed about the study. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.

The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study. conditions: Chronic Leukemia Myelogenous studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Bosulif measure: Incidence of AEs measure: Hematologic response: CHR, not achieved measure: Cytogenetic response: CCyR, PCyR, mCyR, not achieved measure: Molecular response: EMR, MMR, MR4.0, MR4.5, not achieved measure: Relapse after Bosulif response sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06297148 id: 2023/590816 briefTitle: The HIP Self-management Study acronym: HIPS overallStatus: RECRUITING date: 2024-03-12 date: 2026-07-01 date: 2027-01-01 date: 2024-03-07 date: 2024-03-21 name: Oslo University Hospital class: OTHER name: Oslo Metropolitan University name: Fysiofondet name: University of Oslo briefSummary: The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT).

The main purpose of the study is:

1. To investigate the clinical effectiveness of a self- management program versus usual care for patients with greater trochanteric pain syndrome (GTPS).

   * H0: There is no difference between a self-management program and usual care on pain and function in patients with GTPS.
   * H1: There is a difference between a self-management program and usual care on pain and function in patients with GTPS.
2. To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS.

Participants will be randomly allocated into one of two groups: 1) self-management program or 2) usual care.

Follow-up will be at 3-, 6- and 12-months. conditions: GTPS - Greater Trochanteric Pain Syndrome conditions: Gluteal Tendinopathy conditions: Trochanteric Bursitis conditions: Lateral Hip Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Self-management name: Usual care measure: Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G) measure: Numeric rating scale (NRS) measure: Painful sites measure: The Pain Self-Efficacy Questionnaire (PSEQ) measure: EuroQoL-5 dimensions-5 Level (Eq-5D-5L) measure: Hopkins Symptoms checklist-10 (HSCL-10) measure: iMTA Medical Consumption Questionnaire (iMCQ) measure: iMTA Productivity Cost Questionnaire (iPCQ) measure: Expectations related to VISA-G measure: Expectations on numeric rating scale (NRS) measure: Global rating of change (GROC) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital, Ullevål status: RECRUITING city: Oslo zip: 0450 country: Norway name: Marianne Bakke Johnsen, PhD role: CONTACT phone: + 47 92439663 email: m.b.johnsen@medisin.uio.no name: Marianne Bakke Johnsen, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.91273 lon: 10.74609 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-22 uploadDate: 2024-03-07T09:23 filename: SAP_001.pdf size: 1180746 hasResults: False

 nctId: NCT06297135 id: HSR-2023-020 briefTitle: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits overallStatus: RECRUITING date: 2024-02-01 date: 2025-03-31 date: 2025-03-31 date: 2024-03-07 date: 2024-03-07 name: Okinawa Institute of Science and Technology Graduate University class: OTHER name: Miyazaki International College name: Japan society for the promotion of science briefSummary: This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges children face, a transition to a non-preferred activity. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with daily transition routines are invited to participate in the study. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Behavioral Parent Training measure: Number of videos viewed measure: Percentage of completed daily ratings measure: Participant satisfaction measure: Parent-rated child's difficulties with daily transitions measure: Parent-rated child's impairment related to transition difficulties measure: Positive parenting measure: Negative parenting measure: Parenting stress measure: ADHD symptoms measure: ODD symptoms sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Okinawa Institute of Science and Technology Graduate University status: RECRUITING city: Onna state: Okinawa zip: 904-0495 country: Japan name: Emi Furukawa, PhD role: CONTACT phone: +81989668814 email: adhd@oist.jp name: Emi Furukawa, PhD role: PRINCIPAL_INVESTIGATOR facility: Miyazaki International College status: RECRUITING city: Miyazaki zip: 889-1605 country: Japan name: Aya Kasai, PhD role: CONTACT phone: +81985855931 email: akasai@sky.miyazaki-mic.ac.jp name: Aya Kasai, PhD role: PRINCIPAL_INVESTIGATOR lat: 31.91667 lon: 131.41667 hasResults: False

 nctId: NCT06297122 id: APHP240002 briefTitle: Severe Group A Streptococcus Infections in Paris, France, 2018-2023 acronym: IGASI overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-07 date: 2024-03-12 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Streptococcus pyogenes, commonly referred to as Group A Streptococcus (GAS), has the ability to induce a diverse range of illnesses.

In several European countries and the United States, a notable surge in invasive GAS (iGAS) infections has been documented since mid-2022. This sharp increase contrasts with the gradual rise in iGAS incidence observed among children over the past three decades. As demonstrated for several viral infections, the recent upturn in iGAS infections is potentially linked to the relaxation of mitigation measures implemented during the COVID-19 pandemic, such as face mask usage and school closures.

Since November 2022, concerns have been raised by French public health authorities regarding the rise in levels of iGAS infections, and an unexpected increase in pediatric severe GAS infections was reported in a French single-center study. However, this study ended in December 2022 and could only explore short-term trends. The Necker - Enfants malades Hospital in Paris, France, represents an excellent opportunity to examine the impact of the COVID-19 pandemic and the associated non-pharmaceutical interventions on the incidence of severe GAS infections, during, and after the pandemic.

This study aims to investigate trends of severe GAS infection incidence in children in the Paris area over the course of the COVID-19 pandemic. conditions: Invasive Group A Beta-Haemolytic Streptococcal Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Collection of data from the patient's medical file measure: Monthly incidence of severe Group A Streptococcus (GAS) infections per 1000 pediatric hospital admissions measure: Age of children age with group A Streptococcus (GAS) infections measure: Proportion of children needing surgical intervention for the management of GAS infection measure: Proportion of cases admitted in the PICU for GAS infection measure: Proportion of deaths from GAS infection measure: Hospital length of stay for the management of GAS infection measure: Distribution of infection type of GAS infection measure: Proportion of healthcare-associated infections during the management of GAS infection sex: ALL maximumAge: 17 Years stdAges: CHILD facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Jérémie Cohen, M.D., PhD role: CONTACT phone: 1 44 49 48 72 phoneExt: +33 email: jeremie.cohen2@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06297109 id: S-20230033 briefTitle: Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery overallStatus: RECRUITING date: 2023-09-12 date: 2027-08-31 date: 2027-08-31 date: 2024-03-07 date: 2024-03-07 name: Hospital of South West Jutland class: OTHER name: University of Southern Denmark briefSummary: Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved.

Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.

Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.

The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:

* Does using PSIs provide accurate movements of the maxilla pieces?
* Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?
* Does using PSIs provide stable movements of the maxilla pieces after 2 years?
* Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?

Participants will get orthognathic surgery as part of their normal orthodontic treatment.

Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method. conditions: Retrognathia conditions: Malocclusion, Angle Class II studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The care provider and the investigator are blinded up to the selection of the device used for the surgery, as blinding is no longer possible from this state. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Patient-specific implants name: Conventional mini-plates measure: The accuracy of segmental Le Fort I bone movements measure: The stability of segmental Le Fort I bone movements measure: The stability of the upper airway measure: The Diagnostic Criteria for Temporomandibular Disorders Symptom questionnaire measure: The Jaw Functional Limitation Scale measure: The STOP-BANG - Snorting, Tiredness, Observed apnea, blood Pressure, BMI, Age, Neck circumference, Gender questionnaire measure: The Epworth Sleepiness Scale questionnaire measure: The occlusion including horizontal/vertical overlap sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Southern Denmark status: RECRUITING city: Esbjerg zip: 6700 country: Denmark name: Michael B Holte, ph.d. role: CONTACT phone: +4520645760 email: Michael.Boelstoft.Holte@rsyd.dk lat: 55.47028 lon: 8.45187 hasResults: False

 nctId: NCT06297096 id: NIGRIR_004NINTOC-TU briefTitle: Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease acronym: NINTOC-TU overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-30 date: 2028-03-30 date: 2024-03-06 date: 2024-03-21 name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland class: NETWORK name: Medical Research Agency, Poland briefSummary: The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks. conditions: Systemic Sclerosis conditions: Interstitial Lung Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 86 type: ESTIMATED name: Tocilizumab name: Nintedanib name: Standard therapy measure: The decrease in forced vital capacity (FVC) of the lungs measure: Change in percent lung involvement measure: Assessment of absolute changes in DLCO measure: Assessment of the absolute changes in predicted FVC% measure: Change in the Six-minute walk test (6MWT) result measure: Change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score measure: A change in the patient's global assessment of disease activity measure: A change in the physician's global assessment of disease activity measure: Assessment of the absolute changes from baseline in total scores in St. George's Respiratory Questionnaire (SGRQ) measure: Assessment of absolute changes compared to baseline values on the modified Rodnan skin Score (mRSS) measure: Percentage of participants with threshold improvement from baseline in modified Rodnan skin Score (mRSS) measure: Percentage of participants with modified Rodnan skin Score (mRSS) improvement greater than or equal to (>/=) 20%, 40%, or 60% sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centrum Wsparcia Badań Klinicznych city: Warsaw state: Mazowieckie zip: 02-637 country: Poland name: Justyna Kwiatkowska-Golańska role: CONTACT phone: 22 6880632 phoneExt: +48 email: justyna.kwiatkowska-golanska@spartanska.pl name: Maria Maślińska, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06297083 id: 100992 briefTitle: Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy acronym: HILO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-02 date: 2027-12 date: 2024-03-06 date: 2024-04-08 name: Murdoch Childrens Research Institute class: OTHER briefSummary: This study will compare the effectiveness of three different treatments to treat peanut allergy conditions: Peanut Allergy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a three-arm, multi-center, head-to-head randomized study primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants, outcome assessors, other research staff, treating clinicians, investigators and trial statistician will be blinded to treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 130 type: ESTIMATED name: Peanut Oral Powder [PEANUT POWDER] name: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin) measure: Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment. measure: Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment measure: Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE) measure: Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ). measure: Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size. measure: Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels measure: Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant measure: Difference between treatment arms in participant experience as assessed from qualitative interviews measure: Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) measure: Difference between clinical outcome groups in quality adjusted life year (QALY) will be estimated at 32 months using the Food Allergy Quality of Life Form (FAQLQ) mapped to the generic health utility instrument Assessment of Quality of Life-6D (AQoL-6D) measure: Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment measure: Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment sex: ALL minimumAge: 1 Year maximumAge: 10 Years stdAges: CHILD facility: Womans and Childrens Hospital city: Adelaide state: South Australia zip: 5006 country: Australia name: Michael Gold role: CONTACT phone: +61881617000 email: Michael.gold@adelaide.edu.au lat: -34.92866 lon: 138.59863 facility: Murdoch Childrens Research Institute city: Melbourne state: Victoria zip: 3052 country: Australia name: Julie Burns role: CONTACT phone: +61399366184 email: hilo.study@mcri.edu.au lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06297070 id: STUDY20231406 briefTitle: Lifestyle Care for Fertility Outcome Evaluation acronym: PROWESS overallStatus: RECRUITING date: 2024-01-24 date: 2025-06-01 date: 2025-08-01 date: 2024-03-06 date: 2024-03-08 name: Christine Kaiser, LAc, DACM class: OTHER briefSummary: An observational outcome evaluation of the Lifestyle Care for Fertility program. conditions: Fertility Issues studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 55 type: ESTIMATED name: Whole Health Lifestyle Care for Reproductive Well-being pilot program measure: Servings of Fruit measure: Servings of Vegetables measure: Glasses of Water measure: Caffeinated Beverages measure: Aerobic Exercise measure: Strengthening Exercise measure: Stretching Exercise measure: Sleep Hygiene measure: Hours of Sleep measure: Self Care - Biofeedback measure: Self Care - Breathing Exercises measure: Self Care - Guided Imagery measure: Self Care - Mindfulness/Meditation measure: Self Care - Progressive Relaxation measure: Self Care - Journaling/Gratitude Journaling measure: Self Care - Tai Chi/Chi Gong measure: Self-Care - Massage Therapy measure: Self Care - Acupuncture/Acupressure measure: Self Care - Nature Walking measure: PROMIS Sleep Disturbance 8a measure: Perceived Stress Scale - 4 measure: Infertility Self Efficacy measure: Chemical pregnancy measure: Stress Change (level of stress: none [0] to worst possible [10]) - SMA measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA measure: Stress Change (level of stress: none [0] to worst possible [10]) - HWC measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC measure: Recruitment Rate measure: Retention Rate measure: Pace of Accrual measure: Data Completeness measure: Helpfulness of group sessions in addressing needs measure: Coverage of important issues in the sessions measure: Helpfulness of tools presented in nutrition session measure: Helpfulness of tools presented in movement session measure: Helpfulness of tools presented in relaxation and sleep session measure: Helpfulness of tools presented in integrate session measure: Enjoyed group sessions measure: Enjoyed health and wellness coaching session measure: Group setting was beneficial measure: Comfortable in group setting measure: Helpfulness of individual health coaching sessions measure: Feedback questionnaire: Location Preference question 1 measure: Feedback questionnaire: Location Preference question 2 measure: Feedback questionnaire: Number of Sessions question. measure: Feedback questionnaire: Length of Sessions question. measure: Rating of level of support during each SMA measure: Rating of level of support during HWC measure: Overall level of satisfaction during each SMA measure: Overall level of satisfaction during each HWC sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University Hospitals Cleveland Medical Center status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Christine Kaiser, DACM LAc role: CONTACT phone: 216-285-4070 email: Christine.Kaiser@UHhospitals.org name: Jessica Surdam, MPH role: CONTACT phone: 216-844-7925 email: Jessica.Surdam@UHhospitals.org lat: 41.4995 lon: -81.69541 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-20 uploadDate: 2024-01-10T14:17 filename: Prot_SAP_000.pdf size: 238937 hasResults: False

 nctId: NCT06297057 id: 2021.07 briefTitle: Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings acronym: MEEGOPTI overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-03-06 date: 2024-03-06 name: IRCCS San Camillo, Venezia, Italy class: OTHER name: University Ghent name: University of Padova briefSummary: The study aims to optimize and validate protocols for acquiring neurophysiological data, specifically resting state functional connectivity, using advanced research techniques (hdEEG and MEG) and a user-friendly device (MUSE). Previous studies have extensively explored functional connectivity repeatability in resting conditions using functional MRI, yet few have focused on hdEEG and MEG data. Additionally, the impact of subjects' eye conditions (open or closed) during resting state recordings on network identification remains debated.

The investigation involves assessing the effect of eye conditions on brain network identification and determining the most stable and repeatable measures of functional connectivity over time. This analysis is crucial for discerning whether observed changes in patients' functional connections are intrinsic to the methodology or indicative of genuine physiological alterations.

The study aims to optimize protocols for rehabilitation by evaluating changes in functional connectivity metrics during and between experimental sessions. Furthermore, it seeks to identify the conditions (eyes closed or open) that yield more reliable and repeatable functional measurements.

Following the optimization of advanced techniques, the study explores the feasibility of utilizing the MUSE EEG system in clinical settings. MUSE, known for its portability and user-friendliness, has demonstrated quality in experimental psychology and clinical research. The objective is to establish relevant functional correspondences between measurements obtained through research techniques (hdEEG and MEG) and those acquired with MUSE.

The primary goal is to establish a protocol highlighting subjects' responses to acoustic stimuli or a reproducible pattern of resting state activity. The secondary objectives include investigating temporal and spatial characteristics of neurophysiological signals in healthy subjects over time and defining prognostic biomarkers for monitoring patients undergoing rehabilitation. This comprehensive approach aims to enhance the understanding of resting state functional connectivity and its applications in clinical settings.

Therefore, to meet these goals, the present study will consist of multiple recordings of brain activity: by high-density electroencephalography (hdEEG), magnetoencephalography (MEG), and low-density EEG with a MUSE handheld device, during five experimental blocks on healthy subjects. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Neurophysiological Recordings measure: Neurophysiological data acquisition protocol - resting state measure: Neurophysiological data acquisition protocol - resting state measure: Neurophysiological data acquisition protocol - auditory stimulation sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: San Camillo IRCCS s.r.l. city: Venice-Lido state: Venice zip: 30126 country: Italy lat: 45.4131 lon: 12.3742 hasResults: False

 nctId: NCT06297044 id: 2017.20 briefTitle: Neural and Cognitive Correlates of Pragmatic Abilities acronym: APACS_Neuro overallStatus: ACTIVE_NOT_RECRUITING date: 2018-03-29 date: 2025-12-31 date: 2025-12-31 date: 2024-03-06 date: 2024-03-06 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. They are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. Despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation.

This study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective Rehabilitation Plans. conditions: Right Hemispheric Stroke conditions: Left Hemispheric Stroke conditions: Traumatic Brain Injury conditions: Right Hemispheric Brain Tumor conditions: Left Hemispheric Brain Tumor conditions: Mild Cognitive Impairment conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 324 type: ESTIMATED name: Neuropsychological assessment measure: Pragmatic Profile measure: Theory of Mind measure: Functional Communication Abilities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Camillo IRCCS s.r.l. city: Venice-Lido state: Venice zip: 30126 country: Italy lat: 45.4131 lon: 12.3742 hasResults: False

 nctId: NCT06297031 id: 2020/20 briefTitle: Heat Application to the Sacral Region and Pain Level During the First Stage of Labor overallStatus: COMPLETED date: 2020-04-01 date: 2021-05-01 date: 2021-05-30 date: 2024-03-06 date: 2024-03-06 name: Istanbul Demiroglu Bilim University class: OTHER briefSummary: The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process. conditions: Heat Exposure conditions: Labor Pain conditions: Apgar Score conditions: Duration of Labor studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 134 type: ACTUAL name: heat application measure: Change From Baseline labor Pain at three times measure: Duration of the first stage of labor measure: Change From Baseline APGAR score after delivery measure: Change From Baseline Fetal Heart Rate sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Demiroglu Bilim University city: Istanbul zip: 34384 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06297018 id: February 18, 2024 briefTitle: Bioenergy, Depression, Anxiety and Stress After Liver Transplantation overallStatus: TERMINATED date: 2024-01-01 date: 2024-02-02 date: 2024-02-09 date: 2024-03-06 date: 2024-03-06 name: Istanbul Aydın University class: OTHER briefSummary: In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Interventional Crossover Assignment primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: Experimental whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ACTUAL name: Bioenergy application measure: Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Semra Bulbuloglu city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06297005 id: 21/FFP-P/10154 briefTitle: The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study acronym: ECHO overallStatus: RECRUITING date: 2023-10-09 date: 2027-08-31 date: 2027-08-31 date: 2024-03-06 date: 2024-04-12 name: University College Dublin class: OTHER name: Royal College of Surgeons, Ireland briefSummary: Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy.

The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age. conditions: Vaping conditions: Pregnancy Related conditions: Pediatric Respiratory Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED measure: Incidence of preterm birth measure: Incidence of low birth weight measure: Incidence of wheeze during the first two years of life measure: Incidence of smoking and vaping measure: Estimated foetal weight measure: Trends in carbon monoxide levels measure: Blood pressure measurements (both diastolic and systolic) measure: Urine cotinine measurements measure: Incidence of maternal cough, wheeze and/or asthma measure: Maternal history of abnormal cervical screening cytology measure: Incidence of pre-eclampsia and/or hypertension during pregnancy measure: Incidence of birth complications measure: Edinburgh postnatal depression score measure: APGAR scores at 1, 5 and 10 minutes after birth measure: Admission to neonatal intensive care measure: Incidence of neonatal complications measure: Neonatal and paediatric anthropometric measurements over first two years of life measure: Neonatal body composition measurements measure: Incidence of respiratory illnesses measure: Number of attendances/admissions to hospital measure: Frequency of prescribed respiratory medications use measure: Barkely Functional Impairment score (BFIS) measure: Early Executive Functions Questionnaire (EEFQ) measure: Infant Behaviour Questionnaire (IBQ) measure: Child Behaviour Checklist (CBCL) measure: Early Childhood Behaviour Questionnaire (ECBQ) measure: Bayley Scales of Infant and Toddler Development (BSID) sex: FEMALE minimumAge: 18 Years maximumAge: 46 Years stdAges: ADULT facility: Rotunda Hospital status: RECRUITING city: Dublin zip: D01 P5W9 country: Ireland name: Adele Reddin, BSc/MSc role: CONTACT email: areddin@rotunda.ie lat: 53.33306 lon: -6.24889 facility: National Maternity Hospital, Holles Street status: RECRUITING city: Dublin zip: D02 YH21 country: Ireland name: Emma Doyle, BSc/MSc role: CONTACT email: emma.doyle@nmh.ie lat: 53.33306 lon: -6.24889 facility: Coombe Womens Hospital status: RECRUITING city: Dublin zip: D08 XW7X country: Ireland name: Eibhlin Cary Healy, MRCPI role: CONTACT email: ehealy@coombe.ie name: Mariapia Dado, BSc/MSc role: CONTACT phone: +35314085571 phoneExt: 4541 email: MDado@coombe.ie lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06296992 id: B2023:035 briefTitle: Type 1 Diabetes, Exercise and Mentoring Trial acronym: TEAM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-05 date: 2024-03-06 date: 2024-03-06 name: University of Manitoba class: OTHER name: Juvenile Diabetes Research Foundation name: Canadian Institutes of Health Research (CIHR) briefSummary: The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D. conditions: Type 1 Diabetes conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 12-week TEAM peer mentor program measure: Enrollment rates measure: Adherence to the intervention arms measure: Retention for follow-up measurements measure: Physical activity measure: Quality of Life (DQOL) measure: Quality of Life (PedsQL 4.0) measure: Diabetes Distress measure: Mastery measure: Autonomy measure: Motivation for physical activity (LCE) measure: Readiness for change measure: Motivation to engage in exercise measure: Motivation for Physical Activity (EMI-2) sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06296979 id: 0881-N-23 briefTitle: Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity. overallStatus: RECRUITING date: 2024-03-20 date: 2026-12-01 date: 2026-12-01 date: 2024-03-06 date: 2024-04-15 name: University of Seville class: OTHER briefSummary: Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology. conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Phrenic nerve neuromodulation name: common Physical therapy measure: Numeric Pain Rating Scale measure: Algometry measure: Goniometry passive measure: Quick Dash questionnaire measure: Goniometriy active sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Centro de Salud Ronda Histórica status: RECRUITING city: Sevilla zip: 41008 country: Spain name: Deseada López Carballo, Dra role: CONTACT email: deseada.lopez.sspa@juntadeandalucia.es lat: 37.38283 lon: -5.97317 facility: Centro de Salud las Letanías status: RECRUITING city: Sevilla zip: 41013 country: Spain name: Alicia Valero Sáinz role: CONTACT phone: 649532242 phoneExt: +34 email: aliciavalerio@hotmail.com lat: 37.38283 lon: -5.97317 facility: Centro de Salud Bellavista status: RECRUITING city: Sevilla zip: 41014 country: Spain name: María Isabel Morilla Párraga role: CONTACT phone: 609582376 phoneExt: +34 email: fisioaljarafe@gmail.com lat: 37.38283 lon: -5.97317 hasResults: False

 nctId: NCT06296966 id: VP-VSJ-110-2201 briefTitle: A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye overallStatus: RECRUITING date: 2024-02-29 date: 2024-07 date: 2024-07 date: 2024-03-06 date: 2024-03-06 name: Vanda Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye. conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: VSJ-110 name: Placebo measure: Schirmer's Tear Test measure: Ocular Staining measure: Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanda Investigational Site status: RECRUITING city: Andover state: Massachusetts zip: 01810 country: United States name: Vanda Pharmaceuticals Inc. role: CONTACT phone: 202-734-3400 email: clinicaltrials@vandapharma.com lat: 42.65843 lon: -71.137 hasResults: False

 nctId: NCT06296953 id: PeriSaFe01 id: CIV-23-11-044875 type: OTHER domain: Swedish Medical Product Agency briefTitle: Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis acronym: PeriSaFe01 overallStatus: RECRUITING date: 2024-03-15 date: 2024-09-01 date: 2024-12-01 date: 2024-03-06 date: 2024-04-22 name: STB INN AB class: INDUSTRY name: Scandinavian CRO name: Region Halland briefSummary: This will be an explorative, proof-of-principle, open, multi-center investigation.

The investigation aims to investigate the safety of the PERIsign system and the ability of physicians to differentiate between healthy individuals and subjects with involuntary muscle defense as a sign of peritonitis by utilizing PERIsign data. The investigation will include a total of 20 subjects admitted to hospital for suspected appendicitis and planned for emergency surgery and 20 healthy volunteers. Both male and female subjects aged 18-70 years will be enrolled.

All subjects will undergo PERIsign examinations. Subjects with suspected appendicitis will undergo 1-2 PERIsign examinations before their planned appendectomy surgery. For the healthy volunteers, there is only 1 PERIsign examination. During each examination, 4 PERIsign curves will be obtained, one from each quadrant of the abdomen. The attending physician will interpret the appearance of the PERIsign curves of all subjects, including those from the healthy volunteers. The duration of the PERIsign examination will be documented, and usability data will be gathered, including the need for sensor adjustments, subject perception of the examination, and any discomfort experienced. In addition, blinded physicians will evaluate all subjects' PERIsign curves and determine whether each subject has involuntary muscle defense as a sign of peritonitis. These blinded physicians will have access to all 4 PERIsign curves obtained during each examination, while other data will not be disclosed to them.

Safety will be evaluated through analysis of reported adverse events and device deficiencies conditions: Appendicitis Acute conditions: Appendicitis conditions: Abdominal Pain conditions: Peritonitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 40 type: ESTIMATED name: PERIsign examination measure: Proportion of subjects experiencing any adverse events during the examination measure: Proportion of device deficiencies during the evaluation measure: To estimate the sensitivity and specificity of diagnosing pathological muscle defense when using the PERIsign system measure: Proportion of examinations of the PERIsign system that its performed without usability issues. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hallands Sjukhus Halmstad status: RECRUITING city: Halmstad country: Sweden name: Cleas Hjalmarsson, Ass. Prof. role: CONTACT name: Åsa Anveden, PhD role: SUB_INVESTIGATOR lat: 56.67446 lon: 12.85676 facility: Hallands Sjukhus Varberg status: RECRUITING city: Varberg country: Sweden name: Claes Hjalmarsson, ass. Prof role: CONTACT name: Stefan Lindskog, ass. prof role: PRINCIPAL_INVESTIGATOR lat: 57.10557 lon: 12.25078 hasResults: False

 nctId: NCT06296940 id: WEST 2.0 briefTitle: Written Exposure in Substance Treatment acronym: WEST overallStatus: RECRUITING date: 2022-12-01 date: 2024-06-15 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Potomac Health Foundations class: OTHER name: University of Maryland, Baltimore County briefSummary: The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone? conditions: Posttraumatic Stress Disorder conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We are conducting a randomized controlled trial of approximately 50 randomized subjects (up to 100 total enrollments) who will be assigned 1:1 to treatment as usual (TAU) or TAU+WET. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Written Exposure Therapy name: Treatment as Usual measure: Efficacy of WET measure: Feasibility of WET delivered in residential SUD treatment context measure: Acceptability of WET delivered in residential SUD treatment context sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maryland Treatment Centers status: RECRUITING city: Baltimore state: Maryland zip: 21229 country: United States name: Kevin Wenzel, PhD role: CONTACT phone: 410-233-1400 email: kwenzel@marylandtreatment.org name: Marc Fishman, MD role: CONTACT phone: 410.233.1400 email: mfishman@marylandtreatment.org lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06296927 id: SumeyyeKose-E.138186 briefTitle: The Effect of the Emotional Freedom Technique on Perceived Pain, Situational Anxiety, Cortisol and Satisfaction Levels in Mammography Screening. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-01 date: 2025-03-01 date: 2024-03-06 date: 2024-03-06 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxiety, salivary cortisol and satisfaction level during mammography screening. conditions: Mammography Screening conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a randomized controlled two-group study. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 76 type: ESTIMATED name: Emotional Freedom Technique measure: Anxiety measure: Pain Level measure: Satisfaction Level measure: Cortisol Level sex: FEMALE minimumAge: 40 Years maximumAge: 50 Years stdAges: ADULT facility: Pendik District Health Directorate Maternal Child Health and Family Planning Center city: Istanbul country: Turkey name: SUMEYYE KOSE role: CONTACT phone: 2163961630 phoneExt: 6173 email: sumeyyekose28@gmail.com name: Sümeyye Köse, Phd Student role: PRINCIPAL_INVESTIGATOR name: Handan Özcan, Assoc.Prof role: PRINCIPAL_INVESTIGATOR name: Türkinaz Aşti, Prof.Dr. role: SUB_INVESTIGATOR name: Fatih Hacımustafaoğlu, Lecturer Dr. role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06296914 id: 89776 briefTitle: A mHealth System for Patients With POTS overallStatus: RECRUITING date: 2024-02-20 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Jami Warren class: OTHER briefSummary: Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3 million Americans. This number will only increase due to the large number of patients experiencing POTS due to "long COVID." POTS patients experience several symptoms, including tachycardia, palpitations, dizziness, and pre-syncope or syncope, among others. POTS can be very debilitating and not only affect patients physically but also emotionally and financially. It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses, stigma, and depression and anxiety. Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers. Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology. The two study aims are: 1) Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients; and 2) Evaluate the usability and feasibility of the mHealth app and study design. To achieve these aims, researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance (MAMMA) and stakeholders (patients, caregivers, and providers) to co-design a mHealth app for POTS patients, including key educational components guided by the IDEA model, an instructional risk communication approach. A group of diagnosis-seeking POTS (n=20) patients will pilot test the app and provide feedback for improvement as well as evaluate its usability. Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes, such as patient experience during visits with physicians, perceived stigma, and time to diagnosis. conditions: POTS - Postural Orthostatic Tachycardia Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: POTSapp name: Waitlist Control measure: Change in POTSapp Usability as measured by uMARS measure: Change in POTSapp Usage measure: Change in POTSapp Usability as measured by Health-ITUES measure: Change in POTSapp Effectiveness as measured by Message Effectiveness scale measure: Change in Participant Quality of Life measure: Change in Doctor Patient Communication (DPC) measure: Adapted IBS Perceived Stigma Scale measure: Cognitive Learning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40506 country: United States name: Jami Warren, PhD role: CONTACT phone: 859-323-1100 email: jami.warren@uky.edu lat: 37.98869 lon: -84.47772 hasResults: False

 nctId: NCT06296901 id: 202310353 briefTitle: To Wipe or Not To Wipe?: That Is The Question overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-10 date: 2024-03-06 date: 2024-03-06 name: Joanna A. Orzel class: OTHER briefSummary: The primary aim of this randomized control trial is to characterize whether a mid-stream clean catch sample using a cleansing wipe in the setting of symptomatic UTI in a female patient is associated with a lower rate of contamination. We hypothesize that using a perineal cleansing wipe at the time of a midstream urine sample will decrease rates of contamination for female patients with a symptomatic UTI. conditions: Urinary Tract Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 600 type: ESTIMATED name: Perineal Wipe measure: Rate of Contamination sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296888 id: P-2022-673 id: 2203718 type: OTHER domain: De Videnskabsetiske Medicinske Komiteer briefTitle: Radiofrequency Balloon Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolated and Clinical Outome acronym: RABAAF overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-01 date: 2024-03-15 date: 2024-08-09 date: 2024-03-06 date: 2024-03-06 name: Jim Hansen class: OTHER name: University Hospital, Gentofte, Copenhagen name: Biosense Webster, Inc. briefSummary: Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins.

Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required.

A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure.

In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ACTUAL name: Radiofrequency balloon catheter ablation measure: Proportion of durably isolated PVs observed at repeat EP study measure: Proportion of patients with durable isolation of all PVs observed at repeat EP study measure: Proportion of patients remaining free from recurrence of ATA after the initial PVI measure: Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI measure: Complications measure: Proportion of patients remaining free from recurrence of ATA after the repeat EP study measure: Difference in the effect of AF related symptoms on quality of life between baseline, after the initial PVI, and after the repeat EP study sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gentofte Hospital city: Hellerup zip: 2820 country: Denmark lat: 55.73204 lon: 12.57093 hasResults: False

 nctId: NCT06296875 id: KAMM briefTitle: The Krill Ageing Muscle Mechanisms (KAMM) Study acronym: KAMM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-06 date: 2024-03-08 name: University of Glasgow class: OTHER briefSummary: This study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. The studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oil

Objective 1) Muscle structure and function Hypothesis: Krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length).

Objective 2) Neuromuscular control and central nervous system (CNS) function Hypothesis: Krill oil supplementation will improve Neuromuscular Junction (NMJ) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy.

Objective 3) Gait and functional characteristics Hypothesis: Krill oil supplementation will improve gait and functional characteristics. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 parallel group design primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: All supplements will be matched for taste and look whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Vegetable oil name: Krill oil measure: Grip strength measure: Neuromuscular junction transmission instability measure: Gait speed measure: Knee extensor maximal torque measure: Vastus lateralis muscle cross sectional area measure: Vastus lateralis pennation angle measure: Vastus lateralis fascicle length measure: Erythrocyte fatty acid composition measure: Knee extensor force steadiness measure: Vastus lateralis motor unit conduction velocity measure: Vastus lateralis and vastus medialis intramuscular coherence measure: Hand flexor muscles intermuscular coherence measure: Cortico-muscular coherence between sensory motor cortex and hand extensor muscles measure: Femoral Nerve Stimulation measure: Transcranial Magnetic Stimulation (TMS) measure: TMS Inhibition measure: TMS Excitation measure: Gait characteristics during 4m walk test and the timed up and go test measure: Gait cycle with leg support parameters sex: ALL minimumAge: 65 Years maximumAge: 90 Years stdAges: OLDER_ADULT facility: University of Glasgow city: Glasgow country: United Kingdom lat: 55.86515 lon: -4.25763 hasResults: False

 nctId: NCT06296862 id: STUDY00005563 briefTitle: Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2025-06 date: 2024-03-06 date: 2024-03-06 name: University of Georgia class: OTHER name: Emory University briefSummary: The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Dietary Approaches to Stop Hypertension Diet measure: B-natriuretic peptide (BNP) measure: N-terminal-proBNP (NT-proBNP) measure: Systolic and Diastolic Pulmonary Artery Pressures sex: ALL minimumAge: 65 Years maximumAge: 110 Years stdAges: OLDER_ADULT facility: Emory Clinical Cardiovascular Research Center (ECCRI) city: Atlanta state: Georgia zip: 30322 country: United States name: Arshed A Quyyumi, MD, PhD role: CONTACT phone: 404-727-6635 email: quyyum@emory.edu lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06296849 id: 00007344 briefTitle: Dyadic Financial Incentive Treatments for Dual Smoker Couples overallStatus: RECRUITING date: 2024-01-18 date: 2028-05 date: 2028-05 date: 2024-03-06 date: 2024-03-12 name: University of Georgia class: OTHER name: McMaster University name: University of Kentucky briefSummary: Smokers partnered with other smokers (i.e., dual-smoker couples) represent \~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment.

The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population. conditions: Smoking, Cigarette studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 900 type: ESTIMATED name: Financial Incentive Treatment (FIT) measure: Point-Prevalence Abstinence at End of Treatment measure: Point-Prevalence Abstinence After Treatment measure: Point-Prevalence Abstinence at First Follow-up measure: Point-Prevalence Abstinence at Second Follow-up measure: Partner Point-Prevalence Abstinence measure: Smoking Heaviness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Georgia status: RECRUITING city: Athens state: Georgia zip: 30602 country: United States name: Michelle R vanDellen, PhD role: CONTACT email: mvd@uga.edu lat: 33.96095 lon: -83.37794 hasResults: False

 nctId: NCT06296836 id: 2024-001 briefTitle: Effect of Continuing Versus Holding Metformin During Hospitalizations. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-06-30 date: 2024-03-06 date: 2024-03-06 name: University of Illinois at Chicago class: OTHER name: Emily Hanners name: Dulal Bhaumik name: Avisek Datta name: Peggy Choye name: Hailey Soni name: Annesti Elmasri name: Julie Jun name: Colin Goodman briefSummary: A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, parallel, prospective trial. primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Metformin measure: Mean glucose levels measure: Incidence of hyperglycemia greater than 300 mg/dl. measure: Incidence of hypoglycemia (Glu = 54 - 70). measure: Incidence of moderate hypoglycemia (Glu < 54) measure: Incidence of severe hypoglycemia (Glu < 54 with symptoms) measure: Mean lactic acid levels. measure: Incidence of lactic acid levels greater than 2.0. measure: Mean anion gap. measure: Incidence of anion gap > 11 measure: Incidence of elevated lactic acid level or anion gap. measure: Incidence of inadvertently not continuing metformin on discharge measure: GI adverse effects measure: Mortality measure: Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60612 country: United States lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06296823 id: 22-0466 briefTitle: Biomarkers for Peripheral Circadian Clocks in Humans overallStatus: RECRUITING date: 2023-09-01 date: 2027-08-31 date: 2027-08-31 date: 2024-03-06 date: 2024-03-06 name: University of Colorado, Boulder class: OTHER name: University of Colorado, Denver briefSummary: The purpose of this project is to improve our understanding of peripheral circadian rhythms in humans. Circadian clocks are present in most tissues of the body with importance for optimal physiological function, health, and behavior. This project will utilize simulated jetlag protocols to systematically test novel hypotheses about the regulation of peripheral circadian rhythms in humans. Specifically, we will examine how changes in the time of when we are exposed to light and the timing of when we eat impacts proteins in the blood and saliva that represent rhythms from clocks in the brain (e.g., rhythms of the hormones melatonin and cortisol coordinated by the brain) and rhythms from clocks in body tissues (e.g., proteins made by immune and bone cells, and cells in the stomach and liver). We also aim to discover new blood-based biomarkers of peripheral rhythms in humans. We anticipate our findings will be the first step in developing novel circadian based treatments for aligning peripheral clocks under conditions such as jetlag, and for developing novel circadian biomarkers that will advance our scientific understanding of circadian rhythms. conditions: Circadian Rhythms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: Simulated jetlag protocol measure: PYY measure: Ghrelin measure: Leptin measure: CRP measure: OMD measure: PAI-1 measure: IgE measure: CCL18 measure: PTH measure: Glucose measure: Insulin measure: Proteomics measure: Melatonin measure: Cortisol measure: Core body temperature measure: Skin temperature measure: Cognition measure: Blood pressure measure: Metabolomics (grant application planned to analyze not currently funded) measure: Oral microbiome (grant application planned to analyze not currently funded) measure: Skin microbiome (grant application planned to analyze not currently funded) sex: ALL minimumAge: 17 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Sleep and Chronobiology Laboratory status: RECRUITING city: Boulder state: Colorado zip: 80303 country: United States name: Kenneth Wright role: CONTACT phone: 303-735-1923 email: sleep.study@colorado.edu lat: 40.01499 lon: -105.27055 hasResults: False

 nctId: NCT06296810 id: 23-0847 briefTitle: Adaptive DBS to Offset STN Dysregulation During Exercise in PD overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-03-06 date: 2024-03-06 name: University of Colorado, Denver class: OTHER briefSummary: The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: aDBS measure: identification of L-beta frequency peak power sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296797 id: 5R18HS029432-02 type: AHRQ link: https://reporter.nih.gov/quickSearch/5R18HS029432-02 id: R18HS029432 type: AHRQ link: https://reporter.nih.gov/quickSearch/R18HS029432 briefTitle: Patient-centered Information on Permanent Contraception overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-06 date: 2024-03-06 name: University of California, San Francisco class: OTHER name: Essential Access Health name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives.

Participants will:

* Complete a baseline survey
* Receive access to web-based educational resources
* Complete a brief follow up survey immediately after exploring these web-based resources
* Complete a follow-up survey 3 months after enrolling

The investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization. conditions: Contraception conditions: Reproductive Behavior conditions: Contraception Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 350 type: ESTIMATED name: Control arm: Existing educational website name: Advancing Access Website measure: Perceived Access to Long Acting Contraceptives measure: Person-Centered Contraceptive Counseling Measure measure: Consumer Assessment of Healthcare Providers and Systems measure: Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI) measure: Knowledge of Long-Acting Contraceptives measure: Use of preferred method of contraception measure: Would recommend website to a friend measure: Suggestions for how to improve web-based resources for people considering permanent contraception. sex: FEMALE minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Eleanor Schwarz, MD, MS role: CONTACT email: eleanor.schwarz@ucsf.edu name: Hannah Begna, MS role: CONTACT email: hannah.begna@ucsf.edu lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06296784 id: PG/2021/8551 briefTitle: An E-health Psychoeducation for People With Bipolar Disorders overallStatus: COMPLETED date: 2021-05-26 date: 2021-11-15 date: 2021-11-15 date: 2024-03-06 date: 2024-04-05 name: University of Cagliari class: OTHER name: Alessandra Perra briefSummary: This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic conditions: Bipolar Disorder conditions: Psychoeducation conditions: COVID-19 Pandemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Open-label cross-over randomized controlled trial (two arms) primaryPurpose: TREATMENT masking: NONE count: 36 type: ACTUAL name: e-health psychoeducation measure: Generalized Anxiety Disorder (GAD-7) measure: Hamilton Depression Rating Scale (HDRS21) measure: Short Form Health Survey (SF-12) measure: Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Giovanni di Dio Hospital city: Cagliari state: CA zip: 09100 country: Italy lat: 39.23054 lon: 9.11917 hasResults: False

 nctId: NCT06296771 id: 12345678280233 id: UBath type: REGISTRY domain: Chatwalai briefTitle: The Effect of a Combined Aerobic and Resistance Exercise (CARE) Training Programme on Cardiometabolic Outcomes in Individuals With Chronic Spinal Cord Injury: A Randomised Controlled Trial acronym: CARE training overallStatus: NOT_YET_RECRUITING date: 2024-05-22 date: 2025-02-22 date: 2025-05-22 date: 2024-03-06 date: 2024-03-06 name: University of Bath class: OTHER briefSummary: The goal of this study is to investigate the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on the cardiometabolic health outcomes of individuals with chronic spinal cord injury. This study is a randomised controlled trial conducted at a single centre, consisting of two parallel arms. The main questions it aims to answer are:

1. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on cardiometabolic disease biomarker outcomes in individuals with chronic SCI
2. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on fitness and health outcomes.

Twenty-one participants will be randomly assigned in a 2:1 allocation ratio. The participants will be assigned to either the dietary energy restriction and exercise group (D+E) group, which combines dietary energy restriction and exercise intervention, or the dietary energy restriction group (D) group, which just undergoes dietary energy restriction using sealed envelopes. conditions: Spinal Cord Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Dietary energy restriction group (D) name: Dietary energy restriction and exercise group (D+E) measure: Lipid profile measure: Fasting insulin concentration measure: Insulin sensitivity measure: Resting matabolic rate measure: Body mass measure: Waist and hip circumference measure: Height measure: Total body fat percentage measure: Total Fat-Free Mass measure: Visceral Adipose Tissue measure: Total Fat Mass measure: Muscle, adipose and bone cross-sectional areas around the tibia and femur measure: Bone geometry and tissue densities around the tibia and femur measure: adipose tissue measure: Upper extremity muscle strength measure: Balance measure: Health-related quality of life measure: Shoulder Pain measure: Energy intake and dietary macronutrient composition measure: Energy expended in different physical activity intensities (MET categories) (kJ or kcal) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bath city: Bath state: England zip: BA2 7AY country: United Kingdom name: James Bilzon, PhD role: CONTACT email: jb438@bath.ac.uk name: Jennifer Maher, PhD role: CONTACT email: jilm92@bath.ac.uk name: Chatwalai Sonthikul, Master degree role: PRINCIPAL_INVESTIGATOR lat: 51.3751 lon: -2.36172 hasResults: False

 nctId: NCT06296758 id: SiFi_HIP FRACTURE briefTitle: SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-03-06 date: 2024-03-06 name: University of Alberta class: OTHER briefSummary: The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study. conditions: Hip Fractures conditions: Surgery conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A concealed-allocation parallel-group blinded randomized controlled clinical primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization will be conducted through blocked randomization with blocks of 4 according to a schedule not known to the investigators using a computerized algorithm. The attending surgeon, anesthetist, and nursing team will be blinded to the randomization assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: Regional anesthesia measure: Postoperative pain measure: Postoperative analgesics administered measure: Mobilization measure: Time to readiness for discharge measure: Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alberta Hospital city: Edmonton state: Alberta zip: t6g2b7 country: Canada lat: 53.55014 lon: -113.46871 hasResults: False

 nctId: NCT06296745 id: 2024-KY-008-01 briefTitle: Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2026-01-20 date: 2026-03-20 date: 2024-03-06 date: 2024-03-06 name: Guangzhou Medical University class: OTHER briefSummary: Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. An international multi-center clinical study published in 2019 confirmed that double dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, the choice of treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib. conditions: Leptomeningeal Metastasis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Pemetrexed measure: Clinical response rate measure: Neurological progression-free survival (NPFS) measure: Overall survival measure: Incidence of treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296732 id: NCPHOI-2024-01 briefTitle: Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification acronym: ANLAP-R overallStatus: RECRUITING date: 2023-10-19 date: 2026-10-26 date: 2031-11-01 date: 2024-03-06 date: 2024-03-06 name: Federal Research Institute of Pediatric Hematology, Oncology and Immunology class: OTHER name: Corporate Fund University Medical Centre briefSummary: Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (\>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma. conditions: Neuroblastoma conditions: Ganglioneuroma conditions: Ganglioneuroblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Duration of surgery intervention measure: Duration of surgery intervention measure: The influence of surgical risk factors measure: Cases of conversion from laparoscopic to cavity access measure: Comparison of surgeon's visual assessment of the tumor resection measure: 1-, 3-, 5-years local recurrence-free survival sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Research Institute of Pediatric Hematology, Oncology and Immunology status: RECRUITING city: Moscow country: Russian Federation name: Dmitry m Akhaladze, MD, Doc role: CONTACT phone: +7 (905) 587-89-92, email: d.g.akhaladze@gmail.com lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06296719 id: ACP Community 2024 briefTitle: The Chit-Chat Educational Intervention to Promote Advance Care Planning in the Community overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-03-06 date: 2024-03-06 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity. conditions: Old Age conditions: Family Members studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chit-Chat measure: ACP engagement measure: Knowledge of ACP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296706 id: HB1801-010 briefTitle: A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-01 date: 2027-06-01 date: 2024-03-06 date: 2024-03-06 name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. class: INDUSTRY briefSummary: This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 630 type: ESTIMATED name: Docetaxel for injection (Albumin-bound) name: Taxotere (docetaxel) measure: OS measure: ORR by IRC measure: ORR by investigator measure: PFS measure: DCR measure: DoR measure: AE and SAE measure: Plasma concentration of docetaxel (free and total) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296693 id: 2023.062(051-DEFI/053-CE) briefTitle: Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children acronym: POCUS-L overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-04-30 date: 2024-03-06 date: 2024-03-06 name: Centro Hospitalar Universitário de Santo António class: OTHER briefSummary: 1. Background and study aims Pneumonia is the leading infectious cause of death in children worldwide. Although the diagnosis is clinical, a chest radiograph (CXR) is often necessary to clarify it, exposing the patient to radiation. Ultrasound has been increasingly used in the evaluation of the lung parenchyma without exposing patients to radiation. The pocket-size Point-of-Care Ultrasound (POCUS) can be used at the patient's bedside proving comfort and saving time. Evidence suggests that ultrasound can detect CAP (community-acquired pneumonia) in children with similar accuracy and reliability as CXR. However, few studies evaluated the ability to distinguish the aetiology of pneumonia and none used a pocket-size POCUS device. This study aims to assess, for the first time, the diagnostic accuracy of a pocket-size POCUS device for the etiological diagnosis of CAP vs. CXR, in paediatric ages. Secondarily, the investigators intend to evaluate the correlation between CXR image vs. ultrasound, the correlation between clinical progression and ultrasound images, and the diagnostic accuracy to detect complications.
2. Who can participate:

   The investigators will include, consecutively, all children aged \>12 months and \<18 years hospitalized to the Paediatric Department with the diagnosis of CAP on admission. The investigators will exclude children hospitalized with nosocomial pneumonia, with cystic fibrosis diagnosis or on long-term domiciliary ventilation.
3. What does the study involve:

   The diagnostic accuracy between POCUS and CXR in differentiating the type of pneumonia will be assessed. All participants will perform a POCUS at admission, daily during hospitalization, 15 days and 1 month after discharge. All children will also undergo a CXR upon admission and whenever necessary.
4. What are the possible benefits and risks of participating:

   Children will have a more frequent and serial assessment of CAP, which does not involve risks.
5. Where is the study run from:

   The study if from Centro Materno Infantil do Norte - Centro Hospitalar Universitário de Santo António, a tertiary paediatric referral centre.
6. When is the study starting and how long is it expected to run for:

The recruitment period is expected to start in January/2024 and end in January 2025. conditions: Pneumonia conditions: Pneumonia, Viral conditions: Pneumonia, Bacterial studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 76 type: ESTIMATED name: Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized measure: POCUS vs. CXR for the etiological diagnosis of CAP measure: CXR image vs. ultrasound measure: Clinical progression and ultrasound images measure: Complications sex: ALL minimumAge: 12 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06296680 id: EGE_UNI_SEVCAN_OZ_KAHVECI_0001 briefTitle: Reiki for Cancer: Pain, Anxiety, and Stress overallStatus: COMPLETED date: 2022-09-02 date: 2022-11-30 date: 2023-06-30 date: 2024-03-06 date: 2024-03-06 name: Ege University class: OTHER briefSummary: The goal of this clinical trial is to investigate the effects of Reiki, Sham Reiki, and Progressive Relaxation Exercise on the levels of pain, anxiety, and stress in cancer patients.

The main questions it aims to answer are:

* Question 1: The effect of Reiki applied to cancer patients on the level of pain within the time series is higher in favor of the intervention group.
* Question 2: The effect of Reiki applied to cancer patients on the level of anxiety within the time series is higher in favor of the intervention group.
* Question 3: The effect of Reiki applied to cancer patients on cortisol levels within the time series is higher in favor of the intervention group.
* Question 4: The effect of Reiki applied to cancer patients on the level of stress within the time series is higher in favor of the intervention group.
* Participants have answered the questions in the Individual Identification Form, Visual Comparison Scale, State Anxiety Scale and Perceived Stress Scale and serum cortisol levels were evaluated in the pretest.
* Afterwards, the patients in the intervention group received Reiki for four consecutive days, the patients in the placebo group received Sham Reiki, and the patients in the control group received Progressive Relaxation Exercise.
* The patients in the experimental group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four days, with an average of three minutes.
* The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four days, with an average of three minutes.
* Progressive Relaxation Exercise (PRE) group patients received PRE for four days.
* On the 4th day, pain and anxiety levels (0-10 Likert-type scale) of the patients were evaluated after the last applications.
* On the 21st day, the day of the next chemotherapy cycle, pain and anxiety levels were evaluated, state anxiety scale and perceived stress scale were administered, and serum cortisol level was evaluated in the morning before the start of chemotherapy.
* At the 3rd month follow-up, pain and anxiety levels (0-10 Likert-type scale), state anxiety scale and perceived stress scale were evaluated. conditions: Therapeutic Touch conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study is a three-arm intervention trial. Reiki was applied to the intervention group, Sham Reiki to the placebo group, and Progressive Relaxation Exercise to the control group. The effects of these three methods applied to cancer patients on their levels of pain, anxiety, and cortisol were examined. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: In order to prevent assessment bias, blinding was implemented throughout the collection of data from patients, evaluation of the effectiveness and reliability of the applied dependent variables, data processing, reporting, and statistical analysis. The researcher was provided with a randomization list by a statistical expert. The researcher was included in the study without knowing which group the patients would be assigned to, and the patients were also enrolled without knowledge of their group assignment. Therefore, this study was conducted as a three-arm, double-blind, randomized follow-up study in the experimental research model, with intervention, placebo, and control groups. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 58 type: ACTUAL name: Reiki name: Sham Reiki name: Progressive Relaxation Exercise measure: Stress levels measure: Anxiety levels measure: Pain levels sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: İzmir zip: 35100 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06296667 id: P.T.REC/012/003644 briefTitle: Effect of Core Muscles Training On Patients With Chronic Mechanical Low Back Pain According To SALIBA'S Postural Classification System overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2024-03-15 date: 2024-04-01 date: 2024-03-06 date: 2024-03-06 name: Cairo University class: OTHER briefSummary: This study is designed as a pre and post experimental study. The purposes of this study are to evaluate the effect of core muscles training in patients with chronic mechanical low back pain according to SALIBA'S postural classification system (SPCS) in terms of pain intensity, function, and core muscles endurance. conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: core muscles training exercises measure: pain intensity. measure: function disability measure: core muscles endurance measure: participants gender will be male and females, their age in years,their height in meters,weight in kilograms. sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Cairo University,Faculty of Physical Therapy city: Giza zip: 11432 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06296654 id: 25/2021-22 dt. Dec. 12,2021 briefTitle: Effect of Empowerment-Based Interventions on Self-Efficacy and Self-Care Capacity Among Adults With Sickle Cell Disease overallStatus: COMPLETED date: 2022-03-20 date: 2022-10-21 date: 2022-10-22 date: 2024-03-06 date: 2024-03-06 name: University of Bahrain class: OTHER briefSummary: This study aimed to To investigate the effect of empowerment-based interventions (EBI) on self-efficacy and self-care capacity among adults with Sickle Cell Disease (SCD).

The hypotheses of this study were: Adults with SCD who receive EBI exhibit higher self-efficacy, self- management capacity and HRQoL than those who do not. conditions: Self-Efficacy conditions: Self-Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 68 type: ACTUAL name: Empowerment-Based Interventions name: Standard Health Education measure: Sickle Cell Self-Efficacy measure: Self-Care Capacity sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: College of Health and Sport Sciences, University of Bahrain city: Manama zip: 11511 country: Bahrain lat: 26.22787 lon: 50.58565 hasResults: False

 nctId: NCT06296641 id: AAAU9477 briefTitle: Needs Navigation for Caregivers of AYAs acronym: Cope-CAYAC overallStatus: RECRUITING date: 2024-02-16 date: 2025-02 date: 2025-05 date: 2024-03-06 date: 2024-03-06 name: Columbia University class: OTHER briefSummary: The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA cancer survivors. Aim 1 aimed to refine a needs navigation model in partnership with expert consultants. Aim 2 and 3 will involve the deployment and pilot testing of the adapted needs navigation intervention among caregivers of younger AYAs with cancer. conditions: Cancer in Adolescence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants who screen positive all move forward to receive the intervention primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: Needs navigation intervention measure: Number of (OR percentage of) participants who completed the intervention measure: Percentage of eligible participants who consented to be in study measure: Personal Financial Wellness Scale (PFWS) / Comprehensive Score of Financial Toxicity (COST measure) sex: ALL minimumAge: 15 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: Columbia University Irving Medical Center status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO role: CONTACT lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06296628 id: 2000037049 id: 000 type: OTHER domain: CTGTY briefTitle: Rehabilitation Device for Hand Mirror Therapy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-06 date: 2024-03-06 name: Yale University class: OTHER name: Management Center Innsbruck (MCI), Austria name: Yale School of Engineering Center for Engineering 26 Innovation and Design briefSummary: This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are patients admitted to the acute inpatient rehabilitation unit for rehabilitation of the hand and fingers who have one paralyzed hand without pronounced spasticity. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Miraπ name: Mirror Therapy measure: Change in Jebsen-Taylor Hand Function Test score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital city: Bridgeport state: Connecticut zip: 06610 country: United States lat: 41.16704 lon: -73.20483 hasResults: False

 nctId: NCT06296615 id: 2020-022 briefTitle: Whether Vaginal Microbiota Affects Pregnancy Outcomes After Embryo Transfer overallStatus: COMPLETED date: 2021-04-01 date: 2022-10-30 date: 2022-10-30 date: 2024-03-06 date: 2024-03-08 name: ShangHai Ji Ai Genetics & IVF Institute class: OTHER briefSummary: The goal of this observational study is to learn about vaginal microbial characteristics in the patients under in vitro fertilization treatment. The study aims to address the following questions: (1) Is there any difference in microbial composition between the pregnancy and non-pregnancy groups? (2) Is there any differences in specific bacterial species between the two groups? (3) What are the favorable or unfavorable profiles of vaginal microbiota associated with achieving pregnancy? Patients will be asked to complete a questionnaire regarding their basic characteristics, and vaginal secretions will be collected via vaginal swab during frozen-blastocyst transfer procedures. The study will compare vaginal microbiota between pregnant and non-pregnant patients to assess its potential influence on clinical outcomes. conditions: Infertility, Female conditions: Microbial Colonization studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 161 type: ACTUAL measure: Rate of clinical pregnancy sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Shanghai Ji Ai Genetics & IVF Institute city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06296602 id: 2023/777 briefTitle: Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV) acronym: ANAPreP'HPV overallStatus: RECRUITING date: 2024-03-04 date: 2024-11-04 date: 2024-11-04 date: 2024-03-06 date: 2024-03-08 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation. conditions: Pre-Exposure Prophylaxis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.

A questionnaire will be completed by the doctor to record the data of interest. primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. measure: prevalence HPV measure: typing HPV measure: High risk HPV risk factors measure: Cytologist abnormalies sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Besançon status: RECRUITING city: Besancon zip: 25000 country: France name: Cédric LEBRETON, Dr role: CONTACT lat: 47.24878 lon: 6.01815 hasResults: False

 nctId: NCT06296589 id: HT94252310861 briefTitle: Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure acronym: PORT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-07 date: 2027-08 date: 2024-03-06 date: 2024-03-06 name: Veterans Medical Research Foundation class: OTHER name: University of Minnesota name: Center for Veterans Research and Education briefSummary: The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are:

Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame? conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 158 type: ESTIMATED name: Trauma Informed Guilt Reduction Therapy name: Prolonged Exposure Therapy measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Brief Psychosocial Functioning Inventory (B-IPF) measure: Trauma Related Guilt Inventory Cognitions Scale (TRGI) measure: Trauma Related Shame Inventory (TRSI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Little Rock Veterans Health Care System (LRVHCS) city: Little Rock state: Arkansas zip: 72205 country: United States name: Brandon Griffin role: CONTACT phone: 501-257-1000 email: Brandon.Griffin2@va.gov lat: 34.74648 lon: -92.28959 facility: Southeast Louisiana Veterans Health Care System (SLVHCS) city: New Orleans state: Louisiana zip: 70119 country: United States name: Laurel Franklin, PhD role: CONTACT phone: 800-935-8387 email: Laurel.Franklin@va.gov lat: 29.95465 lon: -90.07507 facility: William S. Middleton Memorial Hospital city: Madison state: Wisconsin zip: 53705 country: United States name: Michael Messina, PhD role: CONTACT phone: 608-284-6302 email: Michael.Messina2@va.gov lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06296576 id: CHM-2023/S49/06 briefTitle: Acceleration Time Assessment for Prediction of Critical Limb Ischemia acronym: ATACLI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-05-01 date: 2026-05-01 date: 2024-03-06 date: 2024-03-06 name: Centre Hospitalier le Mans class: OTHER briefSummary: Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries.

Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset \> 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) \< 50mmHg or toe systolic pressure (TSP) \< 30 mmHg or transcutaneous oxygen pressure (TCPO2) \< 30 mmHg).

Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery).

The main aim of our study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible. conditions: Critical Limb Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 431 type: ESTIMATED name: arterial ultrasound scan measure: Evaluate the intrinsic diagnostic performance of the maximum systolic rise time (TASmax) in the distal arteries of the foot sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de CHOLET city: Cholet zip: 49300 country: France name: Marie GAUME role: CONTACT email: marie.gaume@ch-cholet.fr name: Jean-Eudes TRIHAN, MD role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: -0.88333 facility: Centre Hospitalier du Mans city: Le Mans zip: 72000 country: France name: Christelle JADEAU role: CONTACT phone: 02 44 71 07 81 email: cjadeau@ch-lemans.fr name: Claire NEVEUX-BRECHETEAU, MD role: PRINCIPAL_INVESTIGATOR lat: 48.0 lon: 0.2 hasResults: False

 nctId: NCT06296563 id: SHR1316-ICC-SD-001 briefTitle: Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2029-03-01 date: 2024-03-06 date: 2024-04-17 name: Lei ZHAO class: OTHER briefSummary: The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are:

How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery.

Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: HAIC name: Adebrelimab name: Apatinib measure: Pathologic complete response (pCR) measure: Objective response rate (ORR) measure: Event free survival (EFS) measure: Overall Survival (OS) measure: Disease Control Rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Cancer Hospital and Institute status: RECRUITING city: Jinan state: Shandong zip: 250117 country: China name: Lei Zhao, MD role: CONTACT phone: +86 053167626368 email: drzhaolei@hotmail.com name: Peifei Sun, MD role: CONTACT phone: +86 053167626242 name: Lei Zhao, MD role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06296550 id: Dulce Digital CGM briefTitle: Enhancing Digitally Delivered Diabetes Education With Real-Time CGM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-03-06 date: 2024-03-06 name: Scripps Whittier Diabetes Institute class: OTHER briefSummary: The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients. conditions: Diabetes Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Dulce Digital Text Messaging Intervention name: CGM Device measure: HbA1c measure: CGM Metric Time in Range measure: CGM Metric Time above Range measure: CGM Metric Time Below Range measure: Summary of Diabetes Self Care Activitiers (SDSCA) Survey measure: Diabetes Distress Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scripps Whittier Diabetes Institute city: San Diego state: California zip: 92121-1520 country: United States name: Athena Philis-Tsimikas, MD role: CONTACT phone: 858-729-4830 email: tsimikas.athena@scrippshealth.org name: Kallie Brown, MA role: CONTACT phone: 858-678-6294 email: brown.kallie@scrippshealth.org lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06296537 id: E-10840098-202.3.02-1434 briefTitle: Effectiveness of Balance Training And Dynamic Neuromuscular Stabilization Training in Amateur Athletes With Chronic Ankle Instability overallStatus: RECRUITING date: 2024-03 date: 2024-07 date: 2024-07 date: 2024-03-06 date: 2024-03-06 name: Medipol University class: OTHER briefSummary: The goal of this clinical trial is to determine and compare the effects of balance and dynamic neuromuscular stabilization training on ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance of amateur athletes with chronic ankle instability. The main questions it aims to answer are:

* Do balance and dynamic neuromuscular stabilization training positively affect functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?
* Does balance training or dynamic neuromuscular stabilization training have a more positive effect on functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?

Participants will apply:

* a dynamic neuromuscular stabilization training program consisting of a series of special exercises based on the developmental kinesiology steps of a healthy baby.
* balance training which consist of an effective postural stability program.
* conventional training program which consist of stretching, joint range of motion, strengthening and postural control exercises.

Researchers will compare balance and dynamic neuromuscular stabilization training to see if effectiveness of ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance. conditions: Ankle Inversion Sprain conditions: Chronic Instability of Joint conditions: Chronic Pain conditions: Athlete Foot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is designed as a prospective, randomized, controlled study. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Dynamic Neuromuscular Stabilization Training (DNS) name: Balance Training name: Conventional Training measure: Star Excursion Balance Test measure: Balance Error Scoring System (BESS) measure: Foot and Ankle Ability Measurement (FAAM) measure: Cumberland Ankle Instability Questionnaire measure: International Physical Activity Questionnaire - Short Form measure: Manual Muscle Strength Test with Hand Dynamometer measure: Single Heel Lift Test measure: Joint Position Sense Test measure: Foot Lift Test measure: Blazepod Reaction Time measure: Side Hop Test sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Sevval Yeşilkır status: RECRUITING city: Istanbul state: Beşiktaş zip: 34347 country: Turkey name: Sevval Yeşilkır role: CONTACT phone: +90 530 869 64 76 email: sevvalyslkr98@gmail.com name: Gizem Ergezen role: CONTACT phone: +90 216 681 24 70 email: gergezen@medipol.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06296524 id: SPC-2022-09 briefTitle: Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot overallStatus: RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-03-30 date: 2024-03-06 date: 2024-03-07 name: Maharishi Markendeswar University (Deemed to be University) class: OTHER briefSummary: Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot. conditions: Flatfoot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Footcore exercises and conventional therapy name: conventional therapy measure: Navicular Drop Test measure: Harris Mat for Plantar Pressure Distribution sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: MMIPR status: RECRUITING city: Ambala state: Haryana zip: 133207 country: India name: Mousumi Saha, MPT role: CONTACT phone: +919366787310 email: msaha0029@gmail.com name: subhasish chatterjee, Phd(NEURO) role: CONTACT phone: +918950037407 email: subhasishphysio@gmail.com name: subhasish chatterjee, Phd role: PRINCIPAL_INVESTIGATOR lat: 30.36099 lon: 76.79782 hasResults: False

 nctId: NCT06296511 id: Loughborough University briefTitle: The Influence of Acute Moderate-intensity Continuous Exercise on Appetite Regulation overallStatus: COMPLETED date: 2023-06-23 date: 2023-11-07 date: 2023-11-07 date: 2024-03-06 date: 2024-03-06 name: Loughborough University class: OTHER briefSummary: A key area of obesity research has focused on the link between appetite, energy balance and weight control. Within this area, several appetite-related hormones and cellular cytokines have been identified as key signals influencing appetite and food intake. This includes the appetite-suppressing hormone oxyntomodulin (OXM) and a cellular stress-induced cytokine growth differentiation factor 15 (GDF-15).

The aims of this study are: (1) to investigate the effect of acute moderate-intensity continuous exercise on oxyntomodulin and GDF-15 concentrations; (2) to investigate whether exercise-induced changes in circulating OXM and GDF-15 concentrations are correlated with subjective appetite perceptions and subsequent energy intake. conditions: Obesity conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ACTUAL name: Exercise measure: Oxyntomodulin measure: Growth Differentiation Factor 15 measure: Visual analogue score (VAS) for subjective appetite measure: Energy intake sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Loughborough University city: Loughborough zip: LE11 3TU country: United Kingdom lat: 52.76667 lon: -1.2 hasResults: False

 nctId: NCT06296498 id: 20230505HU briefTitle: Application of L-PRF in Periodontal Surgery overallStatus: RECRUITING date: 2023-08-19 date: 2025-12 date: 2026-03 date: 2024-03-06 date: 2024-03-06 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The proposed study is a split-mouth design, randomized, prospective clinical trial in which we will use either OFD alone or OFD + L-PRF for periodontal surgery. Both procedures are standard of care primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be blinded to the intervention which they are randomized to. whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Leukocyte Platelet-rich fibrin name: Standard of care OFD measure: Probing depth measure: Postoperative Pain (PROM) sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Charles Powell, DDS, MS role: CONTACT phone: 210-567-3593 email: powellc2@uthscsa.edu lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06296485 id: IRB-1996616 id: R01DK134446 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK134446 briefTitle: Safer Aging With Diabetes Monitoring acronym: SAGE overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2027-03-30 date: 2028-01-31 date: 2024-03-06 date: 2024-03-06 name: Kaiser Permanente class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes. conditions: Diabetes Mellitus, Type 2 conditions: Hypoglycemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3-arm pragmatic randomized clinical trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participant randomization status will be masked during data collection (baseline and follow-up surveys) by research assistants whoMasked: OUTCOMES_ASSESSOR count: 360 type: ESTIMATED name: SAGE Group Sessions name: SAGE Group Sessions + Diabetes Pharmacist name: Usual Care measure: Hypoglycemia aggregate outcome measure: Self-reported hypoglycemia measure: Hypoglycemia-related utilization measure: Diabetes Distress measure: Hypoglycemia Confidence measure: Hypoglycemia Distress measure: Technology Proficiency measure: Confidence in Adjusting Insulin measure: Insulin Adjustment measure: Caregiver Action sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296472 id: MDQ23 briefTitle: De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy. overallStatus: RECRUITING date: 2024-02-27 date: 2025-02-01 date: 2025-12-30 date: 2024-03-06 date: 2024-03-06 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: The objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de Quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice:

* the control group will subsequently be subjected to a standard treatment based on the European guidelines of the HANDGUIDE group,
* the experimental group will subsequently carry out a program of eccentric exercises. conditions: De Quervain Disease conditions: Hand Tenosynovitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 134 type: ESTIMATED name: Rehabilitation name: Standard measure: Numeric Pain Rating Scale measure: Numeric Pain Rating Scale measure: Numeric Pain Rating Scale measure: Numeric Pain Rating Scale measure: Disabilities of Arm, Shoulder and Hand measure: Disabilities of Arm, Shoulder and Hand measure: Disabilities of Arm, Shoulder and Hand measure: Disabilities of Arm, Shoulder and Hand measure: Patient-Rated Wrist Evaluation measure: Patient-Rated Wrist Evaluation measure: Patient-Rated Wrist Evaluation measure: Patient-Rated Wrist Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna zip: 40136 country: Italy name: Fabio Vita, MD role: CONTACT email: fabio..vita@ior.it lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06296459 id: 20220556HU briefTitle: Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation overallStatus: RECRUITING date: 2022-09-21 date: 2024-12 date: 2025-03 date: 2024-03-06 date: 2024-03-06 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: A closed sinus augmentation is performed for dental implant placement. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A 2 arm study using two methods of imaging in a participant primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: 3D R100 scanner name: Conventional Radiograph measure: Dimensional Change in augmentation at 8mm measure: Dimensional Change in augmentation at 10mm measure: Dimensional Change in augmentation at 12mm sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Charles Powell, DDS, MS role: CONTACT phone: 210-567-3593 email: powellc2@uthscsa.edu lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06296446 id: disability fibromyalgia briefTitle: Disability of People With Fibromyalgia in Poland overallStatus: RECRUITING date: 2024-04-15 date: 2024-05-01 date: 2024-11-01 date: 2024-03-06 date: 2024-04-16 name: University of Rzeszow class: OTHER briefSummary: Fibromyalgia is a syndrome characterized by chronic, generalized pain in muscles and joints with the presence of characteristic, symmetrically occurring so-called "tender points" - areas of the body that are excessively sensitive to pressure. The condition is associated with a feeling of chronic fatigue, mood and sleep disturbances and a sensation of body stiffness. These complaints are bothersome and significantly impair patients' functioning in every aspect of their lives. There are few studies evaluating the functioning and disability of people with fibromyalgia. No such study has been conducted in Poland to date. Therefore, the purpose of this study is to evaluate the functioning and disability of fibromyalgia patients and the relationship of the level of disability with selected factors, such as pain intensity, emotional state, sleep quality, etc. conditions: Fibromyalgia conditions: Disabilities Multiple studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 700 type: ESTIMATED measure: disability measure: functioning measure: depression measure: Sociodemographic data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rzeszow status: RECRUITING city: Rzeszów state: Podkarpacie zip: 35-310 country: Poland name: Agnieszka Sozańska, professor role: CONTACT phone: +48 530172857 email: asozanska@ur.edu.pl lat: 50.04132 lon: 21.99901 hasResults: False

 nctId: NCT06296433 id: HCB_2023_1196 briefTitle: Extended Reality-Assisted Therapy for Chronic Pain Management acronym: XR-PAIN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2024-12-31 date: 2024-03-06 date: 2024-03-18 name: Institut d'Investigacions Biomèdiques August Pi i Sunyer class: OTHER briefSummary: The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:

Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement. conditions: Chronic Pain conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: VR rehabilitation name: VR video application measure: Brief Pain Inventory measure: Roland-Morris Disability Questionnaire measure: Short-Form 12 measure: Patient Global Impression of Change measure: Pain Catastrophization Scale measure: Spinal Range of motion measure: Adherence to treatment measure: Embodiment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IDIBAPS city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06296420 id: 24C304 briefTitle: Dysphagia After Thyroidectomy acronym: DYSPHATHYR overallStatus: RECRUITING date: 2024-01-31 date: 2025-11-30 date: 2026-11-30 date: 2024-03-06 date: 2024-03-12 name: Istituto Auxologico Italiano class: OTHER briefSummary: The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery.

Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy.

The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy.

In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy. conditions: Goiter conditions: Thyroid Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 420 type: ESTIMATED measure: The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself. measure: Patient and Observer Scar Assessment Scale (POSAS) 2.0. measure: Depression Anxiety Stress Scales-21 (DASS-21). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano status: RECRUITING city: Milan state: MI zip: 20122 country: Italy name: Stefano Scarano, MD role: CONTACT phone: +3902619116717 email: s.scarano@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06296407 id: 01C319 briefTitle: Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB). acronym: PSICOFISADOL overallStatus: RECRUITING date: 2023-08-08 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Istituto Auxologico Italiano class: OTHER briefSummary: Specifically, the project aims to pursue the following objectives:

1. To evaluate in male and female adolescents with obesity the interaction between different psycho-body aspects such as respiration - posture - self-perception and affectivity and tolerance to physical exercise;
2. To evaluate in a subgroup of male and female adolescents the effectiveness of exercises aimed at respiratory muscles and of respiratory consciousness on the parameters above indicated and on their interaction.

The final objective of this project is to define and propose "take home" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity. conditions: Obesity, Childhood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Standard metabolic integrated rehabilitation protocol - duration 3 weeks name: Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks measure: Fat mass measure: Fat-free mass measure: Maximal Inspiratory Pressure measure: Maximal Expiratory Pressure measure: Interoceptive awareness sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Istituto Auxologico Italiano, Site Piancavallo status: RECRUITING city: Oggebbio state: Verbania zip: 28824 country: Italy name: Alessandro Sartorio, MD role: CONTACT phone: +390261911 phoneExt: 2426 email: sartorio@auxologico.it lat: 45.99088 lon: 8.64663 hasResults: False

 nctId: NCT06296394 id: STUDY23080161 id: 1R01HL161164-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL161164-01A1 id: KAZMER22A0 type: OTHER_GRANT domain: Cystic Fibrosis Foundation briefTitle: Health Outcomes of Parents With Cystic Fibrosis-Aim 2 acronym: HOPeCF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2030-02-01 date: 2031-02-01 date: 2024-03-06 date: 2024-04-19 name: University of Pittsburgh class: OTHER name: Cystic Fibrosis Foundation name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are:

H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression.

H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress

H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators

Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link. conditions: Cystic Fibrosis conditions: Parenthood Status studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 146 type: ESTIMATED name: Parenthood measure: Forced Expiratory Volume (FEV1) measure: Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC) measure: Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1) measure: Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75) measure: History of CF Diagnosis measure: History of CF Genotype Information measure: History of CF Mutation measure: Number of Hospitalizations measure: Length of Hospitalizations measure: Number of Pulmonary Exacerbations measure: Severity of Pulmonary Exacerbations measure: Treatment of Pulmonary Exacerbations measure: Rate of Hospitalizations Due to Pulmonary Exacerbations measure: Clinic Visit Attendance measure: Microbiologic Profile measure: Medication use measure: History of CF-Related Diabetes Status measure: CF-Related Diabetes Control - Hemoglobin A1C measure: CF-Related Diabetes Control - Glucose Tolerance measure: CF-Related Diabetes Control - Insulin Prescription Usage measure: Liver Disease Status measure: Transplantation Status measure: Transplantation Type measure: BMI measure: Sleep Quality measure: Parental Stress measure: Life Stressors measure: Cystic Fibrosis Questionnaire to evaluate quality of life domains measure: Parental Responsibility measure: Daily Care Check-In measure: Social Support measure: Anxiety measure: Depression measure: Self-Reported Adherence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama-Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: George M Solomon, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States lat: 39.73915 lon: -104.9847 facility: Northwestern University city: Evanston state: Illinois zip: 60208 country: United States name: Manu Jain, MD role: PRINCIPAL_INVESTIGATOR lat: 42.04114 lon: -87.69006 facility: Indiana University city: Indianapolis state: Indiana zip: 46202 country: United States name: Cynthia Brown, MD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States name: Megan Behrman role: CONTACT email: mbehrman@kumc.edu name: Amanda Bruce, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.11417 lon: -94.62746 facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21218 country: United States lat: 39.29038 lon: -76.61219 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Boston Children's Hospital/Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Jonathan Greenberg role: CONTACT email: jonathan.greenberg@childrens.harvard.edu name: Manuela Cernadas, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Shijing Jia, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Daniel Rosenbluth, MD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 facility: Oregon Health and Science University city: Portland state: Oregon zip: 97239 country: United States name: Aaron Trimble, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Denis Hadjiliadis, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States name: Patrick Flume, MD role: PRINCIPAL_INVESTIGATOR lat: 32.77657 lon: -79.93092 facility: University of Texas-Southwestern city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: University of Washington city: Seattle state: Washington zip: 98195 country: United States lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06296381 id: 6.131.540 briefTitle: Normative Values for Peripheral Muscle Strenght in Critical Patients and Healthy Individuals acronym: HHD-ICU overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-31 date: 2027-12-30 date: 2024-03-06 date: 2024-03-15 name: University of Pernambuco class: OTHER name: Universidade Federal de Pernambuco name: Conselho Nacional de Desenvolvimento Científico e Tecnológico briefSummary: Muscle strength is an important indicator of overall health and is a factor that has been associated with increased mortality in critical patients. Its measurement must be reliable and reproducible to ensure a quality outcome for clinical applicability. Recently, the use of digital handheld dynamometers in intensive care has gained support; however, analysis becomes challenging due to the absence of standardized reference equations for the Brazilian population. The aim of this study is to develop reference equations for the Brazilian population and define specific cutoff points for men, women, healthy individuals, and critical patients. conditions: Intensive Care Unit conditions: Muscle Strength studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED measure: Peripheral muscle strength measured by hand held dynamometer measure: Peripheral muscle strength measured by Medical Research Council score measure: Peripheral muscle strength measured by hand grip dynamometer measure: Mobility in ICU measured by Perme Intensive Care Unit Mobility Score measure: Level of frailty in older adults by the Multidimensional Assessment of Older People (AMPI-AB) measure: Level of physical activity in young adults by the International Physical Activity Questionnaire - Short Form sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federal University of Pernambuco (UFPE) status: RECRUITING city: Recife state: PE zip: 50740-600 country: Brazil name: Shirley Campos role: CONTACT phone: +5581999413087 email: shirley.campos@ufpe.br name: Pedro Vinicius Porfirio role: CONTACT phone: +5581993954400 email: pedro.porfirio@ufpe.br name: Lucas Rafael da Silva Fraga role: SUB_INVESTIGATOR lat: -8.05389 lon: -34.88111 facility: Hospital Otávio de Freitas status: NOT_YET_RECRUITING city: Recife state: PE zip: 50920-460 country: Brazil name: Shirley L Campos role: CONTACT phone: +5581999413087 email: shirley.campos@ufpe.br lat: -8.05389 lon: -34.88111 facility: Hospital Nossa Senhora das Graças status: RECRUITING city: Recife state: PE zip: 51030-020 country: Brazil name: Lidier Roberta Moraes Nogueira role: CONTACT phone: +5581995479644 email: lidierroberta@outlook.com name: Shirley L Campos role: CONTACT phone: +5581999413087 email: shirley.campos@ufpe.br name: Jose Douglas de Souza Cordeiro role: SUB_INVESTIGATOR lat: -8.05389 lon: -34.88111 hasResults: False

 nctId: NCT06296368 id: LCCC2305 briefTitle: DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics acronym: DISCOVERY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2029-04 date: 2024-03-06 date: 2024-03-06 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care. conditions: Hematologic Malignancies conditions: Lymphoma conditions: Multiple Myeloma conditions: Leukemia conditions: Blood Cancers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 500 type: ESTIMATED name: Preference Reporting to Improve Management and Experience (PRIME) measure: Difference in COLLABORATE scores between arms measure: Difference in COLLABORATE scores between arms in a subgroup of patients sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lineberger Comphrehensive Cancer Center at University of North Carolina city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Mireille L Leone role: CONTACT phone: 919-445-0768 email: mireille_leone@med.unc.edu name: Daniel R Richardson,, MD, MA, MSc role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06296355 id: 24-0300d briefTitle: Impacts of Warning Labels on Ultra-Processed Foods overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2024-06-20 date: 2024-06-20 date: 2024-03-06 date: 2024-04-18 name: University of North Carolina, Chapel Hill class: OTHER name: Robert Wood Johnson Foundation briefSummary: Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).

Participants: \~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.

Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned. conditions: Health Behavior conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 4000 type: ESTIMATED name: Health Warning Label name: Identity Warning Label name: Barcode Label measure: Identification of a product as ultra-processed measure: Perceived product healthfulness of ultra-processed products measure: Intentions to purchase ultra-processed products measure: Perceived message effectiveness sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: UNC Carolina Population Center city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Violet Noe role: CONTACT email: violetn@email.unc.edu lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06296342 id: 24-0300c briefTitle: Message Framing and Policy Support for Front-of-package Labeling overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-03-31 date: 2024-03-31 date: 2024-03-06 date: 2024-03-06 name: University of North Carolina, Chapel Hill class: OTHER name: Duke University name: Stanford University briefSummary: This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support. conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 4000 type: ESTIMATED name: Exposure to information framing message name: Exposure to healthier choices framing message name: Exposure to industry framing message measure: Support for the front-of-package labeling policy, proportion sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Marissa G Hall role: CONTACT phone: 919-445-1310 email: mghall@unc.edu lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06296329 id: 21C309 briefTitle: Rubber Hand Illusion in Anorexia Nervosa acronym: RHI_size_AN overallStatus: RECRUITING date: 2023-04-01 date: 2024-02-27 date: 2024-04-30 date: 2024-03-06 date: 2024-03-08 name: Istituto Auxologico Italiano class: OTHER name: University of Turin, Italy briefSummary: The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 28 type: ESTIMATED name: Rubber Hand Illusion measure: Proprioceptive drift in centimeters measure: Score at the Embodiment questionnaires sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe status: RECRUITING city: Piancavallo state: VCO zip: 28824 country: Italy name: Federica Scarpina, PhD role: CONTACT phone: +39032351 phoneExt: 4003 email: f.scarpina@auxologico.it hasResults: False

 nctId: NCT06296316 id: IU022 briefTitle: Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair acronym: REPAIR overallStatus: RECRUITING date: 2023-11-21 date: 2031-12 date: 2031-12 date: 2024-03-06 date: 2024-03-06 name: Coloplast A/S class: INDUSTRY name: International Clinical Trials Association briefSummary: The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery. conditions: Genital Prolapse studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 428 type: ESTIMATED name: Restorelle Polypropylene Mesh measure: The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up measure: Incidence rate of surgical reintervention related to Restorelle mesh use in patients measure: Number of patients who have only had surgical reintervention not related to Restorelle mesh use measure: Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use measure: Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use) measure: Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use) measure: Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use) measure: Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention measure: Number of Adverse Device Effect measure: Percentage of Adverse Device Effect measure: Number of Restorelle mesh Device Deficiencies measure: Percentage of Restorelle mesh Device Deficiencies measure: Description of Restorelle mesh Device Deficiencies measure: Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire measure: Changes of prolapse symptoms measure: Prolapse symptoms - number measure: Prolapse symptoms - percentage measure: Assessment of health related quality of life using the EQ-5D-5L questionnaire measure: Assessment of health related quality of life using the PFIQ-7 questionnaire measure: Assessment of the sexual functioning by the PISQ-IR questionnaire measure: Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active. measure: Number of patients defining success via patient global impression of improvement (PGI-I) scale measure: Percentage of patients defining success via patient global impression of improvement (PGI-I) scale measure: Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8). measure: Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Polyclinique de la Baie status: NOT_YET_RECRUITING city: Avranches state: Choisir Une Région zip: 50300 country: France name: Frédéric Dubois, Dr role: CONTACT name: Frédéric Dubois, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.68333 lon: -1.36667 facility: Centre Aliénor d'Aquitaine status: NOT_YET_RECRUITING city: Bordeaux zip: 33076 country: France name: Claude Hocké, Pr role: CONTACT name: Claude Hocké, Pr role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: CHU Pellegrin status: NOT_YET_RECRUITING city: Bordeaux zip: 33076 country: France name: Grégoire Capon, Dr role: CONTACT name: Grégoire Capon, Dr role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: CH Paul Ardier d'Issoire status: NOT_YET_RECRUITING city: Issoire zip: 63500 country: France name: Clément Bruhat, Dr role: CONTACT name: Clément Bruhat, Dr role: PRINCIPAL_INVESTIGATOR name: Aslam Mansoor, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.55 lon: 3.25 facility: CH La Rochelle status: RECRUITING city: La Rochelle zip: 17019 country: France name: Philippe Ferry, Dr role: CONTACT name: Philippe Ferry, Dr role: PRINCIPAL_INVESTIGATOR name: Yannick Thirouard, Dr role: PRINCIPAL_INVESTIGATOR lat: 46.16667 lon: -1.15 facility: Clinique Bon Secours status: RECRUITING city: Le Puy-en-Velay zip: 43000 country: France name: Jacques Philippe Largeron, Dr role: CONTACT name: Jacques Philippe Largeron, Dr role: PRINCIPAL_INVESTIGATOR name: Marlène Guandalino, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.04366 lon: 3.88523 facility: CH Général Robert Boulin status: NOT_YET_RECRUITING city: Libourne zip: 33505 country: France name: Michel Briex, Dr role: CONTACT name: Michel Briex, Dr role: PRINCIPAL_INVESTIGATOR lat: 44.91667 lon: -0.23333 facility: Institut Mutualiste Montsouris status: NOT_YET_RECRUITING city: Paris zip: 75014 country: France name: Isabelle Sauret role: CONTACT name: Christine Louis Sylvestre, Dr role: PRINCIPAL_INVESTIGATOR name: Yael Levy Zauberman, Dr role: PRINCIPAL_INVESTIGATOR name: Camille Baraud, Dr role: PRINCIPAL_INVESTIGATOR name: Mathilde Allanche, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CH privé Saint Grégoire status: NOT_YET_RECRUITING city: Saint-Grégoire zip: 35760 country: France name: Frédéric Dubois, Dr role: CONTACT name: Frédéric Dubois, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.15085 lon: -1.68706 facility: CH de Saintonge status: NOT_YET_RECRUITING city: Saintes zip: 17108 country: France name: Damien Emeriau, Dr role: CONTACT name: Damien Emeriau, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.75 lon: -0.63333 hasResults: False

 nctId: NCT06296303 id: MBH24 briefTitle: Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-03 date: 2024-06-30 date: 2024-06-30 date: 2024-03-06 date: 2024-03-06 name: Cairo University class: OTHER briefSummary: Purposes of the study

To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients conditions: Lumbar Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Pulsed electromagnetic therapy name: Ultrasound phonophoresis name: Conventional physical therapy measure: Pain measure: Disability measure: Sciatic nerve cross sectional area measure: H-reflex amplitude measure: H-reflex side-to-side amplitude (H/H) ratio sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06296290 id: CARDIOCOLD briefTitle: Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function acronym: CARDIOCOLD overallStatus: COMPLETED date: 2022-06-04 date: 2022-06-06 date: 2022-08-15 date: 2024-03-06 date: 2024-03-06 name: University Hospital, Caen class: OTHER name: INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie briefSummary: A significant medical risk associated with hypothermia during exercise in a cold environment cardiac arrhythmia due to a possible autonomic conflict. However, little is known about the changes in heart rate and cardiac function after prolonged cold water swimming.

The investigators propose to measure the changes in core temperarure during and after a cold water swim at at a water temperature below 15.5°C qualifying for English Channel swim and to test the association with changes in heart rate variability, resting electrocardiogram and left ventricle function. conditions: Hypothermia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ACTUAL measure: Heart rate from a resting ECG recording measure: Heart rate from a 5-minute ECG recording measure: Transthoracic echocardiography (TTE) analysis measure: Change in Body Core Temperature measure: Body composition, body fat mass measure: Body composition, fat-free mass measure: Duration measure: Individual characteristics, gender measure: Individual characteristics, age measure: Individual characteristics, training in cold environment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Caen Normandie city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06296277 id: UPO#1! briefTitle: Mechanical Ventilation in Surgical Patients acronym: MEET VENUS overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-31 date: 2025-03-31 date: 2024-03-06 date: 2024-03-18 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER name: University Of Perugia name: University of Chieti name: Medical University of Vienna name: The Netherlands Cancer Institute name: Monash University briefSummary: This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded conditions: Surgery conditions: Ventilator Lung conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: Intraoperative mechanical ventilation for surgery measure: Postoperative pulmonary complications (PPCs) measure: Intraoperative adverse events (IAEs) measure: Intraoperative mechanical ventilation practice measure: Postoperative clinical outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296264 id: ULTRACATHLON briefTitle: Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-09 date: 2024-03-06 date: 2024-03-06 name: Centre Hospitalier Saint Joseph Saint Luc de Lyon class: OTHER briefSummary: The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.

The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room. conditions: IV Line Placement With Ultrasound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 250 type: ESTIMATED name: Standard ultrasound name: Ultra-portable ultrasound measure: Intravenous (IV) line placement time measure: Placement of the IV line successfully obtained from the first puncture measure: Number of skin perforations measure: Overall success rate after 3 punctures measure: Use an alternative solution (central catheter) measure: Patient satisfaction with IV line placement measure: Nurse satisfaction with IV line placement measure: Immediate complications related to intravenous access measure: Delayed complications related to intravenous access measure: Date of IV line placement and removal sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Joseph Saint Luc Hospital city: Lyon state: Rhone-alpes zip: 69007 country: France name: Emmanuel VIVIER, MD role: CONTACT phone: 0033478618209 email: evivier@saintjosephsaintluc.fr name: Fanny DOROSZEWSKI, Mrs role: CONTACT phone: 0033478618398 email: fdoroszewski@saintjosephsaintluc.fr name: Emmanuel VIVIER, MD role: PRINCIPAL_INVESTIGATOR name: Raphaël STREIFF, MD role: SUB_INVESTIGATOR name: Guillaume MARCOTTE, MD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06296251 id: BIO-2313 briefTitle: Dietary Supplementation on Body Fat Composition overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-12-27 date: 2025-02-27 date: 2024-03-06 date: 2024-04-01 name: Brightseed class: INDUSTRY briefSummary: The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo. conditions: Dyslipidemias conditions: Pre-diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Placebo treatment name: Plant derived phenolics measure: Body fat mass measure: Body composition measure: Android fat mass measure: Gynoid fat mass measure: Abdominal visceral fat mass measure: Abdominal circumference measure: Hip circumference measure: Chest circumference measure: Upper thigh circumference measure: Upper arm circumference measure: Waist to hip ratio measure: Fasting glucose measure: Fasting insulin measure: HbA1c measure: FGF21 measure: Systolic blood pressure measure: Diastolic blood pressure measure: Total-Cholesterol measure: HDL-C measure: LDL-C measure: VLDL-C measure: non-HDL-C measure: Triglycerides measure: Body Weight measure: Physical functioning measure: Bodily pain measure: Role limitations due to physical health measure: Role limitation due to personal or emotional problems measure: Emotional well-being measure: Social functioning measure: Energy/Fatigue measure: General health perceptions measure: Total kcals measure: Total fat measure: Total protein measure: Total carbohydrates measure: Fiber measure: Healthy Eating Index (HEI) score measure: ALT measure: AST sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296238 id: 2023P000461 briefTitle: Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia overallStatus: ENROLLING_BY_INVITATION date: 2023-02-15 date: 2024-06 date: 2025-02 date: 2024-03-06 date: 2024-03-06 name: Brigham and Women's Hospital class: OTHER name: Addis Continental Institute of Public Health name: Boston Children's Hospital name: New York University briefSummary: The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment.

Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment.

The main questions it aims to answer are:

1. What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes?
2. What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment?
3. What are the associations between maternal iodine status and thyroid function on infant neurodevelopment?

We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age. conditions: Prenatal Exposure Delayed Effects studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Visual Evoked Potential (VEP) P1 Latency measure: EEG Functional Connectivity measure: Cecile Attention Task measure: Infant Head Circumference measure: Bayley III, Cognition measure: MAAP - Accuracy and Speed measure: Hammersmith Infant Neurological Exam (HINE) sex: ALL minimumAge: 9 Months maximumAge: 27 Months stdAges: CHILD facility: Harvard Medical School city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Addis Continental Institute of Public Health city: Addis Ababa country: Ethiopia lat: 9.02497 lon: 38.74689 hasResults: False

 nctId: NCT06296225 id: CHRO-2023-07 briefTitle: Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase acronym: VIBRAMAIN1 overallStatus: RECRUITING date: 2024-03-05 date: 2025-09-01 date: 2025-12-01 date: 2024-03-06 date: 2024-03-19 name: Centre Hospitalier Régional d'Orléans class: OTHER briefSummary: It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.

The investigations will be carried out by a specialized physiotherapist from the neurology department.

The experiment consists of three successive phases:

* First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.
* Second : Rest period
* Third: control phase with measurement of the maximum grip force every ten minutes without vibration. conditions: Stroke conditions: Stroke, Acute conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Vibration measure: Maximum handgrip strength measured by a digital dynamometer measure: Fatigue evolution measure: Evolution of handgrip strength during the vibration session measured by a digital dynamometer sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH de Chartres status: NOT_YET_RECRUITING city: Chartres country: France name: Valentin BOHOTIN, Dr role: CONTACT email: vbohotin@ch-chartres.fr name: Valentin BOHOTIN, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.44685 lon: 1.48925 facility: CHU d'ORLEANS status: RECRUITING city: Orleans zip: 45067 country: France name: Canan OZSANCAK, Ph role: CONTACT email: canan.ozsancak@chu-orleans.fr name: Andreea AIGNATOAIE, Ph role: PRINCIPAL_INVESTIGATOR lat: 47.90289 lon: 1.90389 facility: Hopital Pitie Salpetriere status: NOT_YET_RECRUITING city: Paris country: France name: Charlotte ROSSO, Pr role: CONTACT email: charlotte.rosso@aphp.fr name: Charlotte ROSSO, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CHU de Tours status: NOT_YET_RECRUITING city: Tours country: France name: Marco PASI, Dr role: CONTACT email: m.pasi@chu-tours.fr name: Marco PASI, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.38333 lon: 0.68333 hasResults: False

 nctId: NCT06296212 id: GLT-07-22 briefTitle: Study of Intravenous TAD® 600 mg/4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-30 date: 2025-09-30 date: 2024-03-06 date: 2024-03-06 name: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica class: INDUSTRY briefSummary: The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury in patients with pneumonia.

The main question it aims to answer is:

• could TAD® used as an add-on treatment to the standard therapy, due to the presence of the sodium salt glutathione, be effective and safe in preventing the risk of developing myocardial injury in hospitalized patients with pneumonia?

Patients diagnosed with pneumonia (in the emergency department or hospital ward) will be asked to participate in the study and sign the Informed Consent Form (ICF) to assess their eligibility for enrollment.

Eligible patients who meet the study inclusion criteria and complete the required Screening \& Baseline (V0) examinations, will be randomized with a 1:1 ratio allocation to the IMP Test group (TAD® treatment) or IMP Placebo group (Placebo treatment) in a double-blind manner, PI \& Patient blinded.

TAD® (600 mg/4 mL reconstituted solution in 50 mL of 0.9% sodium chloride solution) or Placebo (50 mL of 0.9% sodium chloride solution) will be administered:

* intravenously (with an infusion rate of 10 mL/min)
* 2 times a day (with a dosing interval of 8 hours ± 30 minutes)
* for 5 consecutive days (Day 1, Day 2, Day 3, Day 4 and Day 5)
* patients will then be required to undergo five Follow-up Visits. conditions: Pneumonia conditions: Myocardial Injury studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 178 type: ESTIMATED name: TAD® 600 mg/4 mL powder and solvent for solution for injection name: Saline solution 0.9% of sodium chloride measure: Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria Pisana city: Pisa state: PI zip: 56126 country: Italy name: Massimiliano Desideri role: CONTACT lat: 43.70853 lon: 10.4036 facility: Fondazione Policlinico Universitario Campus Bio-Medico city: Roma state: RM zip: 00128 country: Italy name: Francesco Grigioni role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata city: Roma state: RM zip: 00133 country: Italy name: Francesco Barillà role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I city: Roma state: RM zip: 00161 country: Italy name: Pasquale Pignatelli role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Sant'Andrea city: Roma state: RM zip: 00189 country: Italy name: Alberto Ricci role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliera Santa Maria city: Terni state: TR zip: 05100 country: Italy name: Giacomo Pucci role: CONTACT lat: 42.56335 lon: 12.64329 facility: Ospedale Ca' Foncello city: Treviso state: TV zip: 31100 country: Italy name: Marcello Rattazzi role: CONTACT lat: 45.66673 lon: 12.2416 hasResults: False

 nctId: NCT06296199 id: 2024-2064 briefTitle: Music, Virtual Reality for Inpatients in IUGM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-05 date: 2024-03-06 date: 2024-03-06 name: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal class: OTHER_GOV briefSummary: Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.

Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety. conditions: Aging conditions: Disorder, Neurologic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: VR name: Music only measure: Feasability measure: Emotions variation measure: Affect variation measure: Well-Being Variation measure: Quality of life variation measure: Anxiety variation sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296186 id: HT94252310669 briefTitle: Massed Prolonged Exposure for PTSD in Substance Use Treatment acronym: PREVAIL overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-07 date: 2027-08 date: 2024-03-06 date: 2024-03-06 name: Veterans Medical Research Foundation class: OTHER name: University of Minnesota name: Center for Veterans Research and Education briefSummary: The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:

* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?
* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week. conditions: Stress Disorders, Post-Traumatic conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Prolonged Exposure Therapy measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) measure: Time Line Follow back (TLFB) measure: Psychotherapy Completion Rates measure: Patient Health Questionnaire-9 (PHQ-9) measure: Brief Psychosocial Functioning Inventory (B-IPF) measure: Client Satisfaction Questionnaire-8 (CSQ-8) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA San Diego Healthcare System city: San Diego state: California zip: 92161 country: United States name: Sonya Norman, PhD role: CONTACT phone: 858-518-8266 email: sonya.norman@va.gov lat: 32.71533 lon: -117.15726 facility: VA Tampa Healthcare System city: Tampa state: Florida zip: 33612 country: United States name: Brittany Davis, PhD role: CONTACT phone: 813-972-2000 email: brittany.davis@va.gov lat: 27.94752 lon: -82.45843 facility: VA Atlanta Healthcare System city: Atlanta state: Georgia zip: 30033 country: United States name: Kristin Lamp, PhD role: CONTACT email: kristen.lamp@va.gov lat: 33.749 lon: -84.38798 facility: Hines VA Healthcare System city: Chicago state: Illinois zip: 60141 country: United States name: Jonathan Bayer, PhD role: CONTACT email: jonathan.bayer2@va.gov lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06296173 id: MP-02-2024-12094 briefTitle: Open Lung Protective Extubation Following General Anesthesia acronym: OLEXT-3 overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-01 date: 2026-04-01 date: 2024-03-06 date: 2024-03-06 name: Centre hospitalier de l'Université de Montréal (CHUM) class: OTHER name: CHU de Quebec-Universite Laval name: The Ottawa Hospital name: University Health Network, Toronto name: Canadian Institutes of Health Research (CIHR) briefSummary: Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.

Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications. conditions: Intra-abdominal Surgery conditions: Anesthesia conditions: Lung Injury conditions: Ventilator-Induced Lung Injury conditions: Atelectasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: During surgical closure, the definitive ARISCAT score and exclusion criteria will be assessed. Patients will be randomized equally (1:1) using web-based allocation-concealed methods, with stratification by center and ARISCAT risk category. An unblinded research assistant will reveal group allocation to the anesthesiologist and monitor the emergence procedure. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Until surgical closure, all will be blinded to treatment allocation. Only specific healthcare professionals (anesthesiologist, respiratory therapist, operating room nurses, unblinded research assistant) will be present during emergence to maintain blinding. Other healthcare team members will remain blinded. Outcome adjudicators, Executive and Steering committee members, and the data analyst will also be blinded. No mechanism for unblinding is planned, as both interventions follow the same diagnostic and treatment algorithms for adverse effects. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 216 type: ESTIMATED name: Protective "open-lung" extubation name: Conventional extubation measure: Average weekly patient recruitment rate measure: Protocol adherence rate measure: Postoperative pulmonary complications outcome completion rate measure: Accuracy of self-reported protocol adherence compared to directly observed protocol adherence measure: Postoperative pulmonary complications measure: Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit measure: Quality of recovery measure: Discharge disposition measure: Days alive and out of hospital measure: Health-related quality of life measure: Lowest oxygen saturation post-extubation in the operating room measure: Time in minutes with oxygen saturation < 85% post-extubation in the operating room measure: Re-intubation rate in the operating room and in the post-anesthesia care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ottawa Hospital city: Ottawa state: Ontario zip: K1H 8L6 country: Canada name: Daniel I. McIsaac, MD role: CONTACT phone: 613-761-4940 email: dmcisaac@toh.ca name: Manoj Lalu, MD role: CONTACT email: mlalu@toh.ca name: Daniel I. McIsaac, MD role: PRINCIPAL_INVESTIGATOR name: Manoj Lalu, MD role: SUB_INVESTIGATOR lat: 45.41117 lon: -75.69812 facility: Unity Health Network city: Toronto state: Ontario zip: M5B 1W8 country: Canada name: Michael C. Sklar, MD role: CONTACT phone: 416-864-5071 email: michael.sklar@mail.utoronto.ca name: Ashwin Sankar, MD role: CONTACT email: ashwin.sankar@mail.utoronto.ca name: Michael C. Sklar, MD role: PRINCIPAL_INVESTIGATOR name: Ashwin Sankar, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Centre Hospitalier de l'Université de Montréal (CHUM) city: Montréal state: Quebec zip: H2X 0C1 country: Canada name: Martin Girard, MD role: CONTACT phone: 514-890-8000 email: martin.girard@umontreal.ca name: Eva Amzallag, MSC role: CONTACT phone: 514-890-8000 email: eva.amzallag.chum@ssss.gouv.qc.ca name: Michael Chassé, MD role: SUB_INVESTIGATOR name: François Martin Carrier, MD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: CHU de Québec - Université Laval city: Québec zip: G1V 4G2 country: Canada name: Alexis F. Turgeon, MD role: CONTACT phone: 418-525-4444 phoneExt: 66058 email: alexis.turgeon@fmed.ulaval.ca name: Michael Verret, MD role: CONTACT phone: 418-525-4444 phoneExt: 66847 email: michael.verret.med@ssss.gouv.qc.ca name: Alexis F. Turgeon, MD role: PRINCIPAL_INVESTIGATOR name: Michael Verret, MD role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06296160 id: MRC-01-23-035 id: LUSAM-HD type: OTHER_GRANT domain: COMITE D'ETHIQUE du CHU BRUGMANN c/o Direction Médicale briefTitle: A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis overallStatus: RECRUITING date: 2023-05-28 date: 2024-05-22 date: 2024-05-22 date: 2024-03-06 date: 2024-03-06 name: Hamad Medical Corporation class: INDUSTRY name: Brugmann University Hospital briefSummary: Pulmonary congestion secondary to volume overload or interstitial tissue inflammation is common in chronic hemodialysis patients. This pulmonary congestion occurs mainly during the period between dialysis sessions and is an independent risk factor for cardiovascular event morbidity and mortality in this population. The evaluation of this pulmonary congestion and the estimation of the dry weight of hemodialysis patients according to conventional methods represent a real challenge for clinical nephrologists. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. It would allow a better assessment of dry weight in chronic hemodialysis patients based on the results of preliminary studies, including our latest pilot study. However, there is little evidence comparing this novel approach to traditional approaches. conditions: End Stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will compare two groups according to the dry weight determination method:

(1) Control arm- modification of dry weight according to standardized care only. The standard of care to modify dry weight is what nephrologists use actually to define the best theoretical dry weight, including clinical (blood pressure, edema, shortness of breath, lung auscultation, etc.) and laboratory measures (Protein concentration before and after dialysis sessions ...). (2) Intervention arm- modify patient's dry weight according to standard of care + B lines score on lung ultrasound BLS obtained after the midweek dialysis session, considered as Day one (Day 1) primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: It is a single-blinded trial as the treatment is blinded by Subjects only, meaning that the type of dry weight modification will not be disclosed to the subject, and they will not know which group he/she will be in at the time of consenting to limit the bias in opinion. The investigator and the research team must know the type of treatment, as the investigator will modify the dry weight according to the treatment group. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Intervention Group measure: Assess the effectiveness of adding B-line score evaluation through lung ultrasound to the standard of care to improve pulmonary congestion (measured by B lines score) in hemodialysis patients measure: The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure. measure: The impact of utilizing B lines score based additional fluid removal on intradialytic ambulatory blood pressure sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaysi Saleh status: RECRUITING city: Bruxelles state: Van Gehuchten zip: 1020 country: Belgium name: Nortier Joelle, PHD role: CONTACT phone: +33643250634 email: saleh.kaysi@chu-brugmann.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06296147 id: STUDY23080006 briefTitle: Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy overallStatus: RECRUITING date: 2024-03-10 date: 2024-11-01 date: 2024-11-01 date: 2024-03-06 date: 2024-03-06 name: University of Pittsburgh class: OTHER briefSummary: The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 208 type: ESTIMATED name: Virtual Reality Headset name: Aromatherapy Patch name: Standard of Care measure: Levels of pain, fear, and embarrassment that each group experienced before the TPBx measured using a self-reported survey that asks about experience prior to biopsy. The survey will be provided after the procedure. measure: Levels of pain, fear, and embarrassment that each group experienced during the TPBx measured using a self-reported survey that asks about experience during the biopsy. The survey will be provided after the procedure. measure: Levels of pain, fear, and embarrassment that each group experienced after the TPBx measured using a self-reported survey that asks about experience after to biopsy. The survey will be provided after the procedure. measure: Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure. measure: Safety and feasibility of using a VR device or aromatherapy patch during TPBx via the proportion of procedures completed successfully with no major complications or prolongations. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pittsburgh Medical Center Shadyside Hospital status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Divya Natesan, BS role: CONTACT email: din15@pitt.edu name: John Myrga, MD role: CONTACT email: myrgajm@upmc.edu name: Bruce Jacobs, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06296134 id: 17501 briefTitle: Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation acronym: CO-LAM23 overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-12-31 date: 2025-12-31 date: 2024-03-06 date: 2024-03-06 name: Azienda Sanitaria Universitaria Friuli Centrale class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation. conditions: Pelvic Floor Disorders conditions: Levator Ani Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: perineal massage measure: Comparison of the percentages of women without levator ani muscle co-activation after treatment or after standard care, evaluated at 37-38 weeks of gestation, using chi square test. measure: Evaluation of significant differences in spontaneous or iatrogenic vaginal tears between the groups measure: percentage of women who completely adhere to perineal massage, i.e. who perform the perineal massage once a day, at least 5 days a week, from 34 gestational weeks until delivery. sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Serena Xodo city: Udine zip: 33100 country: Italy name: Serena Xodo role: CONTACT phone: 0432-559699 email: serena.xodo@gmail.com lat: 46.0693 lon: 13.23715 hasResults: False

 nctId: NCT06296121 id: BCD-264-2 briefTitle: A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma acronym: DARVIVA overallStatus: RECRUITING date: 2023-12-21 date: 2025-01 date: 2026-07 date: 2024-03-06 date: 2024-03-06 name: Biocad class: INDUSTRY briefSummary: The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 252 type: ESTIMATED name: BCD-264 name: Darzalex measure: Overall response rate according to IMWG (International Myeloma Working Group) criteria measure: Stringent complete response rate according to IMWG criteria measure: Complete response (CR) rate according to IMWG criteria measure: Very good partial response (VGPR) rate according to IMWG criteria measure: Duration of response measure: Progression-free survival measure: Time to progression measure: Time to response measure: Overall survival measure: Incidence and characteristics of adverse events measure: Proportion of subjects with BAbs/Nabs measure: Time to BAb/NAb development measure: AUC0-168 measure: AUC0-∞ measure: AUC0-336, ss measure: Cmax measure: Cmax, ss measure: Tmax measure: T1/2 measure: Vd measure: Ctrough, ss sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chelyabinsk Regional Clinical Hospital status: RECRUITING city: Chelyabinsk country: Russian Federation name: Alexander Korobkin role: CONTACT phone: +7 (351) 749-37-10 email: chelokb@mail.ru lat: 55.15402 lon: 61.42915 facility: Sverdlovsk Regional Clinical Hospital No. 1 status: RECRUITING city: Ekaterinburg country: Russian Federation name: Tatiana Konstantinova role: CONTACT phone: +7 (343) 363-03-03 email: sokbinfo@mail.ru lat: 56.8519 lon: 60.6122 facility: Kuzbass Regional Clinical Hospital named after S.V. Belyaev status: RECRUITING city: Kemerovo country: Russian Federation name: Marina Kosinova role: CONTACT phone: 8(384-2)39-65-33 email: o5-guz-kokb@kuzdrav.ru lat: 55.33333 lon: 86.08333 facility: Regional Clinical Hospital status: RECRUITING city: Krasnoyarsk country: Russian Federation name: Elena Martynova role: CONTACT phone: +7 (391) 202-68-50 email: kkb@medgorod.ru lat: 56.01839 lon: 92.86717 facility: Moscow City Clinical Hospital 52 status: RECRUITING city: Moscow country: Russian Federation name: Elena Misyurina role: CONTACT phone: +7 (495) 870-36-04 email: gkb52international@gmail.com lat: 55.75222 lon: 37.61556 facility: S.P. Botkin Moscow City Clinical Hospital status: RECRUITING city: Moscow country: Russian Federation name: Vadim Doronin role: CONTACT phone: +7 495 945 9972 email: botkinhospital@zdrav.mos.ru lat: 55.75222 lon: 37.61556 facility: Almazov National Medical Research Centre status: RECRUITING city: Saint Petersburg country: Russian Federation name: Yuri Osipov role: CONTACT phone: +7 (812) 660-37-06 email: fmrc@almazovcentre.ru lat: 59.93863 lon: 30.31413 facility: N.N. Petrov National Medicine Research Center of oncology status: RECRUITING city: Saint Petersburg country: Russian Federation name: Ilya Zyuzgin role: CONTACT phone: +7(812)43-99-555 email: oncl@rion.spb.ru lat: 59.93863 lon: 30.31413 facility: Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency status: RECRUITING city: Saint Petersburg country: Russian Federation name: Sergei Voloshin role: CONTACT phone: +78123097982 email: bloodscience@mail.ru lat: 59.93863 lon: 30.31413 facility: St Petersburg State I.P. Pavlov Medical University status: RECRUITING city: Saint Petersburg country: Russian Federation name: Ivan Moiseev role: CONTACT phone: (812) 338 67 48 email: opmu@spb-gmu.ru lat: 59.93863 lon: 30.31413 facility: State budgetary healthcare institution Leningrad Regional Clinical Hospital status: RECRUITING city: Saint Petersburg country: Russian Federation name: Margarita Ulyanova role: CONTACT phone: 8 (812) 670-18-88 email: lokb@47lokb.ru lat: 59.93863 lon: 30.31413 facility: Samara State Medical University status: RECRUITING city: Samara country: Russian Federation name: Igor Davydkin role: CONTACT phone: 8 (846) 374-91-00 email: clinica@samsmu.ru lat: 53.20007 lon: 50.15 facility: Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory status: RECRUITING city: Sochi country: Russian Federation name: Dmitrii Kirtbaya role: CONTACT phone: (862) 261-43-89 email: onko13@sochi.com lat: 43.59917 lon: 39.72569 facility: Bashkir State Medical University status: RECRUITING city: Ufa country: Russian Federation name: Bulat Bakirov role: CONTACT phone: 8 (347) 272-41-73 email: rectorat@bashgmu.ru lat: 54.74306 lon: 55.96779 hasResults: False

 nctId: NCT06296108 id: I05-310-22 briefTitle: Risk Factors for Acute Kidney Injury in Patients Undergoing Arthroplasty overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-31 date: 2022-12-31 date: 2024-03-06 date: 2024-03-06 name: Ankara University class: OTHER briefSummary: The authors aimed to determine the risk factors associated with postoperative acute kidney injury in patients undergoing total joint arthroplasty. conditions: Postoperative Acute Kidney Injury conditions: Arthroplasty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 911 type: ACTUAL name: acute kidney injury measure: Acute kidney injury in patients undergoing arthroplasty surgery measure: Risk factors causing acute kidney injury in patients undergoing arthroplasty surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara University Medical School Anesthesiology and ICU Department city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06296095 id: KDS-CUD-1 briefTitle: To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis overallStatus: ENROLLING_BY_INVITATION date: 2023-08-09 date: 2024-10-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis conditions: Cirrhosis, Liver studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Cell therapy measure: DLT,MTD measure: fibrosis staging and inflammatory grading measure: All-cause mortality measure: TE（Transient elastography） measure: MELD（Model for End-stage Liver Disease） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui province hospital city: Hefei state: Anhui zip: 230000 country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06296082 id: 49317 briefTitle: Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial acronym: STROKEPOC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2027-06-30 date: 2024-03-06 date: 2024-03-06 name: Universiteit Antwerpen class: OTHER name: McGill University name: Aragon Institute of Health Sciences briefSummary: Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeks

Trial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in \~30° flexion; 7) being able to walk independently with or without aids.

Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up.

The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities. conditions: Stroke conditions: Spasticity as Sequela of Stroke studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Each group will be assessed equally during the 19 weeks of the study duration. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participant will be randomized but ultimately will know which treatment he/she receives. A distinct investigator/assessor and intervention therapist wil be selected to treat or assess the participant whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Botulinum toxin type A name: Dry Needling measure: tonic stretch reflex threshold measure: Passive Resistance measure: Ultrasound Imaging: Morphometric Analysis measure: Ultrasound Imaging: Eco-textural Analysis of Muscle: measure: Dynamometry measure: Gait Analysis measure: 10 Meter Walk Test (10MWT) measure: Timed up and Go Assessment (TUG) measure: Quality of Life EuroQoL 5D measure: EQ visual analogue scale (EQ VAS) measure: Cost-effectiveness measure: Patient Acceptance measure: Frequency and Severity of Adverse Events for DN and BTX A measure: Sample size measure: Sample size and drop out sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296069 id: SwingIT-stroke briefTitle: Exergames on an Unstable Surface in Stroke Inpatients overallStatus: RECRUITING date: 2024-02-28 date: 2024-07-31 date: 2024-07-31 date: 2024-03-06 date: 2024-04-17 name: Eleftheria Giannouli class: OTHER briefSummary: Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.

This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: exergame-based cognitive-motor training on an unstable surface name: exergame-based cognitive-motor training on an stable surface measure: Security incidents measure: Attrition rate measure: Adherence rate measure: Usability measure: Training Load measure: Enjoyment measure: User experience measure: Training Goals measure: Changes in cognitive flexibility measure: Changes in psychomotor speed measure: Changes in selective attention measure: Changes in inhibition and brain activity measure: Changes in functional mobility measure: Changes in coordination measure: Changes in dynamic balance measure: Changes in static balance measure: Changes in gait measure: Changes in leg proprioception measure: Changes in balance confidence measure: Changes in gait confidence sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rehaklinik Zihlschlacht status: RECRUITING city: Zihlschlacht-Sitterdorf state: Thurgau zip: 8588 country: Switzerland name: Detlef Marks role: CONTACT phone: 071 424 37 51 lat: 47.51401 lon: 9.26776 hasResults: False

 nctId: NCT06296056 id: SDH-combi briefTitle: Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2027-06-01 date: 2024-03-06 date: 2024-03-06 name: Nyamdavaa Tuul class: OTHER briefSummary: To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions. conditions: Colorectal Cancer Stage IV conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Combi measure: Number of Patients with grade 1-5 adverse events and list of adverse event frequency measure: immune response measure: potential efficacy sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06296043 id: SBU-FUT-01 briefTitle: The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-07-15 date: 2024-08-15 date: 2024-03-06 date: 2024-04-01 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome. conditions: Premenstrual Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three groups with su-jok group, progressive muscle relaxation exercise group and control group primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Double (Participant, Outcomes Assessor) Since the application will be performed by the researcher, participant will be blinded in this study. The statistician will be blinded in the evaluation of the data. whoMasked: PARTICIPANT count: 135 type: ESTIMATED name: Progressive Muscle Relaxation Exercise Group name: Su-Jok Intervention measure: PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10) measure: FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10) measure: SLEEP STATE Visual Analog Scale (VAS)- (Min:0 - Max:10) measure: NAUSEA VOMITING Visual Analog Scale (VAS)- (Min:0 - Max:10) measure: Change in Premenstrual Symptoms (People with PMS scale scores over 104 points will be determined). sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False

 nctId: NCT06296030 id: 22-0010 briefTitle: Culturally Tailored ACT for Black Trauma overallStatus: WITHDRAWN date: 2021-09-01 date: 2022-09-01 date: 2023-08-31 date: 2024-03-06 date: 2024-03-06 name: Azusa Pacific University class: OTHER briefSummary: Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated.

Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed:

Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants.

Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks.

The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact. conditions: Stress Disorders, Traumatic conditions: Anxiety conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This project's research design is a two-by-two factorial design. Factor one, the type of ACT intervention delivered, has two levels - POOF delivery (level 1) and a classic ACT delivery (level 2). Factor two, the facilitator's first group treatment delivery, also has two levels. There are four (4) group facilitators. The first two facilitators deliver traditional ACT first (level 1), and the second two facilitators deliver POOF first (level 2). Each facilitator providing group treatment will facilitate two groups (classic and POOF), one after the next. However, facilitators will be randomized to the order in which they deliver their first group to reduce experimenter/ clinician history bias. All of the facilitators are licensed, mental health clinicians. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 0 type: ACTUAL name: POOF ACT program name: Classic ACT program measure: Race-Based Traumatic Stress sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azusa Pacific University city: Azusa state: California zip: 91702 country: United States lat: 34.13362 lon: -117.90756 hasResults: False

 nctId: NCT06296017 id: AEŞH- EK1- 2023-115 briefTitle: Effectiveness of Conservative Interventions in the Treatment of Trigger Finger overallStatus: RECRUITING date: 2023-10-02 date: 2024-09 date: 2024-12 date: 2024-03-06 date: 2024-04-29 name: Hacettepe University class: OTHER briefSummary: There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF. conditions: Trigger Finger conditions: Stenosing Tenosynovitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Experimental: Extracorporeal Shock Wave Therapy name: Trigger Finger Splint name: Extracorporeal Shock Wave Therapy+ Trigger Finger Splint measure: Visual analog scale measure: Grip and pinch strength measure: Number of trigger measure: Functional assessment measure: Treatment satisfaction measure: Functional assessment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Feray Karademir status: RECRUITING city: Ankara zip: 06100 country: Turkey name: Feray Karademir role: CONTACT phone: 90 505 313 75 82 email: karademirferay@gmail.com name: Feray Karademir role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06296004 id: CAPILLAROSCOPY behcet disease briefTitle: Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-03-06 date: 2024-03-06 name: Assiut University class: OTHER briefSummary: Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease conditions: Behçet's Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S measure: measuring parameter of Nail Fold Capillaroscopy in behcet disease measure: measuring parameter of Optical Coherence Tomography Angiography in behcet disease measure: measuring parameter of Femoral Vein Wall Thickness in behcet disease measure: relation between Nail Fold Capillaroscopy and activity of behcet disease measure: relation between Optical Coherence Tomography Angiography and activity of behcet disease measure: relation between Femoral Vein Wall Thickness and activity of behcet disease sex: ALL minimumAge: 19 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06295991 id: 2023/005 briefTitle: The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-21 date: 2024-07-30 date: 2024-03-06 date: 2024-03-06 name: Hacettepe University class: OTHER briefSummary: The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis, and the secondary aim was to investigate the effects of lycra clothing on motor function, activity limitation and quality of life in these individuals. conditions: Balanced; Rearrangement conditions: Respiratory Function Test studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Lycra garment measure: Balance parameters measure: Respiratory functions measure: Respiratory muscle strength measurement measure: Gross motor function measurement measure: Functional independence assessment measure: Assessment of activity restriction measure: Quality of life assessment measure: Assessment of posture sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06295978 id: 4896 briefTitle: Multimarker Approach in Acute Chest Pain overallStatus: RECRUITING date: 2021-02-01 date: 2024-05-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.

The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation. conditions: Cardiovascular Disease Other studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Biochemical marker assays measure: The predictive value of markers for the risk of cardiovascular events in chest pain measure: Multimarker approach to improve cardiovascular risk stratification sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario "A. Gemelli" IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: ANDREA PICCIONI, Dr. role: CONTACT phone: 0630153161 email: andrea.piccioni@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06295965 id: RG1123813 id: NCI-2023-10315 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: FHIRB0020162 type: OTHER domain: Fred Hutch/University of Washington Cancer Consortium id: R01CA272594 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA272594 briefTitle: Clonal Hematopoiesis in Ovarian Cancer Survivors and Risk of Secondary Blood Cancers overallStatus: RECRUITING date: 2024-01-02 date: 2028-12-31 date: 2031-12-31 date: 2024-03-06 date: 2024-03-12 name: University of Washington class: OTHER name: National Cancer Institute (NCI) briefSummary: This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer. conditions: Recurrent Fallopian Tube Carcinoma conditions: Recurrent Ovarian Carcinoma conditions: Recurrent Primary Peritoneal Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: Non-Interventional Study measure: Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients measure: Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors measure: Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fred Hutch/University of Washington Cancer Consortium status: RECRUITING city: Seattle state: Washington zip: 98109 country: United States name: Swisher Lab Research Coordinators role: CONTACT phone: 206-616-8927 email: swisherlabrc@uw.edu name: Elizabeth Swisher role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06295952 id: 23-371 briefTitle: A Study of Pasireotide in People With Prolactinoma overallStatus: RECRUITING date: 2024-02-27 date: 2027-02 date: 2027-02 date: 2024-03-06 date: 2024-03-06 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Evergreen Theragnostics name: Recordati Pharmaceutical company briefSummary: The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma. conditions: Prolactin-Producing Pituitary Tumor studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open label single-center pilot study. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Pasireotide measure: biochemical response rate measure: radiographic response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 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: Eliza Geer, MD role: CONTACT phone: 646-608-3797 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: Eliza Geer, MD role: CONTACT phone: 646-608-3797 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: Eliza Geer, MD role: CONTACT phone: 646-608-3797 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: Eliza Geer, MD role: CONTACT phone: 646-608-3797 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 name: Andrew Lin, MD role: CONTACT phone: 212-639-8392 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: Eliza Geer, MD role: CONTACT phone: 646-608-3797 lat: 40.70038 lon: -73.59291 hasResults: False

 nctId: NCT06295939 id: CA code 016/2565, 012/2566 briefTitle: Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-29 date: 2024-03-15 date: 2024-05-31 date: 2024-03-06 date: 2024-03-29 name: Sanpasitthiprasong Hospital class: OTHER_GOV briefSummary: Research Question:

Does participation in a social support program have an impact on the Perinatal Grief Scale of women who experience pregnancy loss through abortion? Research hypothesis

1. The grief scores from pregnancy loss among women who had to terminate their pregnancies in the group receiving social support program were lower than those in the group receiving standard nursing care.
2. The grief scores from pregnancy loss among women who had to terminate their pregnancies after receiving the social support program were lower than those before receiving the social support program.

Primary Objectives:

To study the grief and sorrow resulting from the loss of a fetus due to pregnancy termination in women who have undergone social support programs, in comparison to those who have received regular nursing care.

Secondary Objectives:

1. To investigate the grief and sorrow resulting from the loss of a fetus due to pregnancy termination after receiving social support programs compared to before receiving such programs.
2. To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage.
3. To explore other outcomes of pregnancy termination, such as complete abortion, uterine curettage, and post-miscarriage complications. conditions: Pregnancy Loss conditions: Grief conditions: Social Support studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. The researcher provided information about a research project involving pregnant women diagnosed with fetal demise or abnormalities, who are recommended to undergo pregnancy termination at the third trimester abortion clinic.
2. Pregnant women voluntarily consent to participate in the research by signing the informed consent form.
3. Volunteer participants providing consent will be randomly divided into two groups using the randomization technique with Excel program.
4. Divide into groups of 45 individuals each, totaling 90 participants in the entire sample. primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: social support program name: Routine nursing care measure: The Perinatal Grief Assessment Questionnaire. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Sanpasitthiprasong Hospital city: Ubon Ratchathani zip: 34000 country: Thailand lat: 15.23844 lon: 104.84866 hasResults: False

 nctId: NCT06295926 id: K5236 briefTitle: Serplulimab Combined With CCRT for LS-SCLC. overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2027-01-25 date: 2027-12-31 date: 2024-03-06 date: 2024-03-06 name: Peking Union Medical College Hospital class: OTHER briefSummary: Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis. conditions: Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Serplulimab measure: Progression free survival measure: Overall survival measure: Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 measure: objective response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06295913 id: HYTOLIVE15 briefTitle: Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases acronym: HYTOLIVE15 overallStatus: RECRUITING date: 2024-03 date: 2024-07 date: 2024-12 date: 2024-03-06 date: 2024-03-06 name: National Research Council, Spain class: OTHER_GOV name: Genosa I+D briefSummary: The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging. conditions: Overweight conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1, hydroxytyrosol-rich extract pill (Hytolive®); Group 2, placebo pill primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Participants will be randomly allocated to treatment A and B. Both pills will have the same aspect and will be packed similarly whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Group 1, hydroxytyrosol-rich extract capsule (Hytolive®) name: Group 2, capsule of placebo measure: LDL-ox as marker of oxidative status measure: Emotional well-being determined by Warwick-Edinburgh Mental Well-being Scale measure: Sleep quality determined by Pittsburgh Sleep Quality Index measure: Fatigue test determined by Borg Rating Of Perceived Exertion measure: Fasting glucose measure: Fasting insulin measure: Glycated hemoglobin (HbA1c) measure: Glucagon-like peptide-1 (GLP-1) measure: Total cholesterol measure: High density lipoproteins (HDL) measure: Low density lipoproteins (LDL) triglicéridos, apoliporpotein A1 and B) measure: Triglycerides measure: Apoliporpotein A1 measure: Apoliporpotein B measure: Total antioxidant status (TAS) measure: Total oxidative status (TOS) measure: Oxides of nitrogen (NOx) measure: Thiobarbituric acid reactive substances (TBARS) measure: C reactive protein measure: Interleukine 6 (IL-6) measure: Tumor necrosis factor alpha (TNF-α) measure: Interleukine 10 (IL-10) measure: Alanine aminotransfesare (transaminases ALT) measure: Aspartate aminotransferase (transaminase AST) sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC) status: RECRUITING city: Madrid state: Comunidad Autónoma De Madrid zip: 28040 country: Spain name: Raquel Mateos, PhD role: CONTACT phone: +34 915492300 phoneExt: 436341 email: raquel.mateos@ictan.csic.es name: Mª Ángeles Martín, PhD role: CONTACT phone: +34 915492300 phoneExt: 436340 email: amartina@ictan.csic.es lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06295900 id: 19.10.2023/63 briefTitle: The Effect of Aromatherapy Massage on Sleep Quality overallStatus: RECRUITING date: 2024-01-05 date: 2024-12 date: 2024-12 date: 2024-03-06 date: 2024-03-06 name: Nilgün Erdoğan class: OTHER briefSummary: Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality. conditions: Diabetes Mellitus conditions: Respiratory Failure conditions: Pneumonia conditions: Respiratory Disease conditions: Stroke, Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It will be conducted as a randomized controlled single-blind study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 62 type: ESTIMATED name: Intervention 1 Group name: Intervention 2 Group name: Placebo Control Group measure: Patient Introduction Form measure: Patient Follow-up Form measure: Visual Comparison Sleep Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ömer Halisdemir University Training and Research Hospital status: RECRUITING city: Nigde zip: 51100 country: Turkey name: nilgun erdogan, researcher role: CONTACT phone: 5312599220 email: nilgunerdogan37@gmail.com lat: 37.96583 lon: 34.67935 hasResults: False

 nctId: NCT06295887 id: E-2402 briefTitle: Educational Efficacy of VR vs. Simulator in Emergency Medical Training overallStatus: NOT_YET_RECRUITING date: 2024-04-13 date: 2025-02-28 date: 2025-12-31 date: 2024-03-06 date: 2024-03-08 name: Seoul National University Hospital class: OTHER name: Seoul National University briefSummary: It has not been revealed which is more effective: an education program using virtual reality technology or a simulation education program using Sim-man.

In this study, the participants are new doctors who graduated from medical school and started working as interns at hospitals. The participants were divided into two groups. One group received a training program using virtual reality technology, and the other group received simulation training using Sim-man. The investigators would like to compare the increase in confidence and satisfaction before and after training.

After the classes and surveys are completed for each group, the participants will be able to receive other educational methods if they wish. conditions: Simulation Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: control group vs. test group, 1:1 primaryPurpose: OTHER masking: NONE count: 166 type: ESTIMATED name: Educational Program using VR or simulator designed to improve medical intern's performance managing emergency situation measure: self-rated confidence for managing emergency situation measure: self-rated confidence for managing emergency situation measure: performance in managing emergency situation measure: usability of Virtual Reality simulation program using User Experience Questionnaire Short measure: usability of Virtual Reality simulation program using Simulator Sickness Questionnaire measure: usability of Virtual Reality simulation program using System Usability Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295874 id: 12.10.2022/50 briefTitle: The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort overallStatus: RECRUITING date: 2023-01-05 date: 2024-08-30 date: 2024-08-30 date: 2024-03-06 date: 2024-03-06 name: Nilgün Erdoğan class: OTHER briefSummary: Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients. conditions: Respiratory Insufficiency conditions: Pulmonary Disease, Chronic Obstructive conditions: Diabetes Mellitus, Type 2 conditions: High Blood Pressure conditions: Stroke, Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled single blind study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 61 type: ESTIMATED name: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level measure: Patient Introduction Form measure: Patient Follow-up Form measure: Drug Monitoring Form measure: Visual Pain Scale measure: Face Anxiety Scale measure: Comfort Rating Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ömer Halisdemir University Training and Research Hospital status: RECRUITING city: Nigde zip: 51100 country: Turkey name: nilgun erdogan, researcher role: CONTACT phone: 5312599220 email: nilgunerdogan37@gmail.com lat: 37.96583 lon: 34.67935 hasResults: False

 nctId: NCT06295861 id: 2023-1194 briefTitle: Prospective Cohort Study of Panvascular Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-21 date: 2028-11-30 date: 2028-12-31 date: 2024-03-06 date: 2024-03-06 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: To construct a comprehensive big data platform for Chinese people with panvascular disease, and establish a Chinese panvascular disease oriented to guide treatment decisions Cohort and imaging, biological database; According to the clinical features, morphological structure, pathological characteristics of panvascularization, vascular age As the core of the evaluation, a standard evaluation system and a risk prediction model of intervention technology suitable for the diagnosis and treatment of patients with panvascular disease in China were established. Into the Further optimize the treatment strategies, protocols and clinical pathways for panvascular disease to improve patient prognosis and promote its application. conditions: ASCVD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50000 type: ESTIMATED name: no different intervention between the two cohort. measure: Cardiovascular adverse events measure: Cardiovascular mortality measure: Rate of receiving vascular revascularization measure: Readmission rate for vascular reasons sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 facility: Second Affiliated Hospital, School of Medicine, Zhejiang University city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06295848 id: KayseriCH005 briefTitle: The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients acronym: CARDIRA overallStatus: RECRUITING date: 2022-12-15 date: 2024-04-15 date: 2024-06-15 date: 2024-03-06 date: 2024-03-28 name: Kayseri City Hospital class: OTHER_GOV briefSummary: The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment.

Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program. conditions: Cardiac Rehabilitation conditions: Rheumatoid Arthritis conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Exercise measure: Framingham Risk Score(FRS) measure: QRISK-3 Risk Score measure: 24-Hour Ambulatory Blood Pressure measure: DAS28 measure: Maximal oxygen consumption (VO2max) measure: The Six-Minute Walk Test (6MWT) measure: The 36-Item Short Form Survey (SF-36) measure: International Physical Activity Questionnaire (IPAQ) - Short Form measure: Beck Depression Inventory (BDI) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty status: RECRUITING city: Kayseri state: Kocasinan zip: 38080 country: Turkey name: HAVVA TALAY ÇALIŞ, PROFESSOR role: CONTACT phone: +905326874541 email: htalaycalis@yahoo.com name: PROFESSOR role: CONTACT lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06295835 id: CS-2024-0001 briefTitle: Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-03-06 date: 2024-03-22 name: Abbott Point of Care class: INDUSTRY briefSummary: Method comparison study for Potassium (K) and ionized calcium (iCa). conditions: Potassium (K) and Ionized Calcium (iCa) in Capillary Whole Blood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device. primaryPurpose: DIAGNOSTIC masking: NONE count: 200 type: ESTIMATED name: Fingerstick blood draw measure: Performance comparison measure: Performance comparison sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295822 id: CMUH112-REC2-063 briefTitle: The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea overallStatus: RECRUITING date: 2024-03-04 date: 2025-08-31 date: 2026-02-28 date: 2024-03-06 date: 2024-04-10 name: China Medical University Hospital class: OTHER briefSummary: Primary dysmenorrhea is a common under-diagnosed complaint, with a prevalence of about 45-95% in women of childbearing age and about 10-25% in severe cases. Menstrual pain can be classified as primary or secondary. Primary menstrual pain is a crampy pain in the lower abdomen without any pelvic pathology, which usually occurs 6 to 12 months after the first menstruation. Primary menstrual pain is usually most severe on the first day of the menstrual cycle and lasts for 8 to 72 hours. The cause is still unknown, but studies suggest that it may be related to increased prostaglandins, which cause painful contractions of the uterus. The pain is often accompanied by other menstrual discomfort symptoms, including headache, breast tenderness, drowsiness, nausea, vomiting, constipation or diarrhea, and psychological anxiety, depression or irritability. In the case of secondary menstrual pain, there are clear pelvic pathologies, such as endometriosis, uterine fibroids, and pelvic inflammatory disease. conditions: Chinese Medicine conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 82 type: ESTIMATED name: Nuan-gong-ye name: Placebo measure: Visual Analogue Scale (VAS) measure: Short Form McGill Pain Questionnaire (MPQ-SF) sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: China Medical University Hospital status: RECRUITING city: Taichung zip: 404 country: Taiwan name: HSUAN HSUAN WU role: CONTACT phone: +886928030693 email: whh900710@gmail.com lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06295809 id: V940-007 id: 2023-505712-37 type: OTHER domain: EU CT id: U1111-1292-3589 type: OTHER domain: UTN id: V940 type: OTHER domain: Merck briefTitle: A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) overallStatus: RECRUITING date: 2024-05-06 date: 2029-04-30 date: 2029-04-30 date: 2024-03-06 date: 2024-04-26 name: Merck Sharp & Dohme LLC class: INDUSTRY name: Moderna TX briefSummary: This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints. conditions: Carcinoma, Squamous Cell conditions: Skin Neoplasms studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the Phase 2 of the study design, approximately 600 participants will be randomly assigned into 3 arms in an approximate 5:5:2 ratio (250 to V940 plus pembrolizumab with SOC, 250 participants to SOC only, and 100 participants to pembrolizumab monotherapy with SOC). If the decision is made to expand the study to Phase 3, the 600 participants enrolled in Phase 2 will keep their originally assigned study intervention arms in the Phase 3 Expansion, and 412 new participants will be enrolled and randomly assigned in a 1:1 ratio to receive treatment with either V940 plus pembrolizumab with SOC or SOC only. New participants will not be randomized into the pembrolizumab monotherapy with SOC arm during the Phase 3 Expansion. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1012 type: ESTIMATED name: Pembrolizumab name: V940 name: Surgery measure: Event Free Survival (EFS) measure: Overall response rate (ORR) measure: Freedom from surgery (FFS) rate measure: Pathological complete response (pCR) rate measure: Major pathological response (mPR) rate measure: Disease-free survival (DFS) measure: Disease-specific survival (DSS) measure: Overall Survival (OS) measure: Percentage of participants who experience and adverse event (AE) measure: Percentage of participants who discontinue study intervention due to AEs measure: Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30) measure: Change from baseline in physical functioning score of QLQ (C30 Items 1-5) measure: Change from baseline in Role functioning score of QLQ-C30 Items 6-7 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: One Clinical Research ( Site 3211) status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Study Coordinator role: CONTACT phone: +61862799466 lat: -31.98184 lon: 115.8073 facility: Hadassah Medical Center ( Site 2201) status: RECRUITING city: Jerusalem zip: 9112001 country: Israel name: Study Coordinator role: CONTACT phone: 97226777825 lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center ( Site 2202) status: RECRUITING city: Petah Tikva zip: 4941 492 country: Israel name: Study Coordinator role: CONTACT phone: 97235305201 lat: 32.08707 lon: 34.88747 hasResults: False

 nctId: NCT06295796 id: 8527-008 id: MK-8527-008 type: OTHER domain: Merck briefTitle: A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008) overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2025-04-14 date: 2025-04-14 date: 2024-03-06 date: 2024-04-26 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study. conditions: Renal Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: MK-8527 measure: Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma measure: Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma measure: Maximum concentration (Cmax) of MK-8527 in plasma measure: Time to Maximum concentration (Tmax) of MK-8527 in plasma measure: Apparent terminal half-life (t1/2) of MK-8527 in plasma measure: Apparent Clearance (CL/F) of MK-8527 in plasma measure: Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma measure: Number of participants who experience one or more adverse events (AEs) measure: Number of participants who discontinue study due to an AE measure: AUC0-last of MK-8527-triphosphate (TP) in peripheral blood mononuclear cells (PBMCs) measure: AUC0-inf of MK-8527-TP in PBMCs measure: Cmax of MK-8527-TP in PBMCs measure: Concentration at 168 hours (C168) of MK-8527-TP in PBMCs measure: Concentration at 672 hours (C672) of MK-8527-TP in PBMCs measure: Tmax of MK-8527-TP in PBMCs measure: t1/2 of MK-8527-TP in PBMCs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295783 id: 2023-1059 id: NCI-2024-01955 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2025-02-01 date: 2027-02-01 date: 2024-03-06 date: 2024-03-06 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales. conditions: Radiation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: MDASI-HN name: EORTC QLQ-C30 name: EORTC HN35 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: Amy Moreno, MD role: CONTACT phone: 713-745-4590 email: akmoreno@mdanderson.org name: Amy Moreno, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06295770 id: 23-006712 briefTitle: Obinutuzumab in Treatment of Fibrillary Glomerulonephritis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-06 date: 2024-03-06 name: Mayo Clinic class: OTHER briefSummary: The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN). conditions: Fibrillary Glomerulonephritis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Obinutuzumab measure: Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab measure: Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab measure: Rate of complete or partial remission measure: Improvement in serum albumin measure: Stabilization of kidney function measure: Serious Adverse Events (SAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Angela Reinke role: CONTACT phone: 507-266-1047 email: Reinke.Angela@mayo.edu name: Nicholas Geroux role: CONTACT phone: 507-266-0956 email: Geroux.Nicholas@mayo.edu name: Ladan Zand role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06295757 id: 2023LS102 briefTitle: Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-01 date: 2027-01-01 date: 2024-03-06 date: 2024-03-06 name: Masonic Cancer Center, University of Minnesota class: OTHER name: National Institutes of Health (NIH) briefSummary: Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes. conditions: Tobacco Use conditions: Cigarette Smoking conditions: Nicotine Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Cigarettes measure: Average Nicotine Level measure: Average Puff Volume sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295744 id: 2023-1724 id: Protocol Version 2/5/2024 type: OTHER domain: UW Madison id: A533300 type: OTHER domain: UW Madison id: UW23114 type: REGISTRY domain: UWCCC OnCore ID briefTitle: Outcomes and Cosmesis With Whole Breast Irradiation and Boost overallStatus: RECRUITING date: 2024-04-17 date: 2029-02 date: 2032-02 date: 2024-03-06 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER briefSummary: This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months. conditions: Early-stage Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Radiation Therapy measure: Harvard Breast Cosmesis Scale Score measure: Change in BREAST-Q Score measure: Incidence of Acute Toxicities measure: Incidence of Late Toxicities measure: Ipsilateral Breast Tumor Recurrence-Free Survival measure: Overall Survival (OS) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UW Carbone Cancer Center status: RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06295731 id: INBRX106-01-201 id: EU CT type: OTHER domain: 2024-511323-34 briefTitle: INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-05 date: 2024-03-06 date: 2024-03-06 name: Inhibrx, Inc. class: INDUSTRY briefSummary: This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20. conditions: Head and Neck Squamous Cell Carcinoma (HNSCC) studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Phase 2: open label; Phase 3: double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 410 type: ESTIMATED name: INBRX-106 name: Pembrolizumab measure: Phase 2: Objective Response Rate (ORR) measure: Phase 3: Progression-Free Survival (PFS) measure: Phase 3: Overall Survival (OS) measure: Phase 3: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Clinical Benefit Rate (CBR) measure: Phase 3: Time to Chemotherapy (TTCtx) measure: Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference measure: TTCD in physical functioning (PF) measure: TTCD in role functioning (RF) measure: TTCD in Global Health Status/quality of life (GHS/QoL) measure: Incidence and severity of Adverse Events (AEs) measure: Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295718 id: 2023/51 briefTitle: Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy: Validity and Reliability Study overallStatus: ENROLLING_BY_INVITATION date: 2023-07-01 date: 2024-03-02 date: 2024-05-10 date: 2024-03-06 date: 2024-03-06 name: Sahra Şirvan class: OTHER briefSummary: Thanks to tele-assessment methods, it may be possible to evaluate DMD patients without traveling to clinical centers. In recent years, the applicability of remote assessment methods in DMD patients, as in many populations, is being investigated. However, studies have generally focused on a single evaluation parameter such as physical function, a special evaluation method or a special evaluation tool. The aim of this study is to investigate whether remote assessment of functional performance and quality of life in DMD patients is valid and reliable. If a valid and reliable tele-evaluation method that includes functional performance and quality of life parameters is found to be valid and reliable, the travel burden on patients and caregivers can be eased, patients\&#39; stress and anxiety related to travel can be reduced, caregivers can save time and energy and provide patients with the best possible treatment. conditions: Duchenne Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED measure: Timed Performance Tests measure: Brooke Upper Extremity Functional Classification (BUEFS) measure: Vignos Lower Extremity Functional Classification (VAEFS) measure: PedsQL-3.0 Neuromuscular Module by PedsQL Multidimensional Fatigue Scale sex: MALE minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: İstanbul University - Cerrahpaşa city: Istanbul zip: 34758 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06295705 id: 5230588 briefTitle: Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD) acronym: ASD overallStatus: RECRUITING date: 2024-04-02 date: 2025-04 date: 2025-04 date: 2024-03-06 date: 2024-04-11 name: Loma Linda University class: OTHER briefSummary: This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Hip-Hop Dance measure: Child Description of Impact on Social-Emotional Health measure: Parent Perspective of Impact on Social-Emotional Health measure: Change in Social-Emotional Behavior sex: ALL minimumAge: 7 Years maximumAge: 11 Years stdAges: CHILD facility: Loma Linda University Health status: RECRUITING city: Loma Linda state: California zip: 92350 country: United States name: Julie Kugel, OTD role: CONTACT phone: 909-558-4628 phoneExt: 47473 email: jkugel@llu.edu lat: 34.04835 lon: -117.26115 hasResults: False

 nctId: NCT06295692 id: 77242113PSO3005 id: 77242113PSO3005 type: OTHER domain: Janssen Pharmaceutical K.K. briefTitle: A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis overallStatus: RECRUITING date: 2024-02-09 date: 2025-02-19 date: 2027-12-23 date: 2024-03-06 date: 2024-04-25 name: Janssen Pharmaceutical K.K. class: INDUSTRY briefSummary: The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP). conditions: Generalized Pustular Psoriasis conditions: Erythrodermic Psoriasis studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: JNJ-77242113 measure: Percentage of Participants With Generalized Pustular Psoriasis (GPP) who Experience Treatment Success Based on Clinical Global Impression (CGI) Scale According to Japanese Dermatological Association (JDA) Total Score at Week 16 measure: Percentage of Participants With Erythrodermic Psoriasis (EP) who Experience Treatment Success Based on CGI Scale at Week 16 measure: Percentage of Participants With GPP who Experience Treatment Success Based on CGI Scale According to JDA Total Score Over Time measure: Percentage of Participants With EP who Experience Treatment Success Based on CGI Scale Over Time measure: Change From Baseline in Total Score of JDA Severity Index for GPP measure: Change From Baseline in Severity Classification of JDA Severity Index for GPP measure: Change From Baseline in Body Surface Area (BSA) for EP measure: Percentage of Participants who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) measure: Percentage of Participants who Achieve an IGA Score of Cleared (0) measure: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score measure: Percentage of Participants who Achieve a DLQI Score of 0 or 1 measure: Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: JR Sapporo Hospital status: RECRUITING city: Hokkaido zip: 060-0033 country: Japan lat: 43.41104 lon: 142.88878 facility: Ichinomiya Municipal Hospital status: RECRUITING city: Ichinomiya zip: 491-8558 country: Japan lat: 35.3 lon: 136.8 facility: Teikyo University Hospital status: RECRUITING city: Itabashi Ku zip: 173 8606 country: Japan lat: 35.74893 lon: 139.71497 facility: Hospital of the University of Occupational and Environmental Health status: RECRUITING city: Kitakyushu-shi zip: 807-8556 country: Japan lat: 33.85181 lon: 130.85034 facility: Kumamoto University Hospital status: RECRUITING city: Kumamoto zip: 860-8556 country: Japan lat: 32.80589 lon: 130.69182 facility: Nagoya City University Hospital status: RECRUITING city: Nagoya zip: 467 8602 country: Japan lat: 35.18147 lon: 136.90641 facility: Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital status: RECRUITING city: Osaka zip: 550 0006 country: Japan lat: 34.69374 lon: 135.50218 facility: Tohoku University Hospital status: RECRUITING city: Sendai zip: 980-8574 country: Japan lat: 38.26667 lon: 140.86667 facility: Dokkyo Medical University Hospital status: RECRUITING city: Shimotsuga Gun zip: 321-0293 country: Japan facility: Tokyo Medical University Hospital status: RECRUITING city: Shinjuku zip: 160-0023 country: Japan lat: 35.2946 lon: 139.57059 facility: Fujita Health University Hospital status: RECRUITING city: Toyoake zip: 470-1192 country: Japan lat: 35.038 lon: 136.99931 facility: Mie University Hospital status: RECRUITING city: Tsu zip: 514 8507 country: Japan lat: 34.73333 lon: 136.51667 hasResults: False

 nctId: NCT06295679 id: 20180442 briefTitle: A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease overallStatus: RECRUITING date: 2022-12-19 date: 2028-12-19 date: 2028-12-19 date: 2024-03-06 date: 2024-04-25 name: Amgen class: INDUSTRY briefSummary: The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice. conditions: Major Cardiovascular Event conditions: Established Atherosclerotic Cardiovascular Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 7000 type: ESTIMATED measure: Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First measure: Time to CV Death, MI, or Stroke, Whichever Occurs First measure: Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline measure: Percent Change in LDL-C From Baseline measure: Number of Participants Who Experienced Adverse Events measure: Number of Participants Who Experienced Adverse Drug Reactions sex: ALL minimumAge: 18 Years maximumAge: 150 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Haidian Hospital status: RECRUITING city: Beijing state: Beijing zip: 100086 country: China lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 facility: Chongqing Emergency Medical Center status: RECRUITING city: Chongqing state: Chongqing zip: 400014 country: China lat: 29.56278 lon: 106.55278 facility: Chongqing General Hospital status: RECRUITING city: Chongqing state: Chongqing zip: 401121 country: China lat: 29.56278 lon: 106.55278 facility: Dongguan Songshan Lake Central Hospital status: RECRUITING city: Dong Guan state: Guangdong zip: 523127 country: China facility: The First Peoples Hospital of Foshan status: RECRUITING city: Foshan state: Guangdong zip: 528000 country: China lat: 23.02677 lon: 113.13148 facility: The First Affiliated Hospital of Shantou University Medical College status: RECRUITING city: Guangzhou state: Guangdong zip: 510280 country: China lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510280 country: China lat: 23.11667 lon: 113.25 facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Jinan University status: RECRUITING city: Guangzhou state: Guangdong zip: 510630 country: China lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510630 country: China lat: 23.11667 lon: 113.25 facility: The Third Peoples Hospital of Huizhou City status: RECRUITING city: Huizhou state: Guangdong zip: 516002 country: China lat: 23.11147 lon: 114.41523 facility: Zhuhai Peoples Hospital status: RECRUITING city: Zhuhai state: Guangdong zip: 519050 country: China lat: 22.27694 lon: 113.56778 facility: The First Peoples Hospital of Yulin status: RECRUITING city: Yulin state: Guangxi zip: 537006 country: China lat: 22.63333 lon: 110.15 facility: The Second Affiliated Hospital of Guilin Medical University status: RECRUITING city: Yulin state: Guangxi zip: 541199 country: China lat: 22.63333 lon: 110.15 facility: The Affiliated Hospital of Guizhou Medical University status: RECRUITING city: Guiyang state: Guizhou zip: 550001 country: China lat: 26.58333 lon: 106.71667 facility: Cangzhou Central Hospital status: RECRUITING city: Cangzhou state: Hebei zip: 061001 country: China lat: 38.31667 lon: 116.86667 facility: Tangshan Gongren Hosipital status: RECRUITING city: Tangshan state: Hebei zip: 063000 country: China lat: 39.63333 lon: 118.18333 facility: Heilongjiang Provincial Hospital status: RECRUITING city: Haerbin state: Heilongjiang zip: 150036 country: China lat: 31.8696 lon: 101.742 facility: Huaihe Hospital of Henan University status: RECRUITING city: Kaifeng state: Henan zip: 475000 country: China lat: 34.7986 lon: 114.30742 facility: Nanyang Central Hospital status: RECRUITING city: Nanyang state: Henan zip: 473000 country: China lat: 32.99472 lon: 112.53278 facility: The Seventh Peoples Hospital of Zhengzhou status: RECRUITING city: Zhengzhou state: Henan zip: 450016 country: China lat: 34.75778 lon: 113.64861 facility: The First Affiliated hospital of Zhengzhou University status: RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China lat: 34.75778 lon: 113.64861 facility: The Central Hospital of Wuhan status: RECRUITING city: Wuhan state: Hubei zip: 430014 country: China lat: 30.58333 lon: 114.26667 facility: Union Hospital Tongji Medical College Huazhong University of science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Wuhan No 1 Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 facility: Wuhan Third Hospital-Tongren Hospital Of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430060 country: China lat: 30.58333 lon: 114.26667 facility: Hunan Provincial Peoples Hospital status: RECRUITING city: Changsha state: Hunan zip: 410005 country: China lat: 28.19874 lon: 112.97087 facility: Changshu No1 Peoples Hospital status: RECRUITING city: Changshu state: Jiangsu zip: 215500 country: China lat: 29.44395 lon: 118.88005 facility: Changshu NO2 Peoples Hospital status: RECRUITING city: Changshu state: Jiangsu zip: 215523 country: China lat: 29.44395 lon: 118.88005 facility: Nantong First Peoples Hospital status: RECRUITING city: Nantong state: Jiangsu zip: 226000 country: China lat: 32.03028 lon: 120.87472 facility: The first peoples hospital of Kunshan status: RECRUITING city: Suzhou state: Jiangsu zip: 215300 country: China lat: 31.30408 lon: 120.59538 facility: Wuxi Peoples Hospital status: RECRUITING city: Wuxi state: Jiangsu zip: 214023 country: China lat: 31.56887 lon: 120.28857 facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou state: Jiangsu zip: 221006 country: China lat: 34.18045 lon: 117.15707 facility: Jiangxi Provincial People Hospital status: RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China lat: 28.68396 lon: 115.85306 facility: The first affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China lat: 28.68396 lon: 115.85306 facility: The First Hospital of Nanchang status: RECRUITING city: Nanchang state: Jiangxi zip: 330008 country: China lat: 28.68396 lon: 115.85306 facility: The Second Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin zip: 13041 country: China lat: 43.88 lon: 125.32278 facility: Dalian Municipal Central Hospital Affiliated Of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116000 country: China lat: 38.91222 lon: 121.60222 facility: The First Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116000 country: China lat: 38.91222 lon: 121.60222 facility: The Second Hospital of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116027 country: China lat: 38.91222 lon: 121.60222 facility: The First Affiliated Hospital of Jinzhou Medical University status: RECRUITING city: Jinzhou state: Liaoning zip: 121000 country: China lat: 41.10778 lon: 121.14167 facility: General Hospital of Northern Theater Command status: RECRUITING city: Shenyang state: Liaoning zip: 110016 country: China lat: 41.79222 lon: 123.43278 facility: The Forth Affiliated Hospital of China Medical University status: RECRUITING city: Shenyang state: Liaoning zip: 110032 country: China lat: 41.79222 lon: 123.43278 facility: Tangdu Hospital,Air Force Military Medical University status: RECRUITING city: Xi'an state: Shaanxi zip: 710038 country: China lat: 34.25833 lon: 108.92861 facility: Shaanxi Provincial Peoples Hospital status: RECRUITING city: Xi'an state: Shaanxi zip: 710068 country: China lat: 34.25833 lon: 108.92861 facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China lat: 36.66833 lon: 116.99722 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Shandong Qianfoshan Hospital status: RECRUITING city: Jinan state: Shandong zip: 250014 country: China lat: 36.66833 lon: 116.99722 facility: Shandong Provincial Hospital status: RECRUITING city: Jinan state: Shandong zip: 250021 country: China lat: 36.66833 lon: 116.99722 facility: Affiliated hospital of Jining Medical University status: RECRUITING city: Jining state: Shandong zip: 272009 country: China lat: 35.405 lon: 116.58139 facility: Zibo central Hospital status: RECRUITING city: Zibo state: Shandong zip: 255030 country: China lat: 36.79056 lon: 118.06333 facility: Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200092 country: China lat: 31.22222 lon: 121.45806 facility: The Second Hospital of Shanxi Medical University status: RECRUITING city: Taiyuan state: Shanxi zip: 030001 country: China lat: 37.86944 lon: 112.56028 facility: The First Affiliated Hospital of Xi An Jiaotong University status: RECRUITING city: XI An state: Shanxi zip: 710061 country: China facility: Chengdu First Peoples Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Chengdu Third Peoples Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 61031 country: China lat: 30.66667 lon: 104.06667 facility: Tianjin Peoples Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300120 country: China lat: 39.14222 lon: 117.17667 facility: Tianjin Chest Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300222 country: China lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of Xinjiang Medical University status: RECRUITING city: Urumqi state: Xinjiang zip: 830054 country: China lat: 43.80096 lon: 87.60046 facility: Yanan Hospital of Kunming City status: RECRUITING city: Kunming state: Yunnan zip: 473009 country: China lat: 25.03889 lon: 102.71833 facility: First Affiliated Hospital of Kunming Medical University status: RECRUITING city: Kunming state: Yunnan zip: 650032 country: China lat: 25.03889 lon: 102.71833 facility: Yunnan First Peoples Hospital status: RECRUITING city: Kunming state: Yunnan zip: 650032 country: China lat: 25.03889 lon: 102.71833 facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310016 country: China lat: 30.29365 lon: 120.16142 facility: the First Peoples Hospital of Xiaoshan District Hangzhou status: RECRUITING city: Hangzhou state: Zhejiang zip: 311201 country: China lat: 30.29365 lon: 120.16142 facility: Huzhou Central Hospital status: RECRUITING city: Huzhou state: Zhejiang zip: 310005 country: China lat: 30.8703 lon: 120.0933 facility: The First Peoples Hospital of Huzhou status: RECRUITING city: Huzhou state: Zhejiang zip: 313000 country: China lat: 30.8703 lon: 120.0933 facility: Jiaxing Second Hospital status: RECRUITING city: Jiaxing state: Zhejiang zip: 314000 country: China lat: 30.7522 lon: 120.75 facility: The first affiliated hospital of Ningbo university status: RECRUITING city: Ningbo state: Zhejiang zip: 315010 country: China lat: 29.87819 lon: 121.54945 facility: Ningbo medical center lihuili hospital status: RECRUITING city: Ningbo state: Zhejiang zip: 315046 country: China lat: 29.87819 lon: 121.54945 facility: Shaoxing Second Hospital status: RECRUITING city: Shaoxing state: Zhejiang zip: 312000 country: China lat: 30.00237 lon: 120.57864 facility: Beijing Anzhen Hospital, Capital Medical University status: RECRUITING city: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Tongji Hospital of Tongji University status: RECRUITING city: Shanghai zip: 200065 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06295666 id: 26.12.2018/901 briefTitle: Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta overallStatus: COMPLETED date: 2019-02-19 date: 2019-11-25 date: 2020-01-20 date: 2024-03-06 date: 2024-03-06 name: Akdeniz University class: OTHER briefSummary: Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis conditions: Periodontitis conditions: Gingival Crevicular Fluid conditions: Interleukin 1-beta conditions: Bactericidal Permeability Protein studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ACTUAL measure: Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz Üniversitesi Diş Hekimliği Fakültesi city: Antalya country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06295653 id: 7-23 briefTitle: Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-30 date: 2025-04-30 date: 2024-03-06 date: 2024-03-06 name: Tanta University class: OTHER briefSummary: The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 26 type: ESTIMATED name: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane measure: measure changes in periimplant mucosal thickness measure: mid-buccal keratinized mucosal width sex: ALL minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT facility: Faculity of Dentistry Tanta University city: Tanta state: Elgarbia zip: 6620012 country: Egypt name: Faten a Seddiq, Faculty Dean role: CONTACT phone: 3335631 phoneExt: +20 email: dean_dent@unv.tanta.edu.eg name: ahmed a abdelsayed role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-03 uploadDate: 2024-03-03T10:57 filename: Prot_SAP_000.pdf size: 472866 hasResults: False

 nctId: NCT06295640 id: 300/2022 briefTitle: Relative Contribution of Brain Insulin Action for Postprandial Metabolism acronym: BrainInsPPM overallStatus: RECRUITING date: 2024-03-18 date: 2025-12 date: 2026-01 date: 2024-03-06 date: 2024-03-27 name: University of Ulm class: OTHER briefSummary: The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women.

Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray. conditions: Glucose Metabolism Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, controlled, cross-over design for men. Randomized, controlled, 2x2 factorial cross-over design for women taking the menstrual cycle phase into account. primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Oral glucose tolerance test with double-tracer dilution and intranasal insulin spray name: Oral glucose tolerance test with double-tracer dilution and intranasal placebo spray measure: Endogenous glucose production measure: Rate of glucose disappearance measure: Proglucagon cleavage products measure: Glucose tolerance measure: Whole-body insulin sensitivity measure: Insulin secretion measure: Post-absorptive energy expenditure measure: Sex differences measure: Menstrual cycle effects measure: Autonomic nervous system activity sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Universityhospital Ulm status: RECRUITING city: Ulm zip: 89081 country: Germany name: Julia Hummel, Phd role: CONTACT phone: +4973150044744 email: julia.hummel@uniklinik-ulm.de name: Rebecca Spies, MD role: CONTACT email: rebecca.spies@uniklinik-ulm.de lat: 48.39841 lon: 9.99155 hasResults: False

 nctId: NCT06295627 id: SYSKY-2024-115-01 briefTitle: The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies overallStatus: COMPLETED date: 2023-01-30 date: 2023-09-30 date: 2024-01-15 date: 2024-03-06 date: 2024-03-06 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed. conditions: Catheter-associated Urinary Tract Infection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 291 type: ACTUAL name: There were no interventions in retrospective analysis measure: How many patients in the infected group and how many patients in the non-infected group had bladder irrigation measure: How many patients in the infected group and how many patients in the non-infected group were given enema measure: How many times the indwelling catheter was changed in patients in the infected group and patients in the non-infected group respectively measure: How many patients in the infected group and the non-infected group had co-diabetes sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital city: Canton state: Guangdong zip: 510030 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06295614 id: SPARKL briefTitle: Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease acronym: SPARKL overallStatus: RECRUITING date: 2024-03-01 date: 2029-04-01 date: 2029-04-01 date: 2024-03-06 date: 2024-03-12 name: Ecole Polytechnique Fédérale de Lausanne class: OTHER briefSummary: The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-site, single-arm, non-blinded, non-randomized, interventional primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: ARC-IM System implantation measure: Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system. measure: 10-meter walk test measure: 6-minute walk test measure: Timed up and Go and its cognitive version measure: Freezing of gait circuit measure: Kinematic analysis measure: Muscle analysis measure: Mini Balance Evaluation Systems Test (mini-BESTest) measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III measure: King's Parkinson's disease Pain Scale (KPPS) measure: The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV. measure: Parkinson's Disease Questionnaire-39 (PDQ-39) measure: Activities specific Balance Confidence Questionnaire (ABC-Q) measure: The Freezing of Gait Questionnaire (FOG-Q) measure: Home-use kinematic monitoring measure: Daily falls tracking measure: Satisfaction questionnaire measure: User Evaluation of Satisfaction with technology (QUEST 2.0) measure: System Usability Scale (SUS) measure: Nerve conduction studies (NCS) measure: Somato-sensory evoked potential (SSEP) measure: Cortical signal recording measure: Kinematic analysis in different therapeutic conditions measure: Muscle analysis in different therapeutic conditions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire Vaudois (CHUV) status: RECRUITING city: Lausanne state: Vaud zip: 1011 country: Switzerland name: Jocelyne Dr Bloch, Prof. Dr. role: CONTACT lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06295601 id: 2024/5591 briefTitle: Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-02-15 date: 2025-08-15 date: 2024-03-06 date: 2024-03-06 name: Inonu University class: OTHER briefSummary: This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 10 type: ESTIMATED name: Traditional rehabilitation name: Action observation therapy and motor imagery measure: Berg Balance Scale measure: Berg Balance Scale measure: Muscle strength and functional mobility measure: Muscle strength and functional mobility measure: Fatigue Severity Scale measure: Fatigue Severity Scale measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295588 id: STUDY00009135 id: T32CA102618 type: NIH link: https://reporter.nih.gov/quickSearch/T32CA102618 briefTitle: Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-03-06 date: 2024-03-06 name: University of Rochester class: OTHER name: National Cancer Institute (NCI) briefSummary: To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation. conditions: Fatigue conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Fucoidan extracted from F. Vesiculosus name: Fucoidan extracted from U. Pinnatifida measure: percentage of participants who are randomized to the study out of all participants approached measure: percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention measure: percentage of participants who take at least 80% of the fucoidan pills during the study measure: mean change in Brief Fatigue Inventory measure: mean change in plasma viscosity in blood measure: mean change in erythrocyte sedimentation rate in blood measure: mean change in thyroid stimulating hormone in blood measure: mean change in C-reactive protein in blood measure: mean change in leptin in blood measure: mean change in D Dimer in blood measure: mean change in TNF alpha in blood measure: mean change in neopterin in blood measure: mean change in lactase dehydrogenase in blood measure: mean change in procalcitonin in blood measure: mean change in frailty using a modified Fried's Frailty questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 hasResults: False

 nctId: NCT06295575 id: ZZhang briefTitle: Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass overallStatus: COMPLETED date: 2021-06-01 date: 2022-07-01 date: 2022-07-01 date: 2024-03-06 date: 2024-03-06 name: Nanjing Children's Hospital class: OTHER briefSummary: A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora. conditions: Congenital Heart Disease conditions: Intestinal Disease conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: probiotics containing Bifidobacterium infantis and Lactobacillus name: placebos containing lactose measure: incidence of morbidity measure: gastrointestinal functional recovery indicators measure: biomarkers measure: microbiome sex: ALL minimumAge: 1 Month maximumAge: 1 Year stdAges: CHILD facility: Children's Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210093 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06295562 id: CMUH112-REC3-201 briefTitle: Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-07-31 date: 2024-03-06 date: 2024-03-07 name: China Medical University Hospital class: OTHER briefSummary: This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters. conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: Atomoxetine 80mg combined with oxybutynin 5mg name: Venlafaxine 37.5mg name: Atomoxetine 80mg combined with trazodone 100mg name: Placebo measure: Physiological parameter measure: Endotypic traits measure: Sleep quality measure: Waking sleepiness sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295549 id: LB2304-0001 briefTitle: Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma overallStatus: RECRUITING date: 2024-03-25 date: 2026-06-30 date: 2028-06-30 date: 2024-03-06 date: 2024-03-06 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER name: Nanjing Legend Biotech Co. briefSummary: A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma conditions: Relapsed and Refractory B-cell Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: LUCAR-G39P cells product measure: Incidence, severity and type of TEAEs measure: Pharmacokinetics in peripheral blood measure: Pharmacokinetics in bone marrow measure: The recommended Phase II dose (RP2D) for this cell therapy measure: Overall Response Rate (ORR) measure: Progression-free survival (PFS) measure: Overall Survival (OS) measure: Time to Response (TTR) measure: Duration of Response (DoR) measure: Immunogenicity assessment of LUCAR-G39P cells sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital status: RECRUITING city: Nanjin state: Jiangsu zip: 210029 country: China name: Huayuan Zhu, PhD，MD role: CONTACT phone: 86 25 68306034 email: huayuan.zhu@hotmail.com name: Yeqin Sha, MD role: CONTACT email: yeqinsha@njmu.edu.cn hasResults: False

 nctId: NCT06295536 id: WS10363 briefTitle: Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-08 date: 2024-03-06 date: 2024-03-06 name: Essilor International class: INDUSTRY briefSummary: The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia. conditions: Ametropia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 115 type: ESTIMATED name: Comparator device, Closed-field autorefractometer measure: Objective refractive error sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD hasResults: False

 nctId: NCT06295523 id: STU_2019_1759_COPD briefTitle: Heat Waves and the Elderly With COPD overallStatus: RECRUITING date: 2024-01-01 date: 2025-12 date: 2025-12 date: 2024-03-06 date: 2024-03-06 name: University of Texas Southwestern Medical Center class: OTHER name: American Heart Association briefSummary: The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD. conditions: COPD conditions: Aging conditions: Hyperthermia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 44 type: ESTIMATED name: Water Spray name: Control measure: Core body temperature measure: Forced expiratory volume (FEV1) measure: Forced vital capacity (FVC) measure: FEV1/FVC ratio sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Texas Health Presbyterian Hospital Dallas status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States name: Whitley Atkins, PhD role: CONTACT name: Courtney Kirby, BS RN role: CONTACT phone: 214-345-6502 name: Craig Crandall, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06295510 id: CDUTCM20240223 briefTitle: Observational Study of the Association Between Food Intake and Endometrial Polyps overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-01 date: 2024-05-01 date: 2024-03-06 date: 2024-03-06 name: qinxiu zhang class: OTHER briefSummary: There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps. conditions: Diet Habit conditions: Endometrial Polyp conditions: Women studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: No interventions. measure: Hormonal dietary intake measure: Comparison of daily living habits sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295497 id: LC-SHIELD briefTitle: Lung Cancer Screening by Artificial Intelligence Device overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-06-30 date: 2027-12-31 date: 2024-03-06 date: 2024-03-06 name: Chinese University of Hong Kong class: OTHER briefSummary: Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 1000 type: ESTIMATED name: Lung-SIGHT measure: The prevalence of early-staged lung cancer detected by first-round LDCT thorax (T0) in a high-risk non-smoker population measure: Sensitivity of AI-assisted programme in lung nodule detection and monitoring compared to radiologist assessment measure: Rate of invasive workup and incidence of associated complications. measure: Prevalence of lung cancer detected by second-round LDCT (T1) in patients with negative first-round LDCT measure: Diagnostic accuracy and discrimination ability of plasma-based fragmentomic assay in detection of lung cancer via assessment of sensitivity, specificity, positive predictive value and negative predictive value measure: To determine the quality adjusted life years (QALYs) gained through screening sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Clinical Oncology, Prince of Wales Hospital city: Hong Kong country: Hong Kong name: Molly SC LI, MBBS, MRCP role: CONTACT phone: 3505 2166 email: molly@clo.cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06295484 id: 5136 briefTitle: Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants overallStatus: RECRUITING date: 2021-08-21 date: 2025-12-31 date: 2026-12-31 date: 2024-03-06 date: 2024-03-06 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: Background:

In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.

The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.

Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.

One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding. conditions: Preterm Birth conditions: Premature Lungs conditions: Respiratory Distress Syndrome in Premature Infant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. We will continue to record the Edi signals during the 3 methods.

Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, your baby will be put back to the originally prescribed breathing support.

Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 24 type: ESTIMATED name: Alternating traditional CPAP, NIPPV, and high CPAP measure: The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O). measure: 1. Neural respiratory rate per minute measure: 2. Edi peak measured in MicroVoltage measure: 3. The difference in transcutaneous pCO2 in mmHg measure: 4. The difference in oxygen requirements in percent (i.e, 21%) sex: ALL minimumAge: 1 Day maximumAge: 8 Months stdAges: CHILD facility: Sunnybrook Health Sciences Center status: RECRUITING city: Toronto state: Ontario zip: M4N 3M5 country: Canada name: Maher Shahroor, MD role: CONTACT phone: (416) 480-6100 phoneExt: 687939 email: maher.shahroor@sunnybrook.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06295471 id: 2024P000112 briefTitle: A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-08 date: 2024-03-06 date: 2024-03-06 name: Massachusetts General Hospital class: OTHER briefSummary: This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 23 type: ESTIMATED name: DFG Laser name: CO2 Laser name: Optical coherence tomography (OCT) measure: Visual Analog Scale (VAS) pain score measure: Wound healing time measure: Vessel density via OCT imaging measure: Vessel length via OCT imaging measure: Vessel thickness via OCT imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MGH Clinical Unit for Research Trials & Outcomes in Skin city: Boston state: Massachusetts zip: 02114 country: United States name: Alicia Van Cott, MSN role: CONTACT phone: 617-726-4454 email: avancott@mgb.org name: Abigail Carlson, BS role: CONTACT phone: 617-726-4454 email: acarlson9@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06295458 id: STUDY00006945 briefTitle: Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait acronym: Flicker w FOG overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-06 date: 2024-03-06 date: 2024-03-06 name: Emory University class: OTHER name: Parkinson's Foundation briefSummary: The purpose of the study is to examine the safety of special eyewear and earphones that emit a visual and auditory stimulus in the gamma range (gamma flicker) in patients with Parkinson's disease for 1 hour per day and to assess the effects this stimulus has on reducing a walking problem referred to as freezing of gait (FOG) as well as on a specific spinal fluid chemical marker, amyloid.

Based on previous animal studies this gamma stimulus has the potential as a novel, non-invasive, non-pharmacological approach, to remove amyloid from the brain. The investigators have found in a prior study, that amyloid levels are high in the spinal fluid of Parkinson's patients with FOG.

Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable in nature, a leading cause of falls with injury, and results in loss of independence.

FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD. conditions: Gait Disorders, Neurologic conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: GammaSense Stimulation System name: Control Group measure: Number of participants with Adverse events measure: Number of participants compliant with the study procedures measure: Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD measure: Change in the freezing of gait severity in participants with PD. measure: Change in subjective changes in FOG. measure: Change in the effects of driving gamma on cerebrospinal fluid (CSF) amyloid levels in patients with PD-FOG measure: Change in the effects of driving gamma on cerebrospinal fluid (CSF) inflammatory markers levels in patients with PD-FOG sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory Movement Disorders Center city: Atlanta state: Georgia zip: 30329 country: United States lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06295445 id: Cardiopulmonary Ultrasound briefTitle: Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit overallStatus: COMPLETED date: 2022-03-01 date: 2023-09-01 date: 2023-09-15 date: 2024-03-06 date: 2024-03-12 name: Egymedicalpedia class: INDUSTRY briefSummary: Shock is one of the most common conditions in the intensive care unit (ICU) affecting one-third of critically ill patients. It reduces oxygen and nutrition's perfusion to the solid organs and is closely associated with increased mortality. Most literature has described how hemodynamic monitoring could provide an effective way to identify underlying pathophysiological processes and guide appropriate therapy in shock patients. conditions: Shock studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 108 type: ACTUAL name: care cardio-pulmonary ultrasound name: treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management measure: Mortality rate measure: Number of mortalities sex: ALL minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT facility: Al-Azhar University hospitals city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06295432 id: DZ2022E0001 briefTitle: A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21) overallStatus: RECRUITING date: 2023-06-01 date: 2025-06 date: 2025-06 date: 2024-03-06 date: 2024-03-20 name: Dizal Pharmaceuticals class: INDUSTRY briefSummary: DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: DZD9008+AZD4205 measure: Part A: incidence of DLT , ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial People'S Hospital status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Zhen Wang role: CONTACT phone: 020-83827812 email: wangzhen@gdph.org.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06295419 id: Igdir182 briefTitle: The Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-08-01 date: 2024-03-06 date: 2024-03-08 name: Igdir University class: OTHER briefSummary: The aim of the study is to investigate the effect of dual task conditions on manual dexterity performance in young people and children with CP between the ages of 7-18 and to compare it with their peers.

Evaluations to be made in the study (children with CP) and control (typically developing peers) groups:

* Demographic information, Gross Motor Function Level (GMFCS), Manual Skills Classification System (MACS) and dominant extremity will be noted and the evaluation will begin by applying the Abilhand Kids questionnaire.
* Firstly, the child's performance on a single cognitive task will be evaluated in a supported sitting position on a chair. The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person.
* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.
* In order to evaluate the single motor performance of manual skills, the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.
* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Test and writing a paragraph.
* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.
* The Body Control Measurement Scale will be applied for body evaluation purposes.

As a result of this study, the changes in manual dexterity and cognitive performance in dual-task conditions in children and adolescents with CP will be revealed. Additionally, changes in this performance in dual-task situations will be compared with a control group of typically developing children. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: dual task name: single task measure: Abilhand Kids measure: cognitive task (single task) measure: motor performance of manual skills (writing a paragraph) (single task) measure: motor performance of manual skills (single task) measure: motor performance of manual skills (dual task) measure: motor performance of manual skills (writing a paragraph) (dual task) measure: The Body Control Measurement Scale sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD hasResults: False

 nctId: NCT06295406 id: 21C310 briefTitle: Reading Ability in Childhood Obesity acronym: Lettura_evOB overallStatus: RECRUITING date: 2023-12-01 date: 2025-11-30 date: 2025-11-30 date: 2024-03-06 date: 2024-03-08 name: Istituto Auxologico Italiano class: OTHER briefSummary: There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.

In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory. conditions: Obesity, Childhood conditions: Obesity, Adolescent studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 64 type: ESTIMATED name: Neuropsychological assessment measure: Raw score at the neuropsychological assessment sex: ALL minimumAge: 11 Years maximumAge: 16 Years stdAges: CHILD facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe status: RECRUITING city: Piancavallo state: VCO zip: 28824 country: Italy name: Federica Scarpina, PhD role: CONTACT phone: +39032351 phoneExt: 4003 email: f.scarpina@auxologico.it hasResults: False

 nctId: NCT06295393 id: 20-0229-CCMC briefTitle: Renin Angiotensin Aldosterone System In Septic Kids acronym: RISK overallStatus: RECRUITING date: 2024-01-24 date: 2025-06-01 date: 2025-06-01 date: 2024-03-06 date: 2024-03-06 name: Northwell Health class: OTHER briefSummary: Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.

Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.

Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups. conditions: Sepsis conditions: Acute Kidney Injury Due to Sepsis conditions: Acute Kidney Injury (Nontraumatic) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 74 type: ESTIMATED measure: Difference in serum renin in sepsis measure: Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury measure: Septic induced kidney injury will be associated with alterations in renal blood flow measure: Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients measure: Changes in the components of the RAAS over the first three days in sepsis measure: Changes in renal blood flow on Ultrasound in Sepsis measure: Renal blood flow and RAAS in sepsis sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Cohen Children's Medical Center status: RECRUITING city: New Hyde Park state: New York zip: 11004 country: United States name: Grace Fisler, MD role: CONTACT email: gfisler@northwell.edu name: Shannon A Moriarty role: CONTACT phone: 631-834-0984 email: smoriarty2@northwell.edu lat: 40.7351 lon: -73.68791 hasResults: False

 nctId: NCT06295380 id: CarenAmp briefTitle: Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2025-03 date: 2024-03-06 date: 2024-03-06 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase). conditions: Lower Limb Amputation Knee conditions: Injuries conditions: Biomechanical Lesion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Virtual environment practiced on the Caren name: Conventional physiotherapy measure: Kinematic data measure: Kinetic data measure: Electromyography sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Centro Neurolesi city: Messina state: Sicily zip: 98124 country: Italy name: Rocco Salvatore Calabrò, MD role: CONTACT phone: 09060128179 phoneExt: +39 email: roccos.calabro@irccsme.it lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06295367 id: EAQ222CD id: NCI-2023-09944 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAQ222CD type: OTHER domain: ECOG-ACRIN Cancer Research Group id: ECOG-ACRIN-EAQ222CD type: OTHER domain: DCP id: EAQ222CD type: OTHER domain: CTEP id: R01CA272680 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA272680 id: UG1CA189828 type: NIH link: https://reporter.nih.gov/quickSearch/UG1CA189828 briefTitle: Cost Communication and Financial Navigation in Cancer Patients (COSTCOM) overallStatus: RECRUITING date: 2024-02-29 date: 2029-02-01 date: 2029-08-01 date: 2024-03-06 date: 2024-03-15 name: ECOG-ACRIN Cancer Research Group class: NETWORK name: National Cancer Institute (NCI) briefSummary: This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 760 type: ESTIMATED name: Best Practice name: Financial Navigation name: Interview name: Survey Administration measure: Cost-related cancer care non-adherence measure: Rate of Material Financial Hardship measure: Patient-reported financial worry measure: Patient-reported Quality of life - mental and physical health measure: Patient-reported satisfaction with care at 12 months measure: Out of pocket cost (OOPC) accuracy measure: Proportion of study patient participants that are of minority racial/ethnic background, and with public insurance will be measured and compared with that of practice patient population. measure: Patient reported satisfaction with intervention measure: Receipt of financial navigation via internal practice or external resources measure: Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care measure: longitudinal changes in cost-related cancer care non-adherence measure: longitudinal changes in cost-related cancer care material hardship measure: longitudinal changes in cost-related cancer care financial worry measure: longitudinal changes in cost-related cancer care quality of life measure: longitudinal changes in cost-related cancer care satisfaction with care sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mercy Hospital Fort Smith status: RECRUITING city: Fort Smith state: Arkansas zip: 72903 country: United States name: Site Public Contact role: CONTACT phone: 800-378-9373 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 35.38592 lon: -94.39855 facility: CARTI Cancer Center status: RECRUITING city: Little Rock state: Arkansas zip: 72205 country: United States name: Site Public Contact role: CONTACT phone: 501-906-4199 email: Research@CARTI.com name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: Saint Anthony's Health status: RECRUITING city: Alton state: Illinois zip: 62002 country: United States name: Site Public Contact role: CONTACT phone: 618-463-5623 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.8906 lon: -90.18428 facility: Saint Mary's Hospital status: RECRUITING city: Centralia state: Illinois zip: 62801 country: United States name: Site Public Contact role: CONTACT email: ecog.rss@jimmy.harvard.edu name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.52505 lon: -89.1334 facility: Good Samaritan Regional Health Center status: RECRUITING city: Mount Vernon state: Illinois zip: 62864 country: United States name: Site Public Contact role: CONTACT phone: 618-242-4600 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.31727 lon: -88.90312 facility: Central Care Cancer Center - Garden City status: RECRUITING city: Garden City state: Kansas zip: 67846 country: United States name: Site Public Contact role: CONTACT phone: 913-948-5588 email: aroland@kccop.org name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.97169 lon: -100.87266 facility: Central Care Cancer Center - Great Bend status: RECRUITING city: Great Bend state: Kansas zip: 67530 country: United States name: Site Public Contact role: CONTACT phone: 913-948-5588 email: aroland@kccop.org name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.36446 lon: -98.76481 facility: Saint Louis Cancer and Breast Institute-Ballwin status: RECRUITING city: Ballwin state: Missouri zip: 63011 country: United States name: Site Public Contact role: CONTACT phone: 314-251-7058 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.59505 lon: -90.54623 facility: Central Care Cancer Center - Bolivar status: RECRUITING city: Bolivar state: Missouri zip: 65613 country: United States name: Site Public Contact role: CONTACT phone: 913-948-5588 email: aroland@kccop.org name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.61448 lon: -93.41047 facility: Cox Cancer Center Branson status: RECRUITING city: Branson state: Missouri zip: 65616 country: United States name: Site Public Contact role: CONTACT phone: 417-269-4520 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 36.64367 lon: -93.21851 facility: Freeman Health System status: RECRUITING city: Joplin state: Missouri zip: 64804 country: United States name: Site Public Contact role: CONTACT phone: 417-347-4030 email: LJCrockett@freemanhealth.com name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.08423 lon: -94.51328 facility: Mercy Hospital Joplin status: RECRUITING city: Joplin state: Missouri zip: 64804 country: United States name: Site Public Contact role: CONTACT phone: 417-556-3074 email: esmeralda.carrillo@mercy.net name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.08423 lon: -94.51328 facility: Lake Regional Hospital status: RECRUITING city: Osage Beach state: Missouri zip: 65065 country: United States name: Site Public Contact role: CONTACT phone: 573-302-2768 email: clinicaltrials@lakeregional.com name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.12956 lon: -92.65277 facility: Delbert Day Cancer Institute at PCRMC status: RECRUITING city: Rolla state: Missouri zip: 65401 country: United States name: Site Public Contact role: CONTACT phone: 573-458-7504 email: research@phelpshealth.org name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.95143 lon: -91.77127 facility: Mercy Clinic-Rolla-Cancer and Hematology status: RECRUITING city: Rolla state: Missouri zip: 65401 country: United States name: Site Public Contact role: CONTACT phone: 573-458-6379 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.95143 lon: -91.77127 facility: Heartland Regional Medical Center status: RECRUITING city: Saint Joseph state: Missouri zip: 64506 country: United States name: Site Public Contact role: CONTACT phone: 816-271-7937 email: linda.schumacher@mymlc.com name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 39.76861 lon: -94.84663 facility: Saint Louis Cancer and Breast Institute-South City status: RECRUITING city: Saint Louis state: Missouri zip: 63109 country: United States name: Site Public Contact role: CONTACT phone: 314-353-1870 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Mercy Hospital South status: RECRUITING city: Saint Louis state: Missouri zip: 63128 country: United States name: Site Public Contact role: CONTACT phone: 314-525-6042 email: Danielle.Werle@mercy.net name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Mercy Hospital Saint Louis status: RECRUITING city: Saint Louis state: Missouri zip: 63141 country: United States name: Site Public Contact role: CONTACT phone: 314-251-7066 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Mercy Hospital Springfield status: RECRUITING city: Springfield state: Missouri zip: 65804 country: United States name: Site Public Contact role: CONTACT phone: 417-269-4520 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: CoxHealth South Hospital status: RECRUITING city: Springfield state: Missouri zip: 65807 country: United States name: Site Public Contact role: CONTACT phone: 417-269-4520 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: Mercy Hospital Washington status: RECRUITING city: Washington state: Missouri zip: 63090 country: United States name: Site Public Contact role: CONTACT phone: 636-390-1600 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.55811 lon: -91.01209 facility: Strecker Cancer Center-Belpre status: RECRUITING city: Belpre state: Ohio zip: 45714 country: United States name: Site Public Contact role: CONTACT phone: 800-523-3977 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.27396 lon: -81.5729 facility: Adena Regional Medical Center status: RECRUITING city: Chillicothe state: Ohio zip: 45601 country: United States name: Site Public Contact role: CONTACT phone: 877-779-7585 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.33312 lon: -82.9824 facility: Mount Carmel East Hospital status: RECRUITING city: Columbus state: Ohio zip: 43213 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: The Mark H Zangmeister Center status: RECRUITING city: Columbus state: Ohio zip: 43219 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Mount Carmel Health Center West status: RECRUITING city: Columbus state: Ohio zip: 43222 country: United States name: Site Public Contact role: CONTACT phone: 614-234-5433 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Central Ohio Breast and Endocrine Surgery status: RECRUITING city: Gahanna state: Ohio zip: 43230 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2745 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.01923 lon: -82.87934 facility: Mount Carmel Grove City Hospital status: RECRUITING city: Grove City state: Ohio zip: 43123 country: United States name: Site Public Contact role: CONTACT phone: 877-779-7585 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.88145 lon: -83.09296 facility: Zangmeister Center Grove City status: RECRUITING city: Grove City state: Ohio zip: 43123 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2745 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.88145 lon: -83.09296 facility: Fairfield Medical Center status: RECRUITING city: Lancaster state: Ohio zip: 43130 country: United States name: Site Public Contact role: CONTACT phone: 740-687-8863 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.71368 lon: -82.59933 facility: Saint Rita's Medical Center status: RECRUITING city: Lima state: Ohio zip: 45801 country: United States name: Site Public Contact role: CONTACT phone: 419-226-9617 name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.74255 lon: -84.10523 facility: Marietta Memorial Hospital status: RECRUITING city: Marietta state: Ohio zip: 45750 country: United States name: Site Public Contact role: CONTACT phone: 800-523-3977 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.41535 lon: -81.45484 facility: Memorial Hospital status: RECRUITING city: Marysville state: Ohio zip: 43040 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.23645 lon: -83.36714 facility: Knox Community Hospital status: RECRUITING city: Mount Vernon state: Ohio zip: 43050 country: United States name: Site Public Contact role: CONTACT phone: 740-393-9000 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.3934 lon: -82.48572 facility: Mount Carmel New Albany Surgical Hospital status: RECRUITING city: New Albany state: Ohio zip: 43054 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2745 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.08117 lon: -82.80879 facility: Licking Memorial Hospital status: RECRUITING city: Newark state: Ohio zip: 43055 country: United States name: Site Public Contact role: CONTACT phone: 740-348-4000 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.05812 lon: -82.40126 facility: Newark Radiation Oncology status: RECRUITING city: Newark state: Ohio zip: 43055 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.05812 lon: -82.40126 facility: Mercy Health Perrysburg Cancer Center status: RECRUITING city: Perrysburg state: Ohio zip: 43551 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 41.557 lon: -83.62716 facility: Southern Ohio Medical Center status: RECRUITING city: Portsmouth state: Ohio zip: 45662 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 38.73174 lon: -82.99767 facility: Springfield Regional Cancer Center status: RECRUITING city: Springfield state: Ohio zip: 45504 country: United States name: Site Public Contact role: CONTACT phone: 937-528-2900 email: clinical.trials@daytonncorp.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.92423 lon: -83.80882 facility: Springfield Regional Medical Center status: RECRUITING city: Springfield state: Ohio zip: 45505 country: United States name: Site Public Contact role: CONTACT phone: 937-528-2900 email: clinical.trials@daytonncorp.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.92423 lon: -83.80882 facility: Saint Vincent Mercy Medical Center status: RECRUITING city: Toledo state: Ohio zip: 43608 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 41.66394 lon: -83.55521 facility: Mercy Health - Saint Anne Hospital status: RECRUITING city: Toledo state: Ohio zip: 43623 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 41.66394 lon: -83.55521 facility: Saint Ann's Hospital status: RECRUITING city: Westerville state: Ohio zip: 43081 country: United States name: Site Public Contact role: CONTACT phone: 614-234-5433 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.12617 lon: -82.92907 facility: Clinton Memorial Hospital status: RECRUITING city: Wilmington state: Ohio zip: 45177 country: United States name: Site Public Contact role: CONTACT phone: 937-283-2273 name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.44534 lon: -83.82854 facility: Genesis Healthcare System Cancer Care Center status: RECRUITING city: Zanesville state: Ohio zip: 43701 country: United States name: Site Public Contact role: CONTACT phone: 740-454-5232 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.94035 lon: -82.01319 facility: Mercy Hospital Oklahoma City status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73120 country: United States name: Site Public Contact role: CONTACT phone: 405-752-3402 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 35.46756 lon: -97.51643 hasResults: False

 nctId: NCT06295354 id: 2024-17062 briefTitle: Early Variations in Immune Aging acronym: EVIA-NL overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-12 date: 2028-12 date: 2024-03-06 date: 2024-03-06 name: Radboud University Medical Center class: OTHER briefSummary: Background:

Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes.

Study design:

A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between. conditions: Aging conditions: Aging Well conditions: Immuno Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: No intervention, we just study 'aging' measure: Immunological function measure: Immunological Aging Score measure: Biological Aging Score measure: Metagenomics measure: Genetics and epigenetics measure: Clinical events sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06295341 id: 01C312 briefTitle: Short Stature and Psychological Well-being acronym: PSICOSHORT overallStatus: RECRUITING date: 2023-05-10 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Istituto Auxologico Italiano class: OTHER briefSummary: The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA. conditions: Short Stature conditions: Short; Stature, Psychosocial studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 80 type: ESTIMATED name: Recombinant human growth hormone (only for children with growth hormone deficiency) measure: Psychological well-being through the Psychological Well-Being Scales (PWB) measure: Psychological distress through the Depression Anxiety Stress Scale (DASS-21) measure: Quality of life through the Quality of Life in Short Stature Youth (QoLISSY), measure: Skills and problems through the Strengths and Difficulties Questionnaire (SDQ) measure: Behavioral problems through the Child Behaviour Checklist for Children (CBCL) sex: ALL minimumAge: 6 Years maximumAge: 14 Years stdAges: CHILD facility: Istituto Auxologico Italiano status: RECRUITING city: Milano zip: 20145 country: Italy name: Alessandro Sartorio, MD role: CONTACT phone: +390261911 phoneExt: 2426 email: sartorio@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06295328 id: NL 72439.018.19 briefTitle: From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients acronym: HepBTer overallStatus: RECRUITING date: 2022-04-13 date: 2024-04-01 date: 2024-04-01 date: 2024-03-06 date: 2024-03-06 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: Rationale: Currently, there is no curative therapy available for patients that are chronically infected with the hepatitis B virus (HBV). Especially the presence of a viral reservoir of stable episomal, covalently closed circular DNA (cccDNA) in the nucleus of infected hepatocytes poses a great challenge for the development of curative therapies. HBV cccDNA acts as the template for production of viral proteins and HBV genomes. In a preclinical study, terbinafine (an antifungal agent) was identified as a potent and specific suppressor of HBx-mediated cccDNA transcription. HBx is an accessory viral protein of HBV which has been proven to be essential for HBV replication and enhances replication at the transcriptional level in vivo. The suppression of cccDNA transcription results in a strong reduction of the production of viral genomes (RNA and DNA) as well as viral proteins. This will allow recovery of the immune system, increase viral clearance and prevent replenishment of the cccDNA pool in the hepatocyte, all contributing to cure chronic hepatitis B (CHB).

Objective: to provide proof of concept for the inhibition of HBx mediated cccDNA transcription by terbinafine, both as monotherapy and add-on therapy next to tenofovir. Secondary outcomes will be the safety and tolerability of terbinafine in this specific group.

Study design: This pilot study is a stratified, single center, randomized, double-blinded, placebo-controlled, dose-ascending proof of concept clinical trial.

Study population: patients chronically infected with the hepatitis B virus with a normal liver function and no signs of liver damage, who do not use any antiviral medication (group A, n=16) or are treated with tenofovir \> 6 months (group B, n=16).

Intervention: Patients will be randomly allocated to daily oral treatment with terbinafine or a matched placebo, either as monotherapy (group A) or as add-on therapy to tenofovir (group B).

Main study parameters/endpoints: Primary outcomes: decline in level of serum HBsAg \>0.32log10 IU/mL in both groups A and B and decline in serum HBV DNA \>0.86log10 in group A at the end of study treatment (week 10 vs baseline). Secondary outcomes: 1) Safety and tolerability of terbinafine as mono- or combination therapy; 2) level of serum HBsAg and HBV DNA at 3 months follow-up; 3) decline of HBsAg levels over time (all visits); 4) HBV RNA, large HBsAg (LHBs) HBcrAg levels, and HBeAg status at baseline and end of study 4).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will undergo physical examinations and blood sample collections (13 samples and in total 467.5 mL). They will also be asked to fill in the HBQOL and EQ5D5L quality of life questionnaires and a medicine diary. In total there will be 13 visits in the hospital of which 7 will be for blood collection only. Terbinafine can induce liver damage 1 of 50,000 to 120,000 prescriptions (LiverTox), a weekly safety laboratory control is implemented in the visits to detect possible liver toxicity in an early stage and prevent liver damage. conditions: Chronic Hepatitis b studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase 1b study with two parallel treatment arms and placebo controls. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Terbinafine name: Placebo name: Tenofovir measure: Change in level of serum HBsAG measure: Change in serum HBV DNA measure: Safety of terbinafine measure: Tolerability of terbinafine measure: Serum levels of HBsAG measure: Serum levels of HBV DNA measure: Serum levels of HBV RNA measure: Serum levels of HBcrAg sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: M.W. Peters, RN role: CONTACT phone: +31207320393 email: m.w.peters@amsterdamumc.nl name: D.J. van Doorn, MD role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06295315 id: 01C310 briefTitle: Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome acronym: PROPSICOPWS overallStatus: RECRUITING date: 2023-04-21 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Istituto Auxologico Italiano class: OTHER briefSummary: The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated. conditions: Prader-Willi Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED measure: Psychological well-being through the Psychological General Well-Being Index (PGWBI) measure: Perception of life quality through the 36-Item Short Form Survey (SF-36) measure: Mental distress through the Symptom Checklist-90-R (SCL-90-R) measure: Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21) measure: Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version). measure: Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Istituto Auxologico Italiano IRCCS, site Piancavallo status: RECRUITING city: Oggebbio state: Verbania zip: 28824 country: Italy name: Alessandro Sartorio, MD role: CONTACT phone: +390261911 phoneExt: 2426 email: sartorio@auxologico.it lat: 45.99088 lon: 8.64663 hasResults: False

 nctId: NCT06295302 id: RFCU-IIa-202308 briefTitle: A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria overallStatus: RECRUITING date: 2023-12-13 date: 2025-12 date: 2026-01 date: 2024-03-06 date: 2024-03-07 name: Hubei Biological Medicine Industrial Technology Institute Co., Ltd. class: OTHER briefSummary: This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated. conditions: Chronic Spontaneous Urticaria 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: HWH486 name: Placebo measure: Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7) measure: Change in Hive Severity Score (HSS) over a 7-day period (HSS7) measure: Change in Itch Severity Score (ISS) over a 7-day period (ISS7) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital,Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Bioethics Committee of West China Hospital role: CONTACT phone: +86 28 8512 3237 lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06295289 id: ZRKY-2023-04 briefTitle: Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial overallStatus: RECRUITING date: 2023-10-16 date: 2024-10-04 date: 2024-12-04 date: 2024-03-06 date: 2024-03-06 name: Huazhong University of Science and Technology class: OTHER briefSummary: Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period. conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Hybrid Closed-loop Insulin Delivery System name: Insulin pump measure: TIR measure: TAR measure: TBR measure: MBG measure: postoperative infection sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Xuefeng Yu role: CONTACT phone: 02783662883 email: xfyu188@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06295276 id: HSOsnabruck briefTitle: Effect of Teletherapy-supported Training on Nursing Students overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Hochschule Osnabruck class: OTHER briefSummary: Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.

The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.

The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale conditions: Low Back Pain conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel comparative randomized controlled trial primaryPurpose: TREATMENT masking: NONE maskingDescription: Allocation concealment:

The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality. count: 40 type: ESTIMATED name: teletherapy-guided exercise programme name: Waiting list/control intervention measure: Neck Disability Index (NDI) measure: Oswestry Disability Index (ODI) measure: NRS Numeric rating scale for pain measure: Short-Form: SF 36-Quality of life measure: Global rating scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Diakonie Pflege Schule status: RECRUITING city: Osnabrück state: Niedersachsen zip: 49078 country: Germany name: Roland Simon, BScPTc role: CONTACT phone: 05068932755 email: helmut.simon@hs-osnabrueck.de lat: 52.27264 lon: 8.0498 hasResults: False

 nctId: NCT06295263 id: KYLL-202203-028-1 briefTitle: Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases overallStatus: RECRUITING date: 2022-03-01 date: 2026-06-28 date: 2026-06-29 date: 2024-03-06 date: 2024-03-15 name: Qilu Hospital of Shandong University class: OTHER name: Shandong University briefSummary: 1) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease.

(2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease.

(3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders.

(4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients. conditions: Parkinson Disease conditions: Alzheimer Disease conditions: Nervous System Diseases conditions: Geriatric Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 460 type: ESTIMATED name: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers measure: Handwriting measure: gait measure: speech measure: eye movements measure: biological samples (blood, urine, stool, saliva, etc.) measure: images measure: EEG measure: other relevant markers sex: ALL minimumAge: 8 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: Wenjing Jiang role: CONTACT phone: 18560082210 email: jiangwenjing@qiluhospital.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06295250 id: STUDY00001114 id: 7R01MH127577 type: NIH link: https://reporter.nih.gov/quickSearch/7R01MH127577 briefTitle: ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-12-30 date: 2027-12-30 date: 2024-03-06 date: 2024-03-06 name: University of Massachusetts, Worcester class: OTHER name: International Centre for Diarrhoeal Disease Research, Bangladesh name: Georgetown University name: National Institute of Mental Health (NIMH) name: Albert Einstein College of Medicine briefSummary: The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\[s\] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months. conditions: Depression conditions: Economic Vulnerability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Interventionists and outcome assessors will not be informed regarding the study design and research question. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 660 type: ESTIMATED name: Manualized Group Based Psychotherapy name: Poverty Alleviation measure: Change in Depressive symptoms at 24 Months measure: Change in Depressive symptoms at intermediate timepoints measure: 24 Month Relapse measure: Economic vulnerability measure: Anxiety measure: Function measure: European Quality of Life Five Dimensions Five Level scale measure: Tension Scale measure: Implementation Outcomes--Adoption measure: Implementation Outcomes--Feasibility measure: Implementation outcomes--fidelity sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: International Centre for Diarrhoeal Disease Research city: Dhaka country: Bangladesh name: Fahmida Tofail, MBBS, PhD role: CONTACT email: ftofail@icddrb.org lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06295237 id: i-Sync briefTitle: Automatic Adjustment for Asynchronies During Mechanical Ventilation acronym: i-Sync overallStatus: RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-07-01 date: 2024-03-06 date: 2024-03-08 name: Hospital San Carlos, Madrid class: OTHER name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa briefSummary: Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software. conditions: Mechanical Ventilation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Two 2-hour periods: 1) "off mode" consisting of a control period with optimized ventilator parameters and 2) "on mode" with an active automated detection and adjustment for asynchronies. The starting first period is randomized. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Anonymized evaluation whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intellisync+ measure: Duration of asyncronies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clinico San Carlos status: RECRUITING city: Madrid zip: 28040 country: Spain name: Miguel Sanchez-Garcia, MD role: CONTACT phone: +34658762739 email: miguelsanchez.hcsc@gmail.com name: Paloma Gonzalez-Arenas, MD role: CONTACT phone: +34 670 57 66 45 email: pgarenas@gmail.com name: David Janeiro Lumbreras, MD role: SUB_INVESTIGATOR name: Fernando Suarez-Sipmann, MD role: PRINCIPAL_INVESTIGATOR name: José Antonio Sánchez-Giralt, MD role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06295224 id: GOKAEK-2024/02.19 briefTitle: Retrospective Evaluation of Effect of Anterior Iliac Block overallStatus: RECRUITING date: 2024-01-01 date: 2024-03-10 date: 2024-03-15 date: 2024-03-06 date: 2024-03-06 name: Kocaeli University class: OTHER briefSummary: In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure. conditions: Regional Anesthesia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 14 type: ESTIMATED measure: Morphine consumption measure: NRS score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli Universty status: RECRUITING city: Kocaeli country: Turkey name: Hadi Ufuk Yörükoğlu role: CONTACT email: ufukyorukoglu@gmail.com lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06295211 id: FEDII_HL_PR/R-Bv-Bs briefTitle: Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study. acronym: HL_PR/R-B overallStatus: COMPLETED date: 2013-09-01 date: 2023-09-01 date: 2024-02-22 date: 2024-03-06 date: 2024-03-06 name: Federico II University class: OTHER briefSummary: This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023. conditions: Hodgkin Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 32 type: ACTUAL name: observational measure: Overall survival measure: Progression overall survival measure: Response to treatment measure: Incidence of treatment emergent adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06295198 id: OPMM-Ankle Instability briefTitle: The Effect of Different Talocrural Joint Mobilization Techniques in Lateral Ankle Sprain overallStatus: RECRUITING date: 2023-07-30 date: 2024-03-01 date: 2024-03-30 date: 2024-03-06 date: 2024-03-08 name: Bahçeşehir University class: OTHER briefSummary: Decreased ankle dorsiflexion range of motion (DFROM) has been identified among the factors that increase the risk of lateral ankle sprain (LAS) in basketball players. Restoring the DFROM is important in restoring reduced functional abilities and reducing the risk of re-injury. There is evidence that talocrural joint mobilization improves DFROM, but studies investigating the effectiveness of different mobilization techniques are needed. Our study aims to investigate the effects of single-session Mulligan and Maitland talocrural joint mobilization methods on dorsiflexion joint range of motion, jumping performance, and kinesiophobia in elite basketball players. conditions: Ankle Sprains conditions: Ankle Injuries conditions: Kinesiophobia conditions: Jumping From Height studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants with lateral ankle sprains will be randomized to the Mulligan and Maithland groups, and their evaluations and treatments will be completed. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: After evaluations, the groups determined as a result of randomization via a website were placed in opaque envelopes. The participant is randomized to one of the Mulligan or Maitland groups by selecting an envelope. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Single lep drop jump test measure: Single-leg drop jump test measure: Weight-bearing lunge test measure: Tampa kinesiophobia scale measure: Fear Avoidance Belief Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Bahcesehir University status: RECRUITING city: Besiktas state: Istanbul zip: 34353 country: Turkey name: Pelin Pişirici, PT, PhD role: CONTACT phone: 05055016076 email: pelinpisirici@gmail.com name: Ozlem Feyzioglu, PT, PhD role: CONTACT phone: 05353529794 email: fztozlemfeyzioglu@gmail.com hasResults: False

 nctId: NCT06295185 id: AJOUIRB-IV-2024-097 briefTitle: Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-07-01 date: 2024-03-06 date: 2024-03-06 name: Ajou University School of Medicine class: OTHER briefSummary: The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'. conditions: Depression conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: application MARO name: Sham application measure: Change in network on the Standard Name Generator Approach scale measure: Change in depression symptoms severity on the Patient Health Questionnaire-9 measure: Change in social capital on the Social Capital Scale measure: Change in perceived workload on the Perceived Workload Scale measure: Change in job self-efficacy on the Job Self-Efficacy Scale measure: Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale measure: Change in work orientation toward his or her job on the Work Orientation Scale measure: Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees measure: Change in firm performance on the Company weekly sales records measure: Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities measure: Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire measure: Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale measure: Change in perceived stress level on the Perceived Stress Scale measure: Change in social functioning on Social Adaptation Self Rating Scale measure: Change in positive psychological capital on Korean version of Positive Psychological Capital Scale measure: Change in Organizational Companionship on Organizational Culture Inventory measure: Change in individual's social network on Lubben Social Network Scale-18 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295172 id: LF15_NLF_301 briefTitle: A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2025-09-30 date: 2026-04-30 date: 2024-03-06 date: 2024-03-06 name: Samyang Biopharmaceuticals Corporation class: INDUSTRY briefSummary: The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds conditions: Nasolabial Folds studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 73 type: ESTIMATED name: Lafullen15 name: Lafullen measure: Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator sex: ALL minimumAge: 19 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295159 id: MCC-22574 briefTitle: Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma overallStatus: RECRUITING date: 2024-02-28 date: 2027-03 date: 2027-03 date: 2024-03-06 date: 2024-03-13 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER briefSummary: The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system. conditions: Melanoma Stage III conditions: Melanoma Stage IV conditions: Advanced Melanoma conditions: Melanoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Nivolumab name: Nivolumab + Relatlimab name: Ipilimumab measure: Pathologic Major Response (pMR) measure: Preoperative Radiologic Response Rate measure: Complete Pathologic Response Rate (pCR) measure: Partial Pathologic Response Rate (pPR) measure: Non-Response Pathologic Response Rate (pNR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) 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: Justin Martin role: CONTACT phone: 813-745-7544 email: Justin.Martin@moffitt.org name: Ahmad Tarhini, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06295146 id: STUDY23050075 briefTitle: Virtual Peer Coaching in Manual Wheelchair Skills overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12-30 date: 2027-12-30 date: 2024-03-06 date: 2024-03-06 name: University of Pittsburgh class: OTHER briefSummary: The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program. First, peer coaches will be enrolled and trained. Then, trainees will be enrolled into one of three interventions: intervention with remote feedback (Group 1), wait list control group (Group 2), and structured self-study (Group 3). conditions: Wheelchair conditions: Paraplegia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: For trainees, we will use a randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After we have completed enrollment for Groups 1 and 2 (N=40 per group) we will enroll participants into Group 3 ( N=40 per group). primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 132 type: ESTIMATED name: Intervention A: 1-on-1 wheelchair skills training by a peer coach name: Intervention B: Training via educational videos measure: Capacity, confidence, and performance of wheelchair skills will improve following training measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline following training measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (6 months) measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (12 months) measure: Goal Attainment Scale (GAS) improvement from baseline (post training) measure: Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (6 months) measure: Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (1 year) measure: Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (6 months) measure: Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (1 year) measure: Life Space Assessment (LSA) improvement from baseline (6 months) measure: Life Space Assessment (LSA) improvement from baseline (1 year) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295133 id: PROMESS - STRESS briefTitle: Preventive Remediation of Stress for Optimal MEdical StudentS overallStatus: RECRUITING date: 2023-11-11 date: 2024-09-30 date: 2024-09-30 date: 2024-03-06 date: 2024-03-06 name: Research on Healthcare Performance Lab U1290 class: OTHER briefSummary: Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities.

Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum.

Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies.

The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction. conditions: Health Behavior conditions: Health-Related Behavior conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All volunteers will receive a stress management intervention. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Stress measure: Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS). measure: Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory. measure: Big-5 : scores obtained at the Big-5 questionnaire. measure: Coping strategies : scores obtained at the Brief Cope Inventory (BCI). measure: Perceived level of stress : score obtained at the Perceived Stress Scale measure: Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention. measure: Heart rate variability (HRV) marker: SDNN during the pre-intervention. measure: Heart rate variability (HRV) marker: RMSSD during the pre-intervention. measure: Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention. measure: Heart rate variability (HRV) marker: pnn50% during the pre-intervention. measure: Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI). measure: Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention. measure: Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention. measure: Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention. measure: Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention. measure: Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention. measure: VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors measure: VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress. measure: VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level. measure: VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations. measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RESHAPE status: RECRUITING city: Lyon zip: 69008 country: France name: Sophie Schlatter, Dr. role: CONTACT phone: 07 68 21 05 51 phoneExt: 33 email: sophie.schlatter@univ-lyon1.fr name: Angèle Métais, Dr. role: CONTACT phone: 06 77 39 89 66 phoneExt: 33 email: angele.metais@univ-lyon1.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06295120 id: 362-1 briefTitle: The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D) acronym: CAP-D overallStatus: RECRUITING date: 2023-11-13 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-20 name: Research Unit for General Practice in Aalborg class: OTHER briefSummary: The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.

Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.

Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Phenoxymethylpenicillin 1.2 MIE 4 times daily measure: Treatment failure at day 30 measure: Clinical recovery at day 8 measure: The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score measure: Prolonged antibiotic treatment measure: Change in type of antibiotic measure: Relapse of acute Lower Respiratory Tract Infection (LRTI) measure: Reconsultation measure: New prescriptions within 30 days measure: Hospitalisation measure: Mortality measure: Adverse events measure: Treatment adherence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Research Unit for General Practice Aalborg status: RECRUITING city: Gistrup zip: 9260 country: Denmark name: Line Maj Jensen role: CONTACT phone: +45 25 69 99 33 email: lmj@dcm.aau.dk lat: 56.9943 lon: 9.99085 hasResults: False

 nctId: NCT06295107 id: 2023-00195-01 briefTitle: Reliability of Range of Movement Measurements in Cerebral Palsy overallStatus: RECRUITING date: 2023-10-01 date: 2024-07-01 date: 2024-07-01 date: 2024-03-06 date: 2024-03-06 name: Region Skane class: OTHER briefSummary: The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability. conditions: Cerebral Palsy conditions: Movement Disorders in Children studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: Ankle Passive Range of Movement (pROM) name: Knee Passive Range of Movement (pROM) measure: Ankle range of motion measure: Knee range of motion sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Children Habilitation Unit status: RECRUITING city: Lund state: Skane zip: 22241 country: Sweden name: Olof Linden, MD role: CONTACT phone: 0046708475690 email: olof.linden@skane.se lat: 55.70584 lon: 13.19321 hasResults: False

 nctId: NCT06295094 id: PIPAC-OPC6 briefTitle: The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients. acronym: EPICURE overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-01 date: 2028-01 date: 2024-03-06 date: 2024-03-06 name: Odense University Hospital class: OTHER name: Karolinska University Hospital briefSummary: The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment. conditions: Gastric Cancer conditions: Chemotherapy, Adjuvant conditions: Peritoneal Metastases conditions: Minimally Invasive Surgical Procedures studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 264 type: ESTIMATED name: Cisplatin name: Doxorubicin measure: Peritoneal disease-free survival measure: Disease-free survival measure: Overall survival measure: Length of stay measure: Postoperative toxicity measure: Postoperative complications measure: Postoperative mortality measure: Rate of positive peritoneal lavage measure: Patient-reported Quality of life measure: Patient-reported Quality of life measure: Number of patients not receiving adjuvant chemotherapy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope city: Duarte state: California zip: 91010 country: United States name: Yanghee Woo, PhD role: CONTACT email: yhwoo@coh.org lat: 34.13945 lon: -117.97729 facility: Odense University Hospital city: Odense C zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: University Hospital Lille city: Lille country: France name: Clarisse Eveno, PhD role: CONTACT email: clarisse.eveno@gmail.com lat: 50.63297 lon: 3.05858 facility: Charité, University of Berlin city: Berlin country: Germany name: Beate Rau, PhD role: CONTACT email: beate.rau@charite.de lat: 52.52437 lon: 13.41053 facility: Karolinska University Hospital city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06295081 id: NL79864.091.22 id: 112927 type: OTHER domain: RadboudUMC briefTitle: TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance acronym: TREAT overallStatus: RECRUITING date: 2022-06-15 date: 2024-07-01 date: 2044-07-01 date: 2024-03-06 date: 2024-03-06 name: Radboud University Medical Center class: OTHER name: Maastricht University Medical Center briefSummary: The goal of this observational study is to learn about cardiac biomarker release following exercise in amateur athletes.

The main questions it aims to answer are:

Question 1: What are the reference values for exercise-induced cardiac troponin elevations following walking, cycling and running exercise? Hypothesis 1: We hypothesize that the exercise-induced cTn release is different following walking, cycling and running exercise. Therefore, we will establish reference values for post-exercise cTn concentrations across each of these sport types.

Question 2: Is the prevalence of (subclinical) coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations? Hypothesis 2: We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations.

Question 3: What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events (MACE) and mortality during long-term follow-up? Hypothesis 3: We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up.

This study consists of three phases:

Phase 1: two or three visits to the study location for (amongst other measurements) blood draws to assess cardiac troponin concentrations

Phase 2: CT scan of the heart in 10% of participants to assess the prevalence of (subclinicial) coronary artery disease.

Phase 3: longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up.

Participants will visit our study centre two, three or four times:

Visit 1: baseline measurements including height, weight, body composition and blood pressure will be obtained and a blood sample will be drawn.

Visit 2: a blood sample will be drawn and activity data will be obtained from participants' own sports watch or bike computer.

Optional visit 3: a blood sample will be drawn. Visit 4: 10% of participants will undergo a cardiac CT scan to assess the prevalence of (subclinical) coronary artery disease. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Exercise exposure measure: High-sensitivity cardiac troponin I (hs-cTnI) measure: High-sensitivity cardiac troponin T (hs-cTnT) measure: General CT scan data measure: Coronary artery calcification score measure: Coronary stenosis and plaque characteristics measure: Computed tomography derived Fractional Flow Reserve measure: Incidence of mortality measure: Incidence of major adverse cardiovascular events measure: Participant characteristics (personal info) measure: Participant characteristics (baseline measurements) measure: Participant characteristics (Exercise characteristics): measure: Medical History questionnaire, part 1 (general info and cardiovascular complaints) measure: Medical History questionnaire, part 2 (diseases and/or conditions) measure: Medical History questionnaire, part 3 (family history, COVID-19 info and medication use) measure: Exercise History questionnaire, part 1 (exercise history, participation in endurance races and current training status) measure: Exercise History questionnaire, part 2 (strength exercise) measure: Other biomarker concentrations in blood sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RadboudUMC status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 GC country: Netherlands name: Sylvan Janssen, MSc role: CONTACT phone: +31243613416 email: sylvan.janssen@radboudumc.nl name: IKS Integraal kwaliteitssysteem role: CONTACT phone: +31243614894 email: integraalkwaliteitssysteemwetenschappelijkonderzoek@radboudumc.nl lat: 51.8425 lon: 5.85278 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-01-16 uploadDate: 2023-04-13T09:57 filename: Prot_SAP_ICF_000.pdf size: 852144 hasResults: False

 nctId: NCT06295068 id: PRT-1400-11 briefTitle: Evaluation of ARi With OpSens SavvyWire acronym: ARi overallStatus: RECRUITING date: 2023-11-30 date: 2024-04-30 date: 2024-04-30 date: 2024-03-06 date: 2024-03-06 name: Opsens, Inc. class: INDUSTRY briefSummary: The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography. conditions: Aortic Valve Insufficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Transcatheter Aortic Valve Replacement (TAVR) name: Balloon Aortic Valvuloplasty (BAV) measure: Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography measure: Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography measure: Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AHS Morristown Medical Center status: RECRUITING city: Morristown state: New Jersey zip: 07960 country: United States name: Christine Ciprich role: CONTACT phone: 973-971-7541 email: christine.ciprich@atlantichealth.org name: Philippe Généreux, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79677 lon: -74.48154 hasResults: False

 nctId: NCT06295055 id: Dentistry Prince of Songkla briefTitle: Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA) acronym: SSBS for ABA overallStatus: RECRUITING date: 2024-01-04 date: 2024-10-31 date: 2025-06-30 date: 2024-03-06 date: 2024-03-06 name: Prince of Songkla University class: OTHER briefSummary: This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement. conditions: Guided Bone Regeneration conditions: Bone Formation conditions: Bone Volume studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Before- after augmentation in patients with alveolar bone defects primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Ridge augmentation with semi-rigid shell barrier system measure: Bone gain evaluation measure: Biocompatibility evaluation measure: Ridge volume change of alveolar ridge evaluation sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Songkla status: RECRUITING city: Songkhla state: Hatyai zip: 90110 country: Thailand name: panisa tantiwongs role: CONTACT phone: 0824864497 email: k-kampt@hotmail.com lat: 7.19882 lon: 100.5951 hasResults: False

 nctId: NCT06295042 id: 32-235 ex 19/20 briefTitle: Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction overallStatus: COMPLETED date: 2019-10-10 date: 2023-11-28 date: 2024-02-01 date: 2024-03-06 date: 2024-03-06 name: Medical University of Graz class: OTHER briefSummary: Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive. Despite the great demand for more in-depth, long-term studies of both techniques, current evidence is low or moderate and there are only few studies focusing on both health-related quality of life and complication rates in the same patient collective.

This study aims at investigating the complex relationship between the occurrence of complications and patient-reported long-time satisfaction in autologous and alloplastic breast reconstruction. conditions: Complications, Postoperative/Perioperative conditions: Quality of Life conditions: Satisfaction, Patient studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 162 type: ACTUAL name: BREAST-Q Questionnaire measure: Complications measure: Health-related quality of life and satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz city: Graz zip: 8036 country: Austria lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06295029 id: CPA-Z05-ZC-2023-002 briefTitle: Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-12-31 date: 2027-12-31 date: 2024-03-06 date: 2024-03-06 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: Severe neutropenia caused by venetoclax,a B-cell lymphoma-2(BCL-2) inhibitor, is the main cause of venetoclax tapering, drug discontinuation, and treatment delay. This study combines machine learning and genomics, hoping to develop models to predict venetoclax dose in Acute myeloid leukemia(AML) patients and compare the efficacy and safety differences of model-guided individualized medication regimen with current conventional regimen. According to the demographic information, the drug information, the drug concentration of the target patients, the laboratory examination, the single nucleotide polymorphism(SNP) information and the adverse reactions of the AML patients, and the model was constructed through machine learning. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Overall adverse event rate measure: Incidence of grade III and above adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06295016 id: NYCU112130AE briefTitle: Stressors and Recovery Regulation on the Super-compensation Effect overallStatus: RECRUITING date: 2023-09-01 date: 2024-08-31 date: 2025-08-31 date: 2024-03-06 date: 2024-03-06 name: National Yang Ming University class: OTHER briefSummary: Purpose: Investigating the effects of stressors and recovery regulation on the super-compensation effect of high-intensity intensive training (IT) in endurance athletes. Methods: This study will recruit 176 competitively trained endurance adult athletes. Participants will conduct a 7-week 3-stage experiment, including 3 weeks of regular training, 3 weeks of 130% progressive IT, and 1 week of 55% taper. Measurement will include training responses (performance and fatigue symptoms), stressors, recovery regulation, and mood state at baseline, during and after regular training, IT, and taper separately. According to the performance after taper, all participants will category into either the responder or non-responder of well-response to supercompensation effect. Statistic analysis: Independent t-test, Chi-squared test, and binary logistic regression will be used to compare the difference in training responses, stressors, recovery regulation, and mood state characteristics between responder and non-responder groups. P value sets at 0.15 for identifying the potential predictors. Logistic stepwise multiple regression will be used further to determine the significant predictors for the responders of well-response to the super-compensation among endurance athletes. P value sets at 0.05. conditions: Exercise Overtraining conditions: Stressor, Psychological studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The present study is designed as a prospective intervention and prognostic prediction study, employing a single-subject design with a reversal (ABA) design. This design involves a self-controlled intervention experiment with three phases: baseline training period (A), high-intensity, high-volume training period (B), and reduced training period (A). Subsequently, the study aims to explore predictive factors influencing the presence or absence of favorable compensatory training effects following the intervention. primaryPurpose: SCREENING masking: DOUBLE maskingDescription: Prior to the commencement of the experiment and during the experimental period, both the participants and the investigator will be unaware of whether the participants exhibit a good response to compensatory training effects. After the participants complete the entire experimental procedure, they will be grouped post hoc based on their outcomes following the intervention, according to predetermined criteria.

The criteria for determining whether there is a good response to compensatory training effects:

1. Non-response group: Exercise performance during the tapering period (week 7) shows a significant increase compared to post-intervention (week 6) and is higher than pre-intervention (week 3) exercise performance.
2. Response group: Exercise performance during the tapering period (week 7) shows a significant increase compared to post-intervention (week 6) and is higher than the change in exercise performance during normal training (= week 3 - week 1). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 158 type: ESTIMATED name: High-intensity intensive training name: Taper measure: Stressor measure: Recovery regulation measure: Mood state measure: Peak power output measure: Maximal heart rate measure: Fatigue state sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University status: RECRUITING city: Taipei zip: 112304 country: Taiwan name: Wei-Wun Tsai role: CONTACT phone: +886-02-2826-7939 email: tmwk@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06295003 id: CEFA-COVID briefTitle: Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department overallStatus: COMPLETED date: 2022-04-30 date: 2022-05-30 date: 2022-05-30 date: 2024-03-06 date: 2024-03-06 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Background: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom.

Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. The impact of COVID-19 on evaluation rates was quantified by using the incidence rate ratio (IRR) and 95% confidence intervals (CI) between the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020). conditions: COVID-19 conditions: Headache Disorders conditions: Emergency Service, Hospital studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 700 type: ACTUAL measure: During the study period, 890 evaluations were registered: the number of partecipants was 689 over the prepandemic period and 201 over the pandemic period. Mean age at evaluation was 10 years (range: 1 to 17 years). measure: Evaluation rates per month were 18.1 during the prepandemic period and 8.7 during COVID-19 pandemic, with peaks in autumn and winter and drops in summer. The reduction in evaluation rate was higher for secondary headache when compared with primary one sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06294990 id: 2023-505854-16-00 briefTitle: Klinefelter Syndrome and Testosterone Treatment in Puberty acronym: TiPY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-12-31 date: 2029-12-31 date: 2024-03-06 date: 2024-03-06 name: Lise Aksglæde class: OTHER briefSummary: The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY).

The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.

Participants will be randomized to two years treatment with testosterone or placebo. conditions: Klinefelter Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-center, national, randomized, double-blind, placebo-controlled intervention study primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Testosterone gel name: Placebo measure: Changes in body fat mass measure: Pubertal development and virilization measure: Height measure: Weight measure: Bone mineralization measure: Neuropsychological evaluation measure: Neuropsychological evaluation, sex: MALE minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD hasResults: False

 nctId: NCT06294977 id: CRISI-COVID briefTitle: Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department overallStatus: COMPLETED date: 2022-11-30 date: 2022-12-30 date: 2022-12-30 date: 2024-03-06 date: 2024-03-06 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Background. Seizures are a common cause of evaluation in the pediatric emergency department (ED). Several studies about the impact of COVID-19 pandemic on ED attendances report a considerable reduction in general pediatric care. The aim of our study was to evaluate the impact of COVID-19 on the admission to the pediatric ED for seizures.

Materials and methods. We performed a retrospective study to assess the rate of ED admission for seizures at the pediatric ED of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan between January 2017 and December 2021, comparing the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021). conditions: Epilepsy conditions: Emergency Services, Hospital conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ACTUAL measure: During the study period, 1,091 patients with seizures were admitted to pediatric ED, 776 before the pandemic and 315 during the pandemic. In particular, the evaluation rates per month were 20.4 before the pandemic and 14.3 afterward measure: Patients with a history of previous seizures showed a greater decrease in the monthly number of ED visits compared to those with a first seizure. An increased rate of unprovoked seizures and a decreased rate of provoked ones were observed in the pandemic sex: ALL minimumAge: 1 Month maximumAge: 17 Years stdAges: CHILD facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06294964 id: Sleep Education briefTitle: Intervention and Effect of Sleep Pattern on Cardio-cerebrovascular Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2025-06-01 date: 2026-11-30 date: 2024-03-06 date: 2024-03-06 name: RenJi Hospital class: OTHER briefSummary: Because of the growing population of older people, cardio-cerebrovascular diseases has been the most important aging-related chronic disease, studying the pathogenesis and early warning mechanisms of cardio-cerebrovascular diseases in depth, exploring optimal strategies for early diagnosis and treatments of cardio-cerebrovascular diseases has becoming the urgent public health problem in China. Aging causes cellular changes that change the sleep status in older adults, leading to an increased risk of disease and death. Meanwhile, the rising prevalence of chronic diseases among older adults also increases the impact of sleep deprivation. Insufficient sleep has being a serious challenge to the health status of the elderly. However, there is no clinically significant treatment for sleep disorders caused by chronic diseases. Medication helps to sleep but will also lead to drug dependence and increasing the risk of recurrent sleep disorders, which is unfavorable for disease control.

Studies have shown that older adults who sleep 7-8 hours at night have better physical and mental health, cognition and quality of life. Shorter sleep durations (6 hours or less) and longer sleep durations (greater than 9 hours) had strong associations with adverse health outcomes such as cardiovascular, metabolic, immune, cognitive diseases, other psychiatric disorders, and mortality.

Therefore, on the basis of the established Pudong community cohort, the project applicant led the team to adopt an open-label, blind endpoint, and cluster-randomized two-phase trial method to randomly assign cohort members into intervention group and control group. According to the sleep health intervention plan formulated by the clinical team, family doctor provides health education materials according to the actual situation of the intervention group regularly. Family doctors in the control group used conventional management methods. The final assessment was that compared to control group, whether the intervention group improved members' sleep quality, reduced members' cardiovascular disease events, and individual cardiovascular disease morbidity and all-cause mortality during the study period. conditions: Cardiovascular Diseases conditions: Non-Communicable Chronic Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12800 type: ESTIMATED name: sleep education, behavioral education measure: the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death measure: all cause death sex: ALL minimumAge: 60 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiology, Ren Ji Hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06294951 id: IIT-2023-0225 briefTitle: fMRI for BPS: A Descriptive Study of Findings and Symptoms overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-06 date: 2024-03-06 name: RenJi Hospital class: OTHER briefSummary: The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are:

1. To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population.
2. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS.

Participants will undergo fMRI as well as other routine laboratory tests and queries. conditions: Bladder Pain Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 120 type: ESTIMATED name: fMRI measure: fMRI findings sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: Zhebin Du, Dr. role: CONTACT phone: +86-13512179027 email: Dzbdzb1989@163.com name: Zhebin Du, Dr. role: PRINCIPAL_INVESTIGATOR name: Yinghui Fan, Dr. role: PRINCIPAL_INVESTIGATOR name: Yingfu Jiao, Dr. role: SUB_INVESTIGATOR name: Liang Dong, Dr. role: SUB_INVESTIGATOR name: Qixiang Song, Dr. role: SUB_INVESTIGATOR name: Xinxing Du, Dr. role: SUB_INVESTIGATOR name: Yanhao Dong, Dr. role: SUB_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06294938 id: M.WRI-2023-INQ-2224 briefTitle: Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects overallStatus: COMPLETED date: 2022-09-30 date: 2023-01-24 date: 2023-05-23 date: 2024-03-06 date: 2024-03-06 name: Mars Wrigley class: INDUSTRY name: INQUIS Clinical Research briefSummary: Cacao fruit pulp is a sweet and fruity carbohydrate-rich edible mucilage that is often discarded. The objective of this study is to assess the glycemic response and determine the glycemic index of cacao fruit pulp. conditions: Blood Sugar; High conditions: Blood Sugar; Low studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: acute, open-labeled, randomized design primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ACTUAL name: Cacao fruit pulp name: Dextrose measure: Plasma Glucose measure: Incremental area under the curve measure: Peak plasma glucose sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: INQUIS Clinical Research city: Toronto state: Onterio zip: M5C 2N8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06294925 id: C5041041 id: EFFECT-UC type: OTHER domain: Alias Study Number briefTitle: A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis acronym: EFFECT-UC overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2027-04-01 date: 2027-04-20 date: 2024-03-06 date: 2024-03-06 name: Pfizer class: INDUSTRY briefSummary: The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.

Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.

All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.

The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.

The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod. conditions: Colitis, Ulcerative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 260 type: ESTIMATED name: Etrasimod measure: Proportion of patients with symptomatic remission measure: Proportion of patients with symptomatic remission measure: Proportion of patients with clinical response measure: Proportion of patients with clinical response. measure: Proportion of corticosteroid-free patients with symptomatic remission sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294912 id: 7602-003 id: MK-7602-003 type: OTHER domain: Merck briefTitle: A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003) overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2025-03-10 date: 2025-03-10 date: 2024-03-06 date: 2024-03-06 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection. conditions: Malaria studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Plasmodium falciparum name: MK-7602 name: Artemether/lumefantrine name: Primaquine name: Artesunate name: Atovaquone/proguanil measure: Parasite reduction ratio (PRR48) (Parts 1 and 2) measure: Parasite Clearance Half-life (PCt1/2) (Parts 1 and 2) measure: Parasite Regrowth (Parts 1 and 2) measure: Part 1 Single dose: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of MK-7602 measure: Part 1 Single dose: Maximum Plasma Concentration (Cmax) of MK-7602 measure: Part 1 Single dose: Concentration at 24 Hours (C24) of MK-7602 measure: Part 1 Single dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602 measure: Part 1 Single dose: Elimination Half-life (t1/2) of MK-7602 measure: Part 2 Multiple dose: Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602 measure: Part 2 Multiple dose: Maximum Plasma Concentration (Cmax) of MK-7602 measure: Part 2 Multiple dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602 measure: Part 2 Multiple dose: Elimination Half-life (t1/2) of MK-7602 measure: Number of Participants Who Experience an Adverse Event (AE) measure: Number of Participants Who Discontinue Study Intervention Due to an AE sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06294899 id: 23/222-P briefTitle: CRP and Lung Ultrasound in Respiratory Evaluation acronym: PLURE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-30 date: 2028-09-01 date: 2024-03-06 date: 2024-03-06 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER briefSummary: Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists.

This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections. conditions: C-Reactive Protein conditions: Ultrasonography conditions: Primary Health Care conditions: Lower Respiratory Tract Infection studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 202 type: ESTIMATED name: Lung ultrasound measure: Ultrasound patterns measure: C-Reactive Protein sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294886 id: Innovis RD-2401 briefTitle: Vaginal Fluid Collection for Detection of Endometrial Cancer overallStatus: RECRUITING date: 2024-02-19 date: 2024-06-01 date: 2024-06-01 date: 2024-03-06 date: 2024-03-07 name: Innovis LLC class: INDUSTRY briefSummary: The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).

The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN. conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Screening test to detect endometrial cancer and precancer measure: Detection of endometrial cancer and precancer sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Trials365 status: RECRUITING city: Shreveport state: Louisiana zip: 71118 country: United States name: Jen Cory role: CONTACT phone: 318-408-1198 email: j.cory@trials365.org name: Destin Black, MD role: PRINCIPAL_INVESTIGATOR lat: 32.52515 lon: -93.75018 hasResults: False

 nctId: NCT06294873 id: Innovis RD-2301 briefTitle: Stool Sample Collection Study overallStatus: RECRUITING date: 2023-07-20 date: 2024-04-30 date: 2024-04-30 date: 2024-03-06 date: 2024-03-06 name: Innovis LLC class: INDUSTRY name: Exact Sciences Corporation briefSummary: The primary objective of this study is to obtain de-identified stool specimens from participants with colonoscopic biopsy-based histopathologic diagnosis of colorectal cancer (CRC) and/or a ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.

The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of neoplasms of the aerodigestive tract. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: A screening device for the detection of colorectal and other aerodigestive tract cancers measure: Detection of colon cancer or precancer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Associated Gastroenterology Medical Group status: RECRUITING city: Anaheim state: California zip: 92810 country: United States name: Brian Riff, MD role: CONTACT phone: 714-778-1300 phoneExt: 227 email: briff@agmg.com name: Brian Riff, MD role: PRINCIPAL_INVESTIGATOR lat: 33.83529 lon: -117.9145 facility: Sarkis Clinical Trials status: RECRUITING city: Ocala state: Florida zip: 34474 country: United States name: Jen Corcoran role: CONTACT phone: 352-363-5395 phoneExt: 272 email: merci@ehsfamily.com name: Vishnu Reddy, MD role: PRINCIPAL_INVESTIGATOR lat: 29.1872 lon: -82.14009 facility: Gastro One status: RECRUITING city: Cordova state: Tennessee zip: 38018 country: United States name: Brian Dragutsky role: CONTACT phone: 901-606-8924 email: brian.dragutsky@onegi.com name: Ziad Younes, MD role: PRINCIPAL_INVESTIGATOR lat: 35.15565 lon: -89.7762 hasResults: False

 nctId: NCT06294860 id: 01C317 briefTitle: Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy acronym: ETABIOGHD overallStatus: RECRUITING date: 2023-06-19 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-12 name: Istituto Auxologico Italiano class: OTHER briefSummary: The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism. conditions: Growth Hormone Deficiency conditions: Short Stature studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 12 type: ESTIMATED measure: Measurement of biological (epigenetic) age sex: ALL minimumAge: 5 Years maximumAge: 15 Years stdAges: CHILD facility: Istituto Auxologico Italiano status: RECRUITING city: Milano zip: 20145 country: Italy name: Alessandro Sartorio role: CONTACT phone: +390261911 phoneExt: 2426 email: sartorio@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06294847 id: 2021_0025 briefTitle: Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery acronym: UDCA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-10 date: 2024-03-06 date: 2024-04-11 name: Hopital Foch class: OTHER briefSummary: This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study.

The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).

120 patients will be enrolled and randomized in two groups:

* the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®)
* the control group "Placebo Group," with oral administration of the placebo. conditions: Retinal Detachment studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Ursolvan name: Placebo measure: Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (ETDRS scale) between the two groups (treatment and placebo) measure: Central Nervous Epithelium (CNE) thickness measure: Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups. measure: Contrast sensitivity measurement using the Clinic CSF2.0 application. measure: Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane). measure: Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants). measure: Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE. measure: Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT. measure: Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity. measure: Presence of metamorphopsia. measure: Tolerance and occurrence of adverse events. measure: National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative. measure: Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times. measure: Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Cochin city: Paris zip: 75014 country: France name: EYMARD Pauline, Dr role: CONTACT email: pauline.eymard@aphp.fr name: EYMARD Pauline role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Foch city: Suresnes zip: 92150 country: France name: Behar Cohen Francine, Pr role: CONTACT phone: 01 46 25 22 75 email: .behar-cohen@hopital-foch.com name: Behar Cohen Francine, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.87143 lon: 2.22929 hasResults: False

 nctId: NCT06294834 id: STUDY22010071 id: 90SIMS0010 type: OTHER_GRANT domain: NIDILRR briefTitle: Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users acronym: SKILL overallStatus: RECRUITING date: 2023-02-22 date: 2026-08-30 date: 2026-12-30 date: 2024-03-06 date: 2024-03-06 name: University of Pittsburgh class: OTHER name: Dalhousie University name: National Institute on Disability, Independent Living, and Rehabilitation Research briefSummary: The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program for clinicians. The study will use three-group approach: intervention with remote feedback (Group 1), control group (Group 2), and structured self-study (Group 3). This demonstrates how the intervention compares not only to a control, but also to the next "best alternative" - therapists sourcing web-based training materials and learning independently. conditions: Wheelchair Skills studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After enrollment for Groups 1 and 2 is complete, participants will be enrolled into Group 3. primaryPurpose: OTHER masking: SINGLE maskingDescription: For therapists, we will use a randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After we have completed enrollment for Groups 1 and 2 we will enroll participants into Group 3.

Rehabilitation professionals who are not therapists will be enrolled in Group 4. whoMasked: PARTICIPANT count: 240 type: ESTIMATED name: Part 1 of intervention A - Wheelchair skills training modules name: Part 2 of intervention A - Asynchronous feedback from a remote trainer name: Intervention B: Education on wheelchair provision measure: Change in Wheelchair Skills Test Questionnaire (WST-Q) score measure: Change in Self-Efficacy on Assessing, Training, and Spotting (SEATS) score measure: Change in number of wheelchair users trained measure: Change in quality of wheelchair skills trained measure: Change in rehab professional Wheelchair Skills Test Questionnaire (WST-Q) score measure: Change in rehab professional Self-Efficacy on Assessing, Training, and Spotting (SEATS) score measure: Change in rehab professional quantity of wheelchair users trained measure: Change in rehab professional quality of wheelchair training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pittsburgh / Rehab Neural Engineering Labs status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15219 country: United States name: Lee Tempest, BS role: CONTACT phone: 412-232-9326 email: tempestml@upmc.edu name: Debbie Harrington, BS role: CONTACT phone: 412-383-1355 email: debbie.harrington@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06294821 id: 00003845 briefTitle: 4AP to Delay Carpal Tunnel Release (CTR) acronym: CTR overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-12 date: 2028-07 date: 2024-03-06 date: 2024-03-12 name: John Elfar class: OTHER briefSummary: The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery. conditions: Compression Neuropathy conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: 4-Aminopyridine name: Placebo measure: Results of symptomatic improvement in the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) measure: Results of symptomatic improvement in the Michigan Hand Outcomes Questionnaire (MHQ) measure: Electrodiagnostic improvement following treatment sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294808 id: 2017-2601 briefTitle: Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC overallStatus: COMPLETED date: 2017-07-17 date: 2020-06-30 date: 2020-06-30 date: 2024-03-06 date: 2024-03-06 name: National Cancer Centre, Singapore class: OTHER name: Singapore General Hospital briefSummary: Clinical outcomes after surgical resection in HCC is a continuum and is clearly related to tumor burden but needs better definition. The researchers describe the use of the "metro ticket" approach to analyze surgical outcomes over the whole spectrum of anatomically resectable HCC to define overall survival including intermediate stage tumors (BCLC B). The analysis the researchers provide in this study enables the clinician to select the optimal surgical resection candidate based on robust long term survival data.

In addition, study compares outcome for open surgery vs laparoscopic surgery, survival outcome for viral and non-viral HCC using Albumin-Bilirubin (ALBI) for more comprehensive study result. conditions: Hepatocellular Carcinoma Resectable studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 1043 type: ACTUAL measure: 5-year mortality. measure: Concordance of pre-operative radiological and post operative surgical specimen. measure: Agreement between TBI calculated from pre-operative imaging versus those obtained from post-surgical pathological assessment. sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Centre, Singapore city: Singapore zip: 168583 country: Singapore lat: 1.28967 lon: 103.85007 facility: Singapore General Hospital city: Singapore zip: 169608 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06294795 id: 2-2024 briefTitle: Toric Intraocular Lens Implantation in Pediatric Cataract acronym: TILIPC overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-12-31 date: 2024-03-06 date: 2024-03-15 name: Kazakh Eye Research Institute class: NETWORK briefSummary: To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism conditions: Cataract Congenital conditions: Astigmatism conditions: IOL studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: congenital/pediatric cataract surgery name: Non-Toric IOLs name: Toric IOLs measure: Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity measure: Uncorrected (UCNVA) and corrected (CNVA) near visual acuity measure: Refraction measurements measure: Keratometry measurements sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Kazakh Eye Research Institute status: RECRUITING city: Almaty zip: 050012 country: Kazakhstan name: Kairat Ruslanuly, MD role: CONTACT phone: +77019008387 email: ruslanuly.kairat@gmail.com name: Zhansaya Sultanbayeva, MD role: CONTACT phone: +77023777735 email: sultanbayeva.zhansaya@gmail.com name: Lukpan Orazbekov, MD role: PRINCIPAL_INVESTIGATOR name: Kairat Ruslanuly, MD role: SUB_INVESTIGATOR name: Zhansaya Sultanbayeva, MD role: SUB_INVESTIGATOR name: Meruert Ashimova, MD role: SUB_INVESTIGATOR lat: 43.25667 lon: 76.92861 facility: Kazakh Eye Research Institute status: RECRUITING city: Astana zip: 010000 country: Kazakhstan name: Gulnaz Kassymbekova, MD role: CONTACT phone: +77478538289 email: GulnazKassymbekova@gmail.com name: Asiya Beisebayeva, MD role: CONTACT phone: +77018333953 name: Aigerim Tuletova, MD role: PRINCIPAL_INVESTIGATOR name: Asiya Beisebayeva, MD role: SUB_INVESTIGATOR name: Gulnaz Kassymbekova, MD role: SUB_INVESTIGATOR lat: 51.1801 lon: 71.44598 hasResults: False

 nctId: NCT06294782 id: 36/2022 briefTitle: PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia acronym: POPSTAR overallStatus: RECRUITING date: 2022-04-15 date: 2025-02 date: 2025-02 date: 2024-03-06 date: 2024-03-06 name: University of Turin, Italy class: OTHER name: Azienda Unità Sanitaria Locale Reggio Emilia name: IRCCS Sacro Cuore Don Calabria di Negrar name: Fondazione IRCCS Policlinico San Matteo di Pavia briefSummary: This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized. conditions: Refractory Ventricular Tachycardia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: STereotactic Arhythmia Radioablation (STAR) measure: VT storm and incessant VT measure: adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Turin status: RECRUITING city: Turin country: Italy name: Gaetano Maria De Ferrari role: CONTACT lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06294769 id: 022024 Maria Fernanda briefTitle: Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-06-19 date: 2024-07-19 date: 2024-03-06 date: 2024-03-06 name: University of Sao Paulo class: OTHER briefSummary: Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%. conditions: Acute Pain conditions: Perioperative/Postoperative Complications conditions: CAM conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 138 type: ESTIMATED name: essencial oil of lavandula angustifolia name: grape seed vegetable oil measure: Acute pain measure: Blood pressure (both systolic and diastolic) measure: Heart rate measure: Respiratory frequency measure: Oxygen saturation measure: Temperature sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06294756 id: acquealbuleroma1 id: AR1221816703484E type: OTHER_GRANT domain: La Sapienza University, Rome, Italy briefTitle: Sulfureous Water Therapy in Viral Respiratory Diseases acronym: STWandRVD overallStatus: COMPLETED date: 2023-05-30 date: 2023-08-01 date: 2023-09-30 date: 2024-03-06 date: 2024-03-06 name: University of Roma La Sapienza class: OTHER name: Università degli studi di Roma Foro Italico name: Queen Mary University of London name: Bios Prevention Srl briefSummary: The goal of this double-blind, interventional, randomized case-control, pilot trial is to evaluate the effects of active sulfurous (STW) versus placebo (SDW) inhalations on blood test parameters, serum inflammatory cytokines, spirometry data, as well as qualitative and quantitative changes in the nasal microbiome of subjects affected by long Covid.

The main questions it aims to answer are:

* if STW inhalations are effective on respiratory issues due to long covid compared to the placebo inhalation (SDW)
* if STW inhalations are effective on long covid related fatigue issues compared to the placebo inhalation (SDW)
* if H2S inhaled with STW is effective in modulating (decreasing) cytokines which are related to long covid cytokine storm compared to placebo inhalation with no H2S (SDW)
* if STW inhalation modify nasal microbiome both from a qualitative and quantitative point of view respect to placebo inhalation (SDW) Participants will be randomly assigned to active inhalations (STW) or placebo inhalations (SDW) arm and subjected to 12 consecutive sessions of 20 minutes.

Both arms will be tested for:

* cytokines and inflammatory markers concentration (IL1b, IL6, ACE, GSS, S100B, Hs-CRP)
* spirometry (resting, forced, DLCO)
* exertion response (6 minutes walking test)
* nasal microbiome sampling at visit 1 (enrolment), at visit 2(right after the inhalation treatment) and at visit 3 (3 months after treatment).

Researchers will compare results reported by STW to those of SDW group to see if significative differences are detectable. conditions: Long-COVID conditions: Post COVID-19 Condition conditions: Chronic COVID-19 Syndrome conditions: Post Acute Sequelae of COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a double-blind, interventional, randomized case-control, pilot trial assessing the efficacy of sulfureous thermal water (STW) inhalations in patients diagnosed with long-COVID. The eligible subjects were randomized in a 1:1 ratio to either: active (STW) or placebo (SDW) group for the inhalation therapy and tested at 3 timepoints: Visit 1 (prior treatment), Visit 2 (just after treatment) , Visit 3 (3 months after treatment). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Neither the participants nor any of the medical researchers or laboratory staff involved in the screening, enrolment, clinical evaluation, monitoring, and laboratory as well as statistics of the participant's analyses were aware of the study intervention received (STW vs SDW). A randomization list (1:1 active vs placebo) was created prior to recruiting. The inhalation assistant randomized the participant according to the list and administered the intervention. Therefore, the inhalation assistant was unblinded to the treatment assigned but blinded to the medical condition of the participants. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Inhalation of Sulfurous Thermal Water name: Inhalation of Sterile Distilled non-pyrogenic Water measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters. measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters. measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection measure: to assess whether thermal water inhalation determine changes in the perceived impact of respiratory related impairment on the quality of life (Qol) through a validate Saint George respiratory questionnaire measure: to assess whether thermal water inhalation determine changes in the perceived impact of respiratory related impairment on the quality of life (Qol) through a validate Saint George respiratory questionnaire sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Acque Albule, Terme di Roma city: Tivoli state: Rome zip: 00019 country: Italy lat: 41.95952 lon: 12.8016 hasResults: False

 nctId: NCT06294743 id: C202304001 briefTitle: Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea overallStatus: RECRUITING date: 2023-11-23 date: 2025-12-31 date: 2025-12-31 date: 2024-03-06 date: 2024-03-06 name: Taichung Armed Forces General Hospital class: OTHER_GOV briefSummary: The goal of this crossover study is to assessed the treatment efficacy of posterior tibia nerve neuroprolotherapy on dysmenorrhea. The primary outcome is the improvement of Visual Analogue Scale. The main question it aims to answer is:

•Could the posterior tibial nerve neuroprolotherapy alleviate the pain of dysmenorrhea.

Participants will be randomly allocated into two groups, Group-1 will receive neuroprolotherapy in the first 2 menstrual cycles followed by oral acetaminophen(500mg) for the subsequent 2 menstrual cycles. Group02 will received oral acetaminophen(500mg) in initial 2 menstrual cycles, followed by receiving neuroprolotherapy for the subsequent 2 menstrual cycles. conditions: Dysmenorrhea conditions: Prolotherapy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Group-1, posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles. Conversely.

Group-2, oral acetaminophen (500mg) will be given during the initial two menstrual cycles, followed by a transition to posterior tibial nerve neuroprolotherapy for the last two menstrual cycles. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Posterior tibial nerve neuroprolotherapy name: Acetaminophen 500Mg Tab measure: Visual Analogue Scale measure: The SF-36v2® Health Survey sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Taichung Armed Forces General Hospital status: RECRUITING city: Taichung state: Other (Non US) zip: 41168 country: Taiwan name: Jing-dung Shen, MD role: CONTACT phone: +886958878129 email: jdwhydo@gmail.com name: Jing-dung Shen, MD role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06294730 id: 2018/1891-31 briefTitle: COronary Microcirculation and Troponin Elevation in Septic Shock acronym: COMTESS overallStatus: RECRUITING date: 2019-06-13 date: 2024-06 date: 2024-12 date: 2024-03-05 date: 2024-03-05 name: Karolinska Institutet class: OTHER briefSummary: Plasma cardiac troponin (cTn) elevation is an indicator of increased mortality in patients with sepsis yet the underlying cause of troponin elevation in sepsis is not known. The COMTESS study investigates whether elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in hemodynamically unstable patients with sepsis can be explained by an underlying coronary artery disease or a process within the coronary microcirculation. Fifty patients with sepsis and with hs-cTnT elevation (\>15 ng/L) will undergo coronary angiography, including an assessment of coronary flow using a method called thermo-dilution to record the index of microcirculatory resistance (IMR) in the left anterior descending artery (LAD). The relationship between IMR and hs-cTnT will subsequently be analysed. It is important to identify the underlying causes of elevated cTn during sepsis to target further research with an aim to improve the survival in patients suffering from this condition. conditions: Sepsis conditions: Myocardial Injury conditions: Coronary Microvascular Dysfunction conditions: Endothelial Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Relationship between hs-cTnT and IMR measure: Relationship between hs-cTnT and CFR measure: Relationship between hs-cTnT and BRI measure: Relationship between hs-cTnT and number of diseased epicardial coronary vessels measure: Relationship between hs-cTnT and Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX)-score measure: Relationship between hs-cTnT and left ventricular end diastolic pressure (LVEDP) measure: Relationship between hs-cTnT and Tricuspid annular plane systolic excursion (TAPSE) measure: Relationship between hs-cTnT and echocardiographic measurements of left ventricular global strain measure: Relationship between hs-cTnT and echocardiographic measurements of left diastolic dysfunction measure: Relationship between measures of endothelial dysfunction and IMR measure: Relationship between measures NETs and IMR sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet, Danderyd University Hospital status: RECRUITING city: Stockholm zip: 182 88 country: Sweden name: Jonas Persson, MD, PhD role: CONTACT phone: +46 70-089 1412 email: jonas.persson@regionstockholm.se name: Samantha Lörstad, MD role: CONTACT phone: +46708693973 email: samantha.rutherford-lorstad@regionstockholm.se name: Jonas Persson, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Samantha Lörstad, MD role: SUB_INVESTIGATOR name: Tomas Jernberg, MD, PhD role: SUB_INVESTIGATOR name: Sara Tehrani, MD, PhD role: SUB_INVESTIGATOR name: Per Åstrand, MD role: SUB_INVESTIGATOR name: Christina Ekenbäck, MD role: SUB_INVESTIGATOR name: Fadi Jokhaji, MD role: SUB_INVESTIGATOR name: Kambiz Shahgaldi, PhD role: SUB_INVESTIGATOR name: Charlotte Thålin, MD, PhD role: SUB_INVESTIGATOR name: Patrik Gille-Johnson, MD, PhD role: SUB_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06294717 id: AtaturkUPhStudentNeslihanATLI briefTitle: The Effect of Progressive Relaxation Exercises on Physiological Parameters, Pain and Anxiety After Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-12-01 date: 2024-03-05 date: 2024-03-05 name: Ataturk University class: OTHER briefSummary: Caesarean section is a surgical procedure that can be performed before or during birth in cases where the life of the mother and fetus is threatened or upon the request of the mother and father. One of the most common problems after cesarean section is abdominal pain. Progressive relaxation exercises are a method that allows certain muscle groups in the body to first contract and then relax. Progressive relaxation exercises have been proven to have positive effects on anxiety. By applying progressive relaxation exercises, the parasympathetic nervous system is activated; Thus, heart and respiratory rate and blood pressure can be kept within normal limits. This study will be conducted to determine the physiological parameters, pain and anxiety levels of progressive relaxation exercises, one of the non-pharmacological methods, on women giving birth by cesarean section. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 2 type: ESTIMATED name: Progressive relaxation exercises will be applied. measure: Beck Anxiety Scale measure: Visual Analog Scale (VAS) sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06294704 id: 2024/0004 briefTitle: Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes acronym: PompBariatDT1 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-05 date: 2024-04-08 name: Centre Hospitalier Sud Francilien class: OTHER briefSummary: Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published. conditions: Bariatric Surgery conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: bariatric surgery measure: time spent within glycemic target 70-180 mg/dL measure: Time spent in level 1 hyperglycemia (181-250 mg/dL) measure: Time spent in level 2 hyperglycemia (>250 mg/dL) measure: HbA1c measure: Coefficient of variation measure: Time spent in level 1 hypoglycemia (51-70 mg/dl) measure: Time spent in level 2 hypoglycemia (< 50 mg/gdl) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Sud Francilien city: Corbeil-Essonnes zip: 91106 country: France name: Caroline TOURTE role: CONTACT phone: +33161693150 email: caroline.tourte@chsf.fr lat: 48.60603 lon: 2.48757 hasResults: False

 nctId: NCT06294691 id: infusion time & aGVHD-002 briefTitle: Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-30 date: 2026-08-31 date: 2024-03-05 date: 2024-03-05 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT) conditions: Acute Graft-versus-host Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 198 type: ESTIMATED name: Time of stem cell infusion measure: The cumulative incidence of grade III to IV aGVHD measure: The cumulative incidence of grade II to IV aGVHD measure: The cumulative incidence of neutrophil engraftment at 28 days after transplantation measure: The cumulative incidence of platelet recovery at 100 days after transplantation measure: The cumulative incidence of transplant-related mortality at 180 days after transplantation measure: The cumulative incidence of transplant-related mortality at 360 days after transplantation measure: The cumulative incidence of chronic GVHD at 360 days after transplantation measure: The probability of GVHD-free, relapse-free survival(GRFS) measure: The probability of disease-free survival(DFS) measure: The probability of overall survival(OS) sex: ALL minimumAge: 12 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: NCT06294678 id: infusion time & aGVHD-001 briefTitle: Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-30 date: 2026-08-31 date: 2024-03-05 date: 2024-03-05 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: To observe the effect of stem cell infusion on the development of acute graft-versus-host disease (aGVHD) in patients with malignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT) conditions: Acute Graft-versus-host Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 198 type: ESTIMATED name: Time of stem cell infusion measure: The incidence of grade III to IV aGVHD measure: The incidence of grade II to IV aGVHD measure: The cumulative incidence of neutrophil engraftment at 28 days after transplantation measure: The cumulative incidence of platelet recovery at 100 days after transplantation measure: The cumulative incidence of transplant-related mortality at 180 days after transplantation measure: The cumulative incidence of transplant-related mortality at 360 days after transplantation measure: The cumulative incidence of chronic GVHD at 360 days after transplantation measure: The probability of GVHD-free, relapse-free survival(GRFS) measure: The probability of disease-free survival(DFS) measure: The probability of overall survival(OS) sex: ALL minimumAge: 12 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: NCT06294665 id: MD113/2023 briefTitle: Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-01-01 date: 2024-03-05 date: 2024-03-05 name: Ain Shams University class: OTHER briefSummary: The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries conditions: Hip Fractures conditions: Post Operative Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Pericapsular Nerve Group (PENG) Block measure: The time to the first request of analgesia measure: Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively measure: Occurrence of side effects of drugs. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams University status: RECRUITING city: Cairo zip: 11122 country: Egypt name: Fatma Ebeid role: CONTACT phone: +201095569596 email: dr.fatma_ebeid@yahoo.com name: Mohamed Salama role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06294652 id: AGMT_Lymphoma_Reg briefTitle: AGMT Austrian Lymphoma Registry overallStatus: RECRUITING date: 2024-02-27 date: 2033-12-31 date: 2033-12-31 date: 2024-03-05 date: 2024-03-05 name: Arbeitsgemeinschaft medikamentoese Tumortherapie class: OTHER briefSummary: Lymphomas are a group of cancers that originate in the lymphatic system, a key component of the immune system. They can be broadly categorized into two main types: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).

There are different subtypes of HL, including classical Hodgkin lymphoma (cHL) and nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The subtypes of cHL include nodular sclerosis, mixed cellularity, lymphocyte-rich, and lymphocyte-depleted.

Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes, each with distinct genetic, molecular, and clinical features. Common subtypes of NHL include Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), myeloma, and other rarer subgroups.

Many of these diseases typically present with lymph node enlargement, bone marrow infiltration, general and lymphoma subtype specific symptoms and laboratory abnormalities.

Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients, while maintaining their good prognosis.

Lymphoma disease have not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology, clinical course and molecular and other biologic data of this disease. As lymphomas are a very heterogeneous group, not all subtypes will always be documented simultaneously in this registry. Which lymphoma subtype is to be documented can change over time, depending on which clinical question is currently in focus. conditions: Lymphoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 4000 type: ESTIMATED measure: General Characteristics measure: Genetic Profiling measure: Proportion of lymphoma patients in Austria that require treatment measure: Proportion of lymphoma patients in Austria under active surveillance measure: Number of patients with concomitant diseases measure: Number of treatment and outcome of treatment measure: Patient Outcome measure: Toxicities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinik für Innere Medizin III, PMU Salzburg status: RECRUITING city: Salzburg zip: 5020 country: Austria name: Richard Greil, MD role: PRINCIPAL_INVESTIGATOR lat: 47.79941 lon: 13.04399 hasResults: False

 nctId: NCT06294639 id: XJA-20240224 briefTitle: ED50 of Esketamine for Laser Treatment in Children acronym: ESCALATE overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2025-03-27 date: 2025-04-27 date: 2024-03-05 date: 2024-03-05 name: Air Force Military Medical University, China class: OTHER briefSummary: There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: The Biased coin method is used primaryPurpose: OTHER masking: NONE maskingDescription: Esketamine will be prepared by an investigator who is not involved in anesthesia and outcome assessment. For all participants, esketamine will be diluted to the same volume. count: 40 type: ESTIMATED name: Esketamine measure: half effective dose of inhibition of body movement measure: number of patients with agitation during awake measure: number of patients with dizzy during awake measure: number of patients with nausea and vomiting during awake measure: number of patients with apnea during awake measure: satisfaction score of the parents to the anesthesia sex: ALL minimumAge: 3 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06294626 id: ISozeri briefTitle: Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly overallStatus: COMPLETED date: 2019-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-05 date: 2024-03-05 name: Acıbadem Atunizade Hospital class: OTHER briefSummary: It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases.

21 infants diagnosed with scaphocephaly aged 2-17 months were included.

* Is there any delay in the neuromotor development of scaphocephaly cases?
* If delay is observed, in which area is it most common?

Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants. conditions: Craniosynostosis, Sagittal conditions: Scaphocephaly conditions: Developmental Delay studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 21 type: ACTUAL name: Group 1 measure: Denver-II Developmental Screening Test measure: Alberta Infant Motor Scale sex: ALL minimumAge: 2 Months maximumAge: 17 Months stdAges: CHILD facility: Acıbadem Altunizade Hospital city: Istanbul state: Uskudar country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06294613 id: CIV-23-07-043672 briefTitle: A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases overallStatus: RECRUITING date: 2024-02-08 date: 2024-07 date: 2024-07 date: 2024-03-05 date: 2024-03-13 name: Acusurgical class: INDUSTRY briefSummary: Prospective, interventional, open-label, non-controlled, monocentric study in Belgium of Luca, of up to 7 evaluable subjects, undergoing vitreoretinal surgery to treat intravitreal hemorrhage and macular pucker.

Only one eye per subject can be enrolled. conditions: Vitreoretinal Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 7 type: ESTIMATED name: vitreoretinal surgery measure: Safety Outcome sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Gent status: RECRUITING city: Gent state: East Flanders zip: 9000 country: Belgium name: Bart Leroy, PhD role: CONTACT phone: +32 9 33 25791 email: Bart.Leroy@uzgent.be lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06294600 id: REACT id: 2023-507295-40 type: EUDRACT_NUMBER briefTitle: Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) acronym: REACT overallStatus: RECRUITING date: 2024-02-12 date: 2025-11-05 date: 2026-01-30 date: 2024-03-05 date: 2024-04-25 name: Hellenic Institute for the Study of Sepsis class: OTHER briefSummary: The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, 1:1 randomized, double-blind, placebo-controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: Clarithromycin 500mg name: Tablets measure: Change of baseline respiratory symptoms score measure: Change of baseline total sequential organ failure assessment (SOFA) score measure: Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio measure: The number of patients that succeeded the resolution of CAP at the test of cure (TOC) visit. measure: Need for up-escalation of the SoC administered antibiotics. measure: Survival measure: Change of baseline sequential organ failure assessment (SOFA) score measure: Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio measure: Cytokine production measure: 28-Day Mortality measure: 90-Day Mortality measure: Cost sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming" status: NOT_YET_RECRUITING city: Athens country: Greece name: Nikolaos Tsokos, MD, PhD role: CONTACT phone: 6973388487 email: ntsokos@hotmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki status: NOT_YET_RECRUITING city: Athens country: Greece name: Simeon Metallidis, MD, PhD role: CONTACT phone: 6944361931 email: metallidissimeon@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Theano Kontopoulou, MD, PhD role: CONTACT phone: 6944690525 email: tkontopoulou@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital status: RECRUITING city: Athens country: Greece name: Georgios Adamis, MD, PhD role: CONTACT phone: 6937463999 email: geo.adamis@gmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, General University Hospital of Ioannina status: NOT_YET_RECRUITING city: Athens country: Greece name: Charalampos Milionis, MD, PhD role: CONTACT phone: 6944521512 email: hmilioni@uoi.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital status: RECRUITING city: Athens country: Greece name: Vassiliki Tzavara, MD, PhD role: CONTACT phone: 6944849808 phoneExt: 0030 email: vtzavara2015@gmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis status: RECRUITING city: Athens country: Greece name: Styliani Sympardi, MD, PhD role: CONTACT phone: 6971863078 email: lianasympa@hotmail.com lat: 37.97945 lon: 23.71622 facility: 1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens status: RECRUITING city: Athens country: Greece name: Petros Bakakos, MD, PhD role: CONTACT phone: 6974748113‬ email: petros44@hotmail.com lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, Attikon University Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Eleni Mpoutati, MD, PhD role: CONTACT phone: 6932434399 phoneExt: 0030 email: eboutati@med.uoa.gr lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis status: NOT_YET_RECRUITING city: Athens country: Greece name: Zoi Alexiou, MD, PhD role: CONTACT phone: 6944820763 email: z_alexiou@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital status: RECRUITING city: Athens country: Greece name: Georgios Chrysos, MD, PhD role: CONTACT phone: 6945432120 email: gchrysos@gmail.com lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis status: NOT_YET_RECRUITING city: Athens country: Greece name: Periklis Panagopoulos, MD, PhD role: CONTACT phone: 6944410495 email: ppanago@med.duth.gr lat: 37.97945 lon: 23.71622 facility: 3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital status: RECRUITING city: Athens country: Greece name: Ilias Skopelitis, MD, PhD role: CONTACT phone: 6944688196 email: iskopelitis@hotmail.com lat: 37.97945 lon: 23.71622 facility: 3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S. status: RECRUITING city: Athens country: Greece name: Maria Chini, MD, PhD role: CONTACT phone: 6944576476 email: mariachini@gmail.com lat: 37.97945 lon: 23.71622 facility: 3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases status: RECRUITING city: Athens country: Greece name: Garyfallia Poulakou, MD, PhD role: CONTACT phone: 6945597583 email: gpoulakou@gmail.com lat: 37.97945 lon: 23.71622 facility: 4th Department of Internal Medicine, Attikon University Hospital status: RECRUITING city: Athens country: Greece name: Antonios Papadopoulos, MD, PhD role: CONTACT phone: 6977302400 phoneExt: 0030 email: antpapa1@otenet.gr lat: 37.97945 lon: 23.71622 facility: 6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens status: NOT_YET_RECRUITING city: Athens country: Greece name: Ioannis Dimitroulis, MD, PhD role: CONTACT phone: 6932666007 email: idimit@hotmail.com lat: 37.97945 lon: 23.71622 facility: Department of Chest Medicine, EVANGELISMOS Athens General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Paraskevi Katsaounou, MD, PhD role: CONTACT phone: 2132033384 phoneExt: 0030 email: paraskevikatsaounou@gmail.com lat: 37.97945 lon: 23.71622 facility: Department of Internal Medicine, Larissa University General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: George Dalekos, MD, PhD role: CONTACT phone: 6937759699 email: georgedalekos@gmail.com lat: 37.97945 lon: 23.71622 facility: Department of Internal Medicine, Patras University General Hospital status: RECRUITING city: Athens country: Greece name: Karolina Akinosoglou, MD, PhD role: CONTACT phone: 6977762897 email: akin@upatras.gr lat: 37.97945 lon: 23.71622 facility: Department of Pulmonary Medicine, General Hospital of Kerkira status: NOT_YET_RECRUITING city: Athens country: Greece name: Ilias Papanikolaou, MD, PhD role: CONTACT phone: 6974305925 email: icpapanikolaou@hotmail.com lat: 37.97945 lon: 23.71622 facility: Emergency Department, TZANEIO Piraeus General Hospital status: RECRUITING city: Athens country: Greece name: Styliani Gerakari, MD, PhD role: CONTACT phone: 6973308684 email: sgerakari76@gmail.com lat: 37.97945 lon: 23.71622 hasResults: False

 nctId: NCT06294587 id: IRB-300012407 briefTitle: Evaluation of Free Gingival Graft Timing overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2027-07 date: 2024-03-05 date: 2024-03-05 name: University of Alabama at Birmingham class: OTHER briefSummary: This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft. conditions: Ridge Augmentation conditions: Alveolar Mucosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: FGG Before GBR name: FGG after GBR measure: Volumetric outcome assessment measure: Buccal soft tissue profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unversity of Alabama at Birmingham, School of Dentistry city: Birmingham state: Alabama zip: 35294-0007 country: United States name: Hussein Basma, DDS, MS role: CONTACT phone: 205-975-2888 email: basma86@uab.edu name: Sarah Startley, DMD role: CONTACT phone: 205-975-8711 email: ss1971@uab.edu name: Hussein Basma, DDS, MS role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06294574 id: 300011943 briefTitle: Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2026-12 date: 2026-12 date: 2024-03-05 date: 2024-03-29 name: University of Alabama at Birmingham class: OTHER name: Mammotome briefSummary: The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK. conditions: Breast Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: HydroMARK Plus Clip measure: Retrieval rate of the HydroMARK Plus clip. measure: Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip. sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Kirklin Clinic city: Birmingham state: Alabama zip: 35249 country: United States name: Quenteeria Mooney role: CONTACT phone: 205-996-1082 email: qmooney@uabmc.edu name: Ceren Yalniz, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06294561 id: TGRX-326-1003 briefTitle: TGRX-326 Pharmacokinetic Drug Interaction overallStatus: RECRUITING date: 2024-03-04 date: 2024-04-30 date: 2024-06-30 date: 2024-03-05 date: 2024-03-08 name: Shenzhen TargetRx, Inc. class: INDUSTRY name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School briefSummary: This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Itraconazole+TGRX-326 name: Efavirenz+TGRX-326 measure: Plasma Tmax measure: Plasma Cmax measure: Plasma AUC(0-t) measure: Plasma AUC(0-inf) measure: T1/2 measure: Plasma volume of distribution (Vz/F) measure: Plasma clearance (CL/F) measure: Adverse events/serious adverse events measure: Corrected QT Interval sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Nanjing Drug Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Juan Li, MD role: CONTACT phone: +862583105910 email: juanli2003@163.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06294548 id: IRB-300012272 (UAB 23152) briefTitle: A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-05-31 date: 2027-12-31 date: 2024-03-05 date: 2024-03-15 name: University of Alabama at Birmingham class: OTHER briefSummary: This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Valemetostat name: Atezolizumab name: Bevacizumab measure: Phase 1b measure: Phase II measure: Safety and pharmacokinetics (PK) measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Duration of response (DoR) measure: Disease Control Rate (DCR) 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: Margaret Thomas, MPH role: CONTACT email: margaretannthomas@uabmc.edu name: Mehmet S Akce, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06294535 id: 2024 briefTitle: The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant overallStatus: ENROLLING_BY_INVITATION date: 2023-12-11 date: 2024-05-18 date: 2024-06-06 date: 2024-03-05 date: 2024-03-19 name: Tanta University class: OTHER briefSummary: under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap. conditions: Orbital Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: patient select randomly from closed label whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: reconstruction of orbital walls measure: restoring the accurate position of eye measure: motility of eye measure: volume of orbit sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Faculty of Dentistry, Tanta University city: Tanta zip: 3111 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06294522 id: 1984 briefTitle: Reconstruction of Nasal Floor for Three-dimensional Repair of Alveolar Cleft overallStatus: COMPLETED date: 2023-07-20 date: 2024-01-06 date: 2024-02-16 date: 2024-03-05 date: 2024-03-19 name: Tanta University class: OTHER briefSummary: reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap conditions: Alveolar Cleft studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: reconstruction of alveolar cleft measure: recurrence of oronasal fistula measure: volume of alveolar cleft after reconstruction measure: density of bone sex: ALL minimumAge: 9 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Dentistry, Tanta University city: Tanta zip: 3111 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06294509 id: SMTaVNS 2024 id: 2024-00039 type: REGISTRY domain: BASEC briefTitle: taVNS Application Timing During Robotic Sensorimotor Task acronym: SMTaVNS2024 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-04-01 date: 2024-03-05 date: 2024-03-08 name: Olivier Lambercy class: OTHER briefSummary: The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task.

Main Questions it Aims to Answer:

How does taVNS, with different timing protocols, affect the feasibility and effectiveness of performing a robotic sensorimotor task? What is the impact of taVNS on sensorimotor learning and adaptation?

Participants Will:

Be pseudo-randomly assigned to one of five experimental groups with different taVNS stimulation timings.

Perform a sensorimotor task multiple times across sessions, spanning a maximum of two weeks or until achieving 70% accuracy in two successive sessions.

Have kinematic data collected by a robot during the task. Have physiological data measured using external sensors. Fill out questionnaires about the feasibility of taVNS and other subjective measures after each session.

Comparison Group:

Researchers will compare the four experimental groups to each other to see if different taVNS stimulation timings affect sensorimotor learning outcomes, as well as to a control group that will receive no stimulation. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-blinded, pseudo-randomised, exploratory, single-centre, national, longitudinal study primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 75 type: ESTIMATED name: in-house developed transcutaneous auricular Vagus Nerve Stimulation device measure: Subjectively perceived tolerance of taVNS and perceived difficulty of motor task measure: Success of the sensorimotor challenge measure: Mean Change from Baseline in Galvanic Skin Response (GSR) measure: Mean Change from Baseline in Heart Rate (HR) measure: Mean Change from Baseline in Pupil Diameter (PD) measure: Mean Change from Baseline in electroencephalogram (EEG) measure: Subjectively perceived positive effects of taVNS on motor performance measure: Change of movement parameters from baseline measure: Associations between outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294496 id: 2023YFS0274 briefTitle: Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics overallStatus: RECRUITING date: 2023-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-05 date: 2024-03-05 name: Sichuan Provincial People's Hospital class: OTHER briefSummary: Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear.

This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life. conditions: Carotid Stenosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: CEA/CAS measure: Perioperative cardio-cerebrovascular adverse events measure: Compute fluid dynamics parameters measure: Clinical outcome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610072 country: China name: Li Xiong, Master role: CONTACT phone: 028-87393020 email: lcl1206778081@163.com name: Chaoqun Zeng, Ph.D. role: SUB_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06294483 id: Soh-Med-24-01-09MS briefTitle: Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus. overallStatus: ENROLLING_BY_INVITATION date: 2024-01-10 date: 2024-07-30 date: 2024-08-30 date: 2024-03-05 date: 2024-03-05 name: Sohag University class: OTHER briefSummary: The present study aims to:

Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.

Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity. conditions: Systemic Lupus Erythematosus studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: CBC name: Antinuclear Antibody tests (ANA) name: Rest of ANA profile name: C3 and C4 complement level. name: Anti phospholipid marker name: Serum creatinine and Alb/create ratio name: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. name: SLEDAI scores measure: Evaluate the hematological indices as (mean platelet volume) of our SLE patient. measure: Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient. measure: Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient. measure: Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus. measure: Evaluate the correlation between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university hospital city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06294470 id: 01-2023 briefTitle: Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome overallStatus: COMPLETED date: 2023-05-01 date: 2023-11-30 date: 2023-12-15 date: 2024-03-05 date: 2024-03-05 name: Universidad Central de Venezuela class: OTHER briefSummary: The objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse. conditions: Hemorrhoids conditions: Defecation Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 34 type: ACTUAL name: Ballon expulsion test name: Colonic transit time name: Stapled hemorrhodopexy measure: Postoperative improvement of symptoms of defecatory obstruction measure: Postoperative change of the balloon expulsion test measure: Postoperative change of the colonic transit time sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Domingo Luciani city: Caracas state: Miranda zip: 1073 country: Venezuela lat: 10.48801 lon: -66.87919 hasResults: False

 nctId: NCT06294457 id: CI-2024-480 briefTitle: Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-06 date: 2024-03-05 date: 2024-03-05 name: Universidad Europea de Madrid class: OTHER briefSummary: Objectives

Main objective:

Assess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in Spain

Secondary objectives:

Evaluate the improvement in sleep quality Analyze the improvement in blood pressure quality Measure the improvement in cortisol quality Determine if there is an improvement in heart rate conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: The device will be placed with no current. This type of neuromodulation gives no feeling at all to the patient while administred, so there is no way for the patient to know if the apparatus is connected or not. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Non-Invasive Neuromodulation NESA measure: Quality of life by constipation (CVE-20) measure: Sleep Quality measure: Cardiac Frecuency measure: Arterial pressure sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294444 id: REC/RCR&AHS/23/0741 briefTitle: Comparison of Constraint Induced Movement Therapy and Mirror Therapy overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-15 date: 2024-03-15 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function. conditions: Hemiplegic Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Participants will get separate treatment protocol and possible efforts will be put to mask the both groups about their treatment whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Constraint Induced Movement Therapy name: Mirror therapy measure: fine motor skills sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Imran Amjad status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Muhammad Asif Javed, MS role: CONTACT phone: 923224209422 email: a.javed@riphah.edu.pk name: Imran Amjad, PhD role: CONTACT phone: 923224390125 email: imran.amjad@riphah.edu.pk name: Hurriya Sehar, MS* role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 facility: Riphah International University status: RECRUITING city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06294431 id: RADX-P-2406 briefTitle: Radicle Clarity 24: A Study of Health and Wellness Products on Cognitive Function and Related Health Outcomes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-22 date: 2024-05 date: 2024-07 date: 2024-03-05 date: 2024-04-24 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes conditions: Cognitive Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified based on their gender assigned at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm. 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: 1001 type: ESTIMATED name: Placebo Control Form 1 name: Clarity Active Study Product 1.1 Usage name: Placebo Control Form 2 name: Clarity Active Study Product 2.1 Usage measure: Change in cognitive function measure: Change in fatigue measure: Change in sleep-related impairment measure: Minimal clinical importance difference (MCID) in cognitive function measure: Change 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: NCT06294418 id: 1-037-23 briefTitle: FCI in Post-operative Low Grade Gliomas overallStatus: RECRUITING date: 2024-02-15 date: 2025-03 date: 2025-03 date: 2024-03-05 date: 2024-03-05 name: NHS Grampian class: OTHER_GOV name: University of Aberdeen briefSummary: The aim of this pilot study is to explore the utility of a new imaging technique, called Field Cycling Imaging (FCI), in postoperative low grade gliomas.

The main question it aims to answer is if FCI can differentiate subtypes of low grade gliomas. Participants will have one FCI scan. conditions: Glioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Field Cycling Imaging (FCI) measure: Differentiation of sub-types of low grade glioma assessed by Field Cycling Imaging (FCI) T1 dispersion profiles sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Aberdeen Royal Infirmary status: RECRUITING city: Aberdeen zip: AB25 2ZD country: United Kingdom name: Arnab K Rana, Dr role: CONTACT phone: +441224438363 email: arnab.rana@abdn.ac.uk lat: 57.14369 lon: -2.09814 hasResults: False

 nctId: NCT06294405 id: 24-0010 briefTitle: Intraocular Lens Implant Registry Study overallStatus: RECRUITING date: 2024-02-21 date: 2029-02-14 date: 2029-02-14 date: 2024-03-05 date: 2024-03-05 name: University Hospital Augsburg class: OTHER briefSummary: The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery. conditions: Intraocular Lens Complication conditions: Intraocular Lens Rotation conditions: Intraocular Lens Associated Postoperative Inflammation conditions: Lens Opacities studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 500 type: ESTIMATED name: Intraocular lens Implantation measure: Functional results with different Intraocular lenses measure: Contrast sestivitiy with different Intraocular lenses measure: Anatomical results. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Augsburg status: RECRUITING city: Augsburg country: Germany name: Isabella Baur, MD role: CONTACT lat: 48.37154 lon: 10.89851 hasResults: False

 nctId: NCT06294392 id: 90FA3010 briefTitle: KEEP Connecting Kin acronym: KEEP-CK overallStatus: RECRUITING date: 2024-02-13 date: 2026-04 date: 2026-04 date: 2024-03-05 date: 2024-03-05 name: Oregon Social Learning Center class: OTHER name: Office of Planning, Research & Evaluation briefSummary: The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS. conditions: Internalizing Behavior conditions: Externalizing Behavior conditions: Child Permanency conditions: Parenting conditions: Parent Stress conditions: Service Utilization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Informal kinship caregivers will be randomly assigned to receive the KEEP-CK program either immediately or after waiting 10 months using a randomized blocked design. Blocking factors include: (a) the length of time that the child has been living in informal kinship care (\<=6 months, 7 months to \<2 years, or \>=2 years); (b) child age (4 to 12 years, or 13+ years); and (c) low (or not low) resource families, defined by an annual household income below (or above) 150% of the federal poverty level. primaryPurpose: PREVENTION masking: NONE count: 192 type: ESTIMATED name: KEEP-CK measure: Mean change in youth well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors) measure: Mean change in child permanency (i.e., placement stability and permanency of placements) measure: Mean change in parenting practices and parent/caregiver stress. measure: Mean change in parent/caregiver stress. measure: Mean change in parenting practices. measure: Mean change in parents' use of services from multiple systems (financial, educational, mental health, medical, legal) sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Oregon Center Learning Center status: RECRUITING city: Eugene state: Oregon zip: 97401 country: United States name: Courtenay Padgett role: CONTACT phone: 541-485-2711 email: CourtP@oslc.org lat: 44.05207 lon: -123.08675 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-07-11 uploadDate: 2024-02-27T15:36 filename: SAP_000.pdf size: 239212 hasResults: False

 nctId: NCT06294379 id: OUH_SDM briefTitle: Shared Decision Making in Melanoma Patients Receiving Adjuvant Therapy overallStatus: RECRUITING date: 2022-03-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-05 date: 2024-03-05 name: Odense University Hospital class: OTHER name: University of Copenhagen name: Aarhus University Hospital name: Aalborg University Hospital briefSummary: This study aims to develop test and evaluate a Patient Decision Aid called "The Decision Helper" among melanoma patients eligible for adjuvant treatment.

* Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice?
* Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper (pre-implementation) compared to the ones who have (post-implementation? conditions: Malignant Melanoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED measure: Development of a Patient Decision Aid "The Decision Helper" for melanoma patients receiving adjuvant theory measure: Evaluation of the "The Decision Helper" sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Odense University Hospital status: RECRUITING city: Odense C zip: 5000 country: Denmark name: Lærke Tolstrup role: CONTACT phone: 40295129 email: lctolstrup@mail.dk lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06294366 id: MenoufiaU2022 briefTitle: Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study overallStatus: RECRUITING date: 2022-06-12 date: 2024-04-12 date: 2024-06-12 date: 2024-03-05 date: 2024-03-05 name: Menoufia University class: OTHER briefSummary: Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men .

Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH .

Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP conditions: Prostatic Hyperplasia conditions: Prostate Enucleation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Bipolar Bowa device measure: Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates. sex: MALE minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of medicine status: RECRUITING city: Shibīn Al Kawm state: Menoufia zip: 32866 country: Egypt name: Baher M Abdelraouf, MD role: CONTACT phone: +201069973254 email: maar2002002@gmail.com lat: 30.55258 lon: 31.00904 hasResults: False

 nctId: NCT06294353 id: WCTP-ED-B-01 briefTitle: Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01) overallStatus: RECRUITING date: 2023-03-29 date: 2024-06-30 date: 2024-08-30 date: 2024-03-05 date: 2024-03-06 name: WELT corp class: INDUSTRY briefSummary: The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.

The main questions it aims to answer are:

* Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?
* Is the WELT-ED safe for use in the target population without causing adverse effects?

Participants will:

* Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.
* Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).
* Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects. conditions: Eating Disorders conditions: Binge Eating conditions: Binge-Eating Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 134 type: ESTIMATED name: WELT-ED (CBT based DTx) name: Standard Treatment measure: Binge Eating Frequency measure: Eating Disorder Examination Questionnaire (EDE-Q) measure: Clinical Impairment Assessment (CIA) measure: Patient health questionnaire-9 (PHQ-9) measure: Generalized anxiety disorder 7-item scale (GAD-7) measure: The EuroQol Visual Analogue Scale (EQ-VAS) measure: Clinical Global Impression of Improvement (CGI-I) measure: Clinical Global Impression of Severity (CGI-S) measure: Adherence (Compliance) to WELT-ED (applicable only to WELT-ED Group) measure: BMI (Body Mass Index) measure: WELT-ED App Usage Satisfaction (applicable only to WELT-ED Group) measure: App-Based Lifestyle and Eating Data (applicable only to WELT-ED Group) measure: Change in Regular Meal Frequency (applicable only to WELT-ED Group) sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of name: soohee Choi role: CONTACT phone: 0215885700 email: soohchoi@snu.ac.kr lat: 37.566 lon: 126.9784 facility: Severance Hospital status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of name: Young Chul Jung, MD role: CONTACT phone: 82-2-2228-1622 email: eugenejung@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06294340 id: 1322-IX/42 briefTitle: Noise, Oxidative Stress and Cardiovascular System acronym: NOXYCARD overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2027-12 date: 2028-12 date: 2024-03-05 date: 2024-03-05 name: University of Belgrade class: OTHER briefSummary: Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity. conditions: Noise; Adverse Effect conditions: Noise Exposure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: Exposure to loud pre-recorded road traffic noise measure: Systolic blood pressure measure: Concentration of stress hormone measure: Diastolic blood pressure measure: Concentration of inflammation parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, University of Belgrade city: Belgrade state: Beograd zip: 11040 country: Serbia lat: 44.80401 lon: 20.46513 hasResults: False

 nctId: NCT06294327 id: EC23027 briefTitle: RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress overallStatus: RECRUITING date: 2024-01-22 date: 2025-01-01 date: 2025-04-30 date: 2024-03-05 date: 2024-03-07 name: Vitaz class: OTHER name: University Ghent briefSummary: Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).

The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research \& Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.

This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period \> 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher. conditions: Pressure Injury conditions: Pressure Ulcer conditions: Decubitus Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 308 type: ESTIMATED name: Reactive static air support surfaces measure: Incidence of pressure ulcer, category > I measure: Cost of alternating air pressure mattress compared to reactive static air support surfaces measure: Patient comfort sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vitaz (General Hospital) status: RECRUITING city: Sint-Niklaas state: East Flanders zip: 9100 country: Belgium name: Brecht Serraes, PhD role: CONTACT phone: +3237602039 email: Brecht.Serraes@vitaz.be name: Peter Desmet, MD role: CONTACT lat: 51.16509 lon: 4.1437 hasResults: False

 nctId: NCT06294314 id: 1982669-3 briefTitle: Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace overallStatus: RECRUITING date: 2024-02-26 date: 2026-08-01 date: 2028-07-01 date: 2024-03-05 date: 2024-03-05 name: Marshall University class: OTHER name: Arthrex, Inc. briefSummary: The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information. conditions: Anterior Cruciate Ligament Rupture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Fertilized ACL measure: Return to play measure: Biomechanics testing measure: MRI findings measure: Rerupture sex: ALL minimumAge: 14 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: Marshall University status: RECRUITING city: Huntington state: West Virginia zip: 25755 country: United States name: chad d lavender, md role: CONTACT phone: 304-552-6514 email: doclav@gmail.com name: Kara Cipriani, np role: CONTACT phone: 304-541-5316 email: cipriani6@marshall.edu lat: 38.41925 lon: -82.44515 hasResults: False

 nctId: NCT06294301 id: P10-LP005-01 briefTitle: A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants overallStatus: RECRUITING date: 2023-11-19 date: 2024-04-30 date: 2024-10-30 date: 2024-03-05 date: 2024-03-05 name: Longbio Pharma class: INDUSTRY briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD). conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 78 type: ESTIMATED name: LP-005 Dose 1 (Single) name: LP-005 Dose 2 (Single) name: LP-005 Dose 3 (Single) name: LP-005 Dose 4 (Single) name: LP-005 Dose 5 (Single) name: LP-005 Dose 6 (Single) name: Placebo (Single) name: LP-005 Dose 7 (Multiple) name: LP-005 Dose 8 (Multiple) name: LP-005 Dose 9 (Multiple) name: Placebo (Multiple) measure: Adverse events measure: Time to peak concentration (Tmax) of LP-005 measure: Maximum concentration (Cmax) of LP-005 measure: Elimination half-life (t1/2) of LP-005 measure: Area under the concentration-time curve (AUC0-t) of LP-005 measure: Apparent clearance rate (CL/F) of LP-005 measure: Assessment of immunogenicity measure: Assessment of complement C5 activity measure: Assessment of complement C3b activity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Shanghai Public Health Clinical Center status: RECRUITING city: Shanghai state: Shanghai country: China name: Yun Ling role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06294288 id: P-10-LP003-2022-01 briefTitle: A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2021-07-01 date: 2023-09-03 date: 2024-03-15 date: 2024-03-05 date: 2024-03-05 name: Longbio Pharma class: INDUSTRY briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD). conditions: Chronic Spontaneous Urticaria studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: LP-003 Dose 1 (Single) name: LP-003 Dose 2 (Single) name: LP-003 Dose 3 (Single) name: LP-003 Dose 4 (Single) name: LP-003 Dose 5 (Single) name: Placebo (Single) name: LP-003 Dose 6 (Multiple) name: LP-003 Dose 7 (Multiple) name: LP-003 Dose 8 (Multiple) name: Placebo (Multiple) measure: Adverse events measure: Time to peak concentration (Tmax) of LP-003 measure: Maximum concentration (Cmax) of LP-003 measure: Elimination half-life (t1/2) of LP-003 measure: Area under the concentration-time curve (AUC0-t) of LP-003 measure: Apparent clearance rate (CL/F) of LP-003 measure: Assessment of immunogenicity measure: Assessment of total immunoglobulin E (IgE) measure: Assessment of free IgE sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Shanghai General Hospital city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06294275 id: P-10-LP001-2022-01 briefTitle: A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-16 date: 2024-01-02 date: 2024-04-06 date: 2024-03-05 date: 2024-03-05 name: Longbio Pharma class: INDUSTRY briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-001 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-001 and Part 2, multiple ascending dose (MAD). conditions: Myelodysplastic Syndrome (MDS) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 68 type: ESTIMATED name: LP-001 Dose 1 (Single) name: LP-001 Dose 2 (Single) name: LP-001 Dose 3 (Single) name: LP-001 Dose 4 (Single) name: LP-001 Dose 5 (Single) name: LP-001 Dose 6 (Single) name: Placebo (Single) name: LP-001 Dose 7 (Multiple) name: LP-001 Dose 8 (Multiple) name: Placebo (Multiple) measure: Adverse events measure: Time to peak concentration (Tmax) of LP-001 measure: Maximum concentration (Cmax) of LP-001 measure: Elimination half-life (t1/2) of LP-001 measure: Area under the concentration-time curve (AUC0-t) of LP-001 measure: Apparent clearance rate (CL/F) of LP-001 measure: Assessment of immunogenicity measure: Assessment of hemoglobin (Hb) change measure: Assessment of red blood cell (RBC) count change measure: Assessment of reticulocyte (Rtc) count change sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Shanghai Public Health Clinical Center city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06294262 id: 2023-508230-33-00 briefTitle: Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine acronym: TETRALITE-Ib overallStatus: RECRUITING date: 2024-01-29 date: 2024-09 date: 2025-03 date: 2024-03-05 date: 2024-03-05 name: LiteVax BV class: INDUSTRY name: University Hospital, Ghent name: HarmonyCR, Melle, Belgium briefSummary: The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics. conditions: Vaccination Reaction studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 84 type: ESTIMATED name: TETRALITE measure: Characterise local and systemic AEs, and SAEs, pIMDs and AESIs to TETRALITE measure: Characterise clinical hematology and biochemistry to TETRALITE measure: Characterise HI antibody response to the four vaccine strains of TETRALITE in serum measure: Characterise MN antibody response to the four vaccine strains of TETRALITE in serum measure: Characterise mechanisms of action of LiteVax Adjuvant measure: Characterise T-cell responses to TETRALITE in PBMCs measure: Characterise B-cell response to TETRALITE in PBMCs measure: Characterise molecular features of vaccine-induced immunity by RNA sequencing measure: Characterise antibody response to influenza virus antigens other than hemaglutunin of the vaccine strains of TETRALITE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Gent status: RECRUITING city: Ghent zip: 9000 country: Belgium lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06294249 id: 20045125 briefTitle: Pain Severity in Flapless Dental Implant Placement Using Laser overallStatus: COMPLETED date: 2020-01-01 date: 2023-12-01 date: 2023-12-04 date: 2024-03-05 date: 2024-03-26 name: Shiraz University of Medical Sciences class: OTHER name: Shahid Beheshti University of Medical Sciences briefSummary: The goal of this split-mouth randomized clinical trial study was to investigate the effect of using a laser on pain and discomfort following flapless dental implant surgery. It was hypothesized that laser did not have any impact on post-op pain. Therefore, the study aimed to compare pain and discomfort following flapless dental implant surgeries with or without a laser. conditions: Jaw, Edentulous, Partially studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Laser-induced Incision name: Punch Incision name: Implant Placement measure: Pain Severity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: shiraz University of medical sciences city: Shiraz state: Fars country: Iran, Islamic Republic of lat: 29.61031 lon: 52.53113 hasResults: False

 nctId: NCT06294236 id: SC291-102 briefTitle: Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM) overallStatus: RECRUITING date: 2024-04 date: 2027-12 date: 2028-03 date: 2024-03-05 date: 2024-04-01 name: Sana Biotechnology class: INDUSTRY briefSummary: SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases. conditions: Lupus Erythematosus conditions: Systemic Lupus Erythematosus conditions: SLE (Systemic Lupus) conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis conditions: Granulomatous Polyangiitis conditions: Microscopic Polyangiitis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: SC291 measure: Evaluate safety and tolerability of SC291 measure: Evaluate preliminary clinical response to SC291 measure: Evaluate preliminary clinical response to SC291 measure: Evaluate preliminary clinical response to SC291 measure: Evaluate preliminary clinical response to SC291 measure: Evaluate preliminary clinical response to SC291 (LN and ERL Cohorts) measure: Evaluate preliminary clinical response to SC291 (LN Cohort) measure: Evaluate preliminary clinical response to SC291 (ERL Cohort) measure: Evaluate preliminary clinical response to SC291 (AAV Cohort) measure: Evaluate preliminary clinical response to SC291 (AAV Cohort) measure: Evaluate cellular kinetics and persistence of SC291 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swedish Medical Center status: RECRUITING city: Seattle state: Washington zip: 98122 country: United States name: Richie Satira, RN role: CONTACT phone: 206-386-2000 email: richard.satira@swedish.org name: Danna Caceres-Reyes, RN role: CONTACT phone: 206-386-2000 email: Danna.Caceres-Reyes@swedish.org name: Philip J. Mease, MD, MACR role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06294223 id: SaglikBilU briefTitle: Upper Extremity and Muscle Oxygenation overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-05 date: 2024-03-18 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy. conditions: Near-infrared Spectroscopy conditions: Muscle Oxygenation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Exercise follow up with near-infrared spectroscopy measure: Determination of Blood Pressure measure: Saturation Measurement measure: Muscle Oxygenation Measurement measure: Determination of Heart Rate sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Saglik Bilimleri University status: RECRUITING city: Istanbul zip: 34010 country: Turkey name: Esra Pehlivan, Ass Prof role: CONTACT phone: 05058527913 email: esra.pehlivan@sbu.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06294210 id: REC202307012 briefTitle: Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback acronym: EWSSS overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2025-06-01 date: 2025-07-01 date: 2024-03-05 date: 2024-03-05 name: Royal College of Surgeons, Ireland class: OTHER briefSummary: This study aims to investigate the effects of an app and wearable device on the wellbeing of secondary school students. The app will offer support for stress management, sleep improvement, and time management. Additionally, it will provide access to educational resources, text-based coaching, and biofeedback monitoring through the wearable device. The device, worn around the wrist, will measure heart rate variability as an indicator of stress response. Throughout the study, students will complete bi-monthly surveys on sleep, stress, and overall wellbeing. To assess the specific impact of each feature, the app features will be released incrementally over the course of a year. The intervention group, comprising students in their last two years of secondary school, will have access to the app and wearable device, while a control group within the same class will not use the system but will complete the same wellness surveys. Coaches on this platform will come from the Centre for Positive Health Sciences MSc in Positive Health Coaching as part of their continued training in coaching. Coaching will be asynchronous so that students can post questions at any time during the day, but coaches will respond within 24 hours, during office hours. It will be made clear that this is not a therapeutic service and will be directed to other resources for these services. Coaches will file an incident report if a risk arises from a message with participants. Participants will be given guidelines for the type of questions they can ask such as asking for advice for setting goals related to their digital habits and sleeping better. The study\&#39;s findings will provide valuable insights into the effectiveness of the app and wearable device in enhancing student wellbeing leading up to their leaving certification exams. conditions: No Disease or Condition is Being Studied conditions: Stress Psychological conditions: Overall Wellness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A group of students will be using the mobile app and wrist-monitor to support their wellbeing while a control group of students will be followed at the same time who will not be using the app or wearable. The survey wellbeing, stress, and sleep scores will be compared between these groups. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Mobile app and wrist-worn monitor measure: Wellbeing Survey Results measure: Heart Rate Variability Metrics measure: Routine check-ins measure: App Engagement sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294197 id: PhD Thesis briefTitle: Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women. overallStatus: RECRUITING date: 2024-01-13 date: 2024-07-13 date: 2024-12-13 date: 2024-03-05 date: 2024-03-05 name: Hatice Gulsah Kurne class: OTHER briefSummary: The purpose of this study; To investigate the effects of pelvic floor muscle exercises on vaginal and sexual health in postmenopausal women. Vaginal symptoms such as vaginal dryness, burning and dyspareunia occur in the postmenopausal period. Vaginal symptoms affect sexual function, leading to a decrease in quality of life. In our study, we plan to evaluate vaginal dryness, one of the vaginal symptoms, using Schirmer's Test. Also in our study; Severities of vaginal dryness, burning and dyspareunia will be evaluated with the visual analog scale (VAS), sexual function will be evaluated with the Post-Menopausal Sexuality Questionnaire and Female Sexual Function Scale, vaginal aging will be evaluated with the Daily Effect of Vaginal Aging Scale, and the presence/severity of pelvic floor symptoms will be evaluated with the Pelvic Floor Distress Inventory-20. The cases will be randomized into two groups and pelvic floor exercises will be given to one group. After the exercises are given, vaginal pH and moistness will be evaluated for acute effect. In the other group, vaginal PH and moisture will be measured after 5 minutes. The cases will be followed without any intervention to the control group. After 12 weeks, the same evaluations will be made to both groups and the results will be compared. The data will be compared using appropriate statistical methods (statistical significance value will be taken as p\<0.05) and discussed with the literature. conditions: Sexual Dysfunction conditions: Postmenopausal Symptoms conditions: Pelvic Floor Muscle Weakness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Randomized Healthy Participants primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Pelvic Floor Exercises measure: Schirmer's Test measure: Visual Analogue Scale (VAS) measure: Female Sexual Function Index (FSFI) measure: Postmenopausal Sexuality Questionnaire (PMSQ) measure: Vaginal Daily Impact of Aging Scale (VDIAS) measure: Disturbing Pelvic Floor Inventory-20 measure: Evaluation of Pelvic Floor Muscle Strength sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Training and Research Hospital status: RECRUITING city: Istanbul state: Fatih zip: 34098 country: Turkey name: Nebahat Uzunay, MD role: CONTACT phone: +905052609436 email: nebahatuzunay@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06294184 id: Guangzhou PH tDCS in SD briefTitle: tDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals. overallStatus: RECRUITING date: 2023-11-01 date: 2024-11 date: 2024-12 date: 2024-03-05 date: 2024-03-05 name: Guangzhou Psychiatric Hospital class: OTHER_GOV briefSummary: The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out. conditions: Subthreshold Depression conditions: Young People conditions: Transcranial Direct Current Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: tdcs lDLPFC name: tdcs rVLPFC name: Sham measure: The effect of tDCS in alleviating subthreshold depressive symptoms measure: Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms measure: To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms sex: ALL minimumAge: 12 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Guangzhou Brain hospital(Guangzhou Huiai Hospital) status: RECRUITING city: Guangzhou state: Guangdong zip: 510370 country: China name: Kangguang Lin, M.D;Ph.D role: CONTACT phone: 86-13560360144 email: klin@gzhmu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06294171 id: Modified Alveolar Bone Cut briefTitle: Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone overallStatus: COMPLETED date: 2022-11-15 date: 2023-05-01 date: 2023-11-01 date: 2024-03-05 date: 2024-03-05 name: University of Baghdad class: OTHER briefSummary: The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone. conditions: Dental Implant Failed studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: measurement of alveolar ridge width measure: expansion rate measure: expansion rate sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Baghdad College of Dentistry city: Baghdad zip: 10011 country: Iraq lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06294158 id: LANYARD-ICU-1.1 briefTitle: Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU acronym: LANYARD-ICU overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-11 date: 2024-03-05 date: 2024-03-05 name: Medical University of Graz class: OTHER briefSummary: Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally.

Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future.

This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium.

Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis.

Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors). conditions: Delirium conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Brightness measurement name: Sound level measurement measure: Delirium sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Centre Graz, Dept. of Anaesthesiology and Intensive Care Medicine city: Graz state: Styria zip: 8036 country: Austria name: Andrea Berghofer, Mag role: CONTACT phone: +43 316 385 0 phoneExt: 84663 email: anaesthesie-allgemein@medunigraz.at name: Paul Zajic, MD PhD role: PRINCIPAL_INVESTIGATOR name: Philipp G. H. Metnitz, MD PhD role: SUB_INVESTIGATOR name: Andreas Münch, MD role: SUB_INVESTIGATOR name: Andreas Waltensdorfer, MD role: SUB_INVESTIGATOR name: Gabriel Honnef, MD PhD role: SUB_INVESTIGATOR name: Christian Regvar, MD role: SUB_INVESTIGATOR name: Barbara Hallmann, MD role: SUB_INVESTIGATOR name: Martin Rief, MD PhD role: SUB_INVESTIGATOR name: Alexander Pichler, MD role: SUB_INVESTIGATOR name: Michael Eichlseder, MD role: SUB_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06294145 id: U24AG072699 type: NIH link: https://reporter.nih.gov/quickSearch/U24AG072699 briefTitle: Effects of a Wellbeing Intervention on Inflammation Through Reward and Threat Processes acronym: SAVOR overallStatus: RECRUITING date: 2024-02-07 date: 2025-01-31 date: 2025-01-31 date: 2024-03-05 date: 2024-03-05 name: University of California, Los Angeles class: OTHER name: Network for Emotional Wellbeing name: National Institutes of Health (NIH) briefSummary: This study aims to evaluate how savoring influences reward and threat processes and downstream inflammation. Savoring is designed to enhance positive affect, which may blunt stress responses and reduce downstream inflammation. The investigators aim to examine changes in the brain following the savoring intervention. The investigators are particularly interested in changes in brain activity that are correlated with changes in inflammation-related markers in the blood. In this single-armed pilot trial, the investigators will assess how savoring alters reactivity to rewarding and threatening experiences, and then examine related changes in downstream inflammation. The investigators intend to recruit 20 undergraduate students to complete a 7-week standardized savoring intervention. Participants will complete brain scans, daily diaries, questionnaires, a behavioral task, and blood collection at pre- and post-intervention assessments. conditions: Low Positive Affect studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All 20 participants will be assigned to the same 7-week savoring intervention. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Savoring Intervention measure: Positive affect measure: Negative affect measure: Depression measure: Anxiety measure: Perceived stress measure: Psychological wellbeing measure: Emotions measure: Reward measure: Savoring strategies measure: Interoception measure: Inflammation measure: Sustained Attention measure: Neural Reward Activity measure: Neural Threat Activity measure: Daily diary sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: University of California, Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Robin B Blades role: CONTACT phone: 510-520-5780 email: robinblades@gmail.com name: Julienne Bower, PhD role: CONTACT phone: 310-825-3004 email: jbower@g.ucla.edu name: Julienne Bower, PhD role: PRINCIPAL_INVESTIGATOR name: Chloe Boyle, PhD role: SUB_INVESTIGATOR name: Naomi Eisenberger, PhD role: SUB_INVESTIGATOR name: Steve Cole, PhD role: SUB_INVESTIGATOR name: Michelle Craske, PhD role: SUB_INVESTIGATOR name: Aileen Echiverri, PhD role: SUB_INVESTIGATOR name: Robin Blades role: SUB_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06294132 id: 4016601 briefTitle: Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability overallStatus: RECRUITING date: 2024-02-27 date: 2024-10-21 date: 2024-10-28 date: 2024-03-05 date: 2024-03-08 name: Ithaca College class: OTHER briefSummary: Background / Purpose:

There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion. Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation. Also in question is the mechanism of improvement observed after spinal manipulation. Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion. This study aimed to determine the diagnostic accuracy of a physical therapist's manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion, pain, and disability,

Methods:

Subjects will complete a Numeric Pain Rating Scale (NPR),Oswestry Disability Index (ODI), and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool. They will be screened for contraindications to manipulation and neurological signs and symptoms. Active forward bending will be quantified by measuring the distance of the subject's fingertips to the floor. Two experienced physical therapists will evaluate the subject's lumbar intervertebral mobility. They will identify the lumbar segment with the least motion or hypomobility. The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer (Edge II MSK ultrasound unit, SonoSite, Inc, Bothell, WA) in the sidlying position with their trunk and hips flexed to end-range. The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment (L5-S1, L4-L5, L3-L2,L2-L1). Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation. The lumbar spine will be reimaged. The ultrasound examiner will be blinded to the manipulation and the caliper measurements. Finally, subjects will be asked for their Global Rating of Change (GROC) and to actively bend forward to remeasure the distance of their fingertips to the floor. One week later, patients will receive an e-mail containing links to repeat the NPR, GROC, and ODI. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either receive lumbar manipulation or a sham lumbar manipulation. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participant: the participants will not know whether they received the lumbar manipulation or sham lumbar manipulation.

Care Provider: the care providers (those who perform the lumbar manipulation and sham lumbar manipulation) will not be involved in collecting any outcome data.

Investigator: all investigators collecting outcome measures will not know which subjects received the lumbar manipulation or sham lumbar manipulation.

Outcome assessor: the outcome assessors will not be involved in collecting data. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Lumbar Manipulation name: Sham Lumbar Manipulation measure: Diagnostic Ultrasound measure: Trunk Flexion Range Of Motion Measurement measure: Oswestry Disability Questionnaire measure: Numeric Pain Rating Scale measure: Global Rating of Change sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ithaca College status: RECRUITING city: Ithaca state: New York zip: 14850 country: United States name: John Winslow role: CONTACT phone: 607-229-8792 email: jwinslow@ithaca.edu name: Michael Costello role: CONTACT email: mcostello@ithaca.edu lat: 42.44063 lon: -76.49661 hasResults: False

 nctId: NCT06294119 id: MANCAVA id: 2022SLB5MX type: OTHER_GRANT domain: Italian Ministry of Research briefTitle: Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay overallStatus: RECRUITING date: 2024-02-08 date: 2026-02-08 date: 2026-02-08 date: 2024-03-05 date: 2024-03-05 name: IRCCS Policlinico S. Donato class: OTHER briefSummary: MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.

In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.

Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states. conditions: Cardiac Disease conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Major Cardiac surgery measure: Autoregulation index (ARI) measure: number of patients developing depression measure: Baroreflex sensitivity measure: Cortical activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico San Donato status: RECRUITING city: San Donato Milanese state: Milan zip: 20097 country: Italy name: Vlasta Bari, PhD role: CONTACT phone: +390252774381 email: vlasta.bari@grupposandonato.it name: Pavandeep Singh role: CONTACT email: pavandeep.singh@grupposandonato.it name: Marco Ranucci, MD role: PRINCIPAL_INVESTIGATOR name: Vlasta Bari, PhD role: SUB_INVESTIGATOR name: Alberto Porta, PhD role: SUB_INVESTIGATOR name: Francesca Gelpi, Ms role: SUB_INVESTIGATOR name: Beatrice Cairo, PhD role: SUB_INVESTIGATOR lat: 45.41047 lon: 9.26838 hasResults: False

 nctId: NCT06294106 id: 24-212 briefTitle: eTMS for Veterans and First Responders With PTSD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-03-05 date: 2024-03-05 name: Virginia Polytechnic Institute and State University class: OTHER name: Wave Neuroscience briefSummary: A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial. conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 10 participants will receive eTMS treatment 10 participants will receive sham eTMS treatment primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: eTMS coil will have an 'active' and 'sham' side and the application will look identical to the participant. The technician will not know which side of the coil is which and will additionally be blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS) measure: Adverse Events measure: Report of Symptoms measure: PCL-5 sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fralin Biomedical Research Institute city: Roanoke state: Virginia zip: 24016 country: United States name: Jessica Florig, MPH role: CONTACT phone: 540-526-2261 email: jnw@vtc.vt.edu name: Wynn Legon, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.27097 lon: -79.94143 hasResults: False

 nctId: NCT06294093 id: 026/24 briefTitle: Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-02-15 date: 2025-02-15 date: 2024-03-05 date: 2024-03-07 name: University of Haifa class: OTHER name: Zinman College of Physical Education and Sports Sciences briefSummary: this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners. conditions: Achilles Tendon Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED measure: ultrasound tissue characterized measure: Balance test measure: Proprioception test measure: muscle strength test measure: endurance test gastrocnemius muscle sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06294080 id: DfH2023 briefTitle: Effects of Dance and Tai Chi on Balance and Wellbeing on Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-11 date: 2025-01 date: 2024-03-05 date: 2024-03-05 name: University of Wolverhampton class: OTHER briefSummary: The aim of the proposed randomised controlled study is to compare the effects and efficacy between a dance, a Tai Chi and a waiting list control group intervention over an eight-week period on physical functions and mental benefits among non-clinical adults aged between 18 and 59. The study's primary outcome is mental wellbeing and secondary parameters are physical functional and mood. A tertiary outcome will examine how the physical and mental parameters change during the learning and practice phases conditions: General Population studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Random Controlled Trial: Blind primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Data collection carried out by RAs blinded to participants' group allocation Statistician blinded to the group and test parameters whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Dance name: Tai Chi measure: Well-being measure: Leg strength measure: Balance measure: Mood sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: University of Wolverhampton city: Walsall state: West Midlands zip: WS1 3BD country: United Kingdom lat: 52.58528 lon: -1.98396 hasResults: False

 nctId: NCT06294067 id: 43261 briefTitle: A Dose Response Investigation of Docosahexaenoic Acid (DHA) acronym: DRI-DHA overallStatus: RECRUITING date: 2024-03 date: 2025-04 date: 2025-09 date: 2024-03-05 date: 2024-03-27 name: University of Toronto class: OTHER name: Unity Health Toronto briefSummary: Docosahexaenoic acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3 PUFA), commonly consumed from fish, that regulates many critical functions within the body including the brain, eye, and heart. While the metabolic precursor to DHA, alpha-linolenic acid (ALA) is considered nutritionally essential and has a set Dietary Reference Intake (DRI), DHA has not yet been deemed essential and does not have a set DRI. Currently, research suggests an intake range of dietary DHA to be anywhere from 0 to over 500mg/d. The aim of our study is to further investigate a feedback mechanism or accumulation that occurs with eicosapentaenoic acid (EPA) as a result of increased dietary DHA to provide insight for potential Recommended Dietary Intake (RDI) values.

Hypothesis: The dietary DHA dose at which blood EPA levels increase is the point at which elongation slows, indicating a significant negative feedback pathway is present.

Objectives: 1: To determine the dose-response for DHA to increase blood EPA levels in a mixed vegetarian and vegan population. 2: Investigate the DHA dose and time at dose that increases EPA using natural abundance delta carbon-13 (δ13C) as a tracer. 3: To measure DHA turnover and loss rates. 4: Provide data for exploratory analyses related to PUFA metabolism and the effect of DHA on disease related biomarkers.

Method: During an 8-week trial, 72 healthy vegan or vegetarian males and females (18-50 years) will be supplemented with 1 of 6 algal-oil based DHA doses: 0, 100, 200, 400, 800 or 1000 mg/d. Blood will be collected at days 0, 3, 7, 14, 28 and 56 and will be analyzed for changes in blood EPA levels as the primary outcome and plasma δ13C EPA signature as the secondary outcome.

Significance: Investigating this negative feedback pathway is of great importance in providing evidence to support n-3 PUFA DRIs. EPA and DHA are ecologically sensitive with their major source coming from unsustainably farmed fish stocks and having a set DRI may help to limit the overconsumption of these nutrients. conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blinded, randomized, control, dose-response supplementation trial primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: For randomization we will use the Research Electronic Data Capture (REDCap) program. Following successful completion of informed consent, the questionnaire and anthropometric assessment participants will be randomized into groups, of a possible six, using a blocked (Latin squares) randomization. These groups will represent DHA0 (0mg/d), DHA1 (100mg/d), DHA2 (200mg/d), DHA3 (400mg/d), DHA4 (800mg/d), and DHA5 (1000mg/d) groups. The Latin square sequences will be randomly allocated to participants with a similar number of participants allocated to each treatment sequence. The participants will only be randomized once all information is collected, informed consent has been obtained and questionnaires have been filled out following the first study call/zoom meeting. Then following their first study in person visit and post blood sample extraction they will be given their DHA capsules, which have been organized by a lab member not directly involved in the study. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: docosahexaenoic acid (DHA) name: soybean oil placebo measure: Changes in omega-3 polyunsaturated fatty acid (n-3 PUFA) blood levels measure: Changes in the delta carbon 13 (δ13C) n-3 PUFA signatures measure: Measure of n-3 LC PUFA turnover rates measure: Measure of n-3 LC PUFA half-lives measure: Increased intake of dietary α-Linolenic acid (ALA) and the inhibition of long chained omega-3 polyunsaturated fatty acids (LC n-3 PUFA) synthesis measure: Comparing the potential change in omega-3 long chained polyunsaturated fatty acids (n-3 LC PUFA) levels between male and female participants measure: Comparing the potential change in n-3 LC PUFA δ13C signatures between male and female participants measure: Comparing the potential change in n-3 LC PUFA levels between genetic variations measure: Comparing the potential change in n-3 LC PUFA δ13C signatures between genetic variations measure: Changes in cardiovascular disease (CVD) biomarkers (BMI in kg/m^2) measure: Changes in cardiovascular disease (CVD) biomarkers (Waist circumference in cm/inch) measure: Changes in cardiovascular disease (CVD) biomarkers (blood pressure in mmHg) measure: Changes in cardiovascular disease (CVD) biomarkers (heart rate in beats per minute) measure: Changes in cardiovascular disease (CVD) biomarkers (blood lipid profile changes in mmol/L) measure: Changes in δ13C DHA signature levels to document adherence sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Clinical Nutrition and Risk Factor Modification Centre status: RECRUITING city: Toronto state: Ontario zip: M5C 2T2 country: Canada name: Amy Symington, PhD student role: CONTACT email: dhatrial@unityhealth.to name: John Sievenpiper, MD, PhD, FRCPC role: CONTACT email: john.sievenpiper@alumni.utoronto.ca name: Richard Bazinet, PhD role: SUB_INVESTIGATOR name: John Sievenpiper, MD, PhD, FRCPC role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06294054 id: 2021/0393/HP briefTitle: Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy acronym: SELECT overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2026-03-31 date: 2026-03-31 date: 2024-03-05 date: 2024-03-06 name: University Hospital, Rouen class: OTHER name: Institut Curie briefSummary: This study will allow the investigators to better assess the efficiency of neoadjuvant chemotherapy before cystectomy by training a predictive model on different patient cohorts with bladder cancer. conditions: Bladder Cancer conditions: Genomic Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 707 type: ESTIMATED name: neoadjuvant chemotherapy with cisplatine measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre de lutte contre le cancer François Baclesse city: Caen country: France lat: 49.18585 lon: -0.35912 facility: Centre de recherche des Cordeliers city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Saint-Louis AP-HP city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut Curie Centre de Recherche city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut Curie city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut Gustave Roussy city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Mines ParisTech city: Paris country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06294041 id: UEC23/52 briefTitle: INvestigating the Value of Early Sleep Therapy acronym: INVEST overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-06-01 date: 2025-06-01 date: 2024-03-05 date: 2024-03-05 name: University of Strathclyde class: OTHER name: University of Oxford name: University of Glasgow name: NHS Greater Glasgow and Clyde name: NHS Grampian briefSummary: Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia.

Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment.

This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise. conditions: Acute Insomnia (Disorder) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Due to the nature of the SRT intervention, the research nurse, patients and most of the study team cannot be blinded to treatment allocation. However, the statistician will be blinded to treatment allocation (i.e., SRT or SHE) until after analysis is complete whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Sleep Restriction Therapy (SRT) name: Sleep Hygiene Education (SHE) measure: Recruitment rates measure: Retention rates measure: Intervention fidelity: Therapist adherence measure: Intervention fidelity: Patient engagement measure: Intervention fidelity: Control group contamination measure: Outcome measure completion measure: Intervention acceptability measure: Improvement in insomnia severity measure: Improvement in mental health [depression] measure: Improvement in mental health [anxiety] measure: Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F) measure: Improvement in rest-activity rhythms measure: Improvement in sleep [estimates of subjective sleep] measure: Measure of health related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294028 id: RC31/21/0338 briefTitle: International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction acronym: VIVA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-12-31 date: 2029-12-31 date: 2024-03-05 date: 2024-03-05 name: University Hospital, Toulouse class: OTHER briefSummary: Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.

On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.

Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator. conditions: Ischemic Heart Disease conditions: Ventricular Tachycardia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 268 type: ESTIMATED name: Adverse events collection name: Quality of life questionnaire EQ-5D-5L name: Medical-economic evaluation measure: Monitoring for the occurrence of at least one serious event during the 36 months of follow-up sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294015 id: 2023-5009 briefTitle: Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-04 date: 2024-03-05 date: 2024-03-05 name: Université de Sherbrooke class: OTHER briefSummary: Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops.

Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment.

The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates.

The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue. conditions: Corneal Epitheliopathy conditions: Glaucoma conditions: Corneal Disease conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: 20% ASED + AT name: 0.9% NS + AT measure: National Eye Index Scores measure: Schirmer Test measure: Visual Acuity measure: Tear Break Up Time measure: Ocular Surface Disease Index measure: Intraocular Pressure measure: Complication rates sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06294002 id: 46-06-04/2020-1 briefTitle: Neuromuscular Training & Postural Stability acronym: STABLEFIT overallStatus: COMPLETED date: 2022-02-15 date: 2022-02-20 date: 2022-06-25 date: 2024-03-05 date: 2024-03-06 name: University of Novi Sad class: OTHER briefSummary: Background: Postural stability (PS) is a vital function that helps maintain equilibrium during standing still, locomotion, and any activities requiring high balance performance. Under static and dynamic conditions, PS is a fundamental factor for the quality of movement in everyday activities or sports. PS and adaptive ability are required in sports due to the interactions between the sensory and motor systems, which regulate postural adjustments by processing information from the visual, vestibular, and somatosensory systems, as reported by previous studies. The interest in using different exercises and protocols for improving PS in sports and physiotherapy has grown in the last few decades. Experts have proposed various training modalities to increase neuromuscular stability, balance, postural control, and general stability. Dynamic Neuromuscular Stabilization (DNS) is a complex of correction exercises with a neuromuscular approach based on improving breathing, fundamental movements, and principles of developmental kinesiology. Whole body vibration training (WBV) is a neuromuscular training approach that has recently become very popular among researchers and practitioners in health and sport. It is usually used as an additional method in a conventional training routine. Designing the training program to achieve the optimal benefits for PS in healthy young adults is important in general personal health management. Although different training protocols have improved PS and general stability in everyday activities, there is still considerable debate regarding the optimal exercise modalities within an exercise program. Aim: The purpose of this study is to determine the effects of dynamic neuromuscular stabilisation (DNS), whole-body vibration (WBV), and a combination of DNS and WBV (MIX) training modalities on postural stability (PS) in healthy recreation participants. Method and materials: 180 gender-balanced groups were divided into four groups, MIX, DNS, VIBRO and CONTROL and underwent two months of treatment. The single and double-leg Center of Force (COF) parameters were collected on the Forceplate. conditions: Postural Stability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 180 type: ACTUAL name: Dynamic neuromuscular stabilisation group name: Whole body vibration group name: Dynamic neuromuscular stabilisation with whole body vibration group measure: Double-leg static postural stability sway area measure: Double-leg static postural stability center of force traveled way measure: Double-leg static postural stability medio-lateral displacement measure: Double-leg static postural stability anterior-posterior displacement measure: Single-leg static postural stability sway area measure: Single-leg static postural stability center of force traveled way measure: Single-leg static postural stability anterior-posterior displacement measure: Single-leg static postural stability medio-lateral displacement measure: Sex measure: Date of birth measure: Weight measure: Height measure: Body Mass Index (BMI) measure: Adherence sex: ALL minimumAge: 21 Years maximumAge: 26 Years stdAges: ADULT facility: Faculty of sport and Physical Education, University of Novi Sad city: Novi Sad state: Vojvodina zip: 21000 country: Serbia lat: 45.25167 lon: 19.83694 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-19 uploadDate: 2024-02-27T09:25 filename: Prot_000.pdf size: 468513 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-19 uploadDate: 2024-02-27T09:26 filename: ICF_001.pdf size: 167182 hasResults: False

 nctId: NCT06293989 id: Emergency department briefTitle: Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo acronym: Vertigo overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-03-30 date: 2024-03-05 date: 2024-04-02 name: University of Monastir class: OTHER briefSummary: This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED conditions: Vertigo, Peripheral studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 1000 type: ESTIMATED name: Diazepam 5mg name: Diazepam 10 mg name: Placebo measure: Visual analogue scale (VAS)-3H measure: the Delta-VAS measure: the time required to reach the resolution of the vertigo crisis measure: Patients satisfaction measure: number of patients with adverse effects sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293976 id: 4506 briefTitle: Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study acronym: SEVERE overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-05 date: 2024-03-05 name: Unity Health Toronto class: OTHER briefSummary: Background: Reverse triggering (RT) is a frequent phenomenon observed in sedated patients under a mechanical ventilation mode called assist-control ventilation. RT is when the ventilator would trigger the patient's respiratory effort instead of the correct order of the patient's respiratory effort triggering the ventilator. Reverse triggering can have negative consequences (loss of protective lung ventilation, and causing double breaths - with the ventilator giving two consecutive breaths and not allowing the patient to exhale) but also offer some protective effects (avoid diaphragm disuse atrophy). The balance of its negative vs positive effects depends on its frequency and magnitude of its associated respiratory effort. Respiratory entrainment is the most often referred mechanism involving a change in patient's rate of breathing effort from that of patient's intrinsic rate to the rate of mechanical insufflation. The specific ventilatory settings associated with or responsible for RT remains unknown.

Aims: To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate (RR) and tidal volume (Vt) on the presence/development of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering (RT).

Methods. 30 adult patients (15 in each group), sedated and under assist-controlled ventilation will be included. Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering. Initially, with the ventilator on a mode called volume control, which means the ventilator controls the amount of air (tidal volume) and the number of breaths the patients gets every minute (respiratory rate \[RR\]). The tidal volume will be set at the current standard clinical practice setting (6 ml/kg of predicted body weight). The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver. Next, the number of breaths the ventilator gives per minute (RR) will be changed from 6 breaths less to 6 breaths more, in steps of 2 breaths every minute. The protocol will be repeated again changing the amount of air the patients gets (tidal volume) from 4, 5, 7 and 8 ml/kg. Continuous recordings of airway pressure, flow, esophageal pressure, electrical activity of the diaphragm, main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded. A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT. conditions: Respiration, Artificial conditions: Reverse Triggering studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Changes in the ventilator respiratory rate and tidal volume measure: The rate of of reverse triggered breaths occurring after each change in the ventilator respiratory rate and tidal volume. measure: The magnitude of the effort, measured by the drop in the esophageal pressure in cmH2O, associated with the reverse triggered breaths after each change in the ventilator respiratory rate and tidal volume sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unity Health Toronto - St. Michael's Hospital status: RECRUITING city: Toronto state: Ontario zip: M5B 1T8 country: Canada name: Audery Kim role: CONTACT phone: 416-864-5686 email: audery.kim@unityhealth.to name: Antenor Rodrigues role: SUB_INVESTIGATOR name: Laurent Brochard role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06293963 id: 24-0300a briefTitle: Front-of-package Label Effects in Latine and Limited English Proficiency Populations overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2024-04-15 date: 2024-04-15 date: 2024-03-05 date: 2024-03-18 name: University of North Carolina, Chapel Hill class: OTHER name: Duke University name: Stanford University briefSummary: The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:

What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?

What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?

Additionally, this experiment also aims to answer the following question:

Do the benefits of front-of-package label designs differ by English proficiency and parental status?

Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs. conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 4000 type: ESTIMATED name: Guideline Daily Amounts label name: Interpretive text-only label name: Interpretive magnifying glass icon label name: Separated interpretive magnifying glass icon label measure: Selection of healthiest product for purchase measure: Correct identification of healthiest product measure: Correct identification of least healthy product measure: Correct identification of products high in nutrients sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Marissa G Hall, PhD role: CONTACT phone: 919-445-1310 email: mghall@unc.edu lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06293950 id: AUTISM briefTitle: Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism overallStatus: RECRUITING date: 2022-03-09 date: 2024-06 date: 2024-12 date: 2024-03-05 date: 2024-03-05 name: University of Jordan class: OTHER briefSummary: Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. conditions: Autism studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: WJMSC measure: safety profile lab tests measure: efficacy change in Adult ADHD Self-Report Scale (ASRS) sex: ALL minimumAge: 4 Years maximumAge: 14 Years stdAges: CHILD facility: Cell Therapy Center status: RECRUITING city: Amman zip: 00962 country: Jordan name: Hanan Jafar, PhD role: CONTACT phone: 00962798871087 email: hanan.jafar@gmail.com name: Abdallah Awidi, MD role: CONTACT phone: 0096265355000 phoneExt: 23960 email: abdalla.awidi@gmail.com lat: 31.95522 lon: 35.94503 hasResults: False

 nctId: NCT06293937 id: 24-0300b briefTitle: Impact of Front-of-package Labels on Weight Bias Among Latines overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-04-30 date: 2024-04-30 date: 2024-03-05 date: 2024-04-03 name: University of North Carolina, Chapel Hill class: OTHER name: Duke University name: Stanford University briefSummary: The goal of this experiment is to examine the effects on explicit weight bias of a selection task using 4 different types of front-of-package food labels to select healthy or unhealthy foods among a sample of Latine and low English proficiency adults. The main questions this experiment aims to answer are:

* Does the use of different front-of-package label designs in a selection task lead to different effects on explicit weight bias among Latine and low English proficiency consumers?
* Does the use of different front-of-package label designs in a selection task lead to different effects on attribution of personal responsibility for body weight among Latine and low English proficiency consumers?

Participants will be randomly assigned to 1 of 4 types of front-of-package label designs. They will view 3 sets of products (frozen meals, frozen pizzas, and frozen desserts), shown in random order. For each product set, participants will view 3 products shown in random arrangement, each with participants' randomly assigned label shown on the front of package. After viewing all 3 product types, participants will answer questions about explicit weight bias and attribution of responsibility for body weight. Researchers will compare results across label designs. conditions: Weight Prejudice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 4000 type: ESTIMATED name: Numerical label name: Interpretive text-only label name: Interpretive magnifying glass icon label name: Separated interpretive magnifying glass icon label measure: Explicit weight bias, mean score measure: Attribution of personal responsibility for body weight, mean score sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Aline D'Angelo Campos, MPP role: CONTACT phone: 919-966-3215 email: adangelo-campos@unc.edu lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06293924 id: The PEFLANA Trial briefTitle: Pericardial Fluid Analysis in Recurrent Pericarditis acronym: PEFLANA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2029-02 date: 2031-02 date: 2024-03-05 date: 2024-03-05 name: ASST Fatebenefratelli Sacco class: OTHER briefSummary: This clinical trial aims to examine the biochemical and cytological features of pericardial effusion during acute and recurrent pericarditis and to understand the molecular factors responsible for pathogenesis. The primary objective of this study is to identify and validate diagnostic criteria in pericardial fluid analysis that can differentiate patients with acute and recurrent pericarditis from those with only pericardial fluid but no inflammation.

This study will enroll patients with acute pericarditis who require pericardiocentesis for either diagnostic or therapeutic purposes. Two control groups will also be included: one consisting of patients who need cardiac surgery with a collection of pericardial fluid, and the other consisting of patients who require pericardiocentesis for non-inflammatory pericardial effusion. The purpose of the study is to compare the cell activation status and cytokines present in pericardial fluid during acute pericarditis with those present during other pericardial pathologies. conditions: Acute Pericarditis conditions: Pericardial Effusion conditions: Pericardial Disease conditions: Pericardial Fluid Exudate conditions: Autoinflammatory Disorders conditions: Autoinflammatory Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 432 type: ESTIMATED name: Pericardiocentesis name: Pericardiotomy name: Cytofluorometry and Gene expression analysis measure: Differences in cell counts among inflammatory and non-inflammatory pericardial effusion. measure: Difference in biochemical parameters among inflammatory and non-inflammatory pericardial effusion measure: Difference of IL-1 expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion measure: Differences of inflammatory cytokine expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion measure: Differences of gene expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion measure: Differences of gene expression in pericardial fluid and blood cells during pericarditis measure: Differences in cytokine and other molecule concentrations between pericardial fluid and blood cells in pericarditis measure: Correlation of inflammatory mediators in pericardial fluid and clinical features during pericarditis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293911 id: 2024-POSTBIOTICSDOWNSYNDROME briefTitle: Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome overallStatus: ENROLLING_BY_INVITATION date: 2024-03-15 date: 2025-07-17 date: 2025-07-28 date: 2024-03-05 date: 2024-04-26 name: University of Pavia class: OTHER briefSummary: The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome.

Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders.

Then, they will be randomly divided into two groups according to the home treatment:

* in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study
* in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study.

Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint. conditions: Down Syndrome conditions: Gingival Bleeding 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: Biorepair Plus Parodontgel Intensive name: Placebo gel measure: Change in Bleeding on Probing (BOP%) measure: Change in Plaque Control Record (PCR%) measure: Change in Dental mobility measure: Change in Modified Gingival Index measure: Change in compliance measure: Change in product satisfaction sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino" city: Turin zip: 10128 country: Italy lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06293898 id: BL-M07D1-ST-101 briefTitle: Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors overallStatus: RECRUITING date: 2024-02-09 date: 2025-08-24 date: 2027-08-24 date: 2024-03-05 date: 2024-03-05 name: SystImmune Inc. class: INDUSTRY briefSummary: The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors. conditions: Endometrial Cancer conditions: Cervical Cancer conditions: Ovarian Cancer conditions: Urothelial Carcinoma conditions: Biliary Tract Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 280 type: ESTIMATED name: BL-M07D1 measure: Summary of safety measure: To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SystImmune Recruiting Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: SystImmune role: CONTACT lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06293885 id: PLUG-II briefTitle: Pleurodesis Using Hypertonic Glucose acronym: PLUG-II overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-04-30 date: 2025-04-30 date: 2024-03-05 date: 2024-03-05 name: Lawson Health Research Institute class: OTHER briefSummary: Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection. conditions: Air Leak From Lung studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Dextrose 50 name: Standard of Care - No Dextrose 50 measure: Prolonged Air Leak measure: Duration of Chest Tubes measure: Home with Chest Tube sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London Health Sciences Centre city: London state: Ontario zip: N6A 5W9 country: Canada lat: 42.98339 lon: -81.23304 hasResults: False

 nctId: NCT06293872 id: IZC miniscrew briefTitle: Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region overallStatus: COMPLETED date: 2023-02-25 date: 2023-07-10 date: 2023-12-28 date: 2024-03-05 date: 2024-03-05 name: University of Baghdad class: OTHER briefSummary: Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate. conditions: Orthodontic Appliance Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: 12*2 mm length miniscrew measure: failure rate measure: primary stability measure: secondary stability measure: pain perception sex: ALL minimumAge: 15 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: University of Baghdad College of Dentistry city: Baghdad zip: 10011 country: Iraq lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06293859 id: 5047292 briefTitle: Effect of 12-week Probiotic Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers and Human Microbiome acronym: FOODBIOMES CT2 overallStatus: COMPLETED date: 2023-02-15 date: 2023-07-07 date: 2023-07-30 date: 2024-03-05 date: 2024-03-05 name: University of the Aegean class: OTHER name: Democritus University of Thrace briefSummary: The purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 54 type: ACTUAL name: Probiotic oat flakes name: Conventional oat flakes measure: Inflammatory biomarkers sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of the Aegean city: Myrina state: Limnos/Lesvos zip: 81 400 country: Greece lat: 39.87483 lon: 25.06359 hasResults: False

 nctId: NCT06293846 id: IRB-300012108 id: IRB Designation type: OTHER domain: UAB briefTitle: BeFit Toolbox Collaboration: Building Empowerment Through Fitness acronym: BEFIT overallStatus: RECRUITING date: 2024-03-15 date: 2025-12-31 date: 2026-12-31 date: 2024-03-05 date: 2024-03-28 name: University of Alabama at Birmingham class: OTHER briefSummary: This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population. conditions: Low-Income Population conditions: Women's Health studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 50 type: ESTIMATED name: What I Learned at Home measure: Barriers to Physical Activity Self-Report sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham status: RECRUITING city: Birmingham state: Alabama zip: 35233 country: United States name: Kimberly McCall, PhD role: CONTACT phone: 205-934-3378 email: kmccall@uab.edu name: Keith Mcgregor, PhD role: CONTACT phone: 3523598084 phoneExt: Mcgregor email: kmmcgreg@uab.edu name: Keith Mcgregor role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06293833 id: 003315 briefTitle: Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan acronym: ZORALCS overallStatus: ENROLLING_BY_INVITATION date: 2024-09-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-05 date: 2024-03-05 name: University Hospital, Antwerp class: OTHER name: Universiteit Antwerpen name: Belgian Cancer Registry briefSummary: The goal of this clinical trial is to implement lung cancer screening in a targeted high-risk population of heavy (ex-)smokers in Flanders (Belgium). This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation. conditions: Lung Cancer, Nonsmall Cell conditions: Lung Cancer conditions: Smoking Cessation conditions: Lung Cancer, Small Cell studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 700 type: ESTIMATED name: Low-dose CT scan name: Smoking Cessation measure: Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA measure: Responders measure: Number of true and false positive nodules measure: Impact of smoking cessation intervention measure: Success of smoking cessation intervention measure: Evaluation of shared decision making tool sex: ALL minimumAge: 55 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZA city: Edegem state: Antwerp zip: 2650 country: Belgium lat: 51.15662 lon: 4.44504 hasResults: False

 nctId: NCT06293820 id: TL-925-304 briefTitle: A Study Of TL-925 For The Treatment of AC overallStatus: RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-05 date: 2024-04-01 name: Telios Pharma, Inc. class: INDUSTRY briefSummary: In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.

The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis. conditions: Allergic Conjunctivitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The sponsor, investigators, and study staff will be masked throughout the study. The study site will have the capacity to unmask in case of emergency.

Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject, and the database has been locked. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: TL-925 name: Placebo measure: Ocular Itching measure: Conjunctival Redness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Andover Eye Associates status: RECRUITING city: Andover state: Massachusetts zip: 01810 country: United States lat: 42.65843 lon: -71.137 hasResults: False

 nctId: NCT06293807 id: 20220162HU briefTitle: Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine overallStatus: COMPLETED date: 2022-06-06 date: 2023-04-16 date: 2023-04-16 date: 2024-03-05 date: 2024-03-08 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized, placebo-controlled, parallel design study. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Both the surgeon and patient will be blinded as to the intervention provided by covering identifying marks of the anesthetic carpules to be administered. Randomization will be assured by random selection of a slip of paper drawn from a sealed envelope assigning the patient to one of three groups. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ACTUAL name: Xylocaine 2 % with 1:100,000 epinephrine name: Bupivicaine 0.5% with 1:200,000 epinephrine name: Placebo measure: Change in pain using Visual Analog Scale (VAS) measure: Number of Ibuprofen administered measure: Number of Tylenol administered measure: Arch Response measure: Number of teeth measure: Type of procedure measure: Gender of patient measure: Age of patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at San Antonio city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06293794 id: 22-0991 briefTitle: Decision Support for Heart Failure Prescribing overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2025-09 date: 2024-03-05 date: 2024-03-05 name: University of Colorado, Denver class: OTHER briefSummary: Clinical decision support (CDS) tools can 'nudge' clinicians to make the best decisions easy. Although required by "meaningful use" regulations, more than 40% of CDS lead to no change and the remaining lead to improvements that are modest at best. This is because CDS tools often ignore contextual factors and present irrelevant information. Although many tools have undergone patient-specific optimization, 'traditional CDS' are rarely clinician-specific. For example, a traditional CDS tool for beta blockers and heart failure with reduced ejection fraction (HFrEF) addresses common prescribing misconceptions by stating asthma is not a contraindication and providing a safe threshold for blood pressure. For clinicians without these misconceptions, these statements are irrelevant and distract from key information. A 'personalized CDS' would evaluate clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. The objective of this research is to create personalized clinician-specific CDS that overcome shortcomings of traditional CDS. The central hypothesis is a personalized CDS that minimizes irrelevant information will lead to a higher rate of prescribing guideline-directed management and therapy (GDMT) for HFrEF compared to a traditional CDS. conditions: Decision Support Systems, Clinical conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Compare traditional and personalized CDS in a pragmatic randomized controlled trial at one health system. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1075 type: ESTIMATED name: Personalized Clinical Decision Support (CDS) name: Traditional Clinical Decision Support (CDS) measure: Number of CDS alerts resulting in the prescription of a recommended medication measure: Number of patients the CDS alerted for measure: Number of alerts that were not outright dismissed measure: Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293781 id: GachonU briefTitle: Application of the Web-based Acceptance and Commitment Therapy for Depression acronym: ACTION overallStatus: RECRUITING date: 2022-12-19 date: 2025-02-28 date: 2025-02-28 date: 2024-03-05 date: 2024-03-05 name: Gachon University class: OTHER briefSummary: PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Web-based ACT name: Treatment as usual measure: Acceptance and Action Questionnaire-II measure: Cognitive Fusion Questionnaire sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kyoung-Sae Na status: RECRUITING city: Incheon state: Please Incheon zip: 21565 country: Korea, Republic of name: Kyoung-Sae Na, MD, PhD role: CONTACT phone: 82324689932 email: ksna13@gmail.com lat: 37.45646 lon: 126.70515 hasResults: False

 nctId: NCT06293768 id: FADOI.05.2018 briefTitle: Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T) acronym: GreenLineH-T overallStatus: COMPLETED date: 2019-09-23 date: 2023-12-31 date: 2024-02-20 date: 2024-03-05 date: 2024-03-05 name: Fadoi Foundation, Italy class: OTHER briefSummary: Monocentric prospective controlled randomized in open-label study. The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control), aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring. conditions: Hospitalization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control). 50 of the patients undergoing continuous monitoring come from the group A and 100 from group B, same ratio in the control group.

Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 208 type: ACTUAL name: continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients) measure: difference in the incidence of major complications at 30 days measure: number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward measure: Difference in the incidence of major complications at the end of the telemonitoring phase sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale di Albano - Polo H2 city: Roma country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06293755 id: COA022/66 briefTitle: Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-28 date: 2024-03-05 date: 2024-06-25 date: 2024-03-05 date: 2024-03-05 name: Dhurakij Pundit University class: OTHER briefSummary: The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores. conditions: Enlarged Pores studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Microneedle patch name: Intradermal injection measure: Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dhurakij Pundit University city: Lak Si state: Bangkok country: Thailand lat: 13.88724 lon: 100.5792 hasResults: False

 nctId: NCT06293742 id: EC0007 briefTitle: ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants overallStatus: RECRUITING date: 2024-02-09 date: 2024-04-19 date: 2024-04-19 date: 2024-03-05 date: 2024-03-05 name: Eccogene class: INDUSTRY briefSummary: This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: ECC5004 name: Midazolam name: Rosuvastatin name: Digoxin name: Atorvastatin measure: Atorvastatin PK parameters: AUC(0-tlast) measure: Atorvastatin PK parameters: AUC(0-inf) measure: Atorvastatin PK parameters: Cmax measure: Rosuvastatin PK parameters: AUC(0-tlast) measure: Rosuvastatin PK parameters: AUC(0-inf) measure: Rosuvastatin PK parameters: Cmax measure: Digoxin PK parameters: AUC(0-tlast) measure: Digoxin PK parameters: AUC(0-inf) measure: Digoxin PK parameters: Cmax measure: Midazolam PK parameters: AUC(0-tlast) measure: Midazolam PK parameters: AUC(0-inf) measure: Midazolam PK parameters: Cmax measure: ECC5004 Safety parameters: Number of participants with adverse events (AEs) measure: ECC5004 Safety parameters: Number of participants with vital sign abnormalities measure: ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: ECC5004 Safety parameters: Number of participants with physical examination abnormalities measure: ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities measure: Atorvastatin safety parameters: Number of participants with adverse events (AEs) measure: Atorvastatin safety parameters: Number of participants with vital sign abnormalities measure: Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG) measure: Atorvastatin safety parameters: Number of participants with physical examination abnormalities measure: Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities measure: Rosuvastatin safety parameters: Number of participants with adverse events (AEs) measure: Rosuvastatin safety parameters: Number of participants with vital sign abnormalities measure: Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Rosuvastatin safety parameters: Number of participants with physical examination abnormalities measure: Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities measure: Digoxin safety parameters: Number of participants with adverse events (AEs) measure: Digoxin safety parameters: Number of participants with vital sign abnormalities measure: Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Digoxin safety parameters: Number of participants with physical examination abnormalities measure: Digoxin safety parameters: Number of participants with clinical laboratory abnormalities measure: Midazolam safety parameters: Number of participants with adverse events (AEs) measure: Midazolam safety parameters: Number of participants with vital sign abnormalities measure: Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Midazolam safety parameters: Number of participants with physical examination abnormalities measure: Midazolam safety parameters: Number of participants with clinical laboratory abnormalities measure: ECC5004 PK parameters: AUC (0-τ) measure: ECC5004 PK parameters: AUC(0-24) measure: ECC5004 PK parameters: tmax measure: ECC5004 PK parameters: t1/2 measure: ECC5004 PK parameters: CL/F measure: ECC5004 PK parameters: Ctau sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eccogene Investigational Site status: RECRUITING city: Anaheim state: California zip: 92801 country: United States name: Eccogene role: CONTACT lat: 33.83529 lon: -117.9145 hasResults: False

 nctId: NCT06293729 id: NGGT006-P-2302 briefTitle: Safety and Efficacy Study of NGGT006 in Refractory Hypercholesterolemia Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-31 date: 2029-03-01 date: 2024-03-05 date: 2024-04-17 name: Suzhou Municipal Hospital class: OTHER briefSummary: This is an early phase 1, open-label, single-center, dose-escalation pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in patients with refractory Hypercholesterolemia diagnosed by gene testing for familial hypercholesterolemia. NGGT006 uses adeno-associated virus (AAV) as a vector, carrying a liver specific promoter and codon optimized human LDLR gene, driving the expression of LDLR protein with normal function and promoting the clearance of low-density lipoprotein cholesterol (LDL-C). conditions: Refractory Hypercholesterolemia conditions: Familial Hypercholesterolemia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: NGGT006 measure: Incidence of treatment-related adverse events (AE) and serious adverse events (SAE) measure: Absolute change and percent change in LDL-C measure: Absolute change and percent change in non-high density lipoprotein cholesterol measure: Absolute change and percent change in apolipoprotein B measure: Absolute change and percent change in total cholesterol measure: Absolute change and percent change in HDL-C measure: Absolute change and percent change in triglycerides measure: Absolute change and percent change in very low-density lipoprotein cholesterol measure: Absolute change and percent change in lipoprotein(a) measure: Absolute change and percent change in apolipoprotein A-I sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06293716 id: CVL237-A2001 briefTitle: CVL237 Tablets for APDS/PASLI overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-12-29 date: 2026-03-30 date: 2024-03-05 date: 2024-03-05 name: Convalife (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: This study was designed to evaluate the efficacy and safety of CVL237 tablets in patients with APDS/PASLI (activated phosphoinositol 3-kinase δ syndrome /p110 delta-activated mutation leading to senescent T cells, lymphadenopathy, and immune deficiency). conditions: PI3K and P110delta Hyperactivation Syndrome studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CVL237 tablets for APDS/PASLI (Activated phosphoinositol 3-kinase delta syndrome /p110 delta-activated Mutation leading to senescent T cells, lymphadenopathy, and immune deficiency) primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Part II is a randomized, double-blind, placebo-controlled study of approximately 30 patients with APDS/PASLI. On day 1, patients were randomly assigned to the trial and placebo groups in a 2:1 ratio to take an oral CVL237 tablet or a placebo CVL237 simulant once daily. Efficacy and safety were evaluated on days 29, 57, and 85. The efficacy of CVL237 tablets in reducing lymphadyopathy will be investigated as measured by changes in the sum of diameter products (SPD) of target lesions selected from MRI or CT imaging according to the Lugano 2014 method, as well as changes in the percentage of naive B cells to total B cells, relative to baseline. The CVL237 tablets will also be evaluated for safety, PK whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 35 type: ESTIMATED name: CVL237 tablets name: CVL237 placebo tablets measure: part 1 : Incidence of Treatment-Emergent Adverse Events measure: part 2:After 84 days of treatment, changes in the sum of diameter product (SPD) of log10 conversion in target lesions and changes in the percentage of naive B cells to total B cells from baseline were observed measure: Cmax measure: t1/2 measure: AUC measure: Tmax sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Public Health Clinical Center city: Shanghai state: Shanghai zip: 201508 country: China name: Yun Ling, ph.D role: CONTACT phone: 18121157875 email: yun.ling@vip.126.com name: Ying Lv role: CONTACT phone: 18916099680 lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06293703 id: 23-1228 briefTitle: Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study) acronym: CLIMB II overallStatus: RECRUITING date: 2024-01-12 date: 2025-12-11 date: 2030-12-11 date: 2024-03-05 date: 2024-03-05 name: Salvador Navarrete class: OTHER briefSummary: The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics. conditions: Morbid Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be a prospective, randomized controlled trial with a 1:1 recruitment allocation ratio coordinated at the Cleveland Clinic Foundation (CCF) primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 262 type: ESTIMATED name: Surgery measure: To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients measure: To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis measure: To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity measure: To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Salvador Navarrete, MD role: CONTACT phone: 216-219-9211 email: navarrs@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06293690 id: L23-407 briefTitle: Toripalimab Combined With SBRT for NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-06-30 date: 2026-06-30 date: 2024-03-05 date: 2024-03-06 name: Shanghai Pulmonary Hospital, Shanghai, China class: OTHER briefSummary: This study aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC conditions: Non-small Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Toripalimab name: Toripalimab measure: Major pathological remission rate measure: Complete pathological remission rate measure: disease-free survival（DFS） measure: overall survival measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital city: Shanghai state: Shanghai zip: 200000 country: China name: Deping Zhao role: CONTACT phone: 0086-20-65115006 email: zdp1992@163.com name: Deping Zhao role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06293677 id: 2023-01013 briefTitle: Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance acronym: DAR-ARC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03 date: 2026-03 date: 2024-03-05 date: 2024-03-05 name: Centre Hospitalier Universitaire Vaudois class: OTHER name: Unisanté Centre universitaire de médecine générale et santé publique name: FORCE Fondation Recherche sur le Cancer de l'Enfant briefSummary: This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those that defend against bacterial infections (neutrophils). One significant concern is febrile neutropenia, where children experience a fever during a period of low white blood cell count. This condition often results from bacterial infections, necessitating prompt wide-spectrum antibiotic treatment. However, some children eliminate antibiotics in the urine too quickly during febrile neutropenia. Their kidneys function more than they normally do (renal hyperfiltration). This can lead to insufficient exposure to antibiotics to control the infection. The current standard antibiotic regimens do not account for this variable elimination rate. In this study we focus on two antibiotics used in this context: piperacillin-tazobactam and meropenem.

The main questions this study aims to answer are, in these children:

* Would higher doses of antibiotics result in better blood levels of antibiotics?
* Would they have more sides effects with higher antibiotics dosages?
* Would they recover more quickly with higher antibiotic doses? All patients will undergo a blood test upon hospital arrival, including an assessment of renal function. If renal function is normal or diminished, the patient will receive the standard antibiotic dose. Children with increased renal function will be randomly assigned to two groups during each episode of febrile neutropenia. One group will receive standard antibiotic dosages, while the other will receive higher doses to compensate for renal hyperfiltration. Throughout the study, antibiotic levels in the blood will be monitored for all patients. This monitoring will determine if target concentrations can be achieved more quickly with experimental dosages and will allow doctors to readjust the doses if needed. conditions: Febrile Neutropenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Our study is an open-label, re-randomized controlled trial in multi-episodes settings. So the care team, researchers and patients will be informed of the allocation group. Patients will be able to participate in each episode of febrile neutropenia. At each inclusion the patient may be in a different group. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem name: Standard dosages of piperacillin-tazobactam or meropenem measure: Achievement of antibiotic concentration targets in the intervention group (1i) vs control groupe (1c) measure: Achievement of antibiotic concentration targets in control group 2 measure: Fever duration measure: Side effects of antibiotic therapy measure: Number of dosage adjustments required to achieve the target concentration measure: Difference between eGFR measured by creatinine-based Schwartz formula and other eGFR calculation formulas sex: ALL minimumAge: 61 Days maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Centre Hospitelier Universitaire Vaudois (CHUV) city: Lausanne state: Vaud zip: 1011 country: Switzerland name: Margherita Plebani role: CONTACT phone: +41795563598 email: Margherita.Plebani@chuv.ch name: Pierre-Alex Crisinel role: PRINCIPAL_INVESTIGATOR lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06293664 id: RAHM-2023-006 briefTitle: Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes acronym: α-MSH & T2DM overallStatus: RECRUITING date: 2024-03-04 date: 2024-04-04 date: 2024-04-04 date: 2024-03-05 date: 2024-03-05 name: Dasman Diabetes Institute class: OTHER briefSummary: Alpha-melanocyte stimulatory hormone (α-MSH) is a melanocyte-stimulating hormone produced by the hypothalamus and released from the pituitary gland. It acts as an agonist to the melanocortin 5 receptor (MC5R) in human skeletal muscle, playing a role in glucose uptake and disposal. This study aims to investigate whether α-MSH can enhance glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM). conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The research involves a double-blinded, randomized, placebo-controlled crossover study to assess the therapeutic potential of α-MSH infusion in T2DM patients. primaryPurpose: SCREENING masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 13 type: ESTIMATED name: α-MSH infusion name: Placebo solutions measure: Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. α-MSH infusion measure: Difference in the total or incremental area under the curve of the concentration of metabolites (C-peptide, Glucagon, Gut hormones, α-MSH) during OGTT with saline or α-MSH infusion. measure: Difference in energy intake measured by an ad libitum meal test at the saline vs. α-MSH infusion measure: Adverse events (including flushing) sex: ALL minimumAge: 21 Years maximumAge: 50 Years stdAges: ADULT facility: Dasman Diabetes Institute status: RECRUITING city: Kuwait City country: Kuwait name: Ebaa Al Ozairi, MD role: CONTACT name: Dalal Alsaeed, PhD role: CONTACT name: Carel Roux, MD role: SUB_INVESTIGATOR lat: 29.36972 lon: 47.97833 hasResults: False

 nctId: NCT06293651 id: DA4505_AMST_I/IIa briefTitle: Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2030-04 date: 2024-03-05 date: 2024-03-05 name: Dong-A ST Co., Ltd. class: INDUSTRY briefSummary: This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors. conditions: Locally Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 125 type: ESTIMATED name: DA-4505 name: DA-4505 + Pembrolizumab measure: Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria measure: PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)) measure: PK parameters for DA-4505 (Area Under the Curve (AUC)) measure: PK parameters for DA-4505 (half-life (t1/2)) measure: Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293638 id: 23-1125 briefTitle: Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor acronym: TRaNCE overallStatus: RECRUITING date: 2024-03-25 date: 2026-12-31 date: 2026-12-31 date: 2024-03-05 date: 2024-04-02 name: The Cleveland Clinic class: OTHER briefSummary: The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will be asked to remain seated with their head inside of a Magnetoencephalography (MEG) recording system as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation. conditions: Essential Tremor studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Alcohol name: Alprazolam name: Cold Therapy name: Peripheral Nerve Stimulation measure: CTCM Coherence measure: Power of oscillatory activity across the CTCM network in response to tremor interventions measure: Essential tremor severity: Tremor Research Group Essential Tremor Rating Scale (TETRAS) measure: Essential tremor severity: Grip force measure: Essential tremor severity: Limb acceleration sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Jeff Negrey, MA role: CONTACT phone: 216-636-5504 email: negreyj2@ccf.org name: James Liao, MD role: PRINCIPAL_INVESTIGATOR name: Ken baker, PhD role: SUB_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06293625 id: LEPAGE PHRCK 2022-2 briefTitle: Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced But Resecable Colon Cancer in the Elderly of 70 Years Old or More acronym: FOxTROT2France overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2032-03 date: 2032-03 date: 2024-03-05 date: 2024-03-05 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp).

Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC.

FOxTROT 2, a trial to test the role of NAC in older patients. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Folfox name: Surgery measure: DFS (disease Free Survival) sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: CHU Dijon Bourgogne city: Dijon zip: 21000 country: France name: Côme LEPAGE role: CONTACT email: come.lepage@u-bourgogne.fr lat: 47.31667 lon: 5.01667 hasResults: False

 nctId: NCT06293612 id: 22/449-3651 id: 2022-I2M-C&T-B-077 type: OTHER_GRANT domain: CAMS Innovation Fund for Medical Sciences (CIFMS) id: 7244398 type: OTHER_GRANT domain: Youth program of Beijing Natural Science Foundation id: Beijing Hope Run Special Fund type: OTHER_GRANT domain: LC2021A12 briefTitle: Constructing a Multimodal Imaging System to Predict the Risk of Heterochronous Metastasis of Rectal Cancer acronym: MIS-MRC overallStatus: COMPLETED date: 2015-01-01 date: 2018-12-31 date: 2022-11-30 date: 2024-03-05 date: 2024-03-05 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: The goal of this observational study is to construct a multimodal intelligent model to predict the risk of heterochronous metastasis of rectal cancer, which is helpful for individualized diagnosis and treatment and follow-up planning. The main questions it aims to answer are:

* what are the independent risk factors of distant metastasis (DM) in locally advanced rectal cancer (LARC)
* What is the influence weight of the above factors on the heterochronous metastasis of LARC, and how to build a risk-prediction model

This study will not affect or interfere with the routine medical diagnosis and treatment of participants, and will not increase the cost and risk of participants. Participant's information is protected and identified by a unique code. conditions: Locally Advanced Rectal Cancer conditions: Distant Metastasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 302 type: ACTUAL name: No intervention was administrated to the two cohorts. measure: Heterochronous distant metastasis measure: Distant metastasis-free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College city: Beijing zip: 100021 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06293599 id: P.T.REC/012/003131 briefTitle: Effect of Scapular Stabilization Exercises Versus Virtual Reality Exercises in Basketball Players With Scapular Dyskinesia acronym: SD overallStatus: NOT_YET_RECRUITING date: 2024-03-05 date: 2024-07-30 date: 2024-07-30 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: this study will be conducted to compare virtual reality and scapular stabilizing exercise among basketball player with scapular dyskinesia on scapular muscle performance, rounded shoulder, pain intensity , disability and hand grip strength conditions: Scapular Dyskinesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: scapular stabilization and virtual reality exercise primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: opaque sealed envelope whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: scapular stabilization exercises name: virtual reality exercises name: regular routine exercises measure: agonist antagonist ratio measure: Hand grip strength measure: rounded shoulder posture measure: pain intensity level measure: The disabilities of the arm, shoulder and hand measure: peak force measure: total work measure: work fatigue measure: average power sex: ALL minimumAge: 20 Years maximumAge: 25 Years stdAges: ADULT hasResults: False

 nctId: NCT06293586 id: MD-11-2022 briefTitle: Comparison Between Peribulbar And Sub-tenon Blocks on Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-30 date: 2024-03-30 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The aim of this study is to compare between peribulbar block and subtenon block as an adjunct to general anesthesia in children undergoing strabismus surgery on oculocardiac reflex (OCR), post-operative analgesia and postoperative vomiting. Both techniques will be compared to intra-operative intravenous (IV) paracetamol combined with general anesthesia as a sole anesthetic technique. conditions: Anesthesia, Local conditions: Ophthalmopathy conditions: Strabismus conditions: Pediatric ALL studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: peribulbar block name: sub-tenon block name: Paracetamol measure: The incidence of intraoperative oculocardiac reflex (OCR) measure: blood pressure measure: heart rate measure: Post-operative pain using the MOPS measure: Post-operative analgesia requirements measure: The incidence of POV using numeric scoring measure: Complications resulting from orbital regional anesthesia were recorded measure: Total intraoperative atropine requirements sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD facility: Cairo University faculty of medicine status: RECRUITING city: Cairo zip: 11559 country: Egypt name: Essam Nossair, Masters degree role: CONTACT phone: 0201002014809 email: e.nossair92@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06293573 id: 012/005031 briefTitle: Whole- Body Vibration Among Egyptian Elderly With Sarcopenia acronym: WBV overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-11-29 date: 2025-12-01 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: To investigate and compare between the effectiveness of whole body vibration and aerobic training exercises in management of sarcopenia, muscle mass, physical performance and muscle strength in elderly. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants will be assigned randomly into three groups of equal number (study group A, study group B, and group C) the randomization will be performed by computerized randomization. Assessors will be blinded to the groups of the subjects. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Whole-body vibration name: aerobic exercises name: resistance exercises measure: Muscle Mass measure: muscle strength measure: timed Up and Go Test (TUG) measure: Gait Speed test measure: 400 m Walking Test measure: Six minute walk test (6MWT) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy city: Dokki state: Giza zip: 12612 country: Egypt lat: 30.03823 lon: 31.2113 hasResults: False

 nctId: NCT06293560 id: H-49046 id: 5U01EY032403-03 type: NIH link: https://reporter.nih.gov/quickSearch/5U01EY032403-03 briefTitle: Microphthalmia, Anophthalmia, and Coloboma Genetic Epidemiology in Children acronym: MAGIC overallStatus: RECRUITING date: 2022-09-25 date: 2027-09 date: 2027-09 date: 2024-03-05 date: 2024-03-05 name: Baylor College of Medicine class: OTHER name: National Eye Institute (NEI) name: National Institutes of Health (NIH) briefSummary: The investigators are inviting families to take part in a research study that will help us better understand the physical characteristics associated with children who have Microphthalmia, Anophthalmia, and Coloboma (MAC) and how changes in their DNA sequence, called genetic mutations, play a role in the risk of developing MAC conditions: Microphthalmia conditions: Coloboma conditions: Anophthalmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Stage 1 measure: Stage 2 measure: Stage 3 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor College of Medicine status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: EpiCenter role: CONTACT phone: 713-798-2920 email: epicenter@bcm.edu name: Philip Lupo, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06293547 id: DIS-2022-295 briefTitle: Clinical Effectiveness and Parental Acceptance of Silver Diamine Fluoride in Preschool Children: A Non-randomized Trial overallStatus: COMPLETED date: 2022-08-10 date: 2023-10-30 date: 2023-12-30 date: 2024-03-05 date: 2024-03-05 name: Cumhuriyet University class: OTHER briefSummary: Silver diamine fluoride (SDF) is a topical fluoride agent that has emerged in recent years and has a strong potential to arrest dentinal caries in early childhood caries. SDF has been developed as an effective non-invasive treatment method, especially in the non-cooperative preschool group, with its advantages such as easy application, low cost, and limited technical difficulties. The aims of this study were as follow: (a) to evaluate the efficacy of 38% GDF in arresting active dental caries lesions and reducing or preventing associated dental pain and infections in at-risk young children; and (b) how SDF treatment is perceived and acceptable by parents. The null hypothesis of the study was that 38% SDF treatment will be effective in arresting active dental caries lesions and reducing the incidence of pain and infection in young children, and is well-accepted by parents. The study group of this clinical research will consist of pediatric patients and their parents who were selected by easily accessible case sampling method and applied to Sivas Cumhuriyet University Faculty of Dentistry Pediatric Dentistry clinic. The working group will consist of a total of 48 children and their parents who meet the inclusion criteria. Parents will also be briefed on the GDF, follow-up instructions, oral hygiene instructions, and dietary education. After a baseline examination including radiographs taken during a standard dental examination, 38% GDF will be applied to carious lesions detected in primary teeth. Carious lesions will be treated with 38% SDF application once or twice. Children will be reassessed at 3-week, 3-month and 6-month follow-up sessions to assess color and structural changes in carious lesions (soft/hard). Parents will be asked to answer a questionnaire including questions about pain or infection symptoms and their views on SDF treatment. conditions: Silver Diamine Fluoride studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study group of this non-randomized, prospective, single-arm clinical research consisted of pediatric patients and their parents who presented to the Department of Pediatric Dentistry, Faculty of Dentistry, Cumhuriyet University, selected using convenient sampling method. For determining the sample size in this study, assuming a 5% alpha error, 80% power, and a cessation rate (35.7%) from a previous study, it was calculated that at least 40 participants should be included. Considering potential patient loss/follow-up, the study group was increased by 20%, resulting in a final decision to include 48 children and their parents in the study. primaryPurpose: TREATMENT masking: NONE count: 48 type: ACTUAL name: Silver Diamine Fluoride measure: Clinical Assessment of Arrested Caries Lesions measure: Parental acceptance of SDF treatment sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD facility: Sivas Cumhuriyet University city: Sivas state: Merkez country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False

 nctId: NCT06293534 id: PsychThyroid briefTitle: Thyroid Dysfunction in Patients With Major Psychiatric Disorders overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-02-01 date: 2024-03-05 date: 2024-03-05 name: Assiut University class: OTHER briefSummary: Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital conditions: Thyroid Dysfunction studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 173 type: ESTIMATED name: TSH,T3,T4 measure: the level of thyroid hormones among psychiatric patients sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293521 id: 06091995 briefTitle: Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries overallStatus: NOT_YET_RECRUITING date: 2024-05-16 date: 2024-12-31 date: 2025-01-01 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits conditions: Deep Caries studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Pulpotomy name: Partial Pulpectomy measure: Radiographic assessment measure: Clinical effectiveness measure: Child cooperation measure: Time elapsed till final restoration performed sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: Cairo University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06293508 id: NMRR ID-22-02616-I2I briefTitle: mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public acronym: mBLISS-B overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-03-05 date: 2024-03-05 name: Clinical Research Centre, Malaysia class: OTHER name: Ministry of Health, Malaysia name: National University of Malaysia name: Institute for Health Behavioral Research, Malaysia briefSummary: Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study,

Based on this promising prospect, we designed a randomized controlled trial to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. We hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group. conditions: Breast Neoplasm Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1180 type: ESTIMATED name: Standard Health Communication Intervention name: Behavioural Change Health Communication Intervention measure: Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram). measure: Health literacy level measure: Perception based on domains in Health Belief Model measure: Perceived acceptance and usefulness of health communication program measure: Reasons behind participants not participating in breast cancer screening. sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical Research, National Institutes of Health, Malaysia city: Shah Alam state: Selangor zip: 40170 country: Malaysia name: Nicholas Yee Liang Hing, MSc role: CONTACT email: hingyl@moh.gov.my lat: 3.08507 lon: 101.53281 hasResults: False

 nctId: NCT06293495 id: CUT-OUT briefTitle: Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-30 date: 2026-04-01 date: 2024-03-05 date: 2024-03-05 name: Puerta de Hierro University Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).

Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate. conditions: Proximal Femoral Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, prospective trial with a CE-marked medical devices primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Gamma 3 Nail (Stryker) name: Chimaera Nail (Orthofix) measure: Incidence of cut-out. measure: Functional Ambulatory Categories (FAC) measure: Tip-apex distance measure: Parker index measure: Baumgaertner reduction quality criteria measure: Number of Surgical complications (Intraoperative) measure: Number of Surgical complications (post-operative) sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Hospital Universitario Puerta de Hierro Majadahonda city: Majadahonda state: Madrid zip: 28222 country: Spain lat: 40.47353 lon: -3.87182 hasResults: False

 nctId: NCT06293482 id: CAM5850 briefTitle: Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population acronym: ACE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2028-06 date: 2024-03-05 date: 2024-03-05 name: Cochlear class: INDUSTRY name: NAMSA name: LWB Consulting briefSummary: This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits. conditions: Hearing Loss, Sensorineural conditions: Hearing Loss, Bilateral studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Cochlear™ Nucleus® System measure: Number of device and procedure-related adverse events and serious adverse events measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted measure: Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition measure: Number of device and procedure related adverse events and serious adverse events measure: Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline measure: Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted measure: Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition measure: Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition measure: Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barrow Neurological Institute city: Phoenix state: Arizona zip: 85013 country: United States name: Shawn Stevens role: CONTACT email: shawn.stevens@commonspirit.org lat: 33.44838 lon: -112.07404 facility: University of Miami city: Coral Gables state: Florida zip: 33146 country: United States name: Meredith Holcomb role: CONTACT email: meredith.holcomb@med.miami.edu lat: 25.72149 lon: -80.26838 facility: Midwest Ear Institute city: Kansas City state: Missouri zip: 64111 country: United States name: Sarah Zlomke role: CONTACT email: sking@saint-lukes.org lat: 39.09973 lon: -94.57857 facility: New York University city: New York state: New York zip: 10016 country: United States name: William Shapiro role: CONTACT email: william.shapiro@nyulangone.org lat: 40.71427 lon: -74.00597 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Sarah Sydlowski role: CONTACT email: sydlows@ccf.org lat: 41.4995 lon: -81.69541 facility: University of Pennsylvania Hospitals city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Tiffany Hwa role: CONTACT email: tiffany.hwa@pennmedicine.upenn.edu lat: 39.95233 lon: -75.16379 facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23219 country: United States name: Daniel Coelho role: CONTACT email: daniel.coelho@vcuhealth.org lat: 37.55376 lon: -77.46026 facility: Virginia Mason city: Seattle state: Washington zip: 98101 country: United States name: Daniel Zeitler role: CONTACT email: daniel.zeitler@virginiamason.org lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06293469 id: IRB00434587 briefTitle: Accelerated Flap Coverage in Severe Lower Extremity Trauma acronym: FLAP ATTACK overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-11 date: 2024-03-05 date: 2024-03-08 name: Johns Hopkins University class: OTHER name: McMaster University name: University of Maryland, Baltimore name: Orthopaedic Trauma Association name: Foundation of Orthopedic Trauma briefSummary: The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility). conditions: Open Tibia Fracture conditions: Open Dislocation of Ankle conditions: Extremity Fracture Lower conditions: Extremity Injuries Lower studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 356 type: ESTIMATED name: Accelerated Flap Coverage Surgery name: Standard of Care Flap Timing measure: Clinical status measure: Mortality measure: Amputation measure: Unplanned re-operation measure: Number of days in hospital measure: Quality of life as assessed by the Limb-Q sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293456 id: 23-360 briefTitle: Study of Poetic Dignity Therapy for Sexual and Gender Minority Patients at End of Life overallStatus: ENROLLING_BY_INVITATION date: 2024-01-29 date: 2026-01 date: 2026-01 date: 2024-03-05 date: 2024-03-05 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to find out if dignity therapy is practical and works well for sexual and gender (SGM) patients in hospice care. SGM includes, but is not limited to, people who identify as lesbian, gay, bisexual, transgender, and/or queer/questioning (LGBTQ+). Dignity therapy is a type of psychotherapy where the clinician asks the patient questions to allow the patient to express their individual life story and ultimately be able to create a legacy document of their experiences that can be shared with their loved ones. conditions: End of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 15 type: ESTIMATED name: Dignity Therapy measure: the number of patients who complete the intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06293443 id: IMU-OP-TT-01 briefTitle: Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System overallStatus: RECRUITING date: 2024-02-15 date: 2024-03-15 date: 2024-04-01 date: 2024-03-05 date: 2024-03-05 name: Medipol University class: OTHER briefSummary: The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests. conditions: Amputation conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE maskingDescription: participants underwent functional testing at clinical centers count: 24 type: ESTIMATED name: Lower extremity unilateral amputee measure: Amputee Mobility Scale measure: One Leg Standing Test measure: Houghton Scale measure: 8-Shape Walking Test measure: joint range of motion measure: proprioception measure: l test measure: 10 Meter Walking Test sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medıpol University status: RECRUITING city: Istanbul country: Turkey name: Medipol University role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06293430 id: P002 briefTitle: Registry on Luma Vision's VERAFEYE System (ENLIgHT) acronym: ENLIgHT overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2025-03-15 date: 2025-03-15 date: 2024-03-05 date: 2024-03-07 name: LUMA Vision Ltd. class: INDUSTRY briefSummary: The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.

Results from this study will be used to guide development of the VERAFEYE System. conditions: Atrial Fibrillation conditions: Left Atrial Appendage Closure conditions: Atrial Arrhythmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: VERAFEYE System measure: Clinical Success of procedure measure: Procedural Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293417 id: HT-EF-01 briefTitle: To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM acronym: ENSEMBLE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-02-01 date: 2027-02-01 date: 2024-03-05 date: 2024-03-07 name: Korea University Anam Hospital class: OTHER briefSummary: The goal of this observational study is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:

* major adverse cardiovascular events within 48 months of the trial duration
* microvascular events within 48 months of the trial duration conditions: T2DM (Type 2 Diabetes Mellitus) conditions: Dyslipidemias studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3958 type: ESTIMATED name: Statin and Ezefeno name: Statin doubling measure: major adverse cardiovascular events and diabetic microvascular events for 48 months measure: proportion of patients achieving Non-HDL-C less than 100mg/dL measure: proportion of patients achieving LDL less than 70mg/dL measure: change in Non-HDL-C at 48month from baseline measure: change in LDL at 48month from baseline measure: change in HDL-C at 48month from baseline measure: change in TG at 48month from baseline measure: change in LDL-C/HDL-C ratio at 48month from baseline measure: change in TC/HDL-C ratio at 48month from baseline sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Korea University Anam Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06293404 id: column flexion id: AnkaraCHBilkent type: OTHER domain: AnkaraCHBilkent briefTitle: The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-04 date: 2024-03-05 date: 2024-03-05 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The effect of two different positions on spinal anesthesia in hip fracture surgery conditions: Hip Fractures conditions: Spinal Anesthesia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Bupivacain measure: Hemodynamic change measure: Hemodynamic change measure: Hemodynamic change measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. measure: To compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of bupivacaine 7.5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower measure: To compare the efficacy of bupivacaine 7.5 mg/ml in the duration of sensory block at dermatome T10 level sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293391 id: 2022-11/2097 briefTitle: The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery overallStatus: COMPLETED date: 2023-02-01 date: 2023-03-01 date: 2024-02-05 date: 2024-03-05 date: 2024-03-05 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. The aim of this study was to compare the effects of patient position changes on cardiac indices and vital signs in patients who underwent major abdominal cancer surgery with laparoscopic and open surgery using ODM. conditions: Abdominal Cancer conditions: Blood Pressure conditions: Cardiac Indices studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: cardiac indices in supine and trendelenburg position measure: Cardiac Output measure: Stroke Volume measure: Flow time corrected measure: Peak Velocity measure: Stroke Distance measure: Mean arterial pressure measure: Pulse sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital city: Ankara zip: 06200 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06293378 id: Pengmingli briefTitle: Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis. overallStatus: RECRUITING date: 2024-02-28 date: 2028-10-10 date: 2028-11-10 date: 2024-03-05 date: 2024-04-02 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed. conditions: Cirrhosis, Liver conditions: Fibrosis, Liver studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 330 type: ESTIMATED name: Sulfasalazine enteric-coated tablets measure: Serum alkaline phosphatase (ALP) measure: Serum γ-glutamyl transpeptidase (GGT) measure: Serum bilirubin measure: Serum bile acids measure: Serum aspartate aminotransferase(AST) measure: Serum alanine aminotransferase (ALT) measure: Hepatic fibrosis and the improvement of microbial metabolites measure: Changes in immune cells sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Mingli Peng, Doctor role: CONTACT phone: +8613512362906 email: Peng_mingli@hospital.cqmu.edu.cn name: Yinghua Lan, Doctor role: CONTACT phone: +8613796050629 lat: 29.56278 lon: 106.55278 facility: Chongqing status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Mingli Peng, Doctor role: CONTACT phone: 13512362906 email: peng_mingli@hospital.cqmu.edu.cn name: Yinghua Lan, Doctor role: CONTACT phone: +8613796050629 lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06293365 id: CVAY736A2202 id: 2023-508996-35 type: EUDRACT_NUMBER briefTitle: Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-26 date: 2025-07-29 date: 2029-02-08 date: 2024-03-05 date: 2024-04-09 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).

A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS. conditions: Sjögrens Disease conditions: Systemic Lupus Erythematosus conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 140 type: ESTIMATED name: VAY736 1ml PFS name: VAY736 2 ml PFS name: VAY736 2ml AI measure: Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab measure: Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab measure: Cohort 2 (optional): Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab measure: Cohort 2 (optional): Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab measure: Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab measure: Cohort 2 (optional): Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab measure: Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab measure: Cohort 2 (optional): Concentration at the end of a dosing interval (Ctrough) for ianalumab measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Anti-ianalumab antibodies (ADA) measure: Incidence of ADA positive participants sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293352 id: STU00220012 briefTitle: Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-12 date: 2024-03-05 date: 2024-03-05 name: Northwestern University class: OTHER briefSummary: In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in.

There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in.

We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction. conditions: Prosthetic-joint Infection conditions: Knee Infection conditions: Arthroplasty Complications conditions: Joint Infection conditions: Arthroplasty, Replacement, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 153 type: ESTIMATED name: All-cement articulating spacer name: Durable, real-component articulating spacer name: Rigid Spacer measure: 24 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 week Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 week 10-item PROMIS Global Health survey (PROMIS-10) measure: 6 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 month 10-item PROMIS Global Health survey (PROMIS-10) measure: 12 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 12 month 10-item PROMIS Global Health survey (PROMIS-10) measure: 24 month 10-item PROMIS Global Health survey (PROMIS-10) measure: Revision/reoperation for infection (defined by positive culture by MSIS criteria) measure: revision for aseptic failure (defined by negative culture by MSIS criteria) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Medicine city: Chicago state: Illinois zip: 60611 country: United States name: Orthopaedic Surgery Research role: CONTACT phone: 312-695-0332 email: orthosurveys@nm.org name: Adam I Edelstein, MD role: PRINCIPAL_INVESTIGATOR name: Kevin D Hardt, MD role: SUB_INVESTIGATOR name: Linda I Suleiman, MD role: SUB_INVESTIGATOR name: David W Manning, MD role: SUB_INVESTIGATOR name: William C Thomas, MD role: SUB_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06293339 id: CoGA-Re briefTitle: Durability of Protection After Single Immunisation With GA2 Sporozoites (CoGA-Rechallenge) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2025-05-31 date: 2024-03-05 date: 2024-03-05 name: Leiden University Medical Center class: OTHER briefSummary: This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606) conditions: Malaria,Falciparum studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 14 type: ESTIMATED name: CHMI with 3D7 malaria measure: Protective efficacy measure: Time to parasitaemia measure: Humoral immune responses after homologous CHMI rechallenge measure: Cellular immune responses after homologous CHMI rechallenge sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06293326 id: 22553 briefTitle: A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants overallStatus: RECRUITING date: 2024-03-06 date: 2024-06-06 date: 2024-06-06 date: 2024-03-05 date: 2024-04-19 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus).

Calcium carbonate tablets are used to treat heartburn, indigestion, and related digestive problems. Calcium carbonate works by neutralizing the excess acid in the stomach. The study treatment is a new bi-layer calcium carbonate tablet that has two layers. One layer quickly releases calcium carbonate aimed to provide quick relief (called immediate release) while the other layer releases calcium carbonate slowly to make the relief last longer (called sustained release).

In this study, bi-layer calcium carbonate tablets will be given to healthy men for the first time. This study will provide information on how the new bi-layer tablet works inside the body.

The main purpose of this study is to learn about how the new bi-layer calcium carbonate tablet changes the average acidity levels (measured using pH) compared to the standard calcium carbonate tablet during the night-time.

For this, researchers will measure the acidity levels in the upper part of the stomach at regular intervals during the night-time.

The participants will be randomly (by chance) assigned to one of two treatment groups:

Participants in the first group will take the treatments at night.

Participants in the second group will take the treatments during the day.

All participants in both groups will take 2 bi-layer tablets and 2 standard tablets after a meal with a gap of 6 to 8 days between treatments. However, in each group, half the participants will receive the bi-layer tablets first while the other half will receive the standard tablets first.

Each participant will be in the study for around 52 days with up to 4 visits to the study site. This includes:

1. visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
2. visits for treatment with a gap of 6-8 days between each treatment, and

1 visit 7 to 14 days after the treatment ends during which the doctors will monitor the participants' health.

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

check participants' overall health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)

take images of the stomach at different times after taking the treatment

measure acidity level (pH) using a device called pH probe that is inserted into the upper part of the stomach

ask the participants questions about how easy it is to take the study treatment

ask the participants what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related to the study treatment, or not.

As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned. conditions: Heartburn conditions: Indigestion conditions: Stomach Acid Related Symptoms conditions: Nocturnal Stomach Acid Related Symptoms conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: bi-layer calcium carbonate tablet (BAY1180654) name: Immediate release calcium carbonate tablet (BAY1180654) measure: Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. measure: Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. measure: Percentage of total time gastric pH is above pH 3.5 from time of dosing until 8h post-dose during night-time comparing the bi-layer tablet and standard comparator measure: Percentage of total time gastric pH is above pH 3.5 from time of dosing until 6h post-dose during daytime comparing the bi-layer tablet and standard comparator. measure: Change in mean gastric pH measure: Gastrointestinal tract location using scintigraphic images. measure: Initial radiolabel release time, using scintigraphic images measure: Disintegration rate (t50%) of each formulation will be determined quantitatively via analysis of scintigraphic images. measure: Complete radiolabel release time, using scintigraphic images measure: Gastric emptying kinetics of the dispersed radiolabeled material (t50% and t90%) of each formulation will be determined quantitatively via analysis of the scintigraphic images. measure: Participant questionnaire sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BDD Pharma Bio-imaging Unit status: RECRUITING city: Glasgow zip: G4 0SF country: United Kingdom lat: 55.86515 lon: -4.25763 hasResults: False

 nctId: NCT06293313 id: Inonu-SBF-SO-03 briefTitle: The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level overallStatus: RECRUITING date: 2024-02-28 date: 2024-04-28 date: 2024-08-28 date: 2024-03-05 date: 2024-03-05 name: Inonu University class: OTHER briefSummary: The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test. conditions: Dysmenorrhea conditions: Anxiety conditions: Anxiety Disorders and Symptoms conditions: Pain, Menstrual studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of two groups, a control group and a experimental group wo mindfulness group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The determination of which university would be included in the control and experimental groups in the research was made through a randomization method. The selection was done blindly by an independent academician unrelated to the research. As a result of the randomization, the control group and the experimental groups. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Mindfulness training name: Will not be given any application measure: VAS Pain Scale measure: State and Trait Anxiety Scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bartin University status: RECRUITING city: Bartın zip: 74001 country: Turkey name: Simge Öztürk, Ph.D role: CONTACT phone: 05398751788 email: sozturk@bartin.edu.tr lat: 41.63583 lon: 32.3375 hasResults: False

 nctId: NCT06293300 id: 20231056 id: HT94252310608 type: OTHER_GRANT domain: Department of Defense Awarding Office: U.S. Army Medical Research Acquisition Activity (USAMRAA) briefTitle: Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A) overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-30 date: 2026-08-30 date: 2024-03-05 date: 2024-04-24 name: University of Miami class: OTHER name: United States Department of Defense briefSummary: The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: BoNT A measure: Change in photophobia measured by Numerical Rating Scale measure: Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA) measure: Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8) measure: Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye). measure: Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25) measure: Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS) measure: Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6 measure: Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5) measure: Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI) measure: Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST) measure: Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Mariela Aguilar, PhD role: CONTACT phone: 305-326-6069 email: maguilar1@miami.edu name: Anat Galor, MD/MSPH role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06293287 id: DJ-2023-02 briefTitle: Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy overallStatus: RECRUITING date: 2024-01-31 date: 2024-11-30 date: 2025-01-30 date: 2024-03-05 date: 2024-03-08 name: Zhongshan Hospital (Xiamen), Fudan University class: OTHER briefSummary: The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure conditions: Radial Artery Occlusion studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 156 type: ESTIMATED name: Subcutaneous enoxaparin sodium name: Placebo measure: RAO rate after 24 hours and 21days sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University (Xiamen Branch) status: RECRUITING city: Xiamen state: Fujian zip: 361015 country: China name: BoHeng Zhang, PHD role: CONTACT phone: 0592-3501990 email: zhang.boheng@zs-hospital.sh.cn lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06293274 id: sdilek5 briefTitle: The Importance of Discharge Education for Mommy Blues overallStatus: RECRUITING date: 2024-01-01 date: 2024-03-30 date: 2024-05-30 date: 2024-03-05 date: 2024-03-22 name: Kocaeli University class: OTHER briefSummary: The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.

The sample size of the study was calculated using the G\*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G\*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up. conditions: Postpartum Sadness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Discharge training measure: Motherhood Sadness Scale measure: Edinburgh Postnatal Depression Scale - EPDS sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Kocaeli University status: RECRUITING city: Kocaeli zip: 41380 country: Turkey name: Sena Dilek Aksoy, Ph.D. role: CONTACT phone: +902623034739 email: sena.dilek@kocaeli.edu.tr name: Resmiye Ozdilek, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06293261 id: YMC043 briefTitle: Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia overallStatus: ACTIVE_NOT_RECRUITING date: 2020-06-27 date: 2024-03-31 date: 2024-03-31 date: 2024-03-05 date: 2024-03-05 name: Yuhan Corporation class: INDUSTRY briefSummary: This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia conditions: Hypertension conditions: Hypercholesterolemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 5047 type: ACTUAL name: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg measure: Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) measure: Change from baseline to 6/12 months in SBP and DBP measure: Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C) measure: Change from baseline to 6/12 months in hs-CRP measure: Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose) measure: Change from baseline to 6/12 months in Diabetes indicator ( HbA1c) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hallym University Sacred Heart Hospital city: Anyang-si country: Korea, Republic of lat: 37.3925 lon: 126.92694 facility: Dong-A University Hospital city: Busan zip: 49201 country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Changwon Fatima Hospital city: Changwon country: Korea, Republic of lat: 35.22806 lon: 128.68111 facility: Gyeongsang National University Changwon Hospital city: Changwon country: Korea, Republic of lat: 35.22806 lon: 128.68111 facility: Soon Chun Hyang University Hospital Cheonan city: Chungbuk country: Korea, Republic of lat: 35.55292 lon: 127.49042 facility: Dankook University Hospital city: Chungnam country: Korea, Republic of lat: 36.27333 lon: 128.02522 facility: Daegu Catholic University Medical Center city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Keimyung University Dongsan Medical Center city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Yeungnam University Medical Center city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Daejeon Eulji Medical Center Eulji University city: Daejeon country: Korea, Republic of lat: 36.32139 lon: 127.41972 facility: Myungji Hospital city: Goyang-si country: Korea, Republic of lat: 37.65639 lon: 126.835 facility: Chonnam National University Hospital city: Gwangju country: Korea, Republic of lat: 35.15472 lon: 126.91556 facility: Chosun University Hospital city: Gwangju country: Korea, Republic of lat: 35.15472 lon: 126.91556 facility: Bundang Jesaeng General Hospital city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Cha University Bundang Medical Center city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Hallym University Dongtan Sacred Heart Hospital city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Korea University Ansan Hospital city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: National Health Insurance Service Ilsan Hospital city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Samsung Changwon Hospital city: Gyeongsang country: Korea, Republic of lat: 35.3164 lon: 126.93455 facility: Wonkwang University Hospital city: Iksan country: Korea, Republic of lat: 35.94389 lon: 126.95444 facility: Dongguk University Ilsan Hospital city: Ilsan country: Korea, Republic of lat: 35.5 lon: 129.43333 facility: Inje University Ilsan Paik Hospital city: Ilsan country: Korea, Republic of lat: 35.5 lon: 129.43333 facility: Inha University Hospital city: Incheon country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Kwandong University International St.Mary'S Hospital city: Incheon country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Kwangju Veterance Hospital city: Kwangju country: Korea, Republic of lat: 36.9122 lon: 127.1279 facility: Pusan National University Hospital city: Pusan country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Pusan National University Yangsan Hospital city: Pusan country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Gangnam Severance Hospital city: Seoul zip: 06273 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Ewha Womans University Mokdong Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Ewha Womans University Seoul Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Hallym University Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kangdong Sacred Heart Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Korea University Anam Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Korea University Guro Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kyung Hee University Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: National Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Samsung Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Ulsan University city: Ulsan country: Korea, Republic of lat: 35.53722 lon: 129.31667 facility: Wonju Severance Christian Hospital city: Wŏnju country: Korea, Republic of lat: 37.35139 lon: 127.94528 hasResults: False

 nctId: NCT06293248 id: 77979112 briefTitle: Music Application in Patients Undergoing Percutaneous Coronary Intervention overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-10 date: 2023-12-31 date: 2024-05-31 date: 2024-03-05 date: 2024-03-12 name: Kocaeli University class: OTHER briefSummary: This study was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (CAG) and to obtain the opinions of patients and nurses about music.This study was conducted to examine the effect of music application on recovery in patients undergoing CAG and to obtain the opinions of patients and nurses about music.The study was planned as a pre-test, post-test design, single-center, randomized controlled experimental study. The study is planned to be conducted in the CAG unit of a university hospital between July 2023 and December 2023, the study sample will be composed of a total of 210 individuals, 105 in each group (music applied group before and after the procedure = 105, control group = 105) To collect data in the study, the "Patient Information Form", Vital Signs Evaluation Form", "Numerical Rating Scale", State-Trait Anxiety Inventory, "Perianesthesia Comfort Scale" and "Patient Satisfaction Survey on Nursing Care Quality" were used. conditions: Healthy conditions: Nurse's Role conditions: Patient Satisfaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single (Participant) whoMasked: PARTICIPANT count: 210 type: ESTIMATED name: musical application measure: Means of subjective pain scores measure: Means of body temperature (0C) measure: Means of systolic blood pressure (mmHg) measure: Means of diastolic blood pressure (mmHg) measure: Means of heart rate (/minutes) measure: Means of respiratory rate (/minutes) measure: Means of oxygen saturation (%) measure: Means of subjective anxiety scores measure: Means of Perianesthesia Comfort Scale Scores measure: Means of Patient Satisfaction Survey on Nursing Care Quality Scores sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli University Hospital city: Kocaeli state: Umuttepe Campus, İzmit zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06293235 id: 2024/2120 briefTitle: Towards Optimal Fertility, Fathering and Fatherhood studY acronym: TOFFFY overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-06 date: 2027-03 date: 2024-03-05 date: 2024-03-05 name: KK Women's and Children's Hospital class: OTHER_GOV briefSummary: This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics. conditions: Reproductive Issues conditions: Fertility Issues studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 960 type: ESTIMATED name: Lifestyle and metabolic indicators measure: Pregnancy rate measure: Fertility index measure: Oxidative stress measure: Semen volume measure: Sperm concentration measure: Sperm total motility measure: Sperm progressive motility measure: Total progressive motile sperm count measure: Single strand sperm DNA fragmentation measure: Double strand sperm DNA fragmentation measure: mRNA level measure: sncRNA level measure: DNA methylation measure: Sperm morphology sex: ALL minimumAge: 21 Years maximumAge: 49 Years stdAges: ADULT hasResults: False

 nctId: NCT06293222 id: SCD Support briefTitle: Patient and Public Involvement and Engagement in Research With Children and Young People With Sickle Cell Disorder and Their Families overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-21 date: 2024-04-30 date: 2024-04-30 date: 2024-03-05 date: 2024-03-07 name: King's College London class: OTHER name: Sickle Cell Society briefSummary: Aim: To co-produce resources for inclusive and equitable Patient and Public Involvement and Engagement in research on life-limiting conditions, with children and young people with sickle cell disorder and their families.

Methods: Workshops with a) members of a patient advocacy organisation (Sickle Cell Society n=5) b): i) Children and young people (10-18 years) with sickle cell disorder (n=15) and ii) their siblings (10-18 years, n=10) and iii) their parents (n=15), c) Researchers form the Cicely Saunders Institute Outputs: Resources that enable children and young people with sickle cell disorder and their families to engage in research conditions: Sickle Cell Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Workshops with participants to develop resources that enable children and young people with sickle cell disorder and their families to engage in research sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: King's College London city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06293209 id: Sunpasitthiprasong Hospital id: Sunpasitthiprasong Hospital type: OTHER domain: Sunpasitthiprasong Hospital briefTitle: Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani acronym: 3-armRCT overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-01 date: 2024-02-28 date: 2024-05-28 date: 2024-03-05 date: 2024-03-05 name: Thai Traditional Medical Knowledge Fund class: OTHER_GOV briefSummary: The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear.

The purpose of this study is to compare the efficacy of evaporative coolants with that of ice packs in the preoperative management of edema and pain in patients with an ankle fracture conditions: Ankle Fractures conditions: Swelling conditions: Cryotherapy Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Population

The sample group comprises 30 patients admitted for treatment in the male orthopedic surgery department, female orthopedic surgery department, and accident orthopedic surgery department at Sunpasitthiprasong Hospital, Ubon Ratchathani from August 2023 to January 2024. . primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: 3M cold pack name: Perskindol cold spray name: Placebo measure: swelling measure: pain score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Orthopedics, Sunpasitthiprasong hospital, Ubonratchathani, Thailand. city: Multiple Locations state: Ubonrachathani zip: 34000 country: Thailand hasResults: False

 nctId: NCT06293196 id: 20231107 briefTitle: Effects of Acupoint Massage Around Eyes on Ocular Biological Indexes overallStatus: RECRUITING date: 2023-09-01 date: 2024-03-31 date: 2025-06-30 date: 2024-03-05 date: 2024-03-05 name: Zhongnan Hospital class: OTHER briefSummary: This study aims to investigate whether the acupoint eye exercise could impact the biological parameters of the eye. conditions: Investigating the Effects of Periocular Acupressure on Ocular Biological Indicators studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 55 type: ESTIMATED name: acupressure measure: Changes in blood flow to the eye sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Min Ke, doctor of medicine role: CONTACT phone: 18672395959 email: Keminyk@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06293183 id: EGE-HEM-STO-01 briefTitle: The Effect of Artificial Intelligence Supported Mobile Learning on Nutrition/Hydration Control and Individual Management overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2024-09-30 date: 2024-12-30 date: 2024-03-05 date: 2024-03-05 name: Ege University class: OTHER briefSummary: The adherence to recommended nutrition and fluid restrictions is crucial for the success of hemodialysis treatment. However, approximately 80% of patients receiving HD treatment are non-compliant with fluid restriction, leading to various complications. Cardiovascular complications are among the most common complications associated with this issue. When reviewing national and international literature on the subject, it is observed that in order to improve treatment adherence in HD patients, written materials are often used in addition to individual or group education sessions, focusing mainly on assessing patients\&#39; quality of life and self-efficacy. However, a mobile-supported learning method that enables patients to manage their nutrition and fluid control individually is not commonly utilized.

This research aims to investigate the impact of an artificial intelligence-supported mobile application developed for HD patients on the control of nutrition/fluid intake and individual management. conditions: Cronich Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 76 type: ESTIMATED name: Mobile app measure: Fluid intake compliance measure: Change of individual management sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293170 id: 2024-DETECTIVENEUROLOGYUKD0001 briefTitle: Automated Screening for Clinically Ascertained Loss of Cerebral Functions acronym: DETECT-IVE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2026-11-01 date: 2024-03-05 date: 2024-03-05 name: Technische Universität Dresden class: OTHER briefSummary: Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF.

Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support.

Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trial

Study population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge.

Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.

Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization.

Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT. conditions: Irreversible Loss of Brain Function (ILBF) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 4800 type: ESTIMATED name: DETECT name: Conventional care measure: Number of patients with diagnosis of ILBF measure: Number of patients who undergo deceased organ donation measure: Number of patients in whom diagnosis of ILBF was missed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden city: Dresden zip: 01307 country: Germany name: Kristian Barlinn, MD role: CONTACT phone: +49 (0)351 458 3565 email: kristian.barlinn@ukdd.de lat: 51.05089 lon: 13.73832 hasResults: False

 nctId: NCT06293157 id: 2023/ABM/01/00013 briefTitle: Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease overallStatus: RECRUITING date: 2023-12-01 date: 2028-12-31 date: 2033-12-31 date: 2024-03-05 date: 2024-03-05 name: Copernicus Memorial Hospital class: OTHER name: Medical Research Agency, Poland briefSummary: Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants.

Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants.

Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment.

Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible. conditions: Metastatic Spinal Cord Compression conditions: Metastasis Spine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 226 type: ESTIMATED name: Transpedicular spinal stabilization - carbon fibers-based implants name: Transpedicular spinal stabilization - titanium implants name: Stereotactic body radiotherapy measure: The assessment of time to local recurrence after treatment with SBRT. measure: The assessment of frequency of local recurrence after treatment with SBRT. measure: DICE convergence factor evaluation between groups of patients. measure: The subjective difficulty of planning radiotherapy treatment. measure: The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC). measure: Failure rate of stabilizing systems. measure: Pain assessment on the VAS scale between groups. measure: Frequency of postoperative infections. measure: Differences in dosimetric parameter Dmin PTV/CTV. measure: Differences in dosimetric parameter D95. measure: Differences in dosimetric parameter D98. measure: Differences in dosimetric parameter D100. measure: Differences in dosimetric parameter conformity index (CI) / homogeneity index (HI)). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copernicus Memorial Hospital in Lodz status: RECRUITING city: Łódź state: Łódzkie zip: 93-513 country: Poland name: Krystkiewicz role: CONTACT lat: 51.75 lon: 19.46667 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-05-16 uploadDate: 2024-02-25T03:37 filename: ICF_000.pdf size: 249036 hasResults: False

 nctId: NCT06293144 id: yuewei20231129 briefTitle: the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People overallStatus: RECRUITING date: 2023-11-29 date: 2024-05 date: 2024-05 date: 2024-03-05 date: 2024-03-05 name: Second Hospital of Shanxi Medical University class: OTHER briefSummary: Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the 95% effective dose of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia using a biased coin design up-and-down sequential method(BCD-UDM) conditions: Sedation conditions: ED95 conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 70 type: ESTIMATED name: Ciprofol measure: Modified Alertness Sedation Score (MOAA/S) measure: Bispectral index (BIS) measure: systolic blood pressure （SBP） measure: diastolic blood pressure（DBP） measure: heart rate (HR) measure: pulse oxygen saturation（SpO2） measure: Occurrence of Sedation-related adverse events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Second Hospital of Shanxi Medical University status: RECRUITING city: Taiyuan state: Shanxi zip: 030001 country: China name: Zheng Guo, M.B.,Ph.D. role: CONTACT phone: +863513365790 email: guozheng713@yahoo.com lat: 37.86944 lon: 112.56028 hasResults: False

 nctId: NCT06293131 id: yuewei20230705 briefTitle: Median Effective Dose of Ciprofol-Assisted Sedation for Elderly Patients Undergoing Knee Arthroplasty overallStatus: COMPLETED date: 2023-05-29 date: 2023-09-28 date: 2023-09-28 date: 2024-03-05 date: 2024-03-05 name: Second Hospital of Shanxi Medical University class: OTHER briefSummary: Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the median effective dose(ED50) of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia conditions: Sedation conditions: ED50 conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 70 type: ACTUAL name: Ciprofol measure: Modified Alertness Sedation Score (MOAA/S) measure: Bispectral index (BIS) measure: systolic blood pressure （SBP） measure: diastolic blood pressure（DBP） measure: heart rate (HR) measure: pulse oxygen saturation（SpO2） measure: Occurrence of Sedation-related adverse events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Second Hospital of Shanxi Medical University city: Taiyuan state: Shanxi zip: 030001 country: China lat: 37.86944 lon: 112.56028 hasResults: False

 nctId: NCT06293118 id: 71055423.3.0000.0071 briefTitle: The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2028-01-15 date: 2024-03-05 date: 2024-03-05 name: Hospital Israelita Albert Einstein class: OTHER briefSummary: Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure and calibrate 200 mmHg on the upper or lower limb. Thus, at alternating intervals of 5 minutes, ischemia or reperfusion occurs, depending on whether the cuff is inflated or deflated. IC induces changes in spinal cord excitability for the last reflex reactions of recruited motoneurons with improved balance control in healthy young people and improved learning in the elderly. The objective of the present study is to evaluate the chronic effect of IC on the motor function and cognitive performance of patients with Parkinson's disease. Furthermore, the investigators will evaluate secondary outcomes such as mobility, quality of life, and immunological responses. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. Ischemic conditioning group
2. control group (Sham) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients were unaware of the allocation. whoMasked: PARTICIPANT count: 34 type: ESTIMATED name: Ischemic conditioning group name: Sham group measure: Motor function measure: Cognitive performance measure: PDQ-39 measure: Timed up and go (TUG) measure: Assessment of cellular and soluble immune response measure: Quantifications of systemic soluble mediators measure: PBMC acquisition and flow cytometry sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06293105 id: MR/T040688/1 briefTitle: Social Responses to Stigma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-31 date: 2025-01-31 date: 2024-03-05 date: 2024-03-05 name: King's College London class: OTHER name: Groundswell name: Lambeth Service Users Council name: Museum of Homelessness name: Inclusive Insight briefSummary: The Social Responses to Stigma study will explore experiences of stigma and discrimination amongst people who are homeless in south London, and then seek to understand how this stigma is created, mediated or mitigated within health, social, housing and legal care and support systems and social contexts.

The methodology is an ethnographic case study of the south London care and support system and its social context. The study will use a range of methods for data collection: interviews with people who are homeless, delivery stakeholders, and policy makers; a survey of peoples' experiences; observation within selected care sites; and gathering of documentary sources.

The study will be implemented through two parallel studies. The first, with KCL-REMAS approval, will operate in non-NHS sites. The second, with NHS-IRAS approval, will operate in NHS sites. The protocols are aligned with adaptations for each type of site.

A linked method to develop theory is cross-case comparison between South London and Vancouver, Canada, through secondary data analysis to linked studies ongoing there. The study will be ongoing from 2022 until January 2025. The project is funded in two phases, with potential to extend the study by a further three years, to January 2028.

The results of the study will inform the design of a novel intervention strategy to address the social dimensions of stigma. Subject to additional funding applications, the intervention strategy will be piloted and evaluated from 2025 onwards. The study results will be disseminated through scientific publications, public reports and a range of public and policy engagement activities. conditions: Stigma, Social conditions: Drug Use studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 200 type: ESTIMATED name: Qualitative interview, participant observation measure: Experiences of stigma and discrimination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: to Be Determined city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06293092 id: P.T.REC/012/004008 briefTitle: Effect of Intradialytic Exercises in Chronic Kidney Disease Patients overallStatus: COMPLETED date: 2022-04-30 date: 2023-10-30 date: 2024-01-30 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease. conditions: Chronic Kidney Disease stage3 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: control group receive medical treatment only ,first study group receive medical treatment and intradialytic aerobic exercise , second study group receive medical treatment and intradialytic resistive exercise primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: leg pedaling cycling device name: sand bags name: hemodialysis sessions measure: Concentration of immunoglobulin g measure: Total leukocyte count measure: lymphocyte count measure: neutrophil count measure: Concentration of HbA1c measure: hemoglobin concentration measure: thrombocytes count measure: diastolic blood pressure measure: Systolic blood pressure measure: six minute walk test measure: (KDQOL-SFTM) questionnaire sex: MALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: Fayoum hospital city: Fayoum country: Egypt lat: 29.30995 lon: 30.8418 hasResults: False

 nctId: NCT06293079 id: BiruniUnive id: Researcher type: OTHER domain: Biruni University briefTitle: The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis overallStatus: RECRUITING date: 2023-08-30 date: 2024-02-12 date: 2024-08-30 date: 2024-03-05 date: 2024-03-05 name: Biruni University class: OTHER briefSummary: The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Exercise Program measure: Gait Speed measure: Functional Capacity measure: EMG muscle activation measure: EMG muscle activation measure: Modified Fatigue Impact Scale measure: Global Rating of Change Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biruni University status: RECRUITING city: İstanbul country: Turkey name: Güzin Kaya Aytutuldu role: CONTACT phone: 05366265884 email: guzinkaya14@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06293066 id: KCH23-257 briefTitle: Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study. overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-03-01 date: 2024-03-01 date: 2024-03-05 date: 2024-03-05 name: King's College Hospital NHS Trust class: OTHER briefSummary: Primary Objective:

To assess whether there is a higher incidence of uninformative ultrasound in black vs white women conditions: Postmenopausal Bleeding conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 330 type: ACTUAL name: Ultrasound measure: To assess whether there is a higher incidence of uninformative ultrasound in black vs white women sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suite 8, King's College Hospital city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06293053 id: PKM17836 id: U1111-1287-7255 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2027-10-28 date: 2027-11-03 date: 2024-03-05 date: 2024-03-05 name: Sanofi class: INDUSTRY name: Regeneron Pharmaceuticals briefSummary: This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.

The study consists of 3 periods:

* Screening period: 2 to 4 weeks.
* Treatment period: 24 weeks.
* Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).

The total number of planned study visits for each participant will be 6. conditions: Prurigo Nodularis studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Dupilumab measure: Concentration of dupilumab in serum measure: Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) measure: Incidence of anti-drug antibodies (ADA) to dupilumab over time sex: ALL minimumAge: 6 Months maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06293040 id: IRB00434441 id: R01DA052295 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA052295 briefTitle: Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-12 date: 2024-03-05 date: 2024-03-05 name: Johns Hopkins University class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states). conditions: Cannabis Intoxication conditions: Alcohol Intoxication studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants will complete all dose conditions (study arms) in a randomized order primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Cannabis name: Alcohol name: Placebo Cannabis name: Placebo Alcohol measure: DRUID application global impairment score measure: Correct Trials on Paced Auditory Serial Addition Task (PASAT) measure: Correct Trials on the Digit Symbol Substitution Task (DSST) measure: Cumulative score on Field Sobriety Tests measure: Drug Effect Questionnaire (DEQ) - Feel Drug Effect measure: Drug Effect Questionnaire (DEQ) - Feel High measure: Drug Effect Questionnaire (DEQ) - Confidence to Drive measure: Drug Effect Questionnaire (DEQ) - Willingness to Drive measure: Biphasic alcohol effects scale (BAES) - Sedative Score measure: Biphasic alcohol effects scale (BAES) - Stimulant Score measure: Subjective high assessment scale (SHAS) measure: Driving performance as assessed by standard deviation of lateral position (SDLP) measure: Driving performance as assessed by composite drive score measure: Driving performance as assessed by standard deviation of speed (SDSP) measure: Driving performance (mean speed) measure: Driving performance (number of speed exceedances) measure: Driving performance (number of accidents) measure: Driving performance (total rule violations) measure: Driving performance (distance to lead vehicles) measure: Attempted Trials on the Digit Symbol Substitution Task (DSST) measure: Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST) measure: Reaction time on Paced Auditory Serial Addition Task measure: Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test measure: Field Sobriety Test - Score on Walk and Turn test measure: Field Sobriety Test - Score on One Leg Stand measure: Field Sobriety Test - Score on Modified Romberg Balance measure: Drug Effect Questionnaire - Like Drug Effect measure: Drug Effect Questionnaire - Want more measure: Drug Effect Questionnaire - Dislike Drug Effect measure: Pharmacokinetics - CMax for THC and THC metabolites measure: Pharmacokinetics - AUC for THC and THC metabolites measure: Pharmacokinetics - Breath Alcohol Concentration (BAC) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Behavioral Pharmacology Research Unit city: Baltimore state: Maryland zip: 21224 country: United States name: Madyson Slutzky role: CONTACT email: mslutzk1@jh.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06293027 id: IMAGINER FXS briefTitle: Optical Imaging as a Tool for Monitoring Brain Function in Fragile X Syndrome overallStatus: RECRUITING date: 2023-06-01 date: 2025-06-15 date: 2025-12-15 date: 2024-03-05 date: 2024-03-05 name: IRCCS Fondazione Stella Maris class: OTHER briefSummary: The objective of this project is to explore the potential of functional near- infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Fragile X Syndrome (FXS) that is still without cure. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With clinical trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. The investigators seek to address this gap by assessing the prognostic reliability of both resting and task- evoked fNIRS. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with FXS; 2. to collect pilot data on individuals with FXS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls. conditions: Fragile X Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Resting-state functional connectivity measure: Amplitude of sensory-evoked hemodynamic responses measure: Correlation between neurophysiology endpoints and the response on neuropsychological scale. sex: MALE minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Marina di Pisa-Tirrenia-Calambrone state: Toscana zip: 56128 country: Italy name: Roberta Battini, MD role: CONTACT phone: +39 050886282 email: roberta.battini@fsm.unipi.it name: Laura Baroncelli, PhD role: CONTACT phone: +39 050886233 email: laura.baroncelli@fsm.unipi.it name: Elena Scaffei, MD role: SUB_INVESTIGATOR lat: 43.62719 lon: 10.29204 hasResults: False

 nctId: NCT06293014 id: QLMA-CRC-IIT-001 briefTitle: TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer overallStatus: RECRUITING date: 2024-02-23 date: 2025-10-15 date: 2026-11-28 date: 2024-03-05 date: 2024-03-05 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 224 type: ESTIMATED name: TAS-102+bevacizumab name: Standard chemotherapy+bevacizumab measure: Time to treatment failure (TTF) 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 Events measure: European Quality of Life Five Dimensions Five Level Scale Questionnaire (EQ-5D-5L) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university status: RECRUITING city: ZhengZhou state: Henan zip: 450008 country: China name: Ying Liu, MD role: CONTACT phone: +86-13783604602 email: Yaya7207@126.com lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06293001 id: SBA 23/349 briefTitle: Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the ADAP Shoulder Scale overallStatus: RECRUITING date: 2023-11-28 date: 2024-04-26 date: 2024-04-26 date: 2024-03-05 date: 2024-04-29 name: Hacettepe University class: OTHER briefSummary: Shoulder pain is a common musculoskeletal problem that increases disability and decreases quality of life in addition to socio-economic impact. Chronic pain is defined as pain lasting longer than three months. Chronic pain is a multidimensional and complex experience. According to this model, chronic pain is a multidimensional and complex experience. This experience may be accompanied by different pain beliefs, pain avoidance behaviours, pain-related fear of movement, anxiety and depression. Many conditions involving the shoulder complex including traumatic and non-traumatic pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to pain-related fear of movement.

Until now, pain-related fear and avoidance behaviours in patients with shoulder pain have been evaluated with the Tampa Kinesiophobia Scale, Pain Avoidance Beliefs Scale and Fear of Pain Scale. However, only patients with low back pain were included in the development of these scales. There was no scale developed specifically for shoulder pain. To fill this gap in the literature, Ansanello et al. developed the "Avoidance Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP)" scale to evaluate pain avoidance behaviours in individuals with shoulder pain. Cross-cultural adaptation, validity and reliability of the Turkish version of the ADAP scale has not been studied.

The aim of our study was to perform cross-cultural adaptation, validity and reliability of the Turkish version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale). conditions: Questionnaire conditions: Shoulder Pain conditions: Validity conditions: Reliability studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 162 type: ESTIMATED name: No intervention measure: Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Elif Turgut status: RECRUITING city: Ankara zip: 06300 country: Turkey name: Elif Turgut, Assoc. Prof. role: CONTACT phone: +90 (544) 264 56 00 email: elifcamci@gmail.com name: Pınar KUYULU HAKSAL, Master role: SUB_INVESTIGATOR name: Kübra CAYLAN GURSES, Master role: SUB_INVESTIGATOR name: Birgül DINGIRDAN, Master role: SUB_INVESTIGATOR name: Büşra PAKOZ, Master role: SUB_INVESTIGATOR name: Irem DUZGUN, Proffessor role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06292988 id: MYELO briefTitle: Predictive Factors for Medullary Thyroid Cancer Aggressiveness acronym: MYELO overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-15 date: 2024-04-15 date: 2024-03-05 date: 2024-03-05 name: Aristotle University Of Thessaloniki class: OTHER briefSummary: This study is a retrospective study trying to find the predictive factors for medullary thyroid aggressiveness in terms of tumor metastasis and patients' survival. conditions: Medullary Thyroid Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: Total Thyroidectomy measure: Central lymph node metastasis measure: Lateral lymph node metastasis measure: Distant metastasis measure: Nuclear atypia as histological predictor of aggressiveness measure: Amyloid as histological predictor of aggressiveness measure: Immunohistochemistry as histological predictor of aggressiveness measure: Desmoplasia as histological predictor of aggressiveness measure: CEA as Biochemical predictor of aggressiveness measure: Calcitonin as Biochemical predictor of aggressiveness measure: White blood cell as Biochemical predictor of aggressiveness measure: Platelet count as Biochemical predictor of aggressiveness measure: CEA drop as Biochemical cure marker measure: Calcitonin drop as Biochemical cure marker sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Health & Science University, Oregon city: Oregon City state: Oregon zip: 97239 country: United States name: James Lim role: CONTACT email: ljam@ohsu.edu lat: 45.35734 lon: -122.60676 facility: Department of Surgery, Saint John of God Hospital, Salzburg, Austria city: Salzburg country: Austria name: Michael De Cilia role: CONTACT email: Michael.DeCillia@bbsalz.at lat: 47.79941 lon: 13.04399 facility: Saint Luc, University Clouvain, Belgium city: Bruxelles country: Belgium name: Antoine Buemi, Prof role: CONTACT email: antoine.buemi@saintluc.uclouvain.be lat: 50.85045 lon: 4.34878 facility: Head and Neck Surgery Department, Hospital Ana Nery, Santa Cruz do Sul, Brazil city: Santa Cruz Do Sul country: Brazil name: Fabio Muradas Girardi role: CONTACT email: fabiomgirardi@gmail.com lat: -29.7175 lon: -52.42583 facility: University Clinic of Surgery, University Hospital "Lozenec" city: Sofia country: Bulgaria name: Rumen Pandev role: CONTACT email: pandevrumen@gmail.com lat: 42.69751 lon: 23.32415 facility: Chinese University of Hong Kong city: Hong Kong country: China name: Shirley Liu role: CONTACT email: liuyw@surgery.cuhk.edu.hk lat: 22.39407 lon: 114.13737 facility: Head and Neck Department Oncologos del Occidente, Universidad de Caldas, Manizales, Colombia city: Manizales country: Colombia name: Andres Chalas role: CONTACT email: andreschalag@hotmail.com lat: 5.06889 lon: -75.51738 facility: the University Hospital Center Sestre milosrdnice, Zagreb, Croatia, Department of Otorhinolaryngology and Head and Neck Surgery city: Zagreb country: Croatia name: Andro Kosec, Prof role: CONTACT email: andro.kosec@yahoo.com lat: 45.81444 lon: 15.97798 facility: Head and Neck Surgery, Brest University Hospital, Brest, France city: Brest country: France name: 27. Jean-Christophe Leclere role: CONTACT email: leclere.jean-christophe@hotmail.fr lat: 48.3903 lon: -4.48628 facility: The University Hospital of Poitiers, France city: Poitiers country: France lat: 46.58333 lon: 0.33333 facility: Thyroid Surgery Clinic IKE, Athens, Greece city: Athens country: Greece name: Stavros Karakozis role: CONTACT email: modernsurgery@gmail.com name: Lampros Karakozis role: SUB_INVESTIGATOR lat: 37.97945 lon: 23.71622 facility: ENT Department University Hospital of Larissa city: Larissa country: Greece name: Jiannis Hajiioannou role: CONTACT email: jhajiioannou@gmail.com lat: 39.63689 lon: 22.41761 facility: Department of Surgery, General University Hospital of Patras city: Patra country: Greece name: Franko Mulita role: CONTACT email: oknarfmulita@hotmail.com lat: 38.24444 lon: 21.73444 facility: Aristotle University of Thessaloniki city: Thessaloníki country: Greece lat: 40.64361 lon: 22.93086 facility: Gennimatas General Hospital city: Thessaloníki country: Greece name: Ioannis Koutelidakis role: CONTACT email: iokoutel@gmail.com name: Nikolaos Voloudakis role: SUB_INVESTIGATOR lat: 40.64361 lon: 22.93086 facility: Department of ENT-Head and Neck Surgery, All India Institute of Medical Sciences, Bhubaneswar city: Bhubaneswar country: India name: Kumar Parida Pradipta role: CONTACT email: drpradipta04@gmail.com lat: 20.27241 lon: 85.83385 facility: KMCH and KMCH Comprehensive Cancer Center city: Coimbatore country: India name: Manoj Dhiwakar role: CONTACT email: dhiwamahi@yahoo.com lat: 11.00555 lon: 76.96612 facility: Department of Endocrine and Breast Surgery at Sanjay Gandhi Post Graduate Institute of Medical Sciences city: Madurai country: India name: Sabaretnam Mayilvaganan role: CONTACT email: drretnam@gmail.com lat: 9.91769 lon: 78.11898 facility: Department of Surgery, Maulana Azad Medical College & Lok Nayak Hospital city: New Delhi country: India name: Lovenish Bains role: CONTACT email: lovenishbains@gmail.com lat: 28.63576 lon: 77.22445 facility: Endocrine and Metabolic Surgery, Bhargav Endocrine Hospital, Vijayawada, India city: Vijayawada country: India name: Ramakanth Bhargav Panchangam role: CONTACT email: endoanswers@gmail.com lat: 16.50745 lon: 80.6466 facility: University of Sulaimani | UNIVSUL ,Department of Surgery, Kurdistan city: Erbil country: Iraq name: Fahmi Hussein role: CONTACT email: fahmi.hussein@univsul.edu.iq lat: 36.19257 lon: 44.01062 facility: ASL VCO - San Biagio Hospital - Domodossola (VB) - Italy city: Domodossola country: Italy name: Luigi Oragano role: CONTACT email: luigioragano@luigioragano.com lat: 46.1165 lon: 8.29313 facility: Dipartimento di Scienze Chirurgiche (DISC), University of Genoa, Italy city: Genoa country: Italy name: Michele Minuto role: CONTACT email: micheleminuto72@gmail.com lat: 44.40478 lon: 8.94438 facility: Asst Santi Paolo e Carlo - Ospedale Polo Universitario San Paolo, Milan, Italy city: Milan country: Italy name: Loredana De Pasquale role: CONTACT email: loredana.depasquale@asst-santipaolocarlo.it lat: 45.46427 lon: 9.18951 facility: UOC Chirurgia Endocrina e Metabolica, Fondazione Policlinico Universitario A Gemelli IRCCS city: Roma country: Italy name: Marco Raffaelli role: CONTACT email: Marco.Raffaelli@unicatt.it name: Francesco Pennestri role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Department of Medical and Surgical Sciences, University of Trieste, Cattinara Teaching Hospital, Trieste, Italy city: Trieste country: Italy name: Chiara Dobrinja role: CONTACT email: ch_dobrinja@yahoo.it lat: 45.64953 lon: 13.77679 facility: Department of Surgery and Oncology, Endocrine Surgery Unit, Verona University Hospital city: Verona country: Italy name: Giacomo DiFilippo role: CONTACT email: giacomo.difilippo@aovr.veneto.it lat: 45.4299 lon: 10.98444 facility: Hashemite University of Zarqa city: Zarqa country: Jordan name: Sohail Bakkar, Prof role: CONTACT email: sohail.bakkar@gmail.com lat: 32.07275 lon: 36.08796 facility: Hepatobiliairy and endocrine surgery, Ibn Sina Hospital, Medical School of Medecine Rabat, Mohamed Vth University of Rabat Morocco city: Marrakech country: Morocco name: Omar El Malki Hadj, Prof role: CONTACT email: oelmalki@hotmail.com lat: 31.63416 lon: -7.99994 facility: Division of General, Endocrine and Transplant Surgery, Medical University of Gdańsk city: Gdańsk country: Poland name: Andrzej Hellman, Prof role: CONTACT email: hellmannandrzej@gumed.edu.pl lat: 54.35205 lon: 18.64637 facility: Surgical Oncology Clinic, Institute for Oncology and Radiology of Serbia, Medical School, University of Belgrade city: Belgrad country: Serbia name: Nada Santrac role: CONTACT email: santrac.nada@gmail.com lat: 44.80401 lon: 20.46513 facility: Comenius University in Bratislava, Department of Paediatric Surgery, National Institute of Children's Diseases city: Bratislava country: Slovakia name: Petra Zahradníková, Prof role: CONTACT email: petra.zahradnikova@nudch.eu lat: 48.14816 lon: 17.10674 facility: Department of oncological surgery, St. Elisabeth cancer Institute city: Bratislava country: Slovakia name: Robert Kralik role: CONTACT email: robert.kralik@ousa.sk lat: 48.14816 lon: 17.10674 facility: Hospital Clinic (Barcelona, Spain) city: Barcelona country: Spain name: Aida Orois role: CONTACT email: aidaorois@hotmail.com name: Òscar Vidal Perez role: SUB_INVESTIGATOR name: Marti Manyalich role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Universitaria de Cordoba city: Córdoba country: Spain name: Constanza Ramacciotti role: CONTACT email: cramacciotti@hotmail.com lat: 37.89155 lon: -4.77275 facility: Hospital Regional de Málaga city: Málaga country: Spain name: Viyey Kishore Doulatram role: CONTACT email: viyu90@hotmail.es name: Marta Iturregui Guevara role: SUB_INVESTIGATOR lat: 36.72016 lon: -4.42034 facility: Department of General and Digestive Surgery, Division of Endocrine Surgery, Complexo Hospitalario Universitario de Vigo, Vigo, Spain city: Vigo country: Spain name: Angel Rivo Vazaquez role: CONTACT email: anxorivo@yahoo.es lat: 42.23282 lon: -8.72264 facility: Bern University Hospital city: Bern country: Switzerland name: Reto Kaderli, Prof role: CONTACT email: Reto.Kaderli@insel.ch name: Nesti Cedric role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 facility: Geneva University Hospital city: Geneva country: Switzerland lat: 46.20222 lon: 6.14569 facility: Division of Endocrinology and Metabolism Department of Medicine Faculty of Medicine Ramathibodi Hospital Mahidol University Bangkok, Thailand city: Bangkok country: Thailand name: Sriphrapradang Chutintorn role: CONTACT email: chutins@gmail.com lat: 13.75398 lon: 100.50144 facility: Ankara University Faculty of Medicine, Department of Endocrine Surgery city: Ankara country: Turkey name: Volkan Cenc role: CONTACT email: volkangenc77@yahoo.com lat: 39.91987 lon: 32.85427 facility: Acibadem MAA University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 facility: Cerrahpasa medical faculty endocrine surgery department city: Istanbul country: Turkey name: Selen Soylu role: CONTACT email: selen_soylu@yahoo.com lat: 41.01384 lon: 28.94966 facility: Department of Endocrin Pathology Unit, University of Health Sciences, Faculty of Medicine, Bakırköy Dr Sadi Konuk Training and Research Hospital, Istanbul, Turkey city: Istanbul country: Turkey name: Altinay Serdar role: CONTACT email: drserdara@yahoo.com lat: 41.01384 lon: 28.94966 facility: Endocrine surgeon-consultant, International medical center "CITIDOCTOR" city: Kyiv country: Ukraine name: Sergii Cherenko role: CONTACT email: sergmakar5@gmail.com lat: 50.45466 lon: 30.5238 facility: Department of Radiology, Thien Hanh Hospital, Buon Ma Thuot, Vietnam city: Việt Trì country: Vietnam name: Hoang Van Trung role: CONTACT email: dr.hoangvantrungradiology@gmail.com lat: 21.32274 lon: 105.40198 hasResults: False

 nctId: NCT06292975 id: RS210 - 326709 briefTitle: Exercise for Improving Radiotherapy Efficacy in Rectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-02 date: 2026-02 date: 2024-03-05 date: 2024-04-24 name: University of Hull class: OTHER name: Hull University Teaching Hospitals NHS Trust briefSummary: This is a single arm feasibility study of exercise for improving short- course neoadjuvant radiotherapy efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patient's will be provided with a 7 weeks course of structured aerobic exercises and resistance training in the periods before, during and after their radiotherapy treatment. The patients will be followed up for 6 months post short course neoadjuvant radiotherapy, with a total of 3 assessment periods. conditions: Locally Advanced Rectal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility study primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Supervised Vigorous intensity aerobic interval exercise measure: Recruitment rate measure: Attendance rate measure: withdrawal rate measure: Serum Carcinoembryonic antigen levels measure: Quality of life assessment measure: Quality of life assessment measure: Physical activity levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292962 id: SH-34988389 briefTitle: Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain acronym: VNSDPN overallStatus: COMPLETED date: 2023-10-01 date: 2024-03-01 date: 2024-03-03 date: 2024-03-05 date: 2024-04-22 name: Saima Abass Tahammal class: OTHER name: Al Ain University briefSummary: The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes. conditions: Diabetes Mellitus conditions: Diabetic Neuropathies conditions: Type2diabetes conditions: Neuropathic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: a randomized, double-blinded, sham-controlled, parallel group clinical trial whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 165 type: ACTUAL name: non-invasive transcutaneous vagal nerve stimulation (tVNS) name: Sham device measure: Neuropathic pain scores measure: Quality of life score sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shifa Hospital city: Lahore country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06292949 id: TJ-IRB20230956 briefTitle: Clinical Study of Resistant Starch in Improving Constipation overallStatus: RECRUITING date: 2023-09-27 date: 2024-09-25 date: 2024-09-25 date: 2024-03-05 date: 2024-03-05 name: Huaping Xie class: OTHER briefSummary: Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation. Clinically, constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. Ruminococcus bromii is a specific microorganism that degrades resistant starch. The starch decomposing enzyme of R. bromii has a unique tissue structure and forms a multi-enzyme complex. Through the adhesion protein and dockerin module, it is attached to the cell surface through the scaffold protein in the cellulose body. Big data analysis showed that the relative abundance of R. bromii in healthy people was significantly higher than that in patients with constipation. Therefore, the purpose of this clinical trial is to supplement resistant starch to patients with constipation: (1) Observe whether the symptoms of patients with constipation have improved; (2) Analyze the changes of intestinal microorganisms in patients with constipation; and (3) Verify whether the relative abundance of R. bromii is increased and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Resistant starch measure: Changes in constipation symptoms measure: Changes in the diversity of intestinal flora measure: Changes in the relative abundance of species of intestinal flora measure: Changes in the number of intestinal flora measure: Changes in the metabolic function of intestinal flora sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: ping h Xie role: CONTACT phone: 86+13437187007 email: hpxie@tjh.tjmu.edu.cn name: qiang Ding role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-21 uploadDate: 2024-02-29T21:24 filename: Prot_SAP_000.pdf size: 358565 hasResults: False

 nctId: NCT06292936 id: 30692 briefTitle: RemI for Post-Bariatric Surgery Weight Regain overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2027-12-31 date: 2028-04-01 date: 2024-03-05 date: 2024-03-05 name: Temple University class: OTHER name: Rush University briefSummary: The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).

The main research aims are:

1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control.
2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.
3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior. conditions: Obesity conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Acceptance-Based Behavioral Intervention measure: Weight measure: Caloric Intake measure: Eating Behavior - Cognitive Constraint measure: Eating Behavior - Disinhibition measure: Eating Behavior - Hunger measure: Physical Activity measure: Weight-Related Medical Comorbidities - Number of participants with hypertension measure: Weight-Related Medical Comorbidities - Number of participants with diabetes measure: Weight-Related Medical Comorbidities - Number of participants with hypercholesterolemia measure: Weight-Related Medical Comorbidities - Number of participants with hyperlipidemia measure: Mechanisms of Action (Exploratory) - Acceptance of food-related internal experiences measure: Mechanisms of Action (Exploratory) - Mindfulness measure: Mechanisms of Action (Exploratory) - Defusion measure: Mechanisms of Action (Exploratory) - Values clarity measure: Mechanisms of Action (Exploratory) - Depressive symptoms measure: Mechanisms of Action (Exploratory) - Anxiety measure: Mechanisms of Action (Exploratory) - Internal states measure: Mechanisms of Action (Exploratory) - Maladaptive eating behaviors sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University city: Chicago state: Illinois zip: 60612 country: United States name: Lauren Bradley, PhD role: CONTACT phone: 312-942-2714 email: lauren_e_bradley@rush.edu lat: 41.85003 lon: -87.65005 facility: Temple University city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: David B Sarwer, PhD role: CONTACT phone: 215-707-8632 email: dsarwer@temple.edu name: Sarah R Fischbach, MPH role: CONTACT phone: 215-707-8633 email: sarah.fischbach@temple.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06292923 id: TILS-021 briefTitle: A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients overallStatus: RECRUITING date: 2023-11-15 date: 2024-11 date: 2024-11 date: 2024-03-05 date: 2024-03-19 name: Tiziana Life Sciences LTD class: INDUSTRY briefSummary: Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases.

The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS).

The primary objectives that this study aims to answer are:

1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo
2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment. conditions: Secondary Progressive Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The treating physician, study staff, and patients will be blinded to treatment. The research pharmacy at each site will have the treatment code assignments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Foralumab name: Placebo measure: The number of patients with adverse event (AE) reports. measure: Changes in the Total Nasal Symptom Score (TNSS). measure: Change from baseline for [18F]PBR06-positron emission tomography (PET) scans for microglial activation after 12 weeks (3 months) of study treatment. measure: Changes in the Expanded Disability Status Scale (EDSS). measure: Changes in the Multiple Sclerosis Functional Composite-4 (MSFC-4). measure: Changes in the Modified Fatigue Impact Scale (MFIS). measure: Changes in the mean number of gadolinium-enhancing lesions per T1-weighted MRI scan, as measured by 3T MRI. measure: Changes in percent brain volume change by 3T MRI analysis pipeline between the Screening Visit (Baseline) and after 3 months of treatment, as measured by 3T MRI. measure: Paramagnetic rim lesions by quantitative susceptibility mapping sequences on MRI, as measured by 3T MRI (if center is able). sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Niveditha Gopalakrishnan role: CONTACT phone: 617-732-5588 email: foralumab@mgb.org name: Tanuja Chitnis, M.D role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06292910 id: REC 64-299-1-1 briefTitle: Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery acronym: VACO2 overallStatus: COMPLETED date: 2021-08-08 date: 2023-12-21 date: 2023-12-26 date: 2024-03-05 date: 2024-03-05 name: Prince of Songkla University class: OTHER briefSummary: The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.

The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research conditions: Congenital Heart Disease conditions: Perioperative/Postoperative Complications conditions: Lactate Blood Increase studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 136 type: ACTUAL name: arterial and central venous blood gas analysis, lactate measure: number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation measure: ventilator days measure: inotrope days measure: length of stay in ICU sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine, Prince of Songkla University city: Hat Yai state: Songkhla zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-05 uploadDate: 2024-02-09T09:23 filename: Prot_SAP_000.pdf size: 745529 hasResults: False

 nctId: NCT06292897 id: 3312 briefTitle: Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression acronym: OBESITA'&PCa overallStatus: RECRUITING date: 2023-03-20 date: 2026-09-15 date: 2027-01-15 date: 2024-03-05 date: 2024-03-05 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: National Research Council briefSummary: Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI \> 27.5) and non-severely overweight/normoweight (BMI \< 27.5) patients affected by prostate carcinoma.

ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.

iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways. conditions: Prostate Cancer conditions: Prostate Adenocarcinoma conditions: Prostate Neoplasm conditions: Prostatic Neoplasm conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 25 type: ESTIMATED name: observational study measure: Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Cà Granda Ospedale Maggiore Policlinico Milano status: RECRUITING city: Milan country: Italy name: giancarlo albo, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06292884 id: IMAGINER CREATINE briefTitle: Optical Imaging as a Tool for Monitoring Brain Function in Creatine Deficiency Syndromes overallStatus: RECRUITING date: 2023-10-06 date: 2025-06-15 date: 2025-12-15 date: 2024-03-05 date: 2024-03-05 name: IRCCS Fondazione Stella Maris class: OTHER briefSummary: The objective of this project is to explore the potential of functional near-infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Creatine Deficiency Syndromes (CDS), a group of rare neurodevelopmental disorders. Among these disorders, effective treatments are lacking for two. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With gene therapy trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. This project seeks to address this gap by assessing the prognostic reliability of both resting and task-evoked fNIRS. Arousal of participants will be also assessed through the measure of spontaneous heart rate (HR) fluctuations. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with CDS; 2. to collect pilot data on individuals with CDS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls. conditions: Creatine Deficiency, X-linked conditions: Creatine Deficiency Syndrome Due to Gamt Deficiency studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Resting-state functional connectivity measure: Amplitude of sensory-evoked hemodynamic responses measure: Correlation between neurophysiology endpoints and the response on neuropsychological scale. sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Pisa zip: 56128 country: Italy name: Roberta Battini, MD role: CONTACT phone: +39 050886282 email: roberta.battini@fsm.unipi.it name: Laura Baroncelli, PhD role: CONTACT phone: +39 050886233 email: laura.baroncelli@fsm.unipi.it name: Elena Scaffei, MD role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06292871 id: 2023/2712 briefTitle: The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2025-05 date: 2024-03-05 date: 2024-03-05 name: KK Women's and Children's Hospital class: OTHER_GOV name: Singapore Institute of Technology briefSummary: To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,

i. To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform.

ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire.

iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM.

iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM. conditions: Gestational Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will employ a randomized controlled trial design, with GDM patients from KKH randomly assigned to either the intervention or control group. Randomization will be conducted via the electronic randomization list. primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Additional GDM management through social media name: Usual care measure: Acceptance levels measure: Satisfaction levels measure: Engagement levels measure: Appropriateness levels measure: Feasibility levels measure: Emotional wellbeing measure: Blood glucose levels measure: Proportion of participants with optimal blood glucose control measure: Confidence levels measure: Meal skipping measure: Proportion of participants with cigarette smoking measure: Proportion of participants with alcohol intake measure: Gestational weight gain rate measure: Proportion of participants with inappropriate weight gain measure: Motivational levels measure: Proportion of participants with induced labour measure: Proportion of participants with caesarean delivery measure: Birth weight measure: Birth length measure: Head circumference measure: Birth size-for-gestational age measure: Gestational length at birth measure: Proportion of participants with preterm delivery measure: Neonatal apgar score measure: Proportion of participants delivering healthy live birth sex: FEMALE minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06292858 id: IMB071703-101 briefTitle: Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2023-02-24 date: 2025-04 date: 2025-08 date: 2024-03-05 date: 2024-03-05 name: Beijng Immunoah Pharma Tech Co., Ltd. class: INDUSTRY briefSummary: A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors conditions: Recurrent or Metastatic, Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 93 type: ESTIMATED name: IMB071703 injection measure: Incidence of adverse events/serious adverse event related with IMB071703 injection measure: Dose-limiting toxicity (DLT) measure: Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of IMB071703 injection measure: Maximum measured plasma concentration (Cmax) of IMB071703 injection. measure: Time to maximum plasma concentration (Tmax) of IMB071703 injection. measure: Half-life (T1/2) of IMB071703 injection. measure: Immunogenicity profile of IMB071703 injection. measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Disease control rate (DCR) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oncology, Shanghai East Hospital, Tongji University status: RECRUITING city: Shanghai state: Shanghai zip: 200120 country: China name: Ye Guo, Doctor role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06292845 id: 11272 briefTitle: Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents acronym: SprayDye overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-01 date: 2027-12-01 date: 2024-03-05 date: 2024-03-05 name: Erasmus Medical Center class: OTHER briefSummary: This is a proof-of-principle study, that uses freshly resected human solid tumor specimens to assess the performance of topically applied fluorescent imaging agents for the detection of tumor tissue and close / tumor-positive resection margins ex vivo. Surgery will be performed in conformity with hospital protocol. The study will not interfere with the standard clinical care. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Topical application of a fluorescent imaging agent measure: Tumor-to-background ratio (TBR) of the fluorescence signal on the resection specimen surface and on 3-5 mm thick tissue slices. measure: Imaging agent fluorescence signal intensity on close / tumor-positive resection planes compared with (wide) tumor-negative resection planes, as confirmed by histopathology measure: Difference in tumor-to-background ratio (TBR) between different imaging time windows measure: The concordance between the presence of tumor cells and fluorescence signal measure: Depth of the fluorescence signal on 4-μm tissue slides sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus University Medical Center city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06292832 id: MSR/AZAST/AIP029/22/222/8/2023 briefTitle: Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-09-10 date: 2024-09-10 date: 2024-03-05 date: 2024-03-05 name: Al-Azhar University class: OTHER briefSummary: The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Ultrasound-guided pain block name: Ultrasound Machine measure: postoperative time to rescue analgesia requirement sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Al-Azhar University city: Assiut country: Egypt name: Warda Ali role: CONTACT phone: 010300020456 email: warda2001@hotmail.com lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06292819 id: CMUH112-REC2-214 briefTitle: Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-05 date: 2024-03-05 name: China Medical University Hospital class: OTHER briefSummary: The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events. conditions: Photobiomodulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Bright light name: Near-infrared light name: Bright light+ near-infrared light measure: Actigraphy-derived sleep indicators measure: Dim-light melatonin onset measure: Sleep quality measure: Emotional state measure: Daytime sleepiness sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292806 id: 001-2024 briefTitle: Inhibin B/AFC Ratio for Ovarian Response overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-20 date: 2025-12-31 date: 2024-03-05 date: 2024-03-05 name: Insemine Humen Reproduction Centre class: NETWORK briefSummary: Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness.

A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality. conditions: IVF conditions: Infertility, Female conditions: Ovulation Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 144 type: ESTIMATED name: FSH-R measure: serum Inhibin B levels measure: serum Anti Mullerian Hormone levels sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06292793 id: STUDY00004696 briefTitle: Cyclical Sighing for Pain overallStatus: COMPLETED date: 2023-12-13 date: 2024-02-26 date: 2024-02-26 date: 2024-03-05 date: 2024-03-05 name: Florida State University class: OTHER briefSummary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 81 type: ACTUAL name: Pain Coping Information name: Cyclical Sighing measure: Change in Pain Unpleasantness Numeric Rating Scale measure: Change in Pain Intensity Numeric Rating Scale measure: Change in Anxiety Numeric Rating Scale measure: Change in Depression Numeric Rating Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tallahassee Orthopedic Clinic (TOC) city: Tallahassee state: Florida zip: 32308 country: United States lat: 30.43826 lon: -84.28073 hasResults: False

 nctId: NCT06292780 id: R5458-ONC-2274 id: 2023-507809-34-00 type: OTHER domain: EUCT Number briefTitle: A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) acronym: LINKER-AL2 overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2028-08-26 date: 2035-02-26 date: 2024-03-05 date: 2024-03-05 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called linvoseltamab ("study drug").

This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.

The study consists of 2 phases (Phase 1 and Phase 2):

* In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.
* In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.

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

* How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long
* How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long
* What the right dosing regimen is for linvoseltamab
* What side effects may happen from taking linvoseltamab
* How much linvoseltamab is in your blood at different times
* Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects) conditions: Relapsed/Refractory Systemic Light Chain Amyloidosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Note: Participants enrolled in Phase 2 will be randomized 1:1 primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: Linvoseltamab measure: Incidence of dose-limiting toxicity (DLTs) measure: Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC) measure: Achievement of hematologic CR, as determined by the IRC measure: Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC measure: Achievement of overall hematologic response (PR or better), as determined by the IRC measure: Time to initial hematologic response measure: Time to best hematologic response measure: Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC measure: Hematologic progression-free survival (PFS) measure: Incidence of death measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Incidence of serious adverse events (SAEs) measure: Severity of SAEs measure: Incidence of adverse events of special interest (AESIs) measure: Severity of AESIs measure: Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2 measure: Incidence of TEAEs in dose regimen 1 vs 2 measure: Severity of TEAEs in dose regimen 1 vs 2 measure: Incidence of SAEs in dose regimen 1 vs 2 measure: Severity of SAEs in dose regimen 1 vs 2 measure: Incidence of AESIs in dose regimen 1 vs 2 measure: Severity of AESIs in dose regimen 1 vs 2 measure: Time from treatment initiation to hematologic disease progression as determined by the IRC measure: Time from treatment initiation to cardiac deterioration, as determined by the IRC measure: Time from treatment initiation to kidney deterioration as determined by the IRC measure: Time from treatment initiation to death as determined by the IRC measure: Time from initiation of treatment to date of death from any cause measure: Achievement of renal response in participants with renal involvement at baseline, as determined by IRC measure: Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC measure: Time to first renal response in participants with renal involvement at baseline measure: Time to first cardiac response in participants with cardiac involvement at baseline measure: Linvoseltamab concentration in serum over time measure: Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time measure: Titers of ADAs to linvoseltamab over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292767 id: 2023/462 briefTitle: Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-01-15 date: 2025-04-25 date: 2024-03-05 date: 2024-03-05 name: TC Erciyes University class: OTHER briefSummary: During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications. conditions: Postoperative Pulmonary Atelectasis conditions: Pneumothorax conditions: Pneumonia conditions: Ards conditions: Respiratory Failure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: mechanical power calculation measure: mechanical power measure: mechanical power sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292754 id: 2023.211 briefTitle: Rotator Cuff Repair With Magnesium Pin overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-12 date: 2024-03-05 date: 2024-03-05 name: Chinese University of Hong Kong class: OTHER briefSummary: Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes. conditions: Arthroscopic Rotator Cuff Repair 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: magnesium pin in additional to the suture anchor name: routine suture anchor measure: Imaging Examinations measure: Cofield classification measure: Sugaya Score measure: Goutallier Classification measure: Height measurement measure: Weight measurement measure: BMI measurement measure: Shoulder flexibility (range of motion) measure: Shoulder muscle strength measure: Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index measure: Constant-Murley Score measure: Visual Analogue Scale (VAS) measure: Adverse events measure: C-reactive protein measurement measure: Calcium (Ca) measurement measure: Magnesium (Mg) measurement measure: Phosphorous (P) measurement measure: Creatinine (Cr) measurement measure: Urea measurement measure: Alanine transaminase (ALT) measurement measure: Aspartate aminotransferase (AST) measurement measure: Total protein (TP) measurement measure: Albumin (ALB) measurement measure: Globulin (GLB) measurement sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06292741 id: 4956 briefTitle: Autonomic Involvement in Patient With Cognitive Decline overallStatus: RECRUITING date: 2023-01-11 date: 2024-07 date: 2026-01 date: 2024-03-05 date: 2024-04-04 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline conditions: Dementia, Mild conditions: Dementia of Alzheimer Type studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 120 type: ESTIMATED name: Sudoscan measure: evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia measure: correlation between the extent of autonomic involvement and the severity of cognitive decline measure: evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction. sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS status: RECRUITING city: Roma state: Lazio zip: 00168 country: Italy name: Camillo Marra, MD role: CONTACT phone: 0630154333 email: camillo.marra@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06292728 id: ENDOPLY1 briefTitle: ENDOPLY System in Humans: a Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-07 date: 2024-03-05 date: 2024-03-05 name: ENDOPLY class: OTHER name: Just 4 Device s.r.o. briefSummary: Prospective, non-randomized study aimed at defining the initial pattern of gastric plication with the ENDOPLY System, and assess feasibility, ergonomics and safety of the device Prospective, single-centre, open label, consecutive enrolment conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: ENDOPLY System measure: Time of duration of the ENDOPLY System study procedure measure: Number of ligatures placed by ENDOPLY System study procedure measure: Gastric perforation events measure: Gastrointestinal bleeding events measure: Initial weight-loss sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Institut klinické a experimentální medicíny (IKEM), Klinika hepatogastroenterologie city: Prague zip: 14021 country: Czechia name: Evžen Machytka, MD, Ph.D. role: CONTACT email: evmac@seznam.cz name: Evžen Machytka, MD, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06292715 id: Microwave Ablation01 briefTitle: Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism overallStatus: RECRUITING date: 2024-01-20 date: 2025-12-31 date: 2026-12-31 date: 2024-03-05 date: 2024-03-05 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism. conditions: Secondary Hypersplenism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: microwave ablation of the spleen name: Splenic artery balloon implantation measure: Portal venous pressure measure: Hepatic artery blood flow velocity measure: Routine blood test measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute & Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300060 country: China name: Huikai Li role: CONTACT phone: +862223340123 phoneExt: 3091 email: lihuikai@tjmuch.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06292702 id: Modified Burch Colposuspension briefTitle: Reducing Early Urinary Disorders After Stress Incontinence Surgery: The Role of Vaginal Wall Tension. overallStatus: COMPLETED date: 2022-01-01 date: 2023-10-01 date: 2024-02-01 date: 2024-03-05 date: 2024-03-05 name: Damascus University class: OTHER briefSummary: The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional retropubic suspension techniques (Burch). This study introduces a modified technique that creates lateral tension for the anterior vaginal wall before the conventional suspending to the Cooper ligament, limiting the tension on the urethra and reducing the risk of postoperative urinary voiding dysfunction with the same success rates. This technique offers the advantages of a tension-free procedure while still providing the benefits of retropubic suspension. Moreover, this modified technique eliminates the need for artificial mesh, reducing the risk of associated complications. This promising alternative offers effective support for the urethra and reduces postoperative emptying disorders. However, further research and studies are necessary to validate the long-term efficacy and safety of this modified technique. conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Traditional Burch colposuspension name: Modified Burch colposuspension measure: Subjective voiding dysfunction after surgery, first evaluation measure: Urinary peak flow rate after surgery, first evaluation measure: Residual urine after surgery, first evaluation measure: Urinary retention after surgery, first evaluation measure: Subjective voiding dysfunction after surgery, second evaluation measure: Urinary peak flow rate after surgery, second evaluation measure: Residual urine after surgery, second evaluation measure: Urinary retention after surgery, second evaluation measure: Subjective voiding dysfunction after surgery, third evaluation measure: Urinary peak flow rate after surgery, third evaluation measure: Residual urine after surgery, third evaluation measure: Urinary retention after surgery, third evaluation measure: Subjective recovery from urinary incontinence, first evaluation measure: Objective recovery from urinary incontinence, first evaluation measure: Subjective recovery from urinary incontinence, second evaluation measure: Objective recovery from urinary incontinence, second evaluation measure: Subjective recovery from urinary incontinence, third evaluation measure: Objective recovery from urinary incontinence, third evaluation sex: FEMALE minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus university city: Damascus country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False

 nctId: NCT06292689 id: IRB-2024-5(IIT) briefTitle: A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2026-03-22 date: 2027-03-22 date: 2024-03-05 date: 2024-03-05 name: Zhejiang Cancer Hospital class: OTHER name: Akeso name: Innovent Biologics, Inc. briefSummary: To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment. conditions: Vulvar and Vaginal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Cardunolizumab measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Adverse events (AEs) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310005 country: China name: Hanmei Lou, MD. role: CONTACT phone: +8619817462599 email: louhm@zjcc.org.cn name: Hanmei Lou, MD. role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06292676 id: ObGynEASC004 briefTitle: Emergency Home Delivery. Learning Skills for Medical Doctors and Nurses. Kirkpatrick Levels of Learning acronym: ERdeliv overallStatus: RECRUITING date: 2024-01-01 date: 2024-05-20 date: 2024-06-30 date: 2024-03-05 date: 2024-03-05 name: G. d'Annunzio University class: OTHER briefSummary: Mannequin training for emergency home delivery on medical doctors and nurses conditions: Home Birth Delivery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: skills retained for home birth delivery in emergency measure: Kirkpatrick levels improvement sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Claudio Celentano status: RECRUITING city: Pescara state: Italia zip: 65100 country: Italy name: Claudio Celentano, MD role: CONTACT phone: 3285577305 email: celentanoclaudio70@gmail.com lat: 42.4584 lon: 14.20283 hasResults: False

 nctId: NCT06292663 id: EMN-2023-08767 briefTitle: Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety? overallStatus: RECRUITING date: 2024-03-05 date: 2024-11 date: 2024-11 date: 2024-03-05 date: 2024-03-12 name: Zealand University Hospital class: OTHER briefSummary: The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. The main question(s) aim(s) to answer if:

* Can preoperative information through a VR headset lower the patients preoperative anxiety?
* Can VR information make the patients more ready for surgery. Painscore will also be collected.

Participants will be randomized into two groups. One that will have preoperative information through VR versus standard information.

If there is a comparison group: Researchers will compare enrolled TKA patients to see if VR have an impact on anxiety, readiness and pain conditions: Anxiety conditions: Surgery conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The subjects are being randomized to one of two groups. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The primary investigator will stay blinded in this study and an assistant to the investigator is screening and including the patients and collecting data. whoMasked: INVESTIGATOR count: 88 type: ESTIMATED name: Virtual Reality measure: Preoperative anxiety measure: Cumulative sedative consumption measure: Opioid consumption measure: Patient preoperatively expectations measure: Patient preoperatively readiness measure: Adverse events measure: Level of pain measure: The need for information sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zealand University Hospital status: RECRUITING city: Køge state: Zealand zip: 4600 country: Denmark name: Karsten Lomholt Lassen, CRNA role: CONTACT phone: 26131350 email: karlas@regionsjaelland.dk name: Nanna Wagner Christiansen, B.Eng role: CONTACT phone: 40306799 email: nanchr@regionsjaelland.dk name: Karsten Lomholt Lassen, Ph.D Student, CRNA role: PRINCIPAL_INVESTIGATOR lat: 55.45802 lon: 12.18214 hasResults: False

 nctId: NCT06292650 id: ZM-02 briefTitle: Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients acronym: ZM-02 overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2027-12-25 date: 2028-12-25 date: 2024-03-05 date: 2024-03-05 name: Zhongmou Therapeutics class: INDUSTRY briefSummary: This trial is meant to evaluate the safety and efficacy of ZM-02 in Retinitis pigmentosa (RP) patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye. conditions: Retinitis Pigmentosa studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 12 type: ESTIMATED name: ZM-02-L name: ZM-02-H name: ZM-02-S measure: Incidence of adverse events and serious adverse events measure: Changes in intraocular pressure (IOP) in Subjects measure: Change of FST outcome measure: Change of MLMT level measure: Change of Quality of Life measure: Change in best corrected visual acuity (BCVA) measure: Change in visual field (VF) measure: Change in Fundus Autofluorescence (FAF) measure: Change in central foveal thickness (CFT) using Optical Coherence Tomography (OCT) measure: Change in central macular thickness (CMT) using Optical Coherence Tomography (OCT) measure: Changes in the fundus using fundus color photography sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tongren Hospital of Capital Medical University city: Beijing state: Beijing country: China name: Pei Cao role: CONTACT phone: +86 18707134160 email: zmt@simbaeye.com name: Yin Shen role: CONTACT name: Wenbin Wei, PhD role: PRINCIPAL_INVESTIGATOR name: Laichun Lu, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06292637 id: 2020-1484 id: A545000 type: OTHER domain: UW Madison id: NUR/FACULTY AFFAIRS/ADMIN type: OTHER domain: UW Madison id: Protocol Version 4/4/2024 type: OTHER domain: UW Madison id: 1R01HS029477-01 type: AHRQ link: https://reporter.nih.gov/quickSearch/1R01HS029477-01 briefTitle: Cognitive Behavioral and Faith Fellowship to Improve Thy Health acronym: CB-FAITH overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-09 date: 2026-09 date: 2024-03-05 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized stepped wedge design (R-SWD), a type of cluster randomized controlled trial, will be used to randomize a cluster (church groups with a group of 10 participants), not individual subjects.

At the start of a R-SWD, all clusters begin as control groups. At certain time points during the course of the trial, some of the clusters are randomly selected to be switched to the CB-FAITH treatment, with all clusters eventually crossing over to receive the treatment. The sample will be comprised of 12 groups, each with 10 individuals (N=120). primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) measure: Patient Health Questionnaire measure: Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR) measure: Multidimensional Measure of Religious Involvement (MMRI) score measure: Client Satisfaction Inventory (CSI) score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Baptist Church city: Madison state: Wisconsin zip: 53711-3800 country: United States name: Anthony Wade role: CONTACT phone: 608-278-1430 email: a.wade4@hotmail.com name: Anthony Wade role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 facility: The Board of Regents of the UW System city: Madison state: Wisconsin zip: 53715-1218 country: United States name: Earlise Ward, PhD role: CONTACT lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06292624 id: HSEARS20230417002 briefTitle: Effectiveness of Intermittent Vacuum Therapy Combined With Aerobic Exercise in Individuals With Diabetes Mellitus overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-01 date: 2024-04-30 date: 2024-04-30 date: 2024-03-05 date: 2024-03-06 name: The Hong Kong Polytechnic University class: OTHER name: Yan Chai Hospital Social Services briefSummary: Consequences of the compromised vascular system in diabetes mellitus (DM) are among the most devastating complications. Reduction in blood flow and oxygen uptake of skeletal muscle leads to muscle fatigue and impaired skeletal muscle post-exercise adaptation. Recent studies showed that intermittent vacuum therapy (IVT) augments the blood flow of the foot in people with DM. This pilot study investigates the effects of combined IVT and aerobic exercise in improving lower limb muscle oxygenation and distal circulation in individuals with DM. Positive results of the study shed light on strategy that enhances the effectiveness of aerobic exercise in people with DM. conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinical trials with a single arm, receiving IVT combined with cycling exercise primaryPurpose: TREATMENT masking: NONE count: 12 type: ACTUAL name: Intermittent vacuum therapy (Weyergans High Care® Medial, Germany) name: Cycling exercise measure: Muscle oxygenation measure: Muscle oxygenation measure: Surface Electromyography measure: Surface Electromyography measure: Foot Sensation measure: Foot Sensation measure: Functional muscle strength measure: Functional muscle strength measure: Functional mobility measure: Functional mobility sex: ALL minimumAge: 55 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06292611 id: ST-23-U35 briefTitle: Two Week Cumulative Extrinsic Stain Removal of a Battery-powered Toothbrush and a Manual Toothbrush overallStatus: COMPLETED date: 2023-11-27 date: 2023-12-12 date: 2024-01-25 date: 2024-03-05 date: 2024-03-05 name: Church & Dwight Company, Inc. class: INDUSTRY briefSummary: To evaluate and compare the extrinsic stain removal efficacy of a battery-powered toothbrush and a manual toothbrush following two weeks of brushing. conditions: Dental Devices, Home Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 102 type: ACTUAL name: Battery operated toothbrush name: Manual toothbrush measure: Extrinsic Stain sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Salus Research, Inc. city: Fort Wayne state: Indiana zip: 46825 country: United States lat: 41.1306 lon: -85.12886 hasResults: False

 nctId: NCT06292598 id: AOI2022/2023/CDR-01 briefTitle: Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control Population acronym: NARCOBIOTE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-05 date: 2024-03-05 date: 2024-03-05 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: Narcolepsy type 1 (NT1) is a rare disease characterized by severe drowsiness, cataplexy, hypnagogic hallucinations, sleep paralysis, poor night sleep, and often obesity. NT1 is caused by irreversible loss of orexin (ORX)/hypocretin neurons in the lateral hypothalamus with decreased ORX levels in the cerebrospinal fluid (CSF). Although the underlying process leading to this destruction remains unclear; an autoimmune origin is suspected.

The study authors recently compared the bacterial communities of the fecal microbiota of NT1 patients and control subjects. Initial results demonstrated a difference in overall bacterial community structure in NT1 compared to controls, as assessed by beta diversity, even after adjusting for body mass index (BMI). The Shannon biodiversity index was also correlated with the duration of NT1 disease. However, no association was found between the structure of the microbial community and the clinical characteristics of NT1 patients.

In 2022, a second study from the SOMNOBANK cohort on a larger population confirmed these results, showing dysbiosis between NT1 patients and the control population. The altered intestinal microbial diversity supports the important role of the environment in the development and pathogenesis of NT1. Other studies have established a link between dysbiosis, intestinal permeability and inflammation in other neuroimmune pathologies. Currently, no study has focused on these phenomena of bacterial translocation, intestinal permeability and immune activation linked to the microbiota in type 1 narcolepsy patients.

The study hypothesis is that NT1 patients with dysbiosis in their intestinal microbiota also present a bacterial translocation with an intestinal origin, leading to a systemic inflammatory syndrome favoring an autoimmune damage destroying hypocretin neurons in the hypothalamus. The study authors suspect that microbial elements (DNA) involved in the autoimmune process could be detected in the CSF. This bacterial translocation could vary over time depending on: i) the progression of the disease and its management; ii) changing dysbiosis and: iii) the increase in intestinal permeability and inflammation. conditions: Narcolepsy Type 1 conditions: Bacterial Translocation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Blood sample name: Stool sample name: CSF sample measure: Plasma bacterial translocation profiles between groups measure: Plasma bacterial translocation profiles in NT1 patients measure: Taxonomic characteristics of DNA in the CSF of NT1 patients according to narcolepsy severity measure: Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation measure: Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation measure: Beta diversity of the intestinal microbiota between groups measure: Beta diversity of the intestinal microbiota in NT1 patients measure: Alpha diversity of the intestinal microbiota between groups measure: Alpha diversity of the intestinal microbiota in NT1 patients measure: Composition of the intestinal microbiota between groups measure: Composition of the intestinal microbiota between groups measure: Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile between groups measure: Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile in NT1 patients measure: Plasma LPS-binding Protein (LBP) profile between groups measure: Plasma LPS-binding Protein (LBP) profile in NT1 patients measure: Plasma Soluble CD14 profile between groups measure: Plasma Soluble CD14 profile in NT1 patients measure: Age of onset of symptoms in NT1 patients measure: Duration of disease progression in NT1 patients measure: Severity of sleep-related symptoms in NT1 patients measure: Severity of narcolepsy symptoms in NT1 patients measure: Description of comorbidities in NT1 patients measure: Sleep onset latency in NT1 patients measure: Number of rapid eye movement sleep episodes in NT1 patients measure: Orexin levels in CSF in NT1 patients sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Nîmes University Hospital city: Nîmes state: Gard zip: 30029 country: France name: Anissa MEGZARI role: CONTACT phone: +33 4 66 68 42 36 email: drc@chu-nimes.fr name: Catherine DUNYACH-REMY role: PRINCIPAL_INVESTIGATOR name: Jean-Philippe LAVIGNE role: SUB_INVESTIGATOR name: Béatrix ABRIL role: SUB_INVESTIGATOR lat: 43.83333 lon: 4.35 facility: Centre Hospitalier Universitaire de Montpellier city: Montpellier country: France name: Yves DAUVILLIERS role: CONTACT email: y-dauvilliers@chu-montpellier.fr name: Yves DAUVILLIERS role: PRINCIPAL_INVESTIGATOR name: Lucie BARATEAU role: SUB_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06292585 id: AEDH-MT briefTitle: Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-08 date: 2026-12 date: 2024-03-05 date: 2024-03-05 name: Changhai Hospital class: OTHER briefSummary: A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study. conditions: EpiDural Hematoma conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 168 type: ESTIMATED name: MMA embolization plus medical therapy name: Medical therapy alone measure: The proportion of patients who die within 72 hours after injury or progress to require craniotomy due to epidural hematoma. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai hospital city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06292572 id: 2024PI029 briefTitle: Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-11-01 date: 2024-11-01 date: 2024-03-05 date: 2024-03-05 name: Central Hospital, Nancy, France class: OTHER briefSummary: To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments conditions: Retinal Detachment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 25 type: ESTIMATED name: Retinal Detachment Surgery measure: Rate of surgical success measure: Visual Acuity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU de Nancy city: Vandoeuvre les nancy state: Meurthe-et-Moselle zip: 54511 country: France lat: 48.65 lon: 6.18333 hasResults: False

 nctId: NCT06292559 id: STN or GPi in Meige Syndrom briefTitle: A Comparison Between STN-DBS and GPi-DBS in Meige Syndrome Evaluated by Flexible Electrodes overallStatus: RECRUITING date: 2023-11-30 date: 2024-11-30 date: 2025-11-30 date: 2024-03-05 date: 2024-03-05 name: Qilu Hospital of Shandong University class: OTHER briefSummary: Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Researchers designed this study to compare the 12-month outcomes for patients who undergo bilateral stimulation of the GPi or STN. conditions: Meige Syndrome 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: Bilateral STN deep brain stimulation name: Bilateral GPi deep brain stimulation measure: Change in motor function measure: health-related quality of life measure: sleep quality status measure: Mental syndrome measure: Mental syndrome sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chao Zhang status: RECRUITING city: Jinan state: Sichuan zip: 250100 country: China name: chao zhang role: CONTACT phone: +8613969007232 email: chao_zhang@sdu.edu.cn lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06292546 id: ZYC-Hp2024 briefTitle: Effect of Intestinal Microecology After HDDT Combined With Probiotics for Helicobacter Pylori Eradication overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-01 date: 2024-09-01 date: 2024-03-05 date: 2024-03-07 name: Zhongshan Hospital (Xiamen), Fudan University class: OTHER briefSummary: The aim of this study was to evaluate the effect of Intestinal microecology after high dose dual therapy combined with probiotics for Helicobacter pylori eradication conditions: H Pylori Infection Eradication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Vonorason name: Amoxicillin name: Bacillus subtilis enteric-coated capsules measure: Gut Microbiota measure: Fecal metabolites measure: Eradication rate measure: Frequency of the adverse events measure: Compliance rate of the drugs sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292533 id: UTAR-30-2024 briefTitle: Effectiveness of Ultrapulse for the Treatment of Androgenic Alopecia Among Malaysian: A Quasi-experimental Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2024-10 date: 2024-03-05 date: 2024-03-05 name: Universiti Tunku Abdul Rahman class: OTHER briefSummary: The goal of this study is to to evaluate the effectiveness of Ultrapulse for the treatment of androgenic alopecia among Malaysian. The main questions it aims to answer are:

* the efficacy of Ultrapulse in treatment of androgenic alopecia among Malaysian
* the safety and adverse effect of Ultrapulse treatment.
* the quality of life of androgenic alopecia among Malaysian. conditions: Androgenic Alopecia conditions: Alopecia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Er:YAG laser measure: Global assessment of hair growth measure: Patient satisfaction measure: Quality of Life of Patient measure: Adverse effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292520 id: 4847 briefTitle: Comparison of ABLLS-R and Portage Guide in the Development of Receptive Language Skills Autism Spectrum Disorder. overallStatus: COMPLETED date: 2023-06-10 date: 2023-08-20 date: 2023-12-10 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: Language is the system someone uses to communicate with another person. This covers the origins and construction of words, their definitions, and the use of language in various contexts. In normally developing children, receptive language skills are typically much more advanced than expressive language skills. However, some studies found that toddlers and kids with ASD had a relatively greater impairment in receptive language skills than in expressive language skills. The study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder (N=12).

The study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABLLS-R protocol and other will receive Interventions under portage guide protocol. The data will be analysed by using SPSS 22 statistical software. The results of the study of both the groups will be compared and conclusion will be made on the basis of results. Receptive language skills are crucial for communication and social interaction. Research comparing these assessment tools can contribute to the development of more effective early intervention programs for children with ASD. By identifying the most appropriate assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes. By understanding the strengths and limitations of each assessment tool, professionals can create more individualized treatment plans for children with ASD conditions: Autism Spectrum Disorders conditions: Non-verbal Learning Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 12 type: ACTUAL name: Portage Guide Protocol name: ABLLS-R protocol measure: ABLLS-R for the development of receptive language in children with Autism measure: Portage Guide for the development of receptive language in children with Autism sex: ALL minimumAge: 3 Years maximumAge: 7 Years stdAges: CHILD facility: Bases Institute city: Lahore state: Punjab zip: 05309 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06292507 id: REC/RCR&AHS/23/0734 briefTitle: Comparative Effects of Myofascial Stretch and Contract-relax in Children With Spastic cp overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-16 date: 2024-03-25 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture.It is one of the three most common lifelong developmental disabilities, the other two being autism and mental retardation causing considerable hardship to affected individuals and their families. CP is a common problem, the worldwide incidence being 2 to 2.5 per 1000 live births. Myofascial therapy is definable by "the facilitation of mechanical, neural and psycho physiological adaptive potential as interfaced by the myofascial system". The PNF contract-relax technique consists of stretching the target muscle, keeping it in position while the patient isometrically contracts it and relaxes in sequence, producing effects such as maintenance and gain in joint mobility, increased muscle strength, and better motor control whereas The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone This study will be randomized clinical trial and will be conducted in Rasool medical centre Gujrat and City hospital Gujrat. This study will be completed within duration of 6 months after the approval of synopsis.Convenience sampling technique will be used to collect the data. A sample size of total 20 patientswill be taken in the study. 20participants will be equally divided into two group's myofascial stretch and contract-relax stretching techniques having 10participants in each group. Informed consent will be sought from them and they will be clearly explained about the purpose of study.Myofascial Stretching will be applied to Group A and Contract-Relax stretching will be applied to Group B.

Results will be analyzed on SPSS. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 22 type: ESTIMATED name: MYOFASCIAL STRETCH name: CONTRACT-RELAX TECHNIQUE measure: Manual Ability Classification system sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Mirza Muhammad Farooq status: RECRUITING city: Gujrāt state: Punjab zip: 50700 country: Pakistan name: imran Amjad, PhD role: CONTACT phone: 033224390125 email: imran.amjad@ripha.edu.pk name: Muhammad asif Javed, MS role: CONTACT phone: 03224209422 email: a.javed@ripha.edu.pk lat: 32.5742 lon: 74.07542 hasResults: False

 nctId: NCT06292494 id: 1129052082 briefTitle: Focused Ultrasound for Drug-resistant Epilepsy overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2027-12-31 date: 2024-03-05 date: 2024-03-05 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV name: InSightec briefSummary: Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. From our previous study, FUS sonication may suppress the number of epileptic signal bursts observed in EEG recordings after the induction of acute epilepsy. The presence of the suppressive effect was found in terms of the number of epileptic EEG spikes from the analysis of the unfiltered and theta-band EEG activity, and further discontinue the seizure attacks. EEG activity has also been consistently reported to have a positive correlation with the level of epilepsy, and FUS-mediated reduction of epileptic EEG activity was most notably observed, no matter lesioning or modulating effects. The aims of this study are to demonstrate the safety and efficacy of FUS technology in epilepsy patients and to estimate the optimal parameters of focused ultrasound exposure that will be used in the case of epilepsy. conditions: Focused Ultrasound conditions: MR-guided FUS conditions: Drug Refractory Epilepsy conditions: Drug Resistant Epilepsy conditions: Medication Resistant Epilepsy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Exablate 4000 Transcranial MRgfUS System measure: pulse rate [Safety] measure: blood oxygen saturation level [Safety] measure: MRI [Safety] measure: Incidence of Treatment-Emergent Adverse Events [Tolerability] measure: seizure frequency [efficacy] measure: scalp EEG [efficacy] measure: No. of seizure-free days [efficacy] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei country: Taiwan name: Cheng-Chia Lee, MD. PhD. role: CONTACT email: cclee12@vghtpe.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06292481 id: REC/RCR&AHS/23/0240 briefTitle: Combine Effects of Brunnstorm Movement Therapy and LLLT in Chronic Stroke Patient overallStatus: COMPLETED date: 2023-08-01 date: 2023-09-30 date: 2023-10-10 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: The primary objective of this study is to determine the combined effects of Brunnstorm movement therapy and low level laser therapy on upper limb function in chronic stroke patient. conditions: Chronic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ACTUAL name: Brunnstorm movement therapy name: Combined Brunnstorm Movement therapy and low level laser therapy measure: Fugle meyer Assessment test measure: Box and block test measure: Nine peg hole test measure: to check Muscle tone measure: to measure grip Strength sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Govt. Mian Munshi DHQ Teaching hospital city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06292468 id: REC/RCR&AHS/23/0238 briefTitle: Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy overallStatus: COMPLETED date: 2023-07-07 date: 2023-08-18 date: 2023-09-18 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: To determine the effects of plantar cutaneous sensory stimulation on foot tactile sensitivity, postural control, and spatiotemporal gait parameters in patients with diabetic neuropathy. conditions: Diabetic Neuropathies studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ACTUAL name: Traditional physical therapy name: Plantar cutaneous sensory stimulation measure: Foot tactile sensitivity measure: Postural control measure: Spatiotemporal gait parameters sex: ALL minimumAge: 45 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PhysioFit city: Faisalabad state: Punjab zip: 38000 country: Pakistan lat: 31.41554 lon: 73.08969 facility: Allied Hospital Faisalabad. city: Faisalābad state: Punjab zip: 38000 country: Pakistan lat: 31.41554 lon: 73.08969 hasResults: False

 nctId: NCT06292455 id: RIPHAH/RCRS/REC/00713 briefTitle: Association of Anthropometrics With Grip Strength and Smash Quality Post Six Week Elastic Resistance Training overallStatus: COMPLETED date: 2020-07-10 date: 2020-11-30 date: 2020-12-15 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: To determine the association of hand and forearm anthropometrics on grip strength and forehand smash quality of badminton players after six-weeks of elastic resistance training. conditions: Anthropometric Measurements and Elastic Resistance Training conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ACTUAL name: Elastic resistance training name: Conventional Resistance Training measure: Smash quality (Power) measure: Smash quality (Speed) measure: Smash quality (Distance) sex: ALL minimumAge: 16 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Riphah international University city: Islamabad state: ICT zip: 44000 country: Pakistan lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06292442 id: REC/RCR&AHS/23/0237 briefTitle: Effects of HIIT on Muscle Strength, Atrophy and Aerobic Capacity in Stroke Patients. overallStatus: COMPLETED date: 2023-09-01 date: 2023-10-01 date: 2023-11-01 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: To determine the effects of High-Intensity Interval Training on muscle strength, atrophy, and aerobic capacity in stroke patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 34 type: ACTUAL name: traditional physical therapy name: High intensity interval training measure: Muscle strength measure: Muscle Atrophy measure: 6-Minute Walk Test (6MWT) measure: Aerobic Capacity measure: Fastest Gait Speed sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Jinnah Hospital, Lahore city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06292429 id: REC/RCR & AHS/23/1104 briefTitle: Effects of Complex Training in Cricket Fast Bowlers overallStatus: RECRUITING date: 2023-06-16 date: 2024-06 date: 2024-06 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: This study will be a randomized controlled trial and the data will be collected from National Cricket Academy and domestic cricket clubs. The sample size will be calculated by conducting a pilot study. There will be three groups. Group-A will be receiving Complex training, Group-B will be receiving Conventional training and Group C as a Control Group. Athletes with same physical fitness level will be recruited. There will be parallel assignment of the participants. Assessor will be kept blinded. All the parameters would be assessed at Baseline, 6 Weeks, 12 Weeks. Physical fitness will be assessed through Field Testing. Bowling performance will be assessed through speed machine and Kinovea Software. Work capacity will be assessed through step testing. Muscle strength will be assessed through Dynamometer. Lastly, BMD will be assessed though Bone Densitometer. conditions: Resistance Training conditions: Plyometric Exercise conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Complex Training name: Conventional Training name: Control Group measure: Physical fitness (linear speed capability) measure: Physical fitness (lower limb explosive power) measure: Physical fitness (upper body strength test) measure: Physical fitness (lower body strength test) measure: Physical fitness (upper body muscular endurance) measure: Physical fitness (aerobic capacity) measure: Bowling performance (Ball speed) measure: Bowling performance (run-up time) measure: Bowling performance (accuracy) measure: Bowling performance (RPE) measure: Work capacity measure: Muscle Strength measure: Bone Density sex: MALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Pakistan Sports Board Coaching Center status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Nasrullah Rana role: CONTACT phone: +92 334 5492964 name: Muhammad Atif Javed, PP-DPT role: PRINCIPAL_INVESTIGATOR name: Syed Asadullah Arslan, Ph.D. role: SUB_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06292416 id: REC/0257Huma Saleem briefTitle: Mirror Therapy With Sensory Motor Training in Children With CP overallStatus: RECRUITING date: 2023-12-30 date: 2024-05-14 date: 2024-05-14 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: The study compares two interventions in CP children: mirror therapy with sensory motor training versus mirror therapy with motor training. Mirror therapy works by manipulating the brain out of pain, ultimately improving movement in patients with one-sided paralysis. It can be used in combination with other therapies to assist patients with cerebral palsy in retraining the brains, restoring function, and enhancing the overall quality of life. The purpose of this study is to use a combination of Mirror therapy with sensory motor training and motor training and observe which one of these combinations has the most desirable effects in improving movement and quality of life in CP Children conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Assignment primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: participants and outcome assessors will be kept blind about the intervention which the patients will be receiving. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Experimental: Mirror therapy with sensory motor training. name: Experimental: Mirror Therapy with motor training name: Experimental: Motor Training measure: The Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment) measure: Jebsen Taylor Hand dysfunction test sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Eliya care Centre Faisalabad status: RECRUITING city: Lahore state: Punjab country: Pakistan name: Ammara Abbas, tDPT role: CONTACT phone: 03214932464 email: ammara.musvi@gmail.com name: Huma Saleem, MS NMPT* role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06292403 id: Farwa Akhtar briefTitle: Effects of Strength Training of Non-paretic Upper and Lower Limb With or Without Mirror Therapy overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-12-30 date: 2025-01-01 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: The aim of this study is to find the effects of strength training with or without mirror therapy of non-paralytic upper limb for functional activities and in lower limb for gait pattern, balance and stability, and ADLs of paralytic side in patients with acute and sub-acute stroke. A randomized controlled trial that will include total 44 participants .The control group will undergo usual rehabilitation training along with strength training. The trial group will undergo strength training and mirror therapy of NHS on the basis of usual rehabilitation training. For the control group, training time will be 30 minutes, once a day, 3 days a week for 8 weeks. IN trial group, training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks. were allowed to rest for 3-5 min during each training. Data collected will be analyzed through SPSS 25. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 groups

1. Strength training only group
2. strength training and mirror therapy group primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 44 type: ESTIMATED name: Strength Training name: Mirror therapy measure: Modified Barthel Index measure: Dynamic Gait Index measure: Berg Balance Scale sex: FEMALE minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: Fatima Hospital city: Rawalpindi state: Punjab country: Pakistan name: Sara Aabroo, NMPT role: CONTACT phone: 03155185508 email: sara.aabroo@riphah.edu.pk name: Farwa Akhtar, NMPT role: CONTACT lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06292390 id: AIBU-SBF-CY-09 briefTitle: The Effect Of Pet Therapy Applıed To Elders's Sleep And Qualıty Of Lıfe overallStatus: COMPLETED date: 2021-11-15 date: 2022-05-12 date: 2023-06-22 date: 2024-03-05 date: 2024-03-15 name: Tokat Gaziosmanpasa University class: OTHER briefSummary: Quality of life is defined as functional abilities that include the ability to fulfill an individual social role, the degree and quality of social interaction, mental health, physical competence, somatic senses such as pain, and satisfaction with life. The World Health Organization (WHO) defined quality of life in 1947 as a decrease not only in disease, disorder or disability, but also in physical, mental and social well-being. Old age is one of the situations in which the quality of life decreases. It is reported that the poor social and financial situation of individuals, low educational level, gender, lack of physical movement, decreased daily life activity level, decreased mobility ability, fall anxiety, sleep problems and other conditions that cause disability are determinants of the quality of life. According to the results of Bloom et al.'s study, elderly people wake up at night due to health problems.

According to the literature, the sleep and life of pet therapy applied to elderly individuals living in a nursing home there have not been any studies examining the effect on quality. For this reason, it was aimed to conduct this study in order to determine the effect of pet therapy applied to elderly individuals living in a nursing home on sleep and quality of life.

The study was planned to be conducted in a randomized controlled manner in order to determine the effect of pet therapy applied for one hour twice a week for 6 weeks to elderly people living in a nursing home in Tokat province on sleep pattern and quality of life. In the study, gender, age group and the presence of chronic diseases were taken as equivalence criteria. Since conducting the study single-blind will increase the reliability of the study, the application of the scales was applied by another researcher/surveyor other than the main researcher. conditions: Pet Therapy Effect of Sleep and Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial (Two groups with intervention and control group) primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: A pollster who did not know the people in the control and intervention group was selected and collected the data. The SPSS data were entered by someone selected other than the surveyor and the researcher. Thus, the study was conducted as a double-blind. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 59 type: ACTUAL name: Pet Therapy measure: PUKI measure: CASP-19 QUALITY OF LIFE sex: ALL minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nursing Home city: Tokat state: Center zip: 60000 country: Turkey lat: 40.31389 lon: 36.55444 hasResults: False

 nctId: NCT06292377 id: BRUFAST briefTitle: Better Understanding of Fatigue After STroke overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-05 date: 2024-03-05 name: Brugmann University Hospital class: OTHER briefSummary: Stroke is worldwide the second most common cause of death following heart attack and the leading cause of disability. Post-stroke fatigue (PSF) is a common complication after stroke and can be defined as 'an overwhelming exhaustion or tiredness, not related to exertion, which does not typically improve with rest'. Fatigue following stroke can be divided into early (\< 3 months) and late (\> 3 months) fatigue. PSF can have a considerable impact on a person's everyday activities and quality of life, participation in the rehabilitation process and levels of caregiver burden. Yet no efficient treatment exists to prevent or cure PSF because the pathophysiology remains unclear and seems to be multifaceted.

Autonomic dysfunction is a common complication after stroke, associated with higher morbidity and mortality. An easy tool to measure the function of the autonomic nervous system (ANS) is heart rate variability (HRV), which is defined as the beat-to-beat variation of the heart rate (= interbeat interval (IBI)). It is the result of alterations in the sympathetic and parasympathetic nervous system. In recent systematic reviews, authors stipulate that HRV can be regarded as a prognostic factor for short- and long-term stroke outcomes. HRV can be derived from 24 hours, 5 minutes (short-term) and \< 5 minutes (ultra-short-term) measurements by applying time-domain and frequency-domain indices.

Autonomic dysfunction has been related to chronic fatigue syndrome, in addition to fatigue in multiple sclerosis, Parkinson's disease and myasthenia gravis. However, to the best of our knowledge, the relationship between autonomic dysfunction and PSF has not yet been fully investigated.

Fatigue is also common in cardiovascular diseases, especially in patients with heart failure (HF). HF can contribute to fatigue after stroke, independently of stroke.

Cardiac complications after acute ischemic stroke (AIS), such as arrhythmias, cardiac dysfunction and myocardial injury, are frequent. The so-called 'stroke-heart syndrome', a concept introduced in 2018, describes a broad spectrum of cardiac changes observed in 10-20% of patients with AIS within the first month after stroke onset, with a peak in the first 72 hours. A dysregulation in the neural-cardiac control after stroke is suspected to be the cause of the cascade leading to cardiac complications, in which autonomic dysfunction and inflammation seem to be part of the underlying mechanism.

Based on previous studies and by analogy with other neurological diseases, the investigators hypothesize that autonomic dysfunction following AIS contributes to PSF and that patients presenting heart failure as a complication following AIS have an increased risk of PSF.

To confirm this hypothesis, the investigators will conduct a prospective, interventional study where patients who are hospitalized at the Stroke Unit, within 72 hours after stroke symptom onset, will be included. Evaluation will take place of (a) the relationship between autonomic dysfunction (HRV) and early and late PSF, and of (b) the relationship between cardiac dysfunction and early PSF and late PSF.

There will also be an investigation into following elements:

* the association between early and late PSF and (a) certain inflammatory markers at admission (CRP, NLR), (b) stroke localization and (c) baseline imaging markers of brain frailty.
* the role of pre-existing fatigue + pre-existing or post-stroke newly diagnosed cognitive impairment, depression and sleep disturbances on the course of PSF. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 250 type: ESTIMATED name: ECG name: Transthoracic echography (TTE) name: Blood sampling measure: Heart rate variability (HRV) measure: Heart rate variability (HRV) measure: Heart rate variability (HRV) measure: Transthoracic echography (TTE) measure: Transthoracic echography (TTE) measure: Transthoracic echography (TTE) measure: Fatigue Severity Scale measure: Fatigue Severity Scale measure: Fatigue Severity Scale measure: N-terminal pro-brain natriuretic peptide (NT-proBNP) measure: N-terminal pro-brain natriuretic peptide (NT-proBNP) measure: N-terminal pro-brain natriuretic peptide (NT-proBNP) measure: cardiac troponin (cTnT) measure: Blood CRP level measure: Blood neutrophil-to-lymphocyte ratio (NLR) measure: Stroke localization in the brain measure: Fazekas scale measure: Global cortical atrophy scale measure: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) measure: Presence for pre-existing fatigue (yes/no) measure: Duration of pre-existing fatigue measure: Patient Health Questionnaire-2 (PHQ-2) measure: Patient Health Questionnaire-2 (PHQ-2) measure: Patient Health Questionnaire-2 (PHQ-2) measure: Montreal Cognitive Assessment (MoCA) questionnaire measure: Montreal Cognitive Assessment (MoCA) score measure: Insomnia Severity Index (ISI) measure: Insomnia Severity Index (ISI) measure: Insomnia Severity Index (ISI) measure: Complete blood count abnormalities: yes/no measure: Renal insufficiency: yes/no measure: Electrolyte imbalance: yes/no measure: Abnormal liver enzymes: yes/no measure: Dyslipidemia: yes/no measure: Diabetes: yes/no measure: Thyroid disorder: yes/no measure: Iron deficiency: yes/no sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Brugmann city: Brussels zip: 1020 country: Belgium name: Anissa OURTANI, MD role: CONTACT phone: 024754819 email: Anissa.OURTANI@chu-brugmann.be name: Anissa OURTANI role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: UZ Brussel city: Brussel zip: 1090 country: Belgium name: Sylvie De Raedt, MD role: CONTACT email: Sylvie.DeRaedt@uzbrussel.be name: Sylvie De Raedt role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06292364 id: PGIDS/BHRC/23/106 briefTitle: Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3D Digital Model Analysis overallStatus: RECRUITING date: 2023-11-05 date: 2024-11-05 date: 2024-12-05 date: 2024-03-05 date: 2024-03-05 name: Postgraduate Institute of Dental Sciences Rohtak class: OTHER briefSummary: Retention has been defined as "the holding of teeth following orthodontic treatment in the treated position for the period of time necessary for the maintenance of the result". Controversies regarding retention regime exist due to lack of high quality evidence regarding duration, type and timing of different type retainer.The present randomised controlled trial will be undertaken to assess the changes and compare if there is any difference in movement of teeth in post orthodontic treatment cases with immediate and delayed (post 7 days) delivery using beggs retainer and change in level of bone biomarker over 6 months period of retention . conditions: Relapse studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: immediate orthodontic retainer delivery name: delayed orthodontic retainer delivery measure: overjet measure: overjet measure: overjet measure: Overjet measure: contact point displacement measure: contact point displacement measure: contact point displacement measure: contact point displacement measure: overbite measure: overbite measure: overbite measure: overbite measure: intermolar width measure: intermolar width measure: intermolar width measure: intermolar width measure: intercanine width measure: intercanine width measure: intercanine width measure: intercanine width measure: GCF - elisa measure: GCF - elisa measure: GCF - elisa measure: GCF - elisa sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Pgids Rohtak status: RECRUITING city: Rohtak state: Haryana zip: 124001 country: India name: Dr. Rekha Sharma, MDS role: CONTACT phone: 8076190296 email: rajsringari@gmail.com lat: 28.89447 lon: 76.58917 hasResults: False

 nctId: NCT06292351 id: DMBN_ALZH-2022-II briefTitle: DMB-I in the Treatment of Alzheimer Type Dementia overallStatus: RECRUITING date: 2023-12-27 date: 2024-12-21 date: 2024-12-21 date: 2024-03-05 date: 2024-03-20 name: Bigespas LTD class: INDUSTRY briefSummary: The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia. conditions: Alzheimer Disease conditions: Dementia of Alzheimer Type studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 135 type: ESTIMATED name: DMB-I (Dimebon) name: Placebo measure: Mean change in Alzheimer's Disease Assessment Scale score after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) in patients receiving the study drug or placebo measure: Mean change in cognitive impairment score on the Alzheimer's Disease Assessment Scale after 12 weeks of therapy compared to baseline measure: Mean change in Mini-Mental State Examination score after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) measure: Change in the quality of life of patients according to the Quality of Life - Alzheimer's Disease questionnaire after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1) measure: Change in the general clinical impression in accordance with the Clinical Global Impressions Scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1) measure: Dynamics on the Lawton's Instrumental activities of daily living scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1) sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: State autonomous healthcare institution "Transregional Clinical Diagnostic Center" status: RECRUITING city: Kazan zip: 420101 country: Russian Federation name: Dina Khasanova role: CONTACT email: Icdc@icdc.ru lat: 55.78874 lon: 49.12214 facility: Federal State Budgetary Institution "Federal center for brain and neurotechnologies" of the Federal Medical and Biological Agency (FSBI "FCBN" of Russia's FMBA) status: RECRUITING city: Moscow zip: 117997 country: Russian Federation name: Anna N. Bogolepova role: CONTACT email: annabogolepova@yandex.ru lat: 55.75222 lon: 37.61556 facility: Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) status: RECRUITING city: Moscow zip: 119991 country: Russian Federation name: Marina A. Kinkulkina role: CONTACT email: Kinkulkina_m_a@staff.sechenov.ru lat: 55.75222 lon: 37.61556 facility: State public healthcare institution Leningrad regional psychoneurologic dispensary status: RECRUITING city: Roshchino zip: 188820 country: Russian Federation name: Natalia A. Penchul role: CONTACT email: penchul@inbox.ru lat: 60.25191 lon: 29.6085 facility: "Medical Center Nova Vita" status: RECRUITING city: Rostov-on-Don zip: 344082 country: Russian Federation name: Dhaval Mavani role: CONTACT email: mavani_dhaval@yahoo.com lat: 47.23135 lon: 39.72328 facility: Saint Petersburg State budgetary healthcare institution "City Hospital № 40 of Kurortniy district" status: RECRUITING city: Saint Petersburg zip: 197706 country: Russian Federation name: Alina S Agaf'yina role: CONTACT email: a.agafina@mail.ru lat: 59.93863 lon: 30.31413 facility: "Centre of evidence-based medicine" LLC status: RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Stanislav O. Pozdnyakov role: CONTACT email: sopozdnyakov@yandex.ru lat: 57.62987 lon: 39.87368 hasResults: False

 nctId: NCT06292338 id: AUCHAU briefTitle: Lung Sonar in Neonatal Respiratory Disorders overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-03-05 date: 2024-03-05 name: Gehad Adel Mohammed Hussein class: OTHER briefSummary: This study aimed to determine the value of chest ultrasonography in comparison to other tools as chest x-ray and ABG in diagnosis and follow up of neonates with respiratory disorders. conditions: Neonatal Respiratory Distress studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1 type: ESTIMATED measure: Comparing between LUS and Chest xRay in neonatal respiratory disorders assessment sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD hasResults: False

 nctId: NCT06292325 id: FDG_88-17 briefTitle: Psychological Aspects in OSA acronym: PSICOSA overallStatus: ENROLLING_BY_INVITATION date: 2023-05-08 date: 2023-05-08 date: 2024-05-31 date: 2024-03-05 date: 2024-03-07 name: Fondazione Don Carlo Gnocchi Onlus class: OTHER name: Catholic University of the Sacred Heart briefSummary: The research project consists of an observational study. Obstructive Sleep Apnea (OSA) is a condition characterized by recurrent episodes of upper airway collapse during sleep, leading to decreased blood oxygen levels and disruptions of normal sleep patterns. Estimates of its prevalence vary, but its impact on patients' quality of life is evident.

The research aims to explore the perception and awareness of the disease and its impact on the individual and couple's lives of patients with OSA and their bed partners, to assess patients' perceptions of the disease and symptoms, as well as their bed partners' perceptions. Moreover, psychological aspects of living with OSA, such as perceived stress, depression, anxiety, sleep quality, daily sleepiness will be studied to observe the association with Continuous Positive Airway Pressure (CPAP) adherence. conditions: Osa Syndrome studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 246 type: ESTIMATED name: Continuous Positive Airway Pressure (CPAP) measure: Brief Illness Perception Questionnaire (Brief IPQ) measure: CPAP therapy adherence (hours/night) measure: Dyadic Adjustment Scale (DAS) measure: The experience in close relationships-revised (ECR-R) Scale measure: The Psychological General Well-Being Index (PGWB-S) measure: The Patient Health Questionnaire - 9 (PHQ-9) measure: The Generalized Anxiety Scale -7 (GAD-7) measure: The Mannheim Dream Questionnaire (MADRE) measure: The EP worth scale (ESS) measure: Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Don Carlo Gnocchi city: Milan state: MI zip: 20148 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06292312 id: 19.12.2023/10-483 briefTitle: Investigation of the Effectiveness of Craniosacral Therapy in Patients With Multiple Sclerosis. overallStatus: RECRUITING date: 2024-02-27 date: 2025-04-15 date: 2025-05-15 date: 2024-03-05 date: 2024-03-05 name: Ankara Yildirim Beyazıt University class: OTHER name: Lokman Hekim Üniversitesi briefSummary: Although the cause of Multiple Sclerosis (MS), one of the common demyelinating diseases of the central nervous system, has not yet been fully elucidated, autonomic nervous system dysfunction has been suggested in its etiology. Symptoms such as fatigue, problems with bladder, bowel, cardiovascular, sleep, sexual and sweating functions, abnormal sympathetic skin response or decreased heart rate variation support this hypothesis.

In the treatment of many neurological diseases such as Multiple Sclerosis, complementary medicine practices and non-traditional therapies have recently been shown to be effective in addition to conventional practices. One of these practices, craniosacral therapy (CST), uses manual palpation and manipulation of the craniosacral system to influence sensory, motor, cognitive and emotional processes in the nervous system. In addition, it is thought that applying external force to certain bone elements can have a positive effect on various symptoms in patients with MS, based on the knowledge that it can be transmitted within the system. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: dual parallel group design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single (outcomes assesor) The evaluation of the patients will be carried out by a blinded investigator. whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Craniosacral therapy name: Conventional physiotherapy measure: Dynamic posturography measure: Heart rate variability measure: Pain level measure: Central sensitization measure: Fatigue measure: Sleep quality measure: Life quality sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Yıldırım Beyazıt University status: RECRUITING city: Ankara zip: 06010 country: Turkey name: Hilal Aslan role: CONTACT phone: 05372565397 email: hilalaslan@aybu.edu.tr lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06292299 id: INGN22RM471P id: 10072600 type: OTHER_GRANT domain: PneumoWave Ltd & Innovate UK briefTitle: The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study acronym: PARS overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12 date: 2025-12 date: 2024-03-05 date: 2024-03-05 name: NHS Greater Clyde and Glasgow class: OTHER name: INNOVATEUK briefSummary: Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment". Children with sensory/behavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomes

Infants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in "low risk" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes.

This observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients. conditions: Sleep Disordered Breathing conditions: Apnea of Prematurity conditions: Respiratory Rate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Pneumowave measure: Assess the feasibility of collecting respiratory waveform data using Pneumowave device in patients who have (1) attended the sleep laboratory for CR- polysomnography and (2) are inpatient in neonatal unit measure: Collate respiratory data in patients who have attended the sleep laboratory for CR- poly or inpatient in neonatal unit. Respiratory data will observe: (1) Normal respiratory effort (2) Response to treatments measure: Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography measure: Collate waveform and motion artefact data in neonatal patients at risk of central apnoea measure: Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient sex: ALL minimumAge: 1 Minute maximumAge: 16 Years stdAges: CHILD facility: Royal Hospital for Children, Glasgow city: Glasgow state: Glasgow City zip: G51 4TF country: United Kingdom name: Ross J Langley, MBChB BSc PhD MRCPCH role: CONTACT phone: 0141 451 6582 email: ross.langley@ggc.scot.nhs.uk name: Hannah Vennard, MBChB BMSc role: CONTACT phone: 0141 451 6582 email: hannah.vennard@ggc.scot.nhs.uk lat: 55.86515 lon: -4.25763 facility: Royal Hospital for Children, Glasgow city: Glasgow zip: G51 4TF country: United Kingdom lat: 55.86515 lon: -4.25763 hasResults: False

 nctId: NCT06292286 id: UW 22-704 briefTitle: Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer acronym: SCENIC overallStatus: RECRUITING date: 2023-11-01 date: 2025-12-31 date: 2026-07-01 date: 2024-03-05 date: 2024-03-05 name: The University of Hong Kong class: OTHER briefSummary: About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known. conditions: Recurrent Ovarian Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Carboplatin or cisplatin name: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar name: Bevacizumab or biosimilar name: Cytoreductive surgery measure: Complete resection rate measure: 12-month progression-free survival rate measure: 12-month overall survival rate measure: Surgical complication rate measure: Quality of life scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Lesley Lau role: CONTACT phone: 852-22554518 name: Ka Yu Tse role: CONTACT phone: 852-22554265 email: tseky@hku.hk name: Ka Yu Tse, MBBS, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06292273 id: ANET19 briefTitle: Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block in Caesarean Section overallStatus: COMPLETED date: 2023-10-10 date: 2024-02-01 date: 2024-02-20 date: 2024-03-05 date: 2024-03-05 name: Menoufia University class: OTHER briefSummary: Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries. this study is conducted to analyse the effect of addition of dexmedetomidine to bupivacaine in Transversus Abdominis Plane (TAP) block. conditions: Post Operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, double blind case control primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Transversus Abdominis Plane Block with bupivacain Plus dexamethasone name: Transversus Abdominis Plane Block with bupivacain measure: Post operative pain measure: Sedation measure: Heart rate measure: Total analgesic consumption measure: Side effects sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medicine Menoufia University city: Cairo state: Governorate zip: 32511 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06292260 id: 2020-2054-2 briefTitle: Digital Toolkit for Skin Diseases in LMICs: Part 2 acronym: MIND-the-SKIN2 overallStatus: RECRUITING date: 2024-03-18 date: 2026-05-31 date: 2026-05-31 date: 2024-03-05 date: 2024-04-17 name: Tulane University class: OTHER name: Hope Commission International name: Institut Pasteur of Cote d'Ivoire name: Institut Raoul Follereau name: Centre Suisse de Recherches Scientifiques en Cote d'Ivoire name: Tokyo Medical and Dental University briefSummary: Impact evaluation of eSkinHealth in improving case detection of skin NTDs and treatment outcomes in rural and urban settings conditions: Skin Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: mHealth app measure: Number of cases of each skin NTD (neglected tropical disease) and other skin conditions as compared to the pre-intervention measure: Case confirmation rate for each skin NTD (neglected tropical disease) and other skin conditions by dermatologists measure: Number of days from registry to confirmatory diagnosis measure: Feasibility, usability, and effectiveness of the surveillance approach using eSkinHealth app measure: Capacity building and effectiveness of training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hope Commission International status: RECRUITING city: Abidjan country: Côte D'Ivoire name: Aubin Yao, MS role: CONTACT email: aubin@hopecommission.org name: Eric-Herman N'da Kouakou role: CONTACT email: ekouakou@hopecommission.org name: Bamba Vagamon, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 5.30966 lon: -4.01266 hasResults: False

 nctId: NCT06292247 id: A0503023 briefTitle: Effectiveness of CBT and APT on Managing Child Anxiety in Dental Office overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2023-10-23 date: 2024-05-01 date: 2024-03-05 date: 2024-03-07 name: Mansoura University class: OTHER briefSummary: This study was conducted to the Effectiveness of Cognitive Behavioral Therapy and Auricular Plaster Therapy on Managing Child Anxiety in Dental Office. conditions: Dental Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1 (CBT) Group 2 (APT) Group3 (control TSD) primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Cognitive behavioral therapy name: Auricular plaster therapy name: Tell Show Do measure: Venham Clinical Anxiety Scale measure: Heart Rate to detect the anxiety. measure: RMS-Self Pictorial scale to detect the anxiety. measure: Parental acceptance of the behavior management technique sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Faculty of dentistry city: Mansoura state: Dakahlia zip: 35511 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06292234 id: OMFS briefTitle: Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-01 date: 2025-03-01 date: 2024-03-05 date: 2024-04-19 name: Cairo University class: OTHER briefSummary: Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue \& better long-term stability \& less relapse rate. conditions: Cleft Lip and Palate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel randomized controlled trial with 1:1 allocation ratio and superiority framework primaryPurpose: TREATMENT masking: SINGLE maskingDescription: single blinded clinical trial whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: PSI name: Conventional miniplates measure: Distraction effectiveness measure: Velopharyngeal insufficiency measure: Speech measure: Operative time measure: Wound dehiscence measure: Infection measure: Nerve affection measure: Screw loosening measure: Overall complications sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False

 nctId: NCT06292221 id: H19-078 id: R01MH119678 type: NIH link: https://reporter.nih.gov/quickSearch/R01MH119678 briefTitle: Personalized Depression Treatment Supported by Mobile Sensor Analytics acronym: DepWatch overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-06 date: 2024-03-05 date: 2024-03-05 name: UConn Health class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The current best practice guidelines for treating depression call for close monitoring of patients, and periodically adjusting treatment as needed. This present study seeks to develop and investigate an innovative digital system, DepWatch, that leverages mobile health technologies and machine learning tools to provide clinicians objective, accurate, and timely assessment of depression symptoms to assist with their clinical decision making process. Specifically, DepWatch collects sensory data passively from smartphones and wristbands, without any user interaction, and uses simple user-friendly interfaces to collect ecological momentary assessments (EMA), medication adherence and safety related data from patients. The collected data will be fed to machine learning models to be developed in the project to provide weekly assessment of patient symptom levels and predict the trajectory of treatment response over time. The assessment and prediction results are then presented using a graphic interface to clinicians to help them make critical treatment decisions. The main question the present clinical trial aims to answer are as follows:

1. Feasibility of the digital tool, DepWatch, to assist clinicians in depression treatment and inform their clinical decision process
2. Effectiveness of the digital tool, DepWatch, to improve depression treatment outcomes All study participants will carry the DepWatch app on their smartphones and wear a Fitbit provided by the study team during the study period. They will also complete brief questionnaires via the app at specific time intervals throughout the study period. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of participants (64 per group) will be enrolled and will participate in the study over a 3 month period . Both will receive standard of care depression treatment with their respective providers in the clinic. Both groups will undergo standard depression assessment using depression questionnaires as well as behavioral assessments using a mobile health (mHealth) tool 'DepWatch' developed by the study team in the phase I of the study. Study clinicians will receive weekly behavioral assessment reports for participants enrolled in the first 'experimental' group and will not receive such reports for the second 'control' group primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: There is no masking count: 128 type: ESTIMATED name: A mobile Health (mHealth) tool called 'DepWatch' measure: Feasibility and Usability measure: Depression outcomes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292208 id: IBD0333-101 briefTitle: A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03-02 date: 2029-12-31 date: 2030-12-31 date: 2024-03-05 date: 2024-03-05 name: SUNHO（China）BioPharmaceutical CO., Ltd. class: INDUSTRY briefSummary: Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT).

Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D).

Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor.

Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma.

Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333. conditions: MTD studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: IBD0333 measure: MTD measure: DRDE measure: Dose limiting toxicity (DLT) measure: RP2D measure: ORR measure: pharmacokinetic parameters measure: pharmacokinetic parameters measure: pharmacokinetic parameters measure: pharmacokinetic parameters measure: ADA measure: ORR measure: DCR measure: DoR measure: PFS measure: Frequency of adverse events (AEs) and SAEs sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292195 id: VitDTracking briefTitle: Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome acronym: VitDTracking overallStatus: RECRUITING date: 2023-11-03 date: 2024-12-31 date: 2025-12-31 date: 2024-03-05 date: 2024-03-05 name: University of Évora class: OTHER name: Comprehensive Health Research Centre name: Unidade Local De Saúde Do Norte Alentejano name: Unidade local de Saúde do Baixo Alentejano name: Unidade Local de Saúde do Alentejo Central name: Universidade Nova de Lisboa name: Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID) briefSummary: The VitDTracking study focuses on the relevance of maternal vitamin D levels and their association with prematurity, aiming to improve maternal and child health outcomes, particularly by reducing avoidable preterm births. In Portugal, vitamin D levels during pregnancy have never been studied. Epidemiological data from other countries reveal a high prevalence of vitamin D deficiency/insufficiency, especially in pregnant women.

The hypovitaminoses prevalence remains high even with a supplementation dosage of 400 to 600 IU/day during pregnancy (dosage used in Portugal), which is considered as a suboptimal dose. This phenomenon is associated with adverse maternal and child outcomes, such as intrauterine growth restriction, preeclampsia, cholestasis, hypertension, and gestational diabetes as major causes of prematurity.

Additionally, the Portuguese population has a higher prevalence of genome alterations that confer a lower capacity to produce vitamin D from sunlight exposure. These genetic characteristics are present in about 19% of the population, representing a prevalence four times higher than the European average (19% versus 4.75%), leading to a higher predisposition to vitamin D deficiency. conditions: Vitamin D Deficiency conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Exposure measure: Differences in the rate of Prematurity with different maternal Vitamin D levels measure: Differences in Birth Weight with different maternal Vitamin D levels measure: Differences in Apgar Scores with different maternal Vitamin D levels measure: Differences in the number of admissions to the Neonatal Intensive Care Unit with different maternal Vitamin D levels measure: Differences in the Neonatal Morbidity rate with different maternal Vitamin D levels measure: Differences in the Neonatal Mortality rate with different maternal Vitamin D levels measure: Differences in the number of Neonatal Infections with different maternal Vitamin D levels measure: Differences in the Number of Congenital Malformation diagnoses with different maternal vitamin D levels measure: Differences in the presence of vitamin D-related polymorphisms with different maternal levels of vitamin D measure: Differences in maternal vitamin D levels between the three groups/cohorts related to prematurity measure: Differences in maternal vitamin D levels between the three groups/cohorts related to birth weight measure: Differences in maternal vitamin D levels between the three groups/cohorts related to Apgar scores measure: Differences in maternal vitamin D levels between the three groups/cohorts related to admission to the Neonatal Intensive Care Unit measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal morbidity measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal mortality measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal infections. measure: Differences in maternal vitamin D levels between the three groups/cohorts related to the diagnosis of congenital malformations measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with prematurity measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with birth weight measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with Apgar scores measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with admission to the Neonatal Intensive Care Unit. measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal morbidity measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal mortality measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal infections measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with the diagnosis of congenital malformations sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unidade Local de Saúde do Baixo Alentejo status: RECRUITING city: Beja zip: 7801-849 country: Portugal name: Inês Gornilho, MD role: CONTACT email: ines.gornilho@ulsba.min-saude.pt lat: 38.01506 lon: -7.86323 facility: Unidade Local de Saúde do Norte Alentejano status: RECRUITING city: Portalegre zip: 7301-853 country: Portugal name: Vera Escoto, MD role: CONTACT email: veraescoto.ca@ulsaale.min-saude.pt lat: 39.29379 lon: -7.43122 facility: Unidade Local de Saúde do Alentejo Central - Hospital Espirito Santo de Évora status: RECRUITING city: Évora zip: 7000-811 country: Portugal name: Maria OP Barbosa, MSc; PhD Student role: CONTACT phone: 00351966056178 email: mobarbosa@hevora.min-saude.pt name: Fernando Fernandes, MD role: CONTACT phone: 00351965753123 email: ffernandes@hevora.min-saude.pt lat: 38.56667 lon: -7.9 hasResults: False

 nctId: NCT06292182 id: 160802 id: 332942 type: OTHER domain: IRAS id: 58964 type: OTHER domain: CPMS briefTitle: Red Light Ptosis Proof-of-Concept overallStatus: RECRUITING date: 2024-02-08 date: 2025-11-30 date: 2025-11-30 date: 2024-03-05 date: 2024-03-05 name: University College, London class: OTHER name: Moorfields Eye Hospital NHS Foundation Trust briefSummary: This study tests a new treatment to help with droopy eyelids (ptosis) and eye movement problems (squint) in children and young people with genetically confirmed mitochondrial conditions - using red-light.

We use a torch to shine a red light through the closed eyelid for 3 minutes a day. The study will run for 18 months.

We believe that this treatment could help strengthen the muscle in the eyelid to make it easier to open the eyes, and could also help some children with squint. conditions: Mitochondrial Diseases conditions: Blepharoptosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Near-infrared light measure: Palpebral fissure width sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Moorfields Eye Hospital NHS Foundation Trust status: RECRUITING city: London zip: EC1V 2PD country: United Kingdom name: Annegret H Dahlmann-Noor, PhD role: CONTACT phone: 020 7253 3411 email: annegret.dahlmann-noor@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06292169 id: STUDY00007201 briefTitle: Pectoralis Minor Release Versus Non-release in RSA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-01 date: 2026-01 date: 2024-03-05 date: 2024-04-09 name: Emory University class: OTHER briefSummary: The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are:

* whether releasing the pectoralis minor prophylactically could have better pain relief
* whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes
* whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release. conditions: Reverse Total Shoulder Arthroplasty conditions: Rotator Cuff Tear Arthropathy conditions: Advanced Glenohumeral Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Electronic random number generator Single-blinded (concealed to the study participant only, Investigator blinded not feasible) whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Pectoralis Minor Release name: RSA measure: Visual analog Scale (VAS) pain scores measure: Visual analog Scale (VAS) pain scores measure: American Shoulder and Elbow Score (ASES) measure: Subjective Shoulder Value (SSV) measure: Change in Range of motion (ROM) measure: Change in Scapulohumeral Rhythm (SHR) on Digital Dynamic Radiography (DDR) measure: Number of complications measure: Number of reoperations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory Clinic city: Atlanta state: Georgia zip: 30322 country: United States name: Eric Wagner, MD role: CONTACT phone: 404-778-7249 email: eric.r.wagner@emory.edu name: Musab Gulzar role: CONTACT phone: 201-344-0298 email: mgulzar@emory.edu name: Michael Gottschalk, MD role: SUB_INVESTIGATOR lat: 33.749 lon: -84.38798 facility: Emory Healthcare Orthopaedics and Spine Center city: Atlanta state: Georgia zip: 30329 country: United States name: Eric Wagner, MD role: CONTACT phone: 404-778-7249 email: Eric.r.wagner@emory.edu name: Musab Gulzar role: CONTACT phone: 201-344-0298 email: mgulzar@emory.edu lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06292156 id: CASPsy7 briefTitle: tACS Treatment for Cognitive Impairments in Methamphetamine Addicts overallStatus: RECRUITING date: 2023-02-20 date: 2024-08 date: 2024-08 date: 2024-03-04 date: 2024-03-04 name: Beijing HuiLongGuan Hospital class: OTHER briefSummary: 1. To evaluate the cognitive function of methamphetamine Patients.
2. Investigate the pathological mechanism of methamphetamine patients from the aspects of EEG and biology;
3. The investigators investigated the effects of transcranial alternating current stimulation (tACS) on cognitive impairments in methamphetamine patients conditions: Methamphetamine Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Theta treatment group name: Alpha active control group name: Sham control group measure: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) measure: ERP components associated with cognitive function measure: Condition stop signal task measure: Neural oscillations associated with cognitive function measure: Functional connection of brain region associated with cognitive function measure: Microstate associated with cognitive function measure: The effect of oxidative stress system on cognitive function measure: The effect of immune system on cognitive function measure: The effect of brain derived neurotrophic factor(BDNF) on cognitive function measure: Genetic mechanism of cognitive function measure: Reverse learning task measure: Beck Depression Scale measure: Barrett impulse Scale measure: Degree of insomnia measure: The Sensitivity to Punishment and Reward Questionnaire measure: Visual analog scale measure: The Desires for Drug Questionnaire measure: Obsessive compulsive drug use scale measure: Obsessive-compulsive inventory measure: Thought Control Ability Questionnaire measure: Thought Suppression Questionnaire measure: Rumination Questionnaire measure: Anger Rumination Questionnaire measure: Beck Anxiety Scale measure: Emotional Regulation Difficulty Scale measure: Aggressive questionnair sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Xin Hua Drug Rehabilitation Center status: RECRUITING city: Mianyang country: China name: China role: CONTACT lat: 31.46784 lon: 104.68168 hasResults: False

 nctId: NCT06292143 id: EU101136769-CLIN2 briefTitle: AI4HOPE Dementia Care Planning Pilot Study 2 ( AI4HOPE2) acronym: AI4HOPE-P2 overallStatus: NOT_YET_RECRUITING date: 2025-07 date: 2026-12 date: 2026-12 date: 2024-03-04 date: 2024-03-04 name: University of Bonn class: OTHER name: University College Cork name: University of Leeds name: Fundacion Intras name: Universidade do Porto name: University Medical Centre Maribor briefSummary: This pilot study will test a digital care planning decision support system for patients with dementia. conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: Advance Care Planning Toolkit measure: Ease of use of digital platform measure: Effect of digital platform on documentation of advance care planning sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bonn city: Bonn zip: 53127 country: Germany lat: 50.73438 lon: 7.09549 hasResults: False

 nctId: NCT06292130 id: 156588-01 briefTitle: Health-Kit Enabled Mobile App for Tobacco Cessation overallStatus: COMPLETED date: 2022-03-21 date: 2023-09-21 date: 2023-09-21 date: 2024-03-04 date: 2024-03-04 name: Pro-Change Behavior Systems class: OTHER briefSummary: Tobacco use remains the leading preventable cause of death in the US, contributing to more than 480,000 premature deaths each year. The Tobacco Treatment Guidelines underscore the need to offer patients who use tobacco products brief interventions that include prescriptions for proven pharmacological smoking cessation aids and proactive connections to evidence-based behavioral support. The rapid expansion of smart phone capabilities enhances the potential for tobacco cessation apps to personalize behavior change guidance and to send contextually relevant tailored behavior change nudges based on readiness to quit and electronic heath record (EHR) data. Rich data from EHRs are now available to third-party apps from the Health app (iOS) via Fast Healthcare Interoperability Resources standard Application Programming Interface (API).

This Phase I SBIR will explore the acceptability and effects of one such innovative health IT solution. Refresh is a highly individualized tobacco cessation HealthKit enabled app that will 1) implement a full range of best practices in tailored health behavior change communications based on readiness to change; 2) individualize behavior change guidance based on Health app data; and 3) concisely provide data and documentation of key actionable insights in the EHR on the patient's smoking status, app usage, and brief micro-message clinicians can deliver to reinforce and accelerate a patient's behavior change progress. This interoperability will provide value to both patients and clinicians; empower and support successful and lasting behavior change; and enable the implementation and evaluation of a best-in-class approach to tobacco and nicotine treatment.

Extensive end user and stakeholder input will ensure refresh is designed for rapid dissemination. Patients of an integrated delivery system with an upcoming appointment (n=100) will be recruited to participate in a 30-day pilot test. Pilot participants will provide quantitative and qualitative data, and utilization and acceptability data will be examined. Pre-post comparisons of PROMIS measure for tobacco (psychosocial expectancies) will provide preliminary data on the effects of the program. Acceptability data from participating clinicians (n=10) who receive and deliver EHR prompts will also be gathered. The hypothesis is that the patients who utilize refresh will have significantly higher psychosocial expectancies regarding tobacco at follow-up. Secondary outcomes will be examined. conditions: Cigarette Smoking studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group, repeated measures (2 timepoints) primaryPurpose: TREATMENT masking: NONE count: 51 type: ACTUAL name: refresh measure: Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome measure: Confidence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pro-Change Behavior Systems, Inc city: South Kingstown state: Rhode Island zip: 02879 country: United States lat: 41.44718 lon: -71.52494 hasResults: False

 nctId: NCT06292117 id: 230247 briefTitle: Implementation of Onsite Rapid CYP2C19 Assay for Genotype Guided Dual Antiplatelet Therapy After Acute Ischemic Stroke acronym: ORCA-AIS overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-06 date: 2026-06 date: 2024-03-04 date: 2024-03-04 name: University of Virginia class: OTHER name: American Heart Association briefSummary: The goal of this observational study is to use a genetic test to help doctors prescribe the most effective medications after a patient has a stroke. One type of stroke is caused by a blood clot in brain vessels. After a patient has this kind of stroke, they are often given a combination of two blood thinners to prevent it from happening again. One of these blood thinners, called clopidogrel, is less effective in some people due to differences in their DNA. Clopidogrel needs to be activated by a specific enzyme in the body known as CYP2C19. This enzyme does not work as well if there are variations in the section of DNA that tells the body how to make CYP2C19. It can be predicted who has less CYP2C19 enzyme activity with a genetic test. If these patients are given a different blood thinner, it can reduce their risk of another stroke compared to if they are given clopidogrel.

The main questions this study aims to answer are:

* What are the best strategies to implement this genetic test in the hospital?
* Does implementation of this genetic test change providers' decisions on which medication to prescribe after a participant has a stroke?

Participants in this study will have a genetic test done onsite looking for variations in the section of DNA that tells the body how to make CYP2C19. This genetic test will only look for 11 known variations; the genome will not be sequenced. The investigators will alert the doctor of the patient's test results so they can prescribe the appropriate blood thinner. Through this, the investigators will learn the best practices for successful implementation of this genetic test. conditions: Ischemic Stroke conditions: CYP2C19 Polymorphism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 350 type: ESTIMATED name: CYP2C19 Genotype measure: Percentage of patients discharged from University of Virginia (UVA) Health on dual antiplatelet therapy with a diagnosis of AIS/TIA meeting eligibility criteria upon presentation that are successfully genotyped measure: Average turnaround time of genotype result from time of collection of blood sample to time result is entered into the electronic health record measure: Number of CYP2C19 LOF carriers for whom a genotype-guided modification to DAPT is made measure: Number needed to genotype (NNG): number of patients who would need to undergo genotyping to have a recommended change in DAPT based on genotype measure: Stroke-free status via the Questionnaire to Verify Stroke-Free Status (QVSFS) of participants at 90 days in participants who received DAPT measure: Major adverse cardiovascular events at 90 days in participants who received DAPT measure: Correlation between P2Y12 reaction units (PRUs) measured via P2Y12 assay and CYP2C19 genotype in patients who received DAPT measure: Acceptability of deferred consent process in participants approached for full informed consent measure: Cost-effectiveness of CYP2C19-guided dual antiplatelet therapy after acute ischemic stroke sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06292104 id: STU-2023-0589 id: 1R01HL166272-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL166272-01A1 briefTitle: Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS) overallStatus: RECRUITING date: 2024-03-05 date: 2028-12 date: 2029-01 date: 2024-03-04 date: 2024-04-26 name: University of Texas Southwestern Medical Center class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities. conditions: Postural Orthostatic Tachycardia Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 350 type: ESTIMATED name: multimodal diagnostic testing measure: Phenotyping POTS measure: Natural history measure: Natural history sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75208 country: United States name: Steven Hopkins role: CONTACT phone: 214-648-9275 email: steve.hopkins@utsouthwestern.edu name: Steven Hopkins role: CONTACT phone: 2146489275 email: steve.hopkins@utsouthwestern.edu name: Steven Vernino, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06292091 id: Ur_ABD_PK briefTitle: A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril overallStatus: COMPLETED date: 2024-02-28 date: 2024-03-27 date: 2024-04-01 date: 2024-03-04 date: 2024-04-17 name: Seoul National University Hospital class: OTHER briefSummary: The aim of this study is to evaluate the effect of urine acid-base disequilibrium on the pharmacokinetics of captopril in healthy male volunteers. conditions: Hypertension studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 12 type: ACTUAL name: Captopril 12.5 Mg name: Sodium bicarbonate 4 G name: Torsemide 20 MG measure: AUClast of captopril measure: Cmax of captopril measure: AUCinf of captopril measure: Tmax of captopril measure: t1/2 of captopril measure: CL/F of captopril measure: Vd/F of captopril measure: fe of captopril measure: urine pH measure: Safety parameters sex: MALE minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT facility: Seoul National University Hospital city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06292078 id: 1R01DA059401-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA059401-01 id: 1R01DA059401-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA059401-01 briefTitle: Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA) acronym: ISLA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-08 date: 2028-08 date: 2024-03-04 date: 2024-03-04 name: University of Oregon class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This project will test the effectiveness of the Inclusive Skill-building Learning Approach (ISLA) in reducing the use of exclusionary discipline, improving teacher practice and student outcomes, and decreasing substance misuse using a randomized controlled trial in 60 middle schools across six states. conditions: Opioid Misuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 5076 type: ESTIMATED name: Instructional Skill-Building Learning Approach (ISLA) measure: Frequency and Duration of Use of Office Discipline Referrals, In-School Suspension, and Out-of-School Suspension measure: Engagement vs. Disaffection with Learning Student-report measure: Inclusive Teaching Practices measure: School Climate Survey- Student measure: School Climate- Teacher measure: Student-Teacher Relationships measure: Opioid and Other Substance Misuse measure: Student Internalizing Behaviors measure: Student Externalizing Behaviors measure: ISLA Acceptability measure: ISLA Implementation Fidelity sex: ALL minimumAge: 8 Years maximumAge: 15 Years stdAges: CHILD hasResults: False

 nctId: NCT06292065 id: Project ID 6171 briefTitle: Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy acronym: GUST overallStatus: RECRUITING date: 2024-04-14 date: 2024-12-31 date: 2024-12-31 date: 2024-03-04 date: 2024-04-05 name: Nils Vlaeminck class: OTHER briefSummary: Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) were first introduced as a therapeutic agent for type 2 diabetes mellitus but they are being increasingly used to target weight loss in obesity.

One of the mechanisms by which weight loss is achieved, is increased satiety and significantly delayed gastric emptying. Tachyphylaxis for this effect has been reported with chronic use of long acting GLP-1-RA (e.g. semaglutide) but this was based on the paracetamol absorption technique or 13C breath test. Recent clinical data suggests semaglutide use does increase perioperative gastric content.This creates uncertainty for anaesthetists who are, anecdotally, more frequently faced with patients who may or may not have full stomachs despite adhering to conventional fasting guidelines.

To address this issue the American Society of Anesthesiologists (ASA) has recently released guidelines in which it advises to hold GLP-1-RA for one day (if administered daily) or one week (if administered weekly).

However, these recommendations are based on sparse empirical evidence and they do not necessarily follow from the known pharmacokinetic properties of these drugs. Typically, GLP-1-RA are administered in increasing doses over several weeks until a therapeutic steady state is achieved. Meanwhile the elimination half-life of e.g. semaglutide is 7 days. This means that holding semaglutide for one day or even one week might not be enough to attenuate its therapeutic effect of delayed gastric emptying. On the other hand if semaglutide were to be held for e.g. 5 terminal half-lifes, this would mean an unpractical 5 weeks during which glycemic control may be worsened and after which semaglutide doses would have to be incrementally increased again. Besides, hyperglycaemia secondary to semaglutide cessation can also delay gastric emptying.

Further confounding the assessment of these patients there can be 'background' delayed gastric emptying in diabetic patients and more pronounced delayed gastric emptying in patients recently started on GLP-1-RA. The presence of gastro-intestinal symptoms (nausea, vomiting, dyspepsia, abdominal distension) might offer clinical information regarding increased gastric residue in this population.

Gastric ultrasound is a point-of-care clinical and research tool that has steadily gained popularity to assess gastric content in patients not compliant with fasting rules or with certain comorbidities. Clinical decisions can be made based on the visualised content (e.g. solids, fluids or nothing) or through calculation of gastric volume by measuring antral circumference. In this study the investigators will examine gastric contents in patients who are taking semaglutide and in patients who are not. The investigators will then evaluate whether there is a difference in the incidence of full stomachs and whether gastric ultrasound influenced the anaesthetic plan of the treating anaesthetist. conditions: Gastroparesis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 45 patients on semaglutide therapy will be included together with 45 age, BMI and diabetes status matched controls. primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: Point-of-care gastric ultrasound measure: Prevalence of full stomach measure: Frequency of changes to the anaesthetic plan measure: Calculated gastric content measure: Prevalence of solid gastric content measure: Association between fasting time for solids and 'full stomach' measure: Association between fasting time for liquids and 'full stomach' measure: Frequency of perioperative aspiration measure: Prevalence of gastric symptoms measure: Association between nausea and 'full stomach' measure: Association between vomiting and 'full stomach' measure: Association between dyspepsia and 'full stomach' measure: Association between abdominal distension and 'full stomach' measure: association between semaglutide dose and calculated gastric content measure: association between semaglutide dose and 'full stomach' measure: Association between frequency of semaglutide administration and calculated gastric content measure: Association between frequency of semaglutide administration and 'full stomach' measure: Association between duration of semaglutide therapy and calculated gastric content measure: Association between duration of semaglutide therapy at current dose and calculated gastric content measure: Association between duration of semaglutide therapy and 'full stomach' measure: Association between duration of semaglutide therapy at current dose and 'full stomach' measure: Association between duration of cessation of semaglutide and calculated gastric content measure: Association between duration of cessation of semaglutide and 'full stomach' measure: Association between preoperative blood glucose levels and calculated gastric content measure: Association between preoperative blood glucose levels and 'full stomach' measure: Association between HbA1c levels and calculated gastric content measure: Association between HbA1c levels and 'full stomach' measure: Association between time since onset of diabetes mellitus and calculated gastric content measure: Association between time since onset of diabetes mellitus and 'full stomach' sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antwerp University Hospital status: RECRUITING city: Edegem state: Antwerp zip: 2650 country: Belgium name: Nils Vlaeminck role: CONTACT phone: 038215865 email: nils.vlaeminck@uza.be name: Vera Saldien role: CONTACT phone: 038214788 email: vera.saldien@uza.be lat: 51.15662 lon: 4.44504 hasResults: False

 nctId: NCT06292052 id: NSCLC-TDLN-001 briefTitle: Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness overallStatus: RECRUITING date: 2017-01-01 date: 2024-03-01 date: 2024-04-01 date: 2024-03-04 date: 2024-03-04 name: Sun Yat-sen University class: OTHER name: Jiangmen Central Hospital name: Henan Cancer Hospital briefSummary: The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness. conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 350 type: ESTIMATED name: Immunotherapy measure: Complete pathologic response measure: Major pathologic response measure: Complete pathologic response in lymph nodes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Hao Long, MD role: CONTACT phone: +86-13802770989 email: longhao@sysucc.org.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06292039 id: P0555788 id: 2KL2TR001870 type: NIH link: https://reporter.nih.gov/quickSearch/2KL2TR001870 briefTitle: Human-centered Injury Thrivorship Pathway for Survivors of Physical Trauma overallStatus: NOT_YET_RECRUITING date: 2025-07 date: 2026-04 date: 2026-06 date: 2024-03-04 date: 2024-03-06 name: University of California, San Francisco class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: The goal of this clinical trial is to pilot and evaluate a human-centered injury thrivorship pathway in injury survivors. The main question it aims to answer is:

• Is the pathway appropriate, acceptable, and feasible to meet the medical and social needs of injury survivors?

Injury survivors will be purposively sampled to enroll in the pathway and asked to participate in in-depth interviews and their use of pathway resources will be tracked. conditions: Injury Traumatic conditions: Survivorship conditions: Trauma Injury studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 25 type: ESTIMATED name: Human-Centered Injury Thrivorship Pathway measure: Early Implementation Outcomes - Acceptability, Appropriateness, Feasibility measure: Participant pathway resource utilization - type measure: Participant pathway resource utilization - frequency measure: Participant pathway resource utilization - duration measure: Participant pathway resource utilization - % utilized 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: Marissa A Boeck, MD, MPH role: CONTACT phone: 415-502-4745 email: marissa.boeck@ucsf.edu lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06292026 id: DFU/1 briefTitle: Efficacy of ProgenaMatrix™ in the Management of DFUs overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-14 date: 2026-03 date: 2026-09 date: 2024-03-04 date: 2024-03-04 name: ProgenaCare Global, LLC class: INDUSTRY briefSummary: This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™. conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The objective of this data collection is to look at outcomes and time points for ProgenaMatrix™ in the treatment of diabetic foot ulcers. Additionally, use the collected data to develop predictive wound closure models. There is a 1-week lead in period after initial debridement. If the wound is rapidly moving to closure after initial debridement and standard moist dressings, the withdrawal of these patients will prevent corruption of the true closure rate of ProgenaMatrix™. The objective of the treatment with ProgenaMatrix™ is to evaluate the closure rate in patients not responding to traditional moist therapy. primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: ProgenaMatrix Keratin graft name: standard of care measure: time to wound closure sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United Wound Healing city: Puyallup state: Washington zip: 98371 country: United States lat: 47.18538 lon: -122.2929 hasResults: False

 nctId: NCT06292013 id: 18812 id: J3L-MC-EZEF type: OTHER domain: Eli Lilly and Company id: 2023-509190-23 type: EUDRACT_NUMBER briefTitle: A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a) overallStatus: RECRUITING date: 2024-03-05 date: 2029-03 date: 2029-03 date: 2024-03-04 date: 2024-04-29 name: Eli Lilly and Company class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). conditions: Atherosclerotic Cardiovascular Disease (ASCVD) conditions: Elevated Lp(a) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12500 type: ESTIMATED name: Lepodisiran Sodium name: Placebo measure: Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint measure: Change from Baseline in Lipoprotein(a) [Lp(a)] at Week 4 measure: Time to First Occurrence of Any of the Component of MACE-3 Composite Endpoint measure: Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction measure: Time to Cardiovascular Death measure: Time to Occurrence of All-Cause Death measure: Time to First Occurrence of Any Component of the MACE-4 Composite Endpoint (In the Population with Established ASCVD and CV Event, or Revascularization) measure: Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population At Risk for First CV event) measure: Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population with Lp(a) ≥ 200 nmol/L) measure: Time to First Occurrence of Any Component of MACE-3 + MALE Composite Endpoint measure: Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Birmingham Clinical Research status: RECRUITING city: Birmingham state: Alabama zip: 35209 country: United States name: Nova Law role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Daphne state: Alabama zip: 36526 country: United States name: Michael T. Ledet role: PRINCIPAL_INVESTIGATOR lat: 30.60353 lon: -87.9036 facility: SEC Clinical Research status: RECRUITING city: Dothan state: Alabama zip: 36305 country: United States name: Andreas Muench role: PRINCIPAL_INVESTIGATOR lat: 31.22323 lon: -85.39049 facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Mobile state: Alabama zip: 36608 country: United States name: Harry E Studdard role: PRINCIPAL_INVESTIGATOR lat: 30.69436 lon: -88.04305 facility: Mobile Heart Specialists status: RECRUITING city: Mobile state: Alabama zip: 36608 country: United States name: Christopher S. Brown role: PRINCIPAL_INVESTIGATOR lat: 30.69436 lon: -88.04305 facility: Alaska Heart and Vascular Institute status: NOT_YET_RECRUITING city: Anchorage state: Alaska zip: 99508 country: United States name: Jacob Kelly role: PRINCIPAL_INVESTIGATOR lat: 61.21806 lon: -149.90028 facility: Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC status: RECRUITING city: Gilbert state: Arizona zip: 85296 country: United States name: Sunildat Maheshwari role: PRINCIPAL_INVESTIGATOR lat: 33.35283 lon: -111.78903 facility: Mercy Gilbert Medical Center status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85297 country: United States name: Nabil Dib role: PRINCIPAL_INVESTIGATOR lat: 33.35283 lon: -111.78903 facility: AMZERN Clinical Trial Organization status: RECRUITING city: Peoria state: Arizona zip: 85381 country: United States name: Kishlay Anand role: PRINCIPAL_INVESTIGATOR lat: 33.5806 lon: -112.23738 facility: Elite Clinical Studies status: RECRUITING city: Phoenix state: Arizona zip: 85018 country: United States name: Joseph Lillo, DO role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Helios Clinical Research - Phoenix status: RECRUITING city: Phoenix state: Arizona zip: 85028 country: United States name: David Francyk role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Absolute Clinical Research status: RECRUITING city: Phoenix state: Arizona zip: 85051 country: United States name: James Beach role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Clinical Research Institute of Arizona (CRI) - Sun City West status: RECRUITING city: Sun City West state: Arizona zip: 85375 country: United States name: Jalal Abbas role: PRINCIPAL_INVESTIGATOR lat: 33.66198 lon: -112.34127 facility: Synexus Clinical Research US, Inc./Orange Grove Family Practice status: RECRUITING city: Tucson state: Arizona zip: 85741 country: United States name: Kevin Lee Pounds role: PRINCIPAL_INVESTIGATOR lat: 32.22174 lon: -110.92648 facility: Eclipse Clinical Research status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85745 country: United States name: Eve C Shapiro role: PRINCIPAL_INVESTIGATOR lat: 32.22174 lon: -110.92648 facility: Cardiology and Medicine Clinic status: NOT_YET_RECRUITING city: Little Rock state: Arkansas zip: 72204 country: United States name: Joe Louis Hargrove role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: Westside Medical Associates of Los Angeles status: NOT_YET_RECRUITING city: Beverly Hills state: California zip: 90211 country: United States name: Norman ELLIOTT Lepor role: PRINCIPAL_INVESTIGATOR lat: 34.07362 lon: -118.40036 facility: Valley Clinical Trials, Inc. status: RECRUITING city: Covina state: California zip: 91723 country: United States name: Fahed G Bitar role: PRINCIPAL_INVESTIGATOR lat: 34.09001 lon: -117.89034 facility: Neighborhood Healthcare Institute of Health status: RECRUITING city: Escondido state: California zip: 92025 country: United States name: James H Schultz role: PRINCIPAL_INVESTIGATOR lat: 33.11921 lon: -117.08642 facility: HB Clinical Trials - Fountain Valley status: RECRUITING city: Fountain Valley state: California zip: 92708 country: United States name: Vinod Malhotra role: PRINCIPAL_INVESTIGATOR lat: 33.70918 lon: -117.95367 facility: Care Access Research - Huntington Beach status: RECRUITING city: Huntington Beach state: California zip: 92648 country: United States name: Christine Thai role: PRINCIPAL_INVESTIGATOR lat: 33.6603 lon: -117.99923 facility: 310 Clinical Research status: RECRUITING city: Inglewood state: California zip: 90301 country: United States name: Soheil Hekmat role: PRINCIPAL_INVESTIGATOR lat: 33.96168 lon: -118.35313 facility: UCSD - Altman Clinical and Translational Research Institute (ACTRI) status: NOT_YET_RECRUITING city: La Jolla state: California zip: 92037-7410 country: United States name: Michael Wilkinson role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Scripps Whittier Diabetes Institute status: NOT_YET_RECRUITING city: La Jolla state: California zip: 92037 country: United States name: James David McCallum role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: First Valley Medical Group status: NOT_YET_RECRUITING city: Lancaster state: California zip: 93534 country: United States name: Kanagaratnam Sivalingam role: PRINCIPAL_INVESTIGATOR lat: 34.69804 lon: -118.13674 facility: MemorialCare Health System - Long Beach Medical Center status: NOT_YET_RECRUITING city: Long Beach state: California zip: 90806 country: United States name: Mark Lee role: PRINCIPAL_INVESTIGATOR lat: 33.76696 lon: -118.18923 facility: Ark Clinical Research status: RECRUITING city: Long Beach state: California zip: 90815 country: United States name: Apinya Vutikullird role: PRINCIPAL_INVESTIGATOR lat: 33.76696 lon: -118.18923 facility: Keck School of Medicine of USC status: NOT_YET_RECRUITING city: Los Angeles state: California zip: 90033 country: United States name: Parveen Garg role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Cardiovascular Research Foundation of Southern California status: NOT_YET_RECRUITING city: Los Angeles state: California zip: 90210 country: United States name: Ronald P Karlsberg role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Desert Oasis Healthcare Medical Group status: RECRUITING city: Palm Springs state: California zip: 92262 country: United States name: Michael Jardula role: PRINCIPAL_INVESTIGATOR lat: 33.8303 lon: -116.54529 facility: Artemis Institute for Clinical Research status: NOT_YET_RECRUITING city: San Diego state: California zip: 92103 country: United States name: Stacey Layle role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Care Access - Santa Clarita status: RECRUITING city: Santa Clarita state: California zip: 91321 country: United States name: Sina Tebi role: PRINCIPAL_INVESTIGATOR lat: 34.39166 lon: -118.54259 facility: Millennium Clinical Trials status: RECRUITING city: Simi Valley state: California zip: 93065 country: United States name: Edward Portnoy role: PRINCIPAL_INVESTIGATOR lat: 34.26945 lon: -118.78148 facility: Stanford University Medical Center status: NOT_YET_RECRUITING city: Stanford state: California zip: 94305 country: United States name: Abha Khandelwal role: PRINCIPAL_INVESTIGATOR lat: 37.42411 lon: -122.16608 facility: Olive View-UCLA Medical Center status: NOT_YET_RECRUITING city: Sylmar state: California zip: 91342 country: United States name: Jonathan Soverow role: PRINCIPAL_INVESTIGATOR lat: 34.30778 lon: -118.44925 facility: Care Access - Thousand Oaks status: RECRUITING city: Thousand Oaks state: California zip: 91360 country: United States name: Irving Loh role: PRINCIPAL_INVESTIGATOR lat: 34.17056 lon: -118.83759 facility: Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. status: RECRUITING city: Toluca Lake state: California zip: 91602 country: United States name: Michael Marsh role: PRINCIPAL_INVESTIGATOR lat: 34.15262 lon: -118.35731 facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center status: NOT_YET_RECRUITING city: Torrance state: California zip: 90502 country: United States name: William French role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 facility: UCLA South Bay Endocrinology status: NOT_YET_RECRUITING city: Torrance state: California zip: 90505 country: United States name: Dianne Cheung role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 facility: InvivoCure status: RECRUITING city: Van Nuys state: California zip: 91405 country: United States name: Rodney Samaan role: PRINCIPAL_INVESTIGATOR lat: 34.18667 lon: -118.44897 facility: Synexus Clinical Research US - Vista status: RECRUITING city: Vista state: California zip: 92083 country: United States name: Isabel J. Pereira role: PRINCIPAL_INVESTIGATOR lat: 33.20004 lon: -117.24254 facility: Interventional Cardiology Medical Group status: RECRUITING city: West Hills state: California zip: 91307 country: United States name: Farhad Rafii role: PRINCIPAL_INVESTIGATOR lat: 34.19731 lon: -118.64398 facility: University of Colorado Anschutz Medical Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Neda Rasouli role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Bridgeport Hospital status: RECRUITING city: Bridgeport state: Connecticut zip: 06610 country: United States name: Adam Schussheim role: PRINCIPAL_INVESTIGATOR lat: 41.16704 lon: -73.20483 facility: Hartford Hospital (HH) status: NOT_YET_RECRUITING city: Hartford state: Connecticut zip: 06102 country: United States name: Antonio Fernandez role: PRINCIPAL_INVESTIGATOR lat: 41.76371 lon: -72.68509 facility: Cardiology Associates of Fairfield County, P.C. status: RECRUITING city: Stamford state: Connecticut zip: 06905 country: United States name: Thomas Nero role: PRINCIPAL_INVESTIGATOR lat: 41.05343 lon: -73.53873 facility: Chase Medical Research, LLC status: RECRUITING city: Waterbury state: Connecticut zip: 06708 country: United States name: Joseph Soufer role: PRINCIPAL_INVESTIGATOR lat: 41.55815 lon: -73.0515 facility: MedStar Washington Hospital Center status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 20010 country: United States name: Ron Waksman role: PRINCIPAL_INVESTIGATOR lat: 38.89511 lon: -77.03637 facility: Excel Medical Clinical Trials status: RECRUITING city: Boca Raton state: Florida zip: 33434 country: United States name: DAVID FUNT role: PRINCIPAL_INVESTIGATOR lat: 26.3669 lon: -80.13033 facility: Clearwater Cardiovascular & Interventional Consultants M.D., P.A. status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33756 country: United States name: Douglas J Spriggs role: PRINCIPAL_INVESTIGATOR lat: 27.96585 lon: -82.8001 facility: Clinical Research of West Florida, Inc. (Clearwater) status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33765 country: United States name: Leonard Jay Dunn role: PRINCIPAL_INVESTIGATOR lat: 27.96585 lon: -82.8001 facility: Elite Cardiac Research Center status: NOT_YET_RECRUITING city: Hialeah state: Florida zip: 33013 country: United States name: Manuel Bouza role: PRINCIPAL_INVESTIGATOR lat: 25.8576 lon: -80.27811 facility: Westside Center for Clinical Research status: RECRUITING city: Jacksonville state: Florida zip: 32205 country: United States name: Albert Lopez role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Encore Research Group- Jacksonville Center for Clinical Research status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States name: Michael Koren role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Clearwater Cardiovascular & Interventional Consultants M.D., P.A. status: NOT_YET_RECRUITING city: Largo state: Florida zip: 33777 country: United States name: Syed Masood Gilani role: PRINCIPAL_INVESTIGATOR lat: 27.90979 lon: -82.78842 facility: K2 Medical Research - Maitland status: RECRUITING city: Maitland state: Florida zip: 32751 country: United States name: Neel Patel role: PRINCIPAL_INVESTIGATOR lat: 28.62778 lon: -81.36312 facility: South Florida Clinical Research Institute status: RECRUITING city: Margate state: Florida zip: 33063 country: United States name: Juan Loy role: PRINCIPAL_INVESTIGATOR lat: 26.24453 lon: -80.20644 facility: Inpatient Research Clinic status: RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States name: Alexis Gutierrez role: PRINCIPAL_INVESTIGATOR lat: 25.90871 lon: -80.30866 facility: Suncoast Research Group status: RECRUITING city: Miami state: Florida zip: 33135 country: United States name: Mark Kutner role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Advanced Research for Health Improvement, LLC status: RECRUITING city: Naples state: Florida zip: 34102 country: United States name: Julian J. Javier role: PRINCIPAL_INVESTIGATOR lat: 26.14234 lon: -81.79596 facility: Renstar Medical Research status: RECRUITING city: Ocala state: Florida zip: 34470 country: United States name: David Lucius Oliver role: PRINCIPAL_INVESTIGATOR lat: 29.1872 lon: -82.14009 facility: Elixia Central Florida status: RECRUITING city: Orlando state: Florida zip: 32806 country: United States name: Arvind Madan role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: Florida Institute For Clinical Research, LLC status: RECRUITING city: Orlando state: Florida zip: 32825 country: United States name: Humberto Cruz role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: Innovative Research Institute - Port Charlotte status: RECRUITING city: Port Charlotte state: Florida zip: 33952 country: United States name: Joseph Ravid role: PRINCIPAL_INVESTIGATOR lat: 26.97617 lon: -82.09064 facility: Peace River Cardiovascular Center status: RECRUITING city: Port Charlotte state: Florida zip: 33952 country: United States name: David Hotchkiss role: PRINCIPAL_INVESTIGATOR lat: 26.97617 lon: -82.09064 facility: Progressive Medical Research status: NOT_YET_RECRUITING city: Port Orange state: Florida zip: 32127 country: United States name: Richard Mohammed role: PRINCIPAL_INVESTIGATOR lat: 29.13832 lon: -80.99561 facility: Clearwater Cardiovascular & Interventional Consultants M.D., P.A. status: NOT_YET_RECRUITING city: Safety Harbor state: Florida zip: 34695 country: United States name: Kenneth C. Sabatino role: PRINCIPAL_INVESTIGATOR lat: 27.99085 lon: -82.69316 facility: Clinical Research of West Florida status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33606 country: United States name: Lon D. Lynn, DO role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: Care Access - Tampa status: RECRUITING city: Tampa state: Florida zip: 33625 country: United States name: Shital Mehta role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: Cardiology Partners Clinical Research Institute - Wellington status: NOT_YET_RECRUITING city: Wellington state: Florida zip: 33449 country: United States name: Jean Foucauld role: PRINCIPAL_INVESTIGATOR lat: 26.65868 lon: -80.24144 facility: American Clinical Trials - Acworth status: RECRUITING city: Acworth state: Georgia zip: 30101 country: United States name: CHINEDU PATRICK NWEKE role: PRINCIPAL_INVESTIGATOR lat: 34.06635 lon: -84.67837 facility: Grady Memorial System status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30303 country: United States name: Jalal Ghali role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 facility: Atlanta Diabetes Associates status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States name: Bruce Bode role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 facility: Emory University School of Medicine status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Arshed Quyyumi role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 facility: Southeastern Clinical Research Institute status: RECRUITING city: Augusta state: Georgia zip: 30904 country: United States name: Barton Brezina role: PRINCIPAL_INVESTIGATOR lat: 33.47097 lon: -81.97484 facility: East Coast Institute for Research - Canton status: RECRUITING city: Canton state: Georgia zip: 30114 country: United States name: Jason Berner role: PRINCIPAL_INVESTIGATOR lat: 34.23676 lon: -84.49076 facility: American Clinical Trials - Douglasville status: RECRUITING city: Douglasville state: Georgia zip: 30134 country: United States name: Ayorinde Soipe role: PRINCIPAL_INVESTIGATOR lat: 33.7515 lon: -84.74771 facility: Center for Advanced Research & Education status: NOT_YET_RECRUITING city: Gainesville state: Georgia zip: 30501 country: United States name: Angela Dawn Ritter role: PRINCIPAL_INVESTIGATOR lat: 34.29788 lon: -83.82407 facility: Georgia Clinical Research - Lawrenceville status: NOT_YET_RECRUITING city: Lawrenceville state: Georgia zip: 30044 country: United States name: George K Rafeedie role: PRINCIPAL_INVESTIGATOR lat: 33.95621 lon: -83.98796 facility: East Coast Institute for Research at The Jones Center status: RECRUITING city: Macon state: Georgia zip: 31210 country: United States name: Thomas Cunningham Jones role: PRINCIPAL_INVESTIGATOR lat: 32.84069 lon: -83.6324 facility: The Queen's Medical Center status: NOT_YET_RECRUITING city: Honolulu state: Hawaii zip: 96813 country: United States name: Helaine Kwong role: PRINCIPAL_INVESTIGATOR lat: 21.30694 lon: -157.85833 facility: Care Research status: RECRUITING city: Boise state: Idaho zip: 83704 country: United States name: David Hinchman role: PRINCIPAL_INVESTIGATOR lat: 43.6135 lon: -116.20345 facility: Chicago Clinical Research Institute status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60607 country: United States name: Dennis J Levinson role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Clinical Investigation Specialists status: RECRUITING city: Gurnee state: Illinois zip: 60031 country: United States name: Luis Gonzalez-Orozco role: PRINCIPAL_INVESTIGATOR lat: 42.3703 lon: -87.90202 facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Park Ridge state: Illinois zip: 60068 country: United States name: Saifullah Nasir role: PRINCIPAL_INVESTIGATOR lat: 42.01114 lon: -87.84062 facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative status: RECRUITING city: Springfield state: Illinois zip: 62711 country: United States name: Diana Widicus role: PRINCIPAL_INVESTIGATOR lat: 39.80172 lon: -89.64371 facility: Accellacare - DuPage status: NOT_YET_RECRUITING city: Winfield state: Illinois zip: 60190 country: United States name: George Nijmeh role: PRINCIPAL_INVESTIGATOR lat: 41.8617 lon: -88.1609 facility: American Health Network of IN, LLC status: RECRUITING city: Avon state: Indiana zip: 46123 country: United States name: Daniel K. Storey role: PRINCIPAL_INVESTIGATOR lat: 39.76282 lon: -86.39972 facility: American Health Network of IN, LLC status: NOT_YET_RECRUITING city: Franklin state: Indiana zip: 46131 country: United States name: George Mitchell Cornett role: PRINCIPAL_INVESTIGATOR lat: 39.48061 lon: -86.05499 facility: Indiana University Health Methodist Hospital status: NOT_YET_RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: Julie Clary role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: Iowa Diabetes and Endocrinology Research Center status: RECRUITING city: West Des Moines state: Iowa zip: 50265 country: United States name: Anuj Bhargava role: PRINCIPAL_INVESTIGATOR lat: 41.57721 lon: -93.71133 facility: Cotton O'Neil Clinical Research Center - Central Office status: RECRUITING city: Topeka state: Kansas zip: 66606 country: United States name: Michael Cox role: PRINCIPAL_INVESTIGATOR lat: 39.04833 lon: -95.67804 facility: Qualmedica Research status: NOT_YET_RECRUITING city: Bowling Green state: Kentucky zip: 42101 country: United States name: J Christopher Sartore role: PRINCIPAL_INVESTIGATOR lat: 36.99032 lon: -86.4436 facility: Cambridge Medical Trials status: NOT_YET_RECRUITING city: Alexandria state: Louisiana zip: 71301 country: United States name: Naseem Jaffrani role: PRINCIPAL_INVESTIGATOR lat: 31.31129 lon: -92.44514 facility: Grace Research - Bossier status: NOT_YET_RECRUITING city: Bossier City state: Louisiana zip: 71111 country: United States name: William Britton Eaves role: PRINCIPAL_INVESTIGATOR lat: 32.51599 lon: -93.73212 facility: Care Access - Lake Charles status: RECRUITING city: Lake Charles state: Louisiana zip: 70601 country: United States name: William Nabours role: PRINCIPAL_INVESTIGATOR lat: 30.21309 lon: -93.2044 facility: IMA Clinical Research status: RECRUITING city: Monroe state: Louisiana zip: 71201 country: United States name: Mark C. Napoli role: PRINCIPAL_INVESTIGATOR lat: 32.50931 lon: -92.1193 facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: New Orleans state: Louisiana zip: 70119 country: United States name: Robert J Noveck role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Louisiana Heart Center - Slidell status: RECRUITING city: Slidell state: Louisiana zip: 70458 country: United States name: Marc Bernstein role: PRINCIPAL_INVESTIGATOR lat: 30.27519 lon: -89.78117 facility: Care Access - Baltimore status: RECRUITING city: Baltimore state: Maryland zip: 21213 country: United States name: Peta-Gay Jackson Booth role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Sinai Hospital Of Baltimore status: NOT_YET_RECRUITING city: Baltimore state: Maryland zip: 21215 country: United States name: Paul Gurbel role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Maryland Cardiovascular Specialists status: RECRUITING city: Baltimore state: Maryland zip: 21229 country: United States name: Jeffrey F. 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L. 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lat: -33.90011 lon: 150.93328 facility: The AIM Centre / Hunter Diabetes Centre status: RECRUITING city: Merewether state: New South Wales zip: 2291 country: Australia name: Claire Morbey role: PRINCIPAL_INVESTIGATOR lat: -32.94801 lon: 151.74325 facility: AusTrials - St. Leonards status: RECRUITING city: Sydney state: New South Wales zip: 2065 country: Australia name: (Alexander) Munro Neville role: PRINCIPAL_INVESTIGATOR lat: -33.86785 lon: 151.20732 facility: Royal Brisbane and Women's Hospital status: NOT_YET_RECRUITING city: Brisbane state: Queensland zip: 4029 country: Australia name: CHRISTOPHER HAMMETT role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 facility: Core Research Group status: RECRUITING city: Brisbane state: Queensland zip: 4064 country: Australia name: David Martin Colquhoun role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 facility: Heart of Australia status: RECRUITING city: Brisbane state: Queensland zip: 4068 country: Australia name: Rolf 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PRINCIPAL_INVESTIGATOR lat: -26.91944 lon: -49.06611 facility: Centro de Pesquisa Clinica do Coracao status: NOT_YET_RECRUITING city: Aracaju state: Sergipe zip: 49055-530 country: Brazil name: FÁBIO SILVEIRA role: PRINCIPAL_INVESTIGATOR lat: -10.91111 lon: -37.07167 facility: Centro de Pesquisa Sao Lucas status: NOT_YET_RECRUITING city: Campinas state: São Paulo zip: 13060-803 country: Brazil name: Aloisio Marchi Rocha role: PRINCIPAL_INVESTIGATOR lat: -22.90556 lon: -47.06083 facility: Instituto Do Coracao De Marilia status: NOT_YET_RECRUITING city: Marilia state: São Paulo zip: 17515-000 country: Brazil name: Raphael Silva role: PRINCIPAL_INVESTIGATOR lat: -22.21389 lon: -49.94583 facility: CAPED Centro Avancado Pesquisa e Diagnostica status: NOT_YET_RECRUITING city: Ribeirao Preto state: São Paulo zip: 14026-020 country: Brazil name: Pedro Vellosa Schwartzmann role: PRINCIPAL_INVESTIGATOR lat: -21.1775 lon: -47.81028 facility: Faculdade de Medicina do ABC status: NOT_YET_RECRUITING 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PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Mingxia Yuan role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100091 country: China name: Ming Cui role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: 2nd Affiliated Hospital Chongqing Medical Universi status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: ZHIYU LING role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: Chongqing Three Gorges Central Hospital status: NOT_YET_RECRUITING city: Wanzhou state: Chongqing zip: 404199 country: China name: Huaming Mou role: PRINCIPAL_INVESTIGATOR facility: Xiamen Cardiovascular Hospital status: NOT_YET_RECRUITING city: Xiamen state: Fujian zip: 361006 country: China name: Cuilian Dai role: PRINCIPAL_INVESTIGATOR lat: 24.47979 lon: 118.08187 facility: The First Hospital of Lanzhou University status: NOT_YET_RECRUITING city: Lanzhou state: Gansu zip: 730000 country: China name: Zheng Zhang role: PRINCIPAL_INVESTIGATOR lat: 36.05701 lon: 103.83987 facility: Lanzhou university second hospital status: NOT_YET_RECRUITING city: Lanzhou state: Gansu zip: 730030 country: China name: Xiaowei Zhang role: PRINCIPAL_INVESTIGATOR lat: 36.05701 lon: 103.83987 facility: Shunde Hospital of Southern Medical Univesity status: NOT_YET_RECRUITING city: Foshan state: Guangdong zip: 528399 country: China name: Yuli Huang role: PRINCIPAL_INVESTIGATOR lat: 23.02677 lon: 113.13148 facility: Guangdong Provincial People's Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Jiyan Chen role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Guangzhou First People's Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510180 country: China name: Jian Liu role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital, Sun Yat-sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China name: Yugang Dong role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Huizhou Municipal Central Hospital status: NOT_YET_RECRUITING city: Huizhou state: Guangdong zip: 516001 country: China name: Xiongwei XIE role: PRINCIPAL_INVESTIGATOR lat: 23.11147 lon: 114.41523 facility: Shenzhen Sun Yat-sen Cardiovascular Hospital status: NOT_YET_RECRUITING city: Shenzhen state: Guangdong zip: 518057 country: China name: Xin Zheng role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: Guangxi People's Hospital status: NOT_YET_RECRUITING city: Nanning state: Guangxi zip: 530021 country: China name: Qingwei Ji role: PRINCIPAL_INVESTIGATOR lat: 22.81667 lon: 108.31667 facility: The First Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150001 country: China name: Yue Li role: PRINCIPAL_INVESTIGATOR lat: 45.75 lon: 126.65 facility: The Fourth Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150001 country: China name: ZhiFeng Cheng role: PRINCIPAL_INVESTIGATOR lat: 45.75 lon: 126.65 facility: The First Affiliated Hospital of Henan University of Science &Technology status: NOT_YET_RECRUITING city: Luoyang state: Henan zip: 471003 country: China name: Hongwei Jiang role: PRINCIPAL_INVESTIGATOR lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Henan University of Science &Technology status: NOT_YET_RECRUITING city: Luoyang state: Henan zip: 471003 country: China name: Zhijuan Li role: PRINCIPAL_INVESTIGATOR lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Nanyang Medical College status: NOT_YET_RECRUITING city: Nanyang state: Henan zip: 473007 country: China name: Dexue Liu role: PRINCIPAL_INVESTIGATOR lat: 32.99472 lon: 112.53278 facility: The First Affiliated Hospital of Nanyang Medical College status: NOT_YET_RECRUITING city: Nanyang state: Henan country: China name: Jie Li role: PRINCIPAL_INVESTIGATOR lat: 32.99472 lon: 112.53278 facility: The Second Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450014 country: China name: Qingju Li role: PRINCIPAL_INVESTIGATOR lat: 34.75778 lon: 113.64861 facility: Jingzhou Central Hospital status: NOT_YET_RECRUITING city: Jingzhou state: Hubei zip: 434020 country: China name: Keping Yang role: PRINCIPAL_INVESTIGATOR lat: 30.35028 lon: 112.19028 facility: Wuhan University Medical College - Hubei Zhongshan Hospital status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Jingyi Zhang role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Wuhan Asia Heart Hospital status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Hua Yan role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Renmin Hospital of Wuhan University status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430060 country: China name: Xuejun Jiang role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Changde First People's Hospital status: NOT_YET_RECRUITING city: Changde state: Hunan zip: 415000 country: China name: Liangqing GE role: PRINCIPAL_INVESTIGATOR lat: 29.04638 lon: 111.6783 facility: The Third Xiangya Hospital of Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410013 country: China name: Weihong Jiang role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: The First People's Hospital of Yueyang status: NOT_YET_RECRUITING city: Yueyang state: Hunan zip: 414000 country: China name: Gang Pan role: PRINCIPAL_INVESTIGATOR lat: 29.37455 lon: 113.09481 facility: Chifeng Hospital status: NOT_YET_RECRUITING city: Chifeng state: Inner Mongolia zip: 024099 country: China name: XIANDONG SUN role: PRINCIPAL_INVESTIGATOR lat: 42.26833 lon: 118.96361 facility: Inner Mongolia People's Hospital status: NOT_YET_RECRUITING city: Hohhot state: Inner Mongolia zip: 010017 country: China name: Liping He role: PRINCIPAL_INVESTIGATOR lat: 40.81056 lon: 111.65222 facility: Changzhou Second People's Hospital status: NOT_YET_RECRUITING city: Changzhou state: Jiangsu zip: 213000 country: China name: Yuan Ji role: PRINCIPAL_INVESTIGATOR lat: 31.77359 lon: 119.95401 facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Biao Xu role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Zhongda Hospital Southeast University status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Genshan Ma role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China name: Yibing Lu role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China name: Mingzhi Long role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Jiangsu Province Hospital status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Dianfu Li role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Wuxi People's Hospital status: NOT_YET_RECRUITING city: Wuxi state: Jiangsu zip: 214023 country: China name: Ruxing Wang role: PRINCIPAL_INVESTIGATOR lat: 31.56887 lon: 120.28857 facility: The Affiliated Hospital of Xuzhou Medical College status: NOT_YET_RECRUITING city: Xuzhou state: Jiangsu zip: 221006 country: China name: Hong Zhu role: PRINCIPAL_INVESTIGATOR lat: 34.18045 lon: 117.15707 facility: The Second Affiliated Hospital of Nanchang University status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China name: Yanqing Wu role: PRINCIPAL_INVESTIGATOR lat: 28.68396 lon: 115.85306 facility: The Third Hospital of Nanchang status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330009 country: China name: Zhaohui Pei role: PRINCIPAL_INVESTIGATOR lat: 28.68396 lon: 115.85306 facility: The First Hospital of Jilin University status: NOT_YET_RECRUITING city: Changchun state: Jilin zip: 100012 country: China name: Qian Tong role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: China-Japan Union Hospital status: NOT_YET_RECRUITING city: Changchun state: Jilin zip: 130033 country: China name: Yuquan He role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: Siping Central People's Hospital status: NOT_YET_RECRUITING city: Siping state: Jilin zip: 136000 country: China name: Zhihua Fang role: PRINCIPAL_INVESTIGATOR lat: 43.16143 lon: 124.37785 facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University status: NOT_YET_RECRUITING city: Dalian state: Liaoning zip: 116033 country: China name: Xiaoqun Zheng role: PRINCIPAL_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: The People's Hospital of Liaoning Province status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110000 country: China name: Aijie Hou role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 facility: Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army status: NOT_YET_RECRUITING city: Xi'an state: Shaanxi zip: 710038 country: China name: Yan Li role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 facility: The First Affiliated Hospital of Xi'an Jiaotong University status: NOT_YET_RECRUITING city: Xi'an state: Shaanxi zip: 710061 country: China name: Zuyi Yuan role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 facility: Shaanxi provincial people's hospital status: NOT_YET_RECRUITING city: Xian state: Shaanxi zip: 710068 country: China name: Junkui Wang role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250013 country: China name: GuoHai Su role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250013 country: China name: Xiaolin Dong role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: Jining Medical University - Affiliated Hospital status: NOT_YET_RECRUITING city: Jining state: Shandong zip: 272029 country: China name: jinguo zhang role: PRINCIPAL_INVESTIGATOR lat: 35.405 lon: 116.58139 facility: Zhongshan Hospital,Fudan University status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Wang Zhen role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: West China Hospital, Sichuan University status: NOT_YET_RECRUITING city: Cheng Du state: Sichuan zip: 610041 country: China name: Yong He role: PRINCIPAL_INVESTIGATOR facility: Sichuan Provincial People's Hospital status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610072 country: China name: Jianhong Tao role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: TEDA International Cardiovascular Hospital status: NOT_YET_RECRUITING city: Tianjin state: Tianjin zip: 300457 country: China name: Jian Zhang role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 facility: Tianjin Fourth Centre Hospital status: NOT_YET_RECRUITING city: Tianjin state: Tianjin zip: Tianjin country: China name: Xiaochun Xing role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of Xinjiang Medical University status: NOT_YET_RECRUITING city: Urumchi state: Xinjiang zip: 830054 country: China name: Xiang Ma role: PRINCIPAL_INVESTIGATOR facility: People's Hospital of Xinjiang Uygur Autonomous Region status: NOT_YET_RECRUITING city: Urumqi state: Xinjiang zip: 830001 country: China name: Hui Peng role: PRINCIPAL_INVESTIGATOR lat: 43.80096 lon: 87.60046 facility: Sir Run Run Shaw Hospital status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang zip: 310016 country: China name: Guosheng Fu role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Lishui Central Hospital status: NOT_YET_RECRUITING city: Lishui City state: Zhejiang country: China name: Lingchun Lv role: PRINCIPAL_INVESTIGATOR facility: Ningbo First Hospital status: NOT_YET_RECRUITING city: Ningbo state: Zhejiang zip: 315010 country: China name: Xiaohong Fei role: PRINCIPAL_INVESTIGATOR lat: 29.87819 lon: 121.54945 facility: The First Affiliated Hospital of Wenzhou Medical University status: NOT_YET_RECRUITING city: Wenzhou state: Zhejiang zip: 325000 country: China name: Hao Zhou role: PRINCIPAL_INVESTIGATOR lat: 27.99942 lon: 120.66682 facility: Shanghai East Hospital status: NOT_YET_RECRUITING city: Shanghai zip: 200120 country: China name: Ying Li role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: General Hospital of Ningxia Medical University status: NOT_YET_RECRUITING city: Yinchuan zip: 750004 country: China name: xueping Ma role: PRINCIPAL_INVESTIGATOR lat: 38.46806 lon: 106.27306 facility: Kardiologická ambulance Brno status: NOT_YET_RECRUITING city: Brno state: Brno-město zip: 612 00 country: Czechia name: Jiri Parenica role: PRINCIPAL_INVESTIGATOR lat: 49.19522 lon: 16.60796 facility: EFERTUS healthcare s.r.o. status: NOT_YET_RECRUITING city: Brno state: Brno-město zip: 635 00 country: Czechia name: Hana Matejovska role: PRINCIPAL_INVESTIGATOR lat: 49.19522 lon: 16.60796 facility: Vojenská Nemocnice Brno status: NOT_YET_RECRUITING city: Brno state: Brno-město zip: 636 00 country: Czechia name: Stanislav Mihola role: PRINCIPAL_INVESTIGATOR lat: 49.19522 lon: 16.60796 facility: Fakultni Nemocnice u sv. Anny v Brne status: NOT_YET_RECRUITING city: Brno state: Brno-město zip: 656 91 country: Czechia name: Robert Prosecky role: PRINCIPAL_INVESTIGATOR lat: 49.19522 lon: 16.60796 facility: Fakultni Nemocnice u sv. Anny v Brne status: NOT_YET_RECRUITING city: Brno state: Jihomoravský Kraj zip: 60200 country: Czechia name: Vladimir Kincl role: PRINCIPAL_INVESTIGATOR lat: 49.19522 lon: 16.60796 facility: EDUMED - Náchod status: NOT_YET_RECRUITING city: Nachod state: Královéhradecký Kraj zip: 547 01 country: Czechia name: Alica Vesela role: PRINCIPAL_INVESTIGATOR lat: 50.4167 lon: 16.16289 facility: Kardiologicka ambulance status: NOT_YET_RECRUITING city: Litovel state: Olomoucký Kraj zip: 784 01 country: Czechia name: Petra Maskova role: PRINCIPAL_INVESTIGATOR lat: 49.70121 lon: 17.07615 facility: Agentura Science Pro status: NOT_YET_RECRUITING city: Olomouc state: Olomoucký Kraj zip: 779 00 country: Czechia name: Tomas Brychta role: PRINCIPAL_INVESTIGATOR lat: 49.59552 lon: 17.25175 facility: Kardiologicka a Angiologicka Ambulance status: NOT_YET_RECRUITING city: Ostrava state: Ostrava Město zip: 700 30 country: Czechia name: Dusan Kucera role: PRINCIPAL_INVESTIGATOR lat: 49.83465 lon: 18.28204 facility: Private Practice - Dr. Miroslav Koliba status: NOT_YET_RECRUITING city: Ostrava state: Ostrava Město zip: 702 00 country: Czechia name: Miroslav Koliba role: PRINCIPAL_INVESTIGATOR lat: 49.83465 lon: 18.28204 facility: Angiocentrum Komorany status: NOT_YET_RECRUITING city: Prague state: Praha 12 zip: 143 00 country: Czechia name: Ales Horacek role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: Poliklinika Lípa Centrum status: NOT_YET_RECRUITING city: Prague state: Praha 13 zip: 158 00 country: Czechia name: Eva Zidkova role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: Synexus Czech status: NOT_YET_RECRUITING city: Prague state: Praha 2 zip: 120 00 country: Czechia name: Katarina Halciakova role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: Nefrologie status: NOT_YET_RECRUITING city: Prague state: Praha 4 zip: 149 00 country: Czechia name: Lucie Hornova role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: DiaVize s.r.o. status: NOT_YET_RECRUITING city: Praha state: Praha 4 zip: 140 00 country: Czechia name: Marta Klementova role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: Centrum Kardiovaskularni Mediciny status: NOT_YET_RECRUITING city: Prague state: Praha 6 zip: 169 00 country: Czechia name: Jean-Claude Lubanda role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: Kardio Uhrineves status: NOT_YET_RECRUITING city: Prague state: Praha, Hlavní Mešto zip: 104 00 country: Czechia name: Marian Levcik role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: Kardiologicka ambulance status: NOT_YET_RECRUITING city: Brandýs nad Labem-Stará Boleslav state: Praha-východ zip: 250 01 country: Czechia name: Jiri Krupicka role: PRINCIPAL_INVESTIGATOR lat: 50.18709 lon: 14.66326 facility: Kardioma status: NOT_YET_RECRUITING city: Kolin state: Středočeský Kraj zip: 280 02 country: Czechia name: Vit Maratka role: PRINCIPAL_INVESTIGATOR lat: 50.02806 lon: 15.1998 facility: Nova kardiologie - Kardiologicka ambulance status: NOT_YET_RECRUITING city: Ricany state: Středočeský Kraj zip: 251 01 country: Czechia name: Jan Kohoutek role: PRINCIPAL_INVESTIGATOR lat: 49.99168 lon: 14.65427 facility: Clinical Trials Service s.r.o. status: NOT_YET_RECRUITING city: Uherské Hradiště state: Zlínský Kraj zip: 686 01 country: Czechia name: Vladimir Cech role: PRINCIPAL_INVESTIGATOR lat: 49.06975 lon: 17.45969 facility: PreventaMed status: NOT_YET_RECRUITING city: Olomouc zip: 779 00 country: Czechia name: Jiri Pumprla role: PRINCIPAL_INVESTIGATOR lat: 49.59552 lon: 17.25175 facility: Kardiologicka ambulance MUDr. Ferkl s.r.o. status: NOT_YET_RECRUITING city: Trutnov zip: 541 01 country: Czechia name: Richard Ferkl role: PRINCIPAL_INVESTIGATOR lat: 50.56101 lon: 15.9127 facility: Cardio Research, s.r.o status: NOT_YET_RECRUITING city: Zlín zip: 760 01 country: Czechia name: Tomas Fiala role: PRINCIPAL_INVESTIGATOR lat: 49.22645 lon: 17.67065 facility: Rigshospitalet status: NOT_YET_RECRUITING city: Copenhagen state: Hovedstaden zip: 2100 country: Denmark name: Christian Hassager role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Herlev and Gentofte Hospital status: NOT_YET_RECRUITING city: Hellerup state: Hovedstaden zip: 2900 country: Denmark name: Gunnar Gislason role: PRINCIPAL_INVESTIGATOR lat: 55.73204 lon: 12.57093 facility: Sanos Clinic status: NOT_YET_RECRUITING city: Herlev state: Hovedstaden zip: 2730 country: Denmark name: Bernt Husoy role: PRINCIPAL_INVESTIGATOR lat: 55.72366 lon: 12.43998 facility: Aarhus Universitetshospital, Skejby status: NOT_YET_RECRUITING city: Aarhus state: Midtjylland zip: 8200 country: Denmark name: Henrik Wiggers role: PRINCIPAL_INVESTIGATOR lat: 56.15674 lon: 10.21076 facility: Sanos Clinic - Nordjylland status: NOT_YET_RECRUITING city: Gandrup state: Nordjylland zip: 9362 country: Denmark name: Cecilie Rovsing role: PRINCIPAL_INVESTIGATOR lat: 56.74249 lon: 9.82298 facility: Holbæk Sygehus status: NOT_YET_RECRUITING city: Holbaek state: Sjælland zip: 4300 country: Denmark name: Morten Lindhardt role: PRINCIPAL_INVESTIGATOR lat: 55.71354 lon: 11.7169 facility: Sygehus Sønderjylland i Aabenraa status: NOT_YET_RECRUITING city: Aabenraa state: Syddanmark zip: 6200 country: Denmark name: Frank-Peter Elpert role: PRINCIPAL_INVESTIGATOR lat: 55.04434 lon: 9.41741 facility: Sydvestjysk Sygehus Esbjerg status: NOT_YET_RECRUITING city: Esbjerg state: Syddanmark zip: 6700 country: Denmark name: Kristian Korsgaard Thomsen role: PRINCIPAL_INVESTIGATOR lat: 55.47028 lon: 8.45187 facility: Sanos Clinic - Syddanmark status: NOT_YET_RECRUITING city: Vejle state: Syddanmark zip: 7100 country: Denmark name: Peter Alexandersen role: PRINCIPAL_INVESTIGATOR lat: 55.70927 lon: 9.5357 facility: CHU de Nice status: NOT_YET_RECRUITING city: Nice state: Alpes-Maritimes zip: 06000 country: France name: Emile Ferrari role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: CHU Strasbourg-Hautepierre status: NOT_YET_RECRUITING city: Strasbourg state: Alsace zip: 67098 country: France name: Alain Pradignac role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: CHU Bordeaux Haut-Leveque status: NOT_YET_RECRUITING city: Pessac state: Aquitaine zip: 33600 country: France name: Sami FAWAZ role: PRINCIPAL_INVESTIGATOR lat: 44.81011 lon: -0.64129 facility: Hôpital Saint Joseph status: NOT_YET_RECRUITING city: Marseille state: Bouches-du-Rhône zip: 13285 country: France name: Patrick KHANOYAN role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand status: NOT_YET_RECRUITING city: Dijon state: Bourgogne zip: 21079 country: France name: FREDERIC CHAGUE role: PRINCIPAL_INVESTIGATOR lat: 47.31667 lon: 5.01667 facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou status: NOT_YET_RECRUITING city: Rennes state: Bretagne zip: 35033 country: France name: francois paillard role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: CHRU Troussau status: NOT_YET_RECRUITING city: Chambray Les Tours state: Centre zip: 37170 country: France name: Fabrice Ivanes role: PRINCIPAL_INVESTIGATOR lat: 47.33537 lon: 0.70286 facility: CHU Besançon status: NOT_YET_RECRUITING city: Besançon state: Doubs zip: 25000 country: France name: francois schiele role: PRINCIPAL_INVESTIGATOR lat: 47.24878 lon: 6.01815 facility: Centre Hospitalier Louis Pasteur status: NOT_YET_RECRUITING city: Le Coudray state: Eure-et-Loir zip: 28630 country: France name: Gregoire Range role: PRINCIPAL_INVESTIGATOR lat: 48.42115 lon: 1.50057 facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau status: NOT_YET_RECRUITING city: Nîmes state: Gard zip: 30029 country: France name: Guillaume Cayla role: PRINCIPAL_INVESTIGATOR lat: 43.83333 lon: 4.35 facility: CHU Rangueil status: NOT_YET_RECRUITING city: Toulouse state: Haute-Garonne zip: 31059 country: France name: Meyer Elbaz role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: CHU Charles Nicolle status: NOT_YET_RECRUITING city: Rouen state: Haute-Normandie zip: 76031 country: France name: Eric Durand role: PRINCIPAL_INVESTIGATOR lat: 49.44313 lon: 1.09932 facility: CHU Montpellier Lapeyronie Hospital status: NOT_YET_RECRUITING city: Montpellier state: Hérault zip: 34295 country: France name: ariane Sultan role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes status: NOT_YET_RECRUITING city: Nantes Cedex 1 state: Loire-Atlantique zip: 44093 country: France name: Bertrand CARIOU role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 facility: Hopital Claude Huriez - CHU de Lille status: NOT_YET_RECRUITING city: Lille state: Nord zip: 59037 country: France name: cecile yelnik role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Centre Hospitalier Compiègne-Noyon status: NOT_YET_RECRUITING city: Compiègne state: Oise zip: 60200 country: France name: Jerome Clerc role: PRINCIPAL_INVESTIGATOR lat: 49.41794 lon: 2.82606 facility: Pitie Salpetriere University Hospital status: NOT_YET_RECRUITING city: Paris state: Orne zip: 75013 country: France name: Antonio Gallo role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Centre Hospitalier de Pau status: NOT_YET_RECRUITING city: Pau state: Pyrénées-Atlantiques zip: 64000 country: France name: NICOLAS DELARCHE role: PRINCIPAL_INVESTIGATOR lat: 43.3 lon: -0.36667 facility: Centre Hospitalier Saint Joseph - Saint Luc status: NOT_YET_RECRUITING city: Lyon state: Rhône-Alpes zip: 69007 country: France name: Lucien MARCHAND role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Hospices Civils de Lyon - Hopital Louis Pradel status: NOT_YET_RECRUITING city: Bron state: Rhône zip: 69677 country: France name: Hospices Civils de Lyon - Hopital Louis Pradel role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Hôpital Bichat - Claude-Bernard status: NOT_YET_RECRUITING city: Paris zip: 75018 country: France name: Gabriel Steg role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Polyclinique Vauban status: NOT_YET_RECRUITING city: Valenciennes zip: 59300 country: France name: Sebastien Caudmont role: PRINCIPAL_INVESTIGATOR lat: 50.35 lon: 3.53333 facility: Hôpital Avicenne status: NOT_YET_RECRUITING city: Bobigny state: Île-de-France zip: 93000 country: France name: Emmanuel Cosson role: PRINCIPAL_INVESTIGATOR lat: 48.9 lon: 2.45 facility: Hôpital Européen Georges Pompidou status: NOT_YET_RECRUITING city: Paris state: Île-de-France zip: 75015 country: France name: Sebastien CZERNICHOW role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Saint Antoine status: NOT_YET_RECRUITING city: Paris state: Île-de-France zip: 75571 country: France name: FRANCK BOCCARA role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: ze:ro ARZTPRAXEN status: RECRUITING city: Mannheim state: Baden-Württemberg zip: 68165 country: Germany name: Peter Salbach role: PRINCIPAL_INVESTIGATOR lat: 49.4891 lon: 8.46694 facility: Universitätsmedizin Mannheim status: RECRUITING city: Mannheim state: Baden-Württemberg zip: 68167 country: Germany name: Ksenija Stach-Jablonski role: PRINCIPAL_INVESTIGATOR lat: 49.4891 lon: 8.46694 facility: Studienzentrum Herzklinik Ulm MVZ status: NOT_YET_RECRUITING city: Ulm state: Baden-Württemberg zip: 89077 country: Germany name: Norbert Jahnke role: PRINCIPAL_INVESTIGATOR lat: 48.39841 lon: 9.99155 facility: Deutsches Herzzentrum München status: RECRUITING city: Munich state: Bayern zip: 80636 country: Germany name: Wolfgang Koenig role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 facility: Universitätsklinikum Regensburg status: NOT_YET_RECRUITING city: Regensburg state: Bayern zip: 93053 country: Germany name: Andrea Baessler role: PRINCIPAL_INVESTIGATOR lat: 49.01513 lon: 12.10161 facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci status: NOT_YET_RECRUITING city: Potsdam state: Brandenburg zip: 14471 country: Germany name: Regina Gaub role: PRINCIPAL_INVESTIGATOR lat: 52.39886 lon: 13.06566 facility: Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair status: NOT_YET_RECRUITING city: Bad Homburg state: Hessen zip: 61348 country: Germany name: Wolfgang Alfred Jungmair role: PRINCIPAL_INVESTIGATOR lat: 50.22683 lon: 8.61816 facility: Cardioangiologisches Centrum Bethanien status: NOT_YET_RECRUITING city: Frankfurt state: Hessen zip: 60389 country: Germany name: Holger Eggebrecht role: PRINCIPAL_INVESTIGATOR lat: 50.11552 lon: 8.68417 facility: Diabetes Zentrum Dr. Tews status: NOT_YET_RECRUITING city: Gelnhausen state: Hessen zip: 63571 country: Germany name: Dietrich Tews role: PRINCIPAL_INVESTIGATOR lat: 50.20164 lon: 9.18742 facility: GPR Gesundheits- und Pflegezentrum Rüsselsheim status: NOT_YET_RECRUITING city: Rüsselsheim state: Hessen zip: 65428 country: Germany name: Ehab Shahock role: PRINCIPAL_INVESTIGATOR lat: 49.98955 lon: 8.42251 facility: Praxis Oedeme status: NOT_YET_RECRUITING city: Lüneburg state: Niedersachsen zip: 21339 country: Germany name: Hans-Eckart Sarnighausen role: PRINCIPAL_INVESTIGATOR lat: 53.2509 lon: 10.41409 facility: Universitätsklinikum Aachen status: RECRUITING city: Aachen state: Nordrhein-Westfalen zip: 52074 country: Germany name: Julia Brandts role: PRINCIPAL_INVESTIGATOR lat: 50.77664 lon: 6.08342 facility: Klinikum Bielefeld Mitte status: NOT_YET_RECRUITING city: Bielefeld state: Nordrhein-Westfalen zip: 33604 country: Germany name: Christoph Stellbrink role: PRINCIPAL_INVESTIGATOR lat: 52.03333 lon: 8.53333 facility: Medizentrum Essen Borbeck status: NOT_YET_RECRUITING city: Essen state: Nordrhein-Westfalen zip: 45355 country: Germany name: Axel Schaefer role: PRINCIPAL_INVESTIGATOR lat: 51.45657 lon: 7.01228 facility: University Hospital of Cologne status: NOT_YET_RECRUITING city: Köln state: Nordrhein-Westfalen zip: 50937 country: Germany name: Ioanna Gouni-Berthold role: PRINCIPAL_INVESTIGATOR lat: 50.93333 lon: 6.95 facility: Institut für Diabetesforschung GmbH Münster status: NOT_YET_RECRUITING city: Münster state: Nordrhein-Westfalen zip: 48145 country: Germany name: Ludger Rose role: PRINCIPAL_INVESTIGATOR lat: 51.96236 lon: 7.62571 facility: Universitaet zu Koeln - Sana-Klinikum Remscheid GmbH - Klinik fuer Kardiologie, Pneumologie und Internisti -T status: NOT_YET_RECRUITING city: Remscheid state: Nordrhein-Westfalen zip: 42859 country: Germany name: Burkhard Sievers role: PRINCIPAL_INVESTIGATOR lat: 51.17983 lon: 7.1925 facility: Zentrum für klinische Studien status: RECRUITING city: Saint Ingbert state: Saarland zip: 66386 country: Germany name: Alexander Segner role: PRINCIPAL_INVESTIGATOR facility: Otto-von-Guericke-Universität Magdeburg status: NOT_YET_RECRUITING city: Magdeburg state: Sachsen-Anhalt zip: 39120 country: Germany name: Rüdiger Braun-Dullaeus role: PRINCIPAL_INVESTIGATOR lat: 52.12773 lon: 11.62916 facility: Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien status: NOT_YET_RECRUITING city: Dresden state: Sachsen zip: 01277 country: Germany name: Maria Kaiser role: PRINCIPAL_INVESTIGATOR lat: 51.05089 lon: 13.73832 facility: Herzzentrum Dresden GmbH Universitätsklinik status: NOT_YET_RECRUITING city: Dresden state: Sachsen zip: 01307 country: Germany name: Felix Matthias Heidrich role: PRINCIPAL_INVESTIGATOR lat: 51.05089 lon: 13.73832 facility: Universitaetsklinikum Carl Gustav Carus Dresden status: NOT_YET_RECRUITING city: Dresden state: Sachsen zip: 01307 country: Germany name: Nikolaos Perakakis role: PRINCIPAL_INVESTIGATOR lat: 51.05089 lon: 13.73832 facility: Universitätsklinikum Leipzig status: NOT_YET_RECRUITING city: Leipzig state: Sachsen zip: 04103 country: Germany name: Irina Mueller-Kozarez role: PRINCIPAL_INVESTIGATOR lat: 51.33962 lon: 12.37129 facility: Herzzentrum Leipzig GmbH status: NOT_YET_RECRUITING city: Leipzig state: Sachsen zip: 04289 country: Germany name: Holger Thiele role: PRINCIPAL_INVESTIGATOR lat: 51.33962 lon: 12.37129 facility: Universitätsklinikum Jena status: NOT_YET_RECRUITING city: Jena state: Thüringen zip: 07747 country: Germany name: Oliver Weingärtner role: PRINCIPAL_INVESTIGATOR lat: 50.92878 lon: 11.5899 facility: Klinikum am Plattenwald status: NOT_YET_RECRUITING city: Bad Friedrichshall zip: 74177 country: Germany name: Thomas Dengler role: PRINCIPAL_INVESTIGATOR facility: Kardiologische Praxen im Spreebogen status: NOT_YET_RECRUITING city: Berlin zip: 10559 country: Germany name: Florian Krackhardt role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: Praxis Rankestrasse status: NOT_YET_RECRUITING city: Berlin zip: 10789 country: Germany name: Werner Albert Rieker role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: DRK Kliniken Berlin - Köpenick status: NOT_YET_RECRUITING city: Berlin zip: 12559 country: Germany name: Martin Lange role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: Charité Campus Virchow-Klinikum status: NOT_YET_RECRUITING city: Berlin zip: 13353 country: Germany name: Ursula Kassner role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: Cardiologicum Hamburg status: NOT_YET_RECRUITING city: Hamburg zip: 22041 country: Germany name: Martin W. Bergmann role: PRINCIPAL_INVESTIGATOR lat: 53.57532 lon: 10.01534 facility: Iatriko Paleou Falirou Medical Center status: NOT_YET_RECRUITING city: Paleo Faliro state: Attikí (Region) zip: 17562 country: Greece name: John Doupis role: PRINCIPAL_INVESTIGATOR facility: Athens Naval Hospital status: NOT_YET_RECRUITING city: Athens state: Attikí zip: 11521 country: Greece name: Anastasios Milkas role: PRINCIPAL_INVESTIGATOR lat: 37.97945 lon: 23.71622 facility: General Hospital of Athens Laiko status: NOT_YET_RECRUITING city: Athens state: Attikí zip: 11527 country: Greece name: Evangelos Liberopoulos role: PRINCIPAL_INVESTIGATOR lat: 37.97945 lon: 23.71622 facility: Athens Medical Center status: NOT_YET_RECRUITING city: Athens state: Attikí zip: 151 25 country: Greece name: Georgia Argyrakopoulou role: PRINCIPAL_INVESTIGATOR lat: 37.97945 lon: 23.71622 facility: Attikon General University Hospital status: NOT_YET_RECRUITING city: Chaidari state: Attikí zip: 12462 country: Greece name: Vaia Lambadiari role: PRINCIPAL_INVESTIGATOR lat: 38.01135 lon: 23.66597 facility: University Hospital of Ioannina status: NOT_YET_RECRUITING city: Ioannina state: Ioánnina zip: 45500 country: Greece name: Vasileios Tsimichodimos role: PRINCIPAL_INVESTIGATOR lat: 39.66486 lon: 20.85189 facility: University General Hospital of Heraklion status: NOT_YET_RECRUITING city: Heraklion state: Irakleío zip: 71110 country: Greece name: Theodosios Filippatos role: PRINCIPAL_INVESTIGATOR lat: 35.32787 lon: 25.14341 facility: AHEPA University General Hospital of Thessaloniki status: NOT_YET_RECRUITING city: Thessaloniki state: Kentrikí Makedonía zip: 546 36 country: Greece name: Konstantinos Tziomalos role: PRINCIPAL_INVESTIGATOR lat: 40.64361 lon: 22.93086 facility: Papageorgiou General Hospital of Thessaloniki status: NOT_YET_RECRUITING city: Thessaloniki state: Thessaloníki zip: 564 29 country: Greece name: Glykeria Tzatzagou role: PRINCIPAL_INVESTIGATOR lat: 40.64361 lon: 22.93086 facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ status: NOT_YET_RECRUITING city: Szeged state: Csongrád zip: 6725 country: Hungary name: Robert Takacs role: PRINCIPAL_INVESTIGATOR lat: 46.253 lon: 20.14824 facility: Vita Verum Medical Egeszsegugyi Szolgaltato status: NOT_YET_RECRUITING city: Szekesfehervar state: Fejér zip: 8000 country: Hungary name: Amalia Benedek role: PRINCIPAL_INVESTIGATOR lat: 47.18995 lon: 18.41034 facility: Medifarma 98 Kft status: NOT_YET_RECRUITING city: Nyiregyhaza state: Nyíregyháza zip: 4400 country: Hungary name: Zsolt Zilahi role: PRINCIPAL_INVESTIGATOR lat: 47.95539 lon: 21.71671 facility: DRC Gyógyszervizsgáló Központ status: NOT_YET_RECRUITING city: Balatongyorok state: Veszprém zip: 8313 country: Hungary name: Margit Dudás role: PRINCIPAL_INVESTIGATOR lat: 46.75833 lon: 17.35462 facility: Belvárosi Egészségház status: NOT_YET_RECRUITING city: Zalaegerszeg state: Zala zip: 8900 country: Hungary name: Geza Lupkovics role: PRINCIPAL_INVESTIGATOR lat: 46.84 lon: 16.84389 facility: Szent Margit Rendelőintézet Nonprofit Kft status: NOT_YET_RECRUITING city: Budapest zip: 1032 country: Hungary name: Timea Tänczer role: PRINCIPAL_INVESTIGATOR lat: 47.49801 lon: 19.03991 facility: Magyar Honvedseg Egeszsegugyi Kozpont status: NOT_YET_RECRUITING city: Budapest zip: 1062 country: Hungary name: Erika Maria Hubina role: PRINCIPAL_INVESTIGATOR lat: 47.49801 lon: 19.03991 facility: Semmelweis University status: NOT_YET_RECRUITING city: Budapest zip: 1122 country: Hungary name: Béla Merkely role: PRINCIPAL_INVESTIGATOR lat: 47.49801 lon: 19.03991 facility: Privát Doktor Egészségügyi Zrt status: NOT_YET_RECRUITING city: Budapest zip: 1132 country: Hungary name: Andras R Vertes role: PRINCIPAL_INVESTIGATOR lat: 47.49801 lon: 19.03991 facility: Debreceni Egyetem Klinikai Kozpont status: NOT_YET_RECRUITING city: Debrecen zip: 4032 country: Hungary name: Denes Pall role: PRINCIPAL_INVESTIGATOR lat: 47.53333 lon: 21.63333 facility: All India Institute of Medical Sciences status: NOT_YET_RECRUITING city: Raipur state: Chhattisgarh zip: 492099 country: India name: Satyajit Singh role: PRINCIPAL_INVESTIGATOR lat: 21.23333 lon: 81.63333 facility: G.B. Pant Institute of Postgraduate Medical Education & Research status: NOT_YET_RECRUITING city: New Delhi state: Delhi zip: 110002 country: India name: Vimal Mehta role: PRINCIPAL_INVESTIGATOR lat: 28.63576 lon: 77.22445 facility: KLES Dr. Prabhakar Kore Hospital & M.R.C status: NOT_YET_RECRUITING city: Belagavi state: Karnataka zip: 590010 country: India name: Prasad M R role: PRINCIPAL_INVESTIGATOR facility: Lisie Hospital status: NOT_YET_RECRUITING city: Kochi state: Kerala zip: 682018 country: India name: Jabir Abdullakutty role: PRINCIPAL_INVESTIGATOR lat: 9.93988 lon: 76.26022 facility: Government Medical College - Kozhikode status: NOT_YET_RECRUITING city: Kozhikode state: Kerala zip: 673008 country: India name: Neeraj Manikath role: PRINCIPAL_INVESTIGATOR lat: 11.24802 lon: 75.7804 facility: Vijan Hospital & Research Centre status: NOT_YET_RECRUITING city: Nashik state: Maharashtra zip: 422005 country: India name: Vikrant Vijan role: PRINCIPAL_INVESTIGATOR lat: 19.99727 lon: 73.79096 facility: Sardar Patel Medical College status: NOT_YET_RECRUITING city: Bikaner state: Rajasthan zip: 334001 country: India name: Devendra Agarwal role: PRINCIPAL_INVESTIGATOR lat: 28.01762 lon: 73.31495 facility: K care Hospital status: NOT_YET_RECRUITING city: Kanpur state: Uttar Pradesh zip: 208001 country: India name: Amit Kumar Gupta role: PRINCIPAL_INVESTIGATOR lat: 26.46523 lon: 80.34975 facility: King George's Medical University status: NOT_YET_RECRUITING city: Lucknow state: Uttar Pradesh zip: 226003 country: India name: S. K. Dwivedi role: PRINCIPAL_INVESTIGATOR lat: 26.83928 lon: 80.92313 facility: Shri Mahant Indiresh Hospital status: NOT_YET_RECRUITING city: Dehradun state: Uttarakhand zip: 248001 country: India name: Tanuj Bhatia role: PRINCIPAL_INVESTIGATOR lat: 30.32295 lon: 78.03168 facility: Soroka Medical Center status: NOT_YET_RECRUITING city: Be'er Sheva state: HaDarom zip: 8410101 country: Israel name: Itzhak Gabizon role: PRINCIPAL_INVESTIGATOR lat: 31.25181 lon: 34.7913 facility: Edith Wolfson Medical Center status: NOT_YET_RECRUITING city: Holon state: HaMerkaz zip: 5810001 country: Israel name: orit twito role: PRINCIPAL_INVESTIGATOR lat: 32.01034 lon: 34.77918 facility: Meir Medical Center status: NOT_YET_RECRUITING city: Kfar Saba state: HaMerkaz zip: 4428164 country: Israel name: Victor Vishlitzky role: PRINCIPAL_INVESTIGATOR lat: 32.175 lon: 34.90694 facility: Rabin Medical Center status: NOT_YET_RECRUITING city: Petah Tikva state: HaMerkaz zip: 4941492 country: Israel name: Avishay Elis role: PRINCIPAL_INVESTIGATOR lat: 32.08707 lon: 34.88747 facility: Rabin Medical Center status: NOT_YET_RECRUITING city: Petah-Tikva state: HaMerkaz zip: 4941492 country: Israel name: Alejandro Solodky role: PRINCIPAL_INVESTIGATOR lat: 32.08707 lon: 34.88747 facility: Sheba Medical Center status: NOT_YET_RECRUITING city: Ramat Gan state: HaMerkaz zip: 5262100 country: Israel name: Michael Shechter role: PRINCIPAL_INVESTIGATOR lat: 32.08227 lon: 34.81065 facility: Sheba Medical Center status: NOT_YET_RECRUITING city: Ramat Gan state: HaMerkaz zip: 5265601 country: Israel name: Hofit Cohen role: PRINCIPAL_INVESTIGATOR lat: 32.08227 lon: 34.81065 facility: Kaplan Medical Center status: NOT_YET_RECRUITING city: Rehovot state: HaMerkaz zip: 7610001 country: Israel name: Viviana Ostrovsky role: PRINCIPAL_INVESTIGATOR lat: 31.89421 lon: 34.81199 facility: Rambam Health Care Campus status: RECRUITING city: Haifa state: HaTsafon zip: 3109601 country: Israel name: oren caspi role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 facility: Galilee Medical Center status: NOT_YET_RECRUITING city: Nahariya state: HaTsafon zip: 2210001 country: Israel name: Shaul Atar role: PRINCIPAL_INVESTIGATOR lat: 33.00892 lon: 35.09814 facility: Sourasky Medical Center status: NOT_YET_RECRUITING city: Tel Aviv state: Tell Abīb zip: 6423906 country: Israel name: Elena Izkhakov role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 facility: Sourasky Medical Center status: NOT_YET_RECRUITING city: Tel Aviv state: Tell Abīb zip: 6423906 country: Israel name: Yaron Arbel role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 facility: Shaare Zedek Medical Center status: NOT_YET_RECRUITING city: Jerusalem state: Yerushalayim zip: 9013102 country: Israel name: Dov Gavish role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 facility: Hadassah Medical Center status: RECRUITING city: Jerusalem state: Yerushalayim zip: 9112001 country: Israel name: Ronen Durst role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 facility: Hadassah Medical Center status: RECRUITING city: Jerusalem state: Yerushalayim zip: 9112001 country: Israel name: Daniel Schurr role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 facility: Rambam Health Care Campus status: NOT_YET_RECRUITING city: Haifa state: Ḥeifā zip: 3109601 country: Israel name: Tony Hayek role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 facility: Carmel Hospital status: NOT_YET_RECRUITING city: Haifa state: Ḥeifā zip: 3436212 country: Israel name: BARAK ZAFRIR role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 facility: Azienda Ospedaliero Universitaria S.Anna status: NOT_YET_RECRUITING city: Ferrara state: Emilia-Romagna zip: 44100 country: Italy name: Alessandro Fucili role: PRINCIPAL_INVESTIGATOR lat: 44.83804 lon: 11.62057 facility: Policlinico Umberto I status: NOT_YET_RECRUITING city: Rome state: Lazio zip: 00161 country: Italy name: Marcello Arca role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Ospedale San Martino status: NOT_YET_RECRUITING city: Genova state: Liguria zip: 16132 country: Italy name: LIVIA PISCIOTTA role: PRINCIPAL_INVESTIGATOR lat: 44.40478 lon: 8.94438 facility: Ospedale Bassini status: NOT_YET_RECRUITING city: Cinisello Balsamo state: Milano zip: 20092 country: Italy name: Paolo Fabbrini role: PRINCIPAL_INVESTIGATOR lat: 45.55823 lon: 9.21495 facility: Centro Cardiologico Monzino status: NOT_YET_RECRUITING city: Milan state: Milano zip: 20138 country: Italy name: José Pablo Werba role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: ASST Grande Ospedale Metropolitano Niguarda status: NOT_YET_RECRUITING city: Milan state: Milano zip: 20162 country: Italy name: Alessandro Maloberti role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Ospedale di Baggiovara status: NOT_YET_RECRUITING city: Baggiovara state: Modena zip: 41126 country: Italy name: Fabio Nascimbeni role: PRINCIPAL_INVESTIGATOR lat: 44.60416 lon: 10.86256 facility: Azienda Ospedaliera Universitaria Careggi status: NOT_YET_RECRUITING city: Firenze state: Toscana zip: 50134 country: Italy name: rossella marcucci role: PRINCIPAL_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliera Universitaria Pisana status: NOT_YET_RECRUITING city: Pisa state: Toscana zip: 56124 country: Italy name: Ferruccio Santini role: PRINCIPAL_INVESTIGATOR lat: 43.70853 lon: 10.4036 facility: Fondazione G. Monasterio status: NOT_YET_RECRUITING city: Pisa state: Toscana zip: 56124 country: Italy name: Francesco Sbrana role: PRINCIPAL_INVESTIGATOR lat: 43.70853 lon: 10.4036 facility: Ospedale Cazzavillan di Arzignano status: NOT_YET_RECRUITING city: Arzignano state: Veneto zip: 36071 country: Italy name: Claudio Bilato role: PRINCIPAL_INVESTIGATOR lat: 45.52027 lon: 11.33446 facility: Azienda Ospedaliera di Padova status: NOT_YET_RECRUITING city: Padova state: Veneto zip: 35128 country: Italy name: Alberto Zambon role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: IRCCS - AOU di Bologna status: NOT_YET_RECRUITING city: Bologna zip: 40138 country: Italy name: Claudio Borghi role: PRINCIPAL_INVESTIGATOR lat: 44.49381 lon: 11.33875 facility: Ospedale San Raffaele status: NOT_YET_RECRUITING city: Milano zip: 20132 country: Italy name: Emanuela Setola role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Hospital Santa Maria della Misericordia in Perugia status: NOT_YET_RECRUITING city: Perugia zip: 06156 country: Italy name: Matteo Pirro role: PRINCIPAL_INVESTIGATOR lat: 43.1122 lon: 12.38878 facility: Kasugai Municipal Hospital status: RECRUITING city: Kasugai state: Aichi zip: 486-8510 country: Japan name: Mitsutoshi Oguri role: PRINCIPAL_INVESTIGATOR lat: 35.24762 lon: 136.97229 facility: Nagoya City University Hospital status: NOT_YET_RECRUITING city: Nagoya state: Aichi zip: 467-8602 country: Japan name: Tomohiro Tanaka role: PRINCIPAL_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Asahi Hospital - Asahi status: RECRUITING city: Asahi state: Chiba zip: 289-2511 country: Japan name: Shunichi Kushida role: PRINCIPAL_INVESTIGATOR lat: 35.71667 lon: 140.65 facility: Saiseikai Futsukaichi Hospital status: RECRUITING city: Chikushino state: Fukuoka zip: 818-8516 country: Japan name: Toshiaki Kadokami role: PRINCIPAL_INVESTIGATOR lat: 33.49631 lon: 130.5156 facility: Kokura Memorial Hospital status: NOT_YET_RECRUITING city: Kitakyushu state: Fukuoka zip: 802-8555 country: Japan name: Kenji Ando role: PRINCIPAL_INVESTIGATOR lat: 33.85181 lon: 130.85034 facility: Chugoku Rosai Hospital status: NOT_YET_RECRUITING city: Kure state: Hiroshima zip: 737-0193 country: Japan name: Keiji Matsuda role: PRINCIPAL_INVESTIGATOR lat: 34.23222 lon: 132.56658 facility: Asahikawa City Hospital status: RECRUITING city: Asahikawa state: Hokkaido zip: 070-8610 country: Japan name: Yoshihiro Miyamoto role: PRINCIPAL_INVESTIGATOR lat: 43.77063 lon: 142.36489 facility: Hospital Hakodate Hokkaido status: NOT_YET_RECRUITING city: Hakodate state: Hokkaido zip: 041-8680 country: Japan name: Yusuke Tokuda role: PRINCIPAL_INVESTIGATOR lat: 41.77583 lon: 140.73667 facility: Tokeidai Memorial Hospital status: NOT_YET_RECRUITING city: Sapporo state: Hokkaido zip: 060-0031 country: Japan name: Michinao Tan role: PRINCIPAL_INVESTIGATOR lat: 43.06667 lon: 141.35 facility: Sapporo Medical University Hospital status: NOT_YET_RECRUITING city: Sapporo state: Hokkaido zip: 060-8543 country: Japan name: Masato Furuhashi role: PRINCIPAL_INVESTIGATOR lat: 43.06667 lon: 141.35 facility: Japan Community Healthcare Organization Hokkaido Hospital status: RECRUITING city: Sapporo state: Hokkaido zip: 062-8618 country: Japan name: Masashige Takahashi role: PRINCIPAL_INVESTIGATOR lat: 43.06667 lon: 141.35 facility: Hyogo Prefectural Harima-Himeji General Medical Center status: RECRUITING city: Himeji state: Hyogo zip: 670-8560 country: Japan name: Tomofumi Takaya role: PRINCIPAL_INVESTIGATOR lat: 34.81667 lon: 134.7 facility: Kobe City Medical Center General Hospital status: NOT_YET_RECRUITING city: Kobe state: Hyogo zip: 650-0047 country: Japan name: Yutaka Furukawa role: PRINCIPAL_INVESTIGATOR lat: 34.6913 lon: 135.183 facility: Higashi Takarazuka Satoh Hospital status: RECRUITING city: Takarazuka state: Hyogo zip: 665-0873 country: Japan name: Katsuyuki Hasegawa role: PRINCIPAL_INVESTIGATOR lat: 34.79936 lon: 135.35697 facility: Takasago Seibu Hospital status: RECRUITING city: Takasago state: Hyogo zip: 676-0812 country: Japan name: Katsunari Matsuoka role: PRINCIPAL_INVESTIGATOR facility: Tsuchiura Kyodo General Hospital status: RECRUITING city: Tsuchiura state: Ibaraki zip: 300-0028 country: Japan name: TSUNEKAZU KAKUTA role: PRINCIPAL_INVESTIGATOR lat: 36.09047 lon: 140.21047 facility: Public Matto Ishikawa Central Hospital status: NOT_YET_RECRUITING city: Hakusan state: Ishikawa zip: 924-0865 country: Japan name: HIROYUKI ODA role: PRINCIPAL_INVESTIGATOR facility: Ishikawa Prefectural Central Hospital status: NOT_YET_RECRUITING city: Kanazawa state: Ishikawa zip: 920-8530 country: Japan name: Kenji Miwa role: PRINCIPAL_INVESTIGATOR lat: 36.6 lon: 136.61667 facility: National Hospital Organization Kanazawa Medical Center status: RECRUITING city: Kanazawa state: Ishikawa zip: 920-8650 country: Japan name: Takahiro Saeki role: PRINCIPAL_INVESTIGATOR lat: 36.6 lon: 136.61667 facility: Komatsu Municipal Hospital status: NOT_YET_RECRUITING city: Komatsu state: Ishikawa zip: 923-8560 country: Japan name: Toshinori Higashikata role: PRINCIPAL_INVESTIGATOR lat: 36.40263 lon: 136.45088 facility: Kanazawa Medical University Hospital status: RECRUITING city: Uchinada state: Ishikawa zip: 920-0293 country: Japan name: Kouji Kajinami role: PRINCIPAL_INVESTIGATOR facility: Iwate Prefectural Central Hospital status: RECRUITING city: Morioka state: Iwate zip: 020-0066 country: Japan name: Akihiro Nakamura role: PRINCIPAL_INVESTIGATOR lat: 39.7 lon: 141.15 facility: Kagawa Prefectural Central Hospital status: NOT_YET_RECRUITING city: Takamatsu state: Kagawa zip: 760-8557 country: Japan name: Masayuki Doi role: PRINCIPAL_INVESTIGATOR lat: 34.33333 lon: 134.05 facility: Tokai University Hospital- Isehara Campus status: NOT_YET_RECRUITING city: Isehara state: Kanagawa zip: 259-1193 country: Japan name: Tsutomu Murakami role: PRINCIPAL_INVESTIGATOR lat: 35.39932 lon: 139.31019 facility: Takai Internal Medicine Clinic status: RECRUITING city: Kamakura-shi state: Kanagawa zip: 247-0056 country: Japan name: Masahiko Takai role: PRINCIPAL_INVESTIGATOR lat: 35.30889 lon: 139.55028 facility: Shonan Oiso Hospital status: RECRUITING city: Naka-gun state: Kanagawa zip: 259-0114 country: Japan name: Saeko Takahashi role: PRINCIPAL_INVESTIGATOR lat: 36.05 lon: 140.16667 facility: Kitasato University Hospital status: NOT_YET_RECRUITING city: Sagamihara state: Kanagawa zip: 252-0375 country: Japan name: Junya Ako role: PRINCIPAL_INVESTIGATOR lat: 35.54899 lon: 139.26064 facility: Saiseikai Yokohamashi Tobu Hospital status: NOT_YET_RECRUITING city: Yokohama state: Kanagawa zip: 230-8765 country: Japan name: Takamasa Ichijo role: PRINCIPAL_INVESTIGATOR lat: 35.43333 lon: 139.65 facility: Yokosukakyosai status: NOT_YET_RECRUITING city: Yokosuka state: Kanagawa zip: 238-8558 country: Japan name: Keiichi Hishikari role: PRINCIPAL_INVESTIGATOR lat: 35.28361 lon: 139.66722 facility: Osaki Citizen Hospital - Furukawahonami status: NOT_YET_RECRUITING city: Ōsaki state: Miyagi zip: 989-6183 country: Japan name: Junpei Yamamoto role: PRINCIPAL_INVESTIGATOR facility: Miyakonojo Medical Association Hospital - Tarobocho status: RECRUITING city: Miyakonojo state: Miyazaki zip: 885-0002 country: Japan name: Hironao Iwakiri role: PRINCIPAL_INVESTIGATOR lat: 31.73333 lon: 131.06667 facility: Aizawa Hospital status: NOT_YET_RECRUITING city: Matsumoto state: Nagano zip: 390-8510 country: Japan name: Koh Yamashita role: PRINCIPAL_INVESTIGATOR lat: 36.23333 lon: 137.96667 facility: National Hospital Organization Shinshu Ueda Medical Center status: NOT_YET_RECRUITING city: Ueda state: Nagano zip: 386-8610 country: Japan name: Yasufumi Takahashi role: PRINCIPAL_INVESTIGATOR lat: 36.40265 lon: 138.28161 facility: Tachikawa Medical Center status: NOT_YET_RECRUITING city: Nagaoka state: Niigata zip: 940-8621 country: Japan name: Koichi Fuse role: PRINCIPAL_INVESTIGATOR lat: 37.45 lon: 138.85 facility: Kurashiki Central Hospital status: NOT_YET_RECRUITING city: Kurashiki state: Okayama zip: 710-8602 country: Japan name: Kazushige Kadota role: PRINCIPAL_INVESTIGATOR lat: 34.58333 lon: 133.76667 facility: Rinku General Medical Center status: RECRUITING city: Izumisano state: Osaka zip: 598-8577 country: Japan name: Daisaku Masuda role: PRINCIPAL_INVESTIGATOR lat: 34.41663 lon: 135.31667 facility: Medical Corporation Heishinkai OCROM Clinic status: RECRUITING city: Suita-shi state: Osaka zip: 565-0853 country: Japan name: Satoshi Inoue role: PRINCIPAL_INVESTIGATOR lat: 34.76143 lon: 135.51567 facility: National Cerebral and Cardiovascular Center status: NOT_YET_RECRUITING city: Suita state: Osaka zip: 564-8565 country: Japan name: Yu Kataoka role: PRINCIPAL_INVESTIGATOR lat: 34.76143 lon: 135.51567 facility: Osaka Medical and Pharmaceutical University Hospital status: NOT_YET_RECRUITING city: Takatsuki state: Osaka zip: 569-8686 country: Japan name: Masaaki Hoshiga role: PRINCIPAL_INVESTIGATOR lat: 34.84833 lon: 135.61678 facility: Shizuoka Medical Center status: NOT_YET_RECRUITING city: Sunto-gun state: Shizuoka zip: 411-8611 country: Japan name: Jun Tanabe role: PRINCIPAL_INVESTIGATOR facility: International University of Health and Welfare Hospital status: NOT_YET_RECRUITING city: Nasushiobara state: Tochigi zip: 329-2763 country: Japan name: Morihiko Takeda role: PRINCIPAL_INVESTIGATOR lat: 36.97817 lon: 140.03054 facility: The Institute for Adult Disease, Asahi Life Foundation status: RECRUITING city: Chuo-ku state: Tokyo zip: 103-0002 country: Japan name: Yukiko Onishi role: PRINCIPAL_INVESTIGATOR lat: 35.57779 lon: 139.71685 facility: Fukuwa Clinic status: RECRUITING city: Chuo-ku state: Tokyo zip: 104-0031 country: Japan name: Yasushi Fukushima role: PRINCIPAL_INVESTIGATOR lat: 35.57779 lon: 139.71685 facility: National Hospital Organization Tokyo Medical Center status: NOT_YET_RECRUITING city: Meguro-ku state: Tokyo zip: 152-8902 country: Japan name: Kojiro Tanimoto role: PRINCIPAL_INVESTIGATOR lat: 42.12755 lon: 143.31736 facility: Nogata Clinic status: RECRUITING city: Nakano-ku state: Tokyo zip: 165-0027 country: Japan name: Shinji Wakui role: PRINCIPAL_INVESTIGATOR lat: 36.75 lon: 138.36667 facility: Medical Corporation Sato Medical clinic status: NOT_YET_RECRUITING city: Ootaku state: Tokyo zip: 143-0015 country: Japan name: Nobuyuki Sato role: PRINCIPAL_INVESTIGATOR facility: Heishinkai Medical Group ToCROM Clinic status: RECRUITING city: Shinjuku-ku state: Tokyo zip: 160-0008 country: Japan name: Osamu Matsuoka role: PRINCIPAL_INVESTIGATOR lat: 35.2946 lon: 139.57059 facility: Center Hospital of the National Center for Global Health and Medicine status: NOT_YET_RECRUITING city: Shinjyuku-ku state: Tokyo zip: 162-8655 country: Japan name: Yukio Hiroi role: PRINCIPAL_INVESTIGATOR facility: Sekino Hospital status: RECRUITING city: Toshimaku state: Tokyo zip: 171-0014 country: Japan name: Hisakuni Sekino role: PRINCIPAL_INVESTIGATOR facility: Toyama University Hospital status: NOT_YET_RECRUITING city: Toyoma state: Toyama zip: 930-0194 country: Japan name: Hiroshi Ueno role: PRINCIPAL_INVESTIGATOR facility: Tokuyama Central Hospital status: NOT_YET_RECRUITING city: Shunan state: Yamaguchi zip: 745-8522 country: Japan name: Takatoshi Wakeyama role: PRINCIPAL_INVESTIGATOR lat: 34.08053 lon: 131.82564 facility: University of Yamanashi Hospital status: NOT_YET_RECRUITING city: Chuo state: Yamanashi zip: 409-3898 country: Japan name: Takamitsu Nakamura role: PRINCIPAL_INVESTIGATOR lat: 35.57779 lon: 139.71685 facility: Fukuoka Wajiro Hospital status: NOT_YET_RECRUITING city: Fukuoka zip: 811-0213 country: Japan name: Takeshi Serikawa role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: Tenyoukai Chuo Clinic status: RECRUITING city: Kagoshima zip: 892-0822 country: Japan name: Nobuhiko Atsuchi role: PRINCIPAL_INVESTIGATOR lat: 31.56667 lon: 130.55 facility: Jinnouchi Hospital status: RECRUITING city: Kumamoto zip: 862-0976 country: Japan name: Hideaki Jinnouchi role: PRINCIPAL_INVESTIGATOR lat: 32.80589 lon: 130.69182 facility: Rakuwakai Marutamachi Hospital status: RECRUITING city: Kyoto zip: 604-8401 country: Japan name: Shinichiro Yamaguchi role: PRINCIPAL_INVESTIGATOR lat: 35.02107 lon: 135.75385 facility: Rakuwakai Otowa Hospital status: RECRUITING city: Kyoto zip: 607-8062 country: Japan name: Hirokazu Yokoi role: PRINCIPAL_INVESTIGATOR lat: 35.02107 lon: 135.75385 facility: Miyazaki Medical Association Hospital status: RECRUITING city: Miyazaki zip: 880-2102 country: Japan name: Yoshisato Shibata role: PRINCIPAL_INVESTIGATOR lat: 31.91667 lon: 131.41667 facility: Okayama City General Medical Center Okayama City Hospital status: RECRUITING city: Okayama zip: 700-8557 country: Japan name: Yusuke Kawai role: PRINCIPAL_INVESTIGATOR lat: 34.65 lon: 133.93333 facility: National Hospital Organization Okayama Medical Center status: NOT_YET_RECRUITING city: Okayama zip: 701-1192 country: Japan name: Atsuyuki Watanabe role: PRINCIPAL_INVESTIGATOR lat: 34.65 lon: 133.93333 facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research status: NOT_YET_RECRUITING city: Osaka zip: 540-0006 country: Japan name: Yasunori Ueda role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: Osaka Police Hospital status: RECRUITING city: Osaka zip: 543-0035 country: Japan name: Yoshiharu Higuchi role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: Kansai Electric Power Hospital status: NOT_YET_RECRUITING city: Osaka zip: 553-0003 country: Japan name: Yoshiyuki Initials Hamamoto role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: Osaka General Medical Center status: NOT_YET_RECRUITING city: Osaka zip: 558-8558 country: Japan name: Takahisa Yamada role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: Saga University Hospital status: NOT_YET_RECRUITING city: Saga zip: 849-8501 country: Japan name: Koichi Node role: PRINCIPAL_INVESTIGATOR lat: 33.23333 lon: 130.3 facility: Sanai Hospital - Saitama status: NOT_YET_RECRUITING city: Saitama zip: 338-0837 country: Japan name: Akitaka Nakata role: PRINCIPAL_INVESTIGATOR lat: 35.90807 lon: 139.65657 facility: Gachon University Gil Medical Center status: RECRUITING city: Namdong-gu state: Incheon-gwangyeoksi [Incheon] zip: 21565 country: Korea, Republic of name: Youngwoo Jang role: PRINCIPAL_INVESTIGATOR facility: Yonsei University-Wonju Severance Christian Hospital status: RECRUITING city: Wonju state: Kang-won-do zip: 26426 country: Korea, Republic of name: Byung-Su Yoo role: PRINCIPAL_INVESTIGATOR lat: 37.35139 lon: 127.94528 facility: Chonnam National University Hospital status: RECRUITING city: Gwangju-si state: Kwangju-Kwangyǒkshi zip: 61469 country: Korea, Republic of name: Youngkeun Ahn role: PRINCIPAL_INVESTIGATOR lat: 35.15472 lon: 126.91556 facility: The Catholic University of Korea, Bucheon St. Mary's Hospital status: RECRUITING city: Bucheon-si state: Kyǒnggi-do zip: 14647 country: Korea, Republic of name: SoonJib Yoo role: PRINCIPAL_INVESTIGATOR lat: 37.49889 lon: 126.78306 facility: Seoul National University Bundang Hospital status: NOT_YET_RECRUITING city: Seongnam state: Kyǒnggi-do zip: 13620 country: Korea, Republic of name: IN-HO CHAE role: PRINCIPAL_INVESTIGATOR lat: 37.43861 lon: 127.13778 facility: Seoul National University Bundang Hospital status: NOT_YET_RECRUITING city: Seongnam state: Kyǒnggi-do zip: 13620 country: Korea, Republic of name: Sung Hee Choi role: PRINCIPAL_INVESTIGATOR lat: 37.43861 lon: 127.13778 facility: Sejong General Hospital status: NOT_YET_RECRUITING city: Sosa-gu state: Kyǒnggi-do zip: 14754 country: Korea, Republic of name: Hyun-Jong Lee role: PRINCIPAL_INVESTIGATOR facility: The Catholic University Of Korea St. Vincent's Hospital status: NOT_YET_RECRUITING city: Suwon-si state: Kyǒnggi-do zip: 16247 country: Korea, Republic of name: Seung Hyun Ko role: PRINCIPAL_INVESTIGATOR lat: 37.29111 lon: 127.00889 facility: Boramae Medical Center status: NOT_YET_RECRUITING city: Dongjak-gu state: Seoul-teukbyeolsi [Seoul] zip: 07061 country: Korea, Republic of name: Min Kyong Moon role: PRINCIPAL_INVESTIGATOR facility: Boramae Medical Center status: NOT_YET_RECRUITING city: Dongjak-gu state: Seoul-teukbyeolsi [Seoul] zip: 07061 country: Korea, Republic of name: SANG-HYUN KIM role: PRINCIPAL_INVESTIGATOR facility: Kyung Hee University Hospital status: NOT_YET_RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 02447 country: Korea, Republic of name: Weon Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Korea University Anam Hospital status: RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 02841 country: Korea, Republic of name: Soon Jun Hong role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Seoul National University Hospital status: NOT_YET_RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 03080 country: Korea, Republic of name: Hyun-Jae Kang role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Kangbuk Samsung Hospital status: RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 03181 country: Korea, Republic of name: ByungJin Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Severance Hospital, Yonsei University Health System status: NOT_YET_RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 03722 country: Korea, Republic of name: Sang-Hak Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: NOT_YET_RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 05505 country: Korea, Republic of name: KI HOON HAN role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: NOT_YET_RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 05505 country: Korea, Republic of name: WOO JE LEE role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital status: NOT_YET_RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 06591 country: Korea, Republic of name: Kiyuk Chang role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital status: NOT_YET_RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 06591 country: Korea, Republic of name: Seung-Hwan Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Kyung Hee University Hospital at Gangdong status: RECRUITING city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 134-090 country: Korea, Republic of name: In-Kyung Jeong role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Daegu Catholic University Medical Center status: NOT_YET_RECRUITING city: Daegu state: Taegu-Kwangyǒkshi zip: 42472 country: Korea, Republic of name: SEUNGPYO HONG role: PRINCIPAL_INVESTIGATOR lat: 35.87028 lon: 128.59111 facility: Keimyung University Dongsan Hospital status: RECRUITING city: Daegu state: Taegu-Kwangyǒkshi zip: 42601 country: Korea, Republic of name: Seung-Ho Hur role: PRINCIPAL_INVESTIGATOR lat: 35.87028 lon: 128.59111 facility: Eulji University Hospital status: NOT_YET_RECRUITING city: Daejeon state: Taejǒn-Kwangyǒkshi zip: 01830 country: Korea, Republic of name: Jun-Hwa Hong role: PRINCIPAL_INVESTIGATOR lat: 36.32139 lon: 127.41972 facility: Ulsan University Hospital status: NOT_YET_RECRUITING city: Ulsan state: Ulsan-Kwangyǒkshi zip: 44033 country: Korea, Republic of name: GYUNGMIN PARK role: PRINCIPAL_INVESTIGATOR lat: 35.53722 lon: 129.31667 facility: Centro de Investigacion Cardiovascular y Metabólica status: NOT_YET_RECRUITING city: Tijuana state: Baja California zip: 22500 country: Mexico name: Pedro Fajardo Campos role: PRINCIPAL_INVESTIGATOR lat: 32.5027 lon: -117.00371 facility: Centro Médico Nacional Siglo XXI status: NOT_YET_RECRUITING city: Ciudad de México state: Distrito Federal zip: 06720 country: Mexico name: Juan Ivey Miranda role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: RM Pharma Specialists status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 03100 country: Mexico name: Mariana Zolandi Crespo role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Clínicos Asociados BOCM status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 03300 country: Mexico name: Israel Olvera-Alvarez role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Grupo Medico Camino Sc status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 03310 country: Mexico name: JORGE SIERRA role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Hospital de Jésus, I.A.P. status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 06090 country: Mexico name: Efrain Villeda Espinosa role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Clinica Omega status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 06700 country: Mexico name: Jose Hector Sanchez Mijangos role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 11650 country: Mexico name: Melchor Alpizar Salazar role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: ProcliniQ Investigación Clínica SA de CV status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 14050 country: Mexico name: Mauricio Lopez Meneses role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 14080 country: Mexico name: Carlos Aguilar Salinas role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Clinstile, S.A. de C.V. status: NOT_YET_RECRUITING city: Mexico state: Distrito Federal zip: 06700 country: Mexico name: Vicente Eduardo Ruiz Ruiz role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Medimanage Research status: NOT_YET_RECRUITING city: Tlalpan state: Distrito Federal zip: 14050 country: Mexico name: Nydia Avila-Vanzzini role: PRINCIPAL_INVESTIGATOR lat: 19.29513 lon: -99.16206 facility: Instituto Cardiovascular de León S.C. status: NOT_YET_RECRUITING city: León state: Guanajuato zip: 37520 country: Mexico name: Luis Adolfo Venegas Carrillo role: PRINCIPAL_INVESTIGATOR lat: 21.12908 lon: -101.67374 facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 04460 country: Mexico name: Guillermo Gonzalez Galvez role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Diseno y Planeacion en Investigacion Medica status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44130 country: Mexico name: Cesar Calvo role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Centro de Investigacion Medica Integral status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44160 country: Mexico name: Carlos Alejandro Stobschinski de Alba role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Unidad de Investigación Clínica y Atención Médica HEPA status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44670 country: Mexico name: Marisol Herrera Marmolejo role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Virgen Cardiovascular Research SC status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44670 country: Mexico name: Luis Ramon Virgen Carrillo role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: CINVEC Medica status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44690 country: Mexico name: Alejandro Avila Carrillo role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Clinica de Enfermedades Crónicas y de Procedimientos Especiales status: NOT_YET_RECRUITING city: Morelia state: Michoacán zip: 58249 country: Mexico name: Helios Vega role: PRINCIPAL_INVESTIGATOR lat: 19.70078 lon: -101.18443 facility: Instituto de Diabetes, Obesidad y Nutricion status: NOT_YET_RECRUITING city: Cuernavaca state: Morelos zip: 62250 country: Mexico name: Leobardo Sauque Reyna role: PRINCIPAL_INVESTIGATOR lat: 18.9261 lon: -99.23075 facility: CHRISTUS Centro de Excelencia en Investigación (Norte) status: NOT_YET_RECRUITING city: General Escobedo state: Nuevo León zip: 66055 country: Mexico name: Ivan Rosendo Salinas Cavazos role: PRINCIPAL_INVESTIGATOR lat: 25.79698 lon: -100.31791 facility: Accelerium Clinical Research status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64000 country: Mexico name: Eduardo Roderick Elizondo Moreno role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Cardiolink Clin Trials status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64060 country: Mexico name: Elías García role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: RAMIRO FLORES-RAMIREZ role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: Jose Gerardo Gonzalez Gonzalez role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Unidad biomedica avanzada monterrey status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: Raymundo Garcia Reza role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Clínica García Flores SC status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64610 country: Mexico name: Pedro Alberto Garcia role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Centro de investigación y control metabólico status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 66465 country: Mexico name: Víctor Castelán Vargas role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Servicios Integrales Nova de Monterrey S.A. de C.V. status: NOT_YET_RECRUITING city: San Nicolas de los Garza state: Nuevo León zip: 66450 country: Mexico name: Maria Elena Romero-Ibarguengoitia role: PRINCIPAL_INVESTIGATOR lat: 25.74167 lon: -100.30222 facility: Centro de Investigacion Clinica de Oaxaca status: NOT_YET_RECRUITING city: Oaxaca de Juarez state: Oaxaca zip: 68020 country: Mexico name: Jesus Antonio Perez Ríos role: PRINCIPAL_INVESTIGATOR lat: 17.06542 lon: -96.72365 facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. status: NOT_YET_RECRUITING city: Culiacan state: Sinaloa zip: 80230 country: Mexico name: Manuel Odin de los Rios Ibarra role: PRINCIPAL_INVESTIGATOR lat: 24.79032 lon: -107.38782 facility: Investigación Médica Sonora, S.C. status: NOT_YET_RECRUITING city: Hermosillo state: Sonora zip: 83270 country: Mexico name: Diego Espinoza Peralta role: PRINCIPAL_INVESTIGATOR lat: 29.1026 lon: -110.97732 facility: Meander Medisch Centrum status: NOT_YET_RECRUITING city: Amersfoort state: Utrecht zip: 3813 TZ country: Mexico name: Arend Mosterd role: PRINCIPAL_INVESTIGATOR facility: Hospital Angeles Xalapa status: NOT_YET_RECRUITING city: Xalapa state: Veracruz zip: 91193 country: Mexico name: Gustavo Mendez Machado role: PRINCIPAL_INVESTIGATOR lat: 19.53124 lon: -96.91589 facility: Medical Care and Research SA de CV status: NOT_YET_RECRUITING city: Merida state: Yucatán zip: 97070 country: Mexico name: Christian Gonzalez role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: Groene Hart Ziekenhuis status: NOT_YET_RECRUITING city: Gouda state: Zuid-Holland zip: 2803HH country: Mexico name: Stefan Koudstaal role: PRINCIPAL_INVESTIGATOR facility: Centro de Investigación Cardiometabólica de Aguascalientes status: NOT_YET_RECRUITING city: Aguascalientes zip: 20230 country: Mexico name: Enrique Cuitlahuac Morales-Villegas role: PRINCIPAL_INVESTIGATOR lat: 21.88234 lon: -102.28259 facility: Fundación Cardiovascular de Aguascalientes A.C. status: NOT_YET_RECRUITING city: Aguascalientes zip: 20230 country: Mexico name: Edmundo Alfredo Bayram Llamas role: PRINCIPAL_INVESTIGATOR lat: 21.88234 lon: -102.28259 facility: Hospital Cardiologica Aguescalientes status: NOT_YET_RECRUITING city: Aguascalientes zip: 20230 country: Mexico name: Guillermo Antonio Llamas Esperon role: PRINCIPAL_INVESTIGATOR lat: 21.88234 lon: -102.28259 facility: Enclifar Ensayos Clínicos Farmacológicos Sc status: NOT_YET_RECRUITING city: Chihuahua zip: 31110 country: Mexico name: Luis Alejandro Nevarez role: PRINCIPAL_INVESTIGATOR lat: 28.63528 lon: -106.08889 facility: Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia status: NOT_YET_RECRUITING city: Durango zip: 34000 country: Mexico name: Juan Carlos Núñez Fragoso role: PRINCIPAL_INVESTIGATOR lat: 24.02032 lon: -104.65756 facility: Centro de Estudios Clínicos de Querétaro (CECLIQ) status: NOT_YET_RECRUITING city: Querétaro zip: 76000 country: Mexico name: Marco Antonio Alcocer Gamba role: PRINCIPAL_INVESTIGATOR facility: PanAmerican Clinical Research - Querétaro - Avenida Antea status: NOT_YET_RECRUITING city: Querétaro zip: 76100 country: Mexico name: Juan Villagordoa Mesa role: PRINCIPAL_INVESTIGATOR facility: Centro de Atención e Investigación Cardiovascular del Potosí status: NOT_YET_RECRUITING city: San Luis Potosí zip: 78200 country: Mexico name: José Rivera Arellano role: PRINCIPAL_INVESTIGATOR lat: 22.14982 lon: -100.97916 facility: Universitair Medisch Centrum Utrecht status: NOT_YET_RECRUITING city: Utrecht zip: 3584 CX country: Mexico name: Jannick Dorresteijn role: PRINCIPAL_INVESTIGATOR facility: Instituto Veracruzano en Investigación Clínica S.C. status: NOT_YET_RECRUITING city: Veracruz zip: 91851 country: Mexico name: Rosa Isela Luna Ceballos role: PRINCIPAL_INVESTIGATOR lat: 19.18095 lon: -96.1429 facility: Medische Centrum Leeuwarden status: NOT_YET_RECRUITING city: Leeuwarden state: Fryslân zip: 8934 AD country: Netherlands name: T. Vossenberg role: PRINCIPAL_INVESTIGATOR lat: 53.20139 lon: 5.80859 facility: Antonius Ziekenhuis, locatie D&A Research and Genetics status: NOT_YET_RECRUITING city: Sneek state: Fryslân zip: 8601 ZR country: Netherlands name: Renee Duitman role: PRINCIPAL_INVESTIGATOR lat: 53.03297 lon: 5.6589 facility: Gelre Ziekenhuis status: NOT_YET_RECRUITING city: Apeldoorn state: Gelderland zip: 7334 DZ country: Netherlands name: Bjorn Groenemeijer role: PRINCIPAL_INVESTIGATOR lat: 52.21 lon: 5.96944 facility: Slingeland Ziekenhuis status: NOT_YET_RECRUITING city: Doetinchem state: Gelderland zip: 7009 BL country: Netherlands name: Jeroen Jaspers Focks role: PRINCIPAL_INVESTIGATOR lat: 51.965 lon: 6.28889 facility: Ziekenhuis Gelderse Vallei status: NOT_YET_RECRUITING city: Ede state: Gelderland zip: 6716 RP country: Netherlands name: Thomas Oosterhof role: PRINCIPAL_INVESTIGATOR lat: 52.03333 lon: 5.65833 facility: Ziekenhuis St. Jansdal status: NOT_YET_RECRUITING city: Harderwijk state: Gelderland zip: 3844 DG country: Netherlands name: Marc van der Zee role: PRINCIPAL_INVESTIGATOR lat: 52.34167 lon: 5.62083 facility: Radboudumc status: NOT_YET_RECRUITING city: Nijmegen state: Gelderland zip: 6525 GA country: Netherlands name: Saloua El Messaoudi role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 facility: VieCuri Medisch Centrum, locatie Venlo status: NOT_YET_RECRUITING city: Venlo state: Limburg zip: 5912 BL country: Netherlands name: Wouter Remkes role: PRINCIPAL_INVESTIGATOR lat: 51.37 lon: 6.16806 facility: Jeroen Bosch ziekenhuis status: NOT_YET_RECRUITING city: Den Bosch state: Noord-Brabant zip: 5223 GZ country: Netherlands name: Martijn van Eck role: PRINCIPAL_INVESTIGATOR lat: 51.27 lon: 5.59167 facility: Catharina Ziekenhuis status: NOT_YET_RECRUITING city: Eindhoven state: Noord-Brabant zip: 5623 EJ country: Netherlands name: Guus Brueren role: PRINCIPAL_INVESTIGATOR lat: 51.44083 lon: 5.47778 facility: Bravis Ziekenhuis, locatie Roosendaal status: NOT_YET_RECRUITING city: Roosendaal state: Noord-Brabant zip: 4708 AE country: Netherlands name: Reinhart Dorman role: PRINCIPAL_INVESTIGATOR lat: 51.53083 lon: 4.46528 facility: ETZ TweeSteden status: NOT_YET_RECRUITING city: Tilburg state: Noord-Brabant zip: 5042 AD country: Netherlands name: Pascalle Monraats role: PRINCIPAL_INVESTIGATOR lat: 51.55551 lon: 5.0913 facility: Maxima Medisch Centrum, locatie Veldhoven status: NOT_YET_RECRUITING city: Veldhoven state: Noord-Brabant zip: 5504 DB country: Netherlands name: Sabine Eijsbouts role: PRINCIPAL_INVESTIGATOR lat: 51.41833 lon: 5.40278 facility: Onze Lieve Vrouwe Gasthuis status: NOT_YET_RECRUITING city: Amsterdam state: Noord-Holland zip: 1091 AC country: Netherlands name: Ton Slagboom role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Amsterdam UMC, locatie AMC status: NOT_YET_RECRUITING city: Amsterdam state: Noord-Holland zip: 1105 AZ country: Netherlands name: Erik Stroes role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Rode Kruis Ziekenhuis status: NOT_YET_RECRUITING city: Beverwijk state: Noord-Holland zip: 1942 LE country: Netherlands name: Iris Westendorp role: PRINCIPAL_INVESTIGATOR lat: 52.48333 lon: 4.65694 facility: Spaarne Gasthuis, Haarlem Zuid status: NOT_YET_RECRUITING city: Haarlem state: Noord-Holland zip: 2035 RC country: Netherlands name: Aaf Kuijper role: PRINCIPAL_INVESTIGATOR lat: 52.38084 lon: 4.63683 facility: Tergooiziekenhuizen, locatie Hilversum status: NOT_YET_RECRUITING city: Hilversum state: Noord-Holland zip: 1212 VG country: Netherlands name: Pieter Kamphuisen role: SUB_INVESTIGATOR lat: 52.22333 lon: 5.17639 facility: Zaans Medisch Centrum status: NOT_YET_RECRUITING city: Zaandam state: Noord-Holland zip: 1502 DV country: Netherlands name: P.A. Dijkmans role: PRINCIPAL_INVESTIGATOR lat: 52.43854 lon: 4.82643 facility: Deventer Ziekenhuis status: NOT_YET_RECRUITING city: Deventer state: Overijssel zip: 7416 SE country: Netherlands name: Elsemiek Engbers role: PRINCIPAL_INVESTIGATOR lat: 52.255 lon: 6.16389 facility: Saxenburgh Medisch Centrum status: NOT_YET_RECRUITING city: Hardenberg state: Overijssel zip: 7772 SE country: Netherlands name: Bas Bemmel role: PRINCIPAL_INVESTIGATOR lat: 52.57583 lon: 6.61944 facility: Admiraal de Ruyter Ziekenhuis, locatie Goes status: NOT_YET_RECRUITING city: Goes state: Zeeland zip: 4462 RA country: Netherlands name: Fesile Basar role: PRINCIPAL_INVESTIGATOR lat: 51.50417 lon: 3.88889 facility: Reinier de Graaf Ziekenhuis, locatie Delft status: NOT_YET_RECRUITING city: Delft state: Zuid-Holland zip: 2625 AD country: Netherlands name: Jan Constandse role: PRINCIPAL_INVESTIGATOR lat: 52.00667 lon: 4.35556 facility: Haga Ziekenhuis locatie Leyweg status: NOT_YET_RECRUITING city: Den Haag state: Zuid-Holland zip: 2545 AA country: Netherlands name: Albert Mairuhu role: PRINCIPAL_INVESTIGATOR lat: 52.07667 lon: 4.29861 facility: Leids Universitair Medisch Centrum status: NOT_YET_RECRUITING city: Leiden state: Zuid-Holland zip: 2333 ZA country: Netherlands name: Wouter Jukema role: PRINCIPAL_INVESTIGATOR lat: 52.15833 lon: 4.49306 facility: Erasmus Medisch Centrum status: NOT_YET_RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands name: Jeanine Roeters van Lennep role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: Ikazia Ziekenhuis status: NOT_YET_RECRUITING city: Rotterdam state: Zuid-Holland zip: 3083 AN country: Netherlands name: Mireille Emans role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: General Practitioners Research Institute (GPRI) status: NOT_YET_RECRUITING city: Groningen zip: 9713 GH country: Netherlands name: Janwillem WH Kocks role: PRINCIPAL_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: Martini Ziekenhuis status: NOT_YET_RECRUITING city: Groningen zip: 9728 NT country: Netherlands name: G.L. Bartels role: PRINCIPAL_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ status: NOT_YET_RECRUITING city: Wrocław state: Dolnośląskie zip: 50-981 country: Poland name: Bartosz Krakowiak role: PRINCIPAL_INVESTIGATOR lat: 51.1 lon: 17.03333 facility: NZOZ Centurm Medyczne SERAFIN-MED status: NOT_YET_RECRUITING city: Zarow state: Dolnośląskie zip: 58-130 country: Poland name: Ryszard Serafin role: PRINCIPAL_INVESTIGATOR lat: 50.94116 lon: 16.49466 facility: NZOZ Centrum Medyczne KERmed status: NOT_YET_RECRUITING city: Bydgoszcz state: Kujawsko-pomorskie zip: 85-231 country: Poland name: Tomasz Lugowski role: PRINCIPAL_INVESTIGATOR lat: 53.1235 lon: 18.00762 facility: INTERCOR status: NOT_YET_RECRUITING city: Bydgoszcz state: Kujawsko-pomorskie zip: 85-605 country: Poland name: Grzegorz Grzesk role: PRINCIPAL_INVESTIGATOR lat: 53.1235 lon: 18.00762 facility: Euromedica status: NOT_YET_RECRUITING city: Grudziadz state: Kujawsko-pomorskie zip: 86-300 country: Poland name: Piotr Kubalski role: PRINCIPAL_INVESTIGATOR lat: 53.48411 lon: 18.75366 facility: 1 Wojskowy Szpital Kliniczny w Lublinie status: NOT_YET_RECRUITING city: Lublin state: Lubelskie zip: 20-043 country: Poland name: Grzegorz Sobieszek role: PRINCIPAL_INVESTIGATOR lat: 51.25 lon: 22.56667 facility: CenterMed Lublin NZOZ status: NOT_YET_RECRUITING city: Lublin state: Lubelskie zip: 20-044 country: Poland name: Grzegorz Drelich role: PRINCIPAL_INVESTIGATOR lat: 51.25 lon: 22.56667 facility: Private Practice - Dr. Michał Tomaszewski status: NOT_YET_RECRUITING city: Lublin state: Lubelskie zip: 20-068 country: Poland name: Michal Tomaszewski role: PRINCIPAL_INVESTIGATOR lat: 51.25 lon: 22.56667 facility: Clinical Best Solutions status: NOT_YET_RECRUITING city: Lublin state: Lubelskie zip: 20-078 country: Poland name: MARZENA JANIK-PALAZZOLO role: PRINCIPAL_INVESTIGATOR lat: 51.25 lon: 22.56667 facility: Wielospecjalistyczny Szpital Samodzielny Publiczny Zakład Opieki Zdrowotnej w Nowej Soli status: NOT_YET_RECRUITING city: Nowa Sol state: Lubuskie zip: 67-100 country: Poland name: Jaroslaw Hiczkiewicz role: PRINCIPAL_INVESTIGATOR lat: 51.80333 lon: 15.71702 facility: WIP Warsaw IBD Point Profesor Kierkus status: NOT_YET_RECRUITING city: Warsaw state: Mazowieckie zip: 00-728 country: Poland name: Agata Krzesiak-Lodyga role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 facility: Balsam Medica status: NOT_YET_RECRUITING city: Warsaw state: Mazowieckie zip: 01-249 country: Poland name: Marcin Grabowski role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 facility: Clinical Best Solutions status: NOT_YET_RECRUITING city: Warszawa state: Mazowieckie zip: 00-710 country: Poland name: Joanna Niegowska role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 facility: Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo-Naczyniowe status: NOT_YET_RECRUITING city: Chrzanow state: Małopolskie zip: 32-500 country: Poland name: Aleksander Zurakowski role: PRINCIPAL_INVESTIGATOR lat: 50.13546 lon: 19.40203 facility: Centrum Medyczne Linden status: NOT_YET_RECRUITING city: Krakow state: Małopolskie zip: 30-721 country: Poland name: Beata Maria Bobrowska role: PRINCIPAL_INVESTIGATOR lat: 50.06143 lon: 19.93658 facility: NZOZ Diab-Endo-Met status: NOT_YET_RECRUITING city: Krakow state: Małopolskie zip: 31-261 country: Poland name: Magdalena Kwiatkowska role: PRINCIPAL_INVESTIGATOR lat: 50.06143 lon: 19.93658 facility: Centrum Szybkiej Diagnostyki Kardiologicznej "Kardiomed" M. Żabówka E. Żabówka status: NOT_YET_RECRUITING city: Tarnow state: Małopolskie zip: 33-100 country: Poland name: Maciej Stanislaw Zabowka role: PRINCIPAL_INVESTIGATOR lat: 50.01381 lon: 20.98698 facility: Polsko-Amerykańskie Kliniki Serca status: NOT_YET_RECRUITING city: Kedzierzyn-Kozle state: Opolskie zip: 47-200 country: Poland name: Janusz Prokopczuk role: PRINCIPAL_INVESTIGATOR lat: 50.34984 lon: 18.22606 facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu status: NOT_YET_RECRUITING city: Przemysl state: Podkarpackie zip: 37-700 country: Poland name: Lukasz Wisniowski role: PRINCIPAL_INVESTIGATOR lat: 49.78498 lon: 22.76728 facility: Specderm Poznanska status: NOT_YET_RECRUITING city: Bialystok state: Podlaskie zip: 15-375 country: Poland name: Katarzyna Ptaszynska role: PRINCIPAL_INVESTIGATOR lat: 53.13333 lon: 23.16433 facility: Uniwersyteckie Centrum Kliniczne status: NOT_YET_RECRUITING city: Gdańsk state: Pomorskie zip: 80-952 country: Poland name: Agnieszka Mickiewicz role: PRINCIPAL_INVESTIGATOR lat: 54.35205 lon: 18.64637 facility: Centrum Kliniczno-Badawcze status: NOT_YET_RECRUITING city: Elblag state: Warmińsko-mazurskie zip: 82-300 country: Poland name: Bozena Gornikiewicz-Brzezicka role: PRINCIPAL_INVESTIGATOR lat: 54.1522 lon: 19.40884 facility: NZOZ TwojeZdrowie status: NOT_YET_RECRUITING city: Elblag state: Warmińsko-mazurskie zip: 82-300 country: Poland name: Waldemar Bieniek role: PRINCIPAL_INVESTIGATOR lat: 54.1522 lon: 19.40884 facility: Poliklinika Kardiologiczna Serce status: NOT_YET_RECRUITING city: Leszno state: Wielkopolskie zip: 64-100 country: Poland name: Witold Piotrowski role: PRINCIPAL_INVESTIGATOR lat: 51.84034 lon: 16.57494 facility: Centra Medyczne Medyceusz status: NOT_YET_RECRUITING city: Lodz state: Łódzkie zip: 91-053 country: Poland name: Wlodzimierz Kus role: PRINCIPAL_INVESTIGATOR lat: 51.75 lon: 19.46667 facility: Pro Salus Centrum Medyczne status: NOT_YET_RECRUITING city: Lodz state: Łódzkie zip: 91-473 country: Poland name: Marcin Ojrzanowski role: PRINCIPAL_INVESTIGATOR lat: 51.75 lon: 19.46667 facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi status: NOT_YET_RECRUITING city: Łódź state: Łódzkie zip: 93-513 country: Poland name: Grzegorz Piotrowski role: PRINCIPAL_INVESTIGATOR lat: 51.75 lon: 19.46667 facility: Polsko-Amerykańskie Kliniki Serca II Oddział Kardiologiczny status: NOT_YET_RECRUITING city: Bielsko-Biala state: Śląskie zip: 43-300 country: Poland name: Krzysztof Milewski role: PRINCIPAL_INVESTIGATOR lat: 49.82245 lon: 19.04686 facility: Polsko-Amerykańskie Kliniki Serca status: NOT_YET_RECRUITING city: Dabrowa Gornicza state: Śląskie zip: 41-300 country: Poland name: Katarzyna Szymczyk role: PRINCIPAL_INVESTIGATOR lat: 50.31818 lon: 19.2374 facility: NZOZ Salvia CM status: NOT_YET_RECRUITING city: Katowice state: Śląskie zip: 40-772 country: Poland name: Andrzej Madej role: PRINCIPAL_INVESTIGATOR lat: 50.25841 lon: 19.02754 facility: AKA-MED Centrum status: NOT_YET_RECRUITING city: Ruda Slaska state: Śląskie zip: 41-710 country: Poland name: Janusz Spyra role: PRINCIPAL_INVESTIGATOR lat: 50.2584 lon: 18.85632 facility: Polsko-Amerykańskie Kliniki Serca status: NOT_YET_RECRUITING city: Tychy state: Śląskie zip: 43-100 country: Poland name: Adam Janas role: PRINCIPAL_INVESTIGATOR lat: 50.13717 lon: 18.96641 facility: Advanced Clinical Research, LLC status: RECRUITING city: Bayamón zip: 00959 country: Puerto Rico name: Angel Comulada-Rivera role: PRINCIPAL_INVESTIGATOR lat: 18.39856 lon: -66.15572 facility: GCM Medical Group, PSC - Hato Rey Site status: RECRUITING city: San Juan zip: 00917 country: Puerto Rico name: Gregorio Cortes-Maisonet role: PRINCIPAL_INVESTIGATOR lat: 18.46633 lon: -66.10572 facility: Nicodiab status: NOT_YET_RECRUITING city: Bucharest state: București zip: 010507 country: Romania name: NICOLETA MINDRESCU role: PRINCIPAL_INVESTIGATOR lat: 44.43225 lon: 26.10626 facility: Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului status: RECRUITING city: Bucharest state: București zip: 011053 country: Romania name: Ciprian Constantin role: PRINCIPAL_INVESTIGATOR lat: 44.43225 lon: 26.10626 facility: Centrul Medical NutriLife status: RECRUITING city: Bucharest state: București zip: 013764 country: Romania name: Marlena Pascu role: PRINCIPAL_INVESTIGATOR lat: 44.43225 lon: 26.10626 facility: Centrul Medical Endocrinologie si Diabet Dr. Paveliu status: RECRUITING city: Bucharest state: București zip: 50538 country: Romania name: Fraga Paveliu role: PRINCIPAL_INVESTIGATOR lat: 44.43225 lon: 26.10626 facility: Mat Cord Biomedica S.R.L. status: NOT_YET_RECRUITING city: Buzau state: Buzău country: Romania name: Florin Lucian Matei role: PRINCIPAL_INVESTIGATOR lat: 45.15 lon: 26.83333 facility: Spitalul Clinic Județean de Urgență status: NOT_YET_RECRUITING city: Craiova state: Dolj zip: 200642 country: Romania name: Octavian Istratoaie role: PRINCIPAL_INVESTIGATOR lat: 44.31667 lon: 23.8 facility: Private Practice - Dr. Mercea Corina Delia status: NOT_YET_RECRUITING city: Baia Mare state: Maramureș zip: 430123 country: Romania name: DELIA MERCEA role: PRINCIPAL_INVESTIGATOR lat: 47.65529 lon: 23.57381 facility: CMI DNBM Dr. Pop Lavinia status: RECRUITING city: Baia Mare state: Maramureș zip: 430222 country: Romania name: Lavinia Pop role: PRINCIPAL_INVESTIGATOR lat: 47.65529 lon: 23.57381 facility: SC Dentosim Queen SRL - Centrul Medical Diamed status: RECRUITING city: Târgu Mureș state: Mureș zip: 540098 country: Romania name: Daniela Ciomos role: PRINCIPAL_INVESTIGATOR lat: 46.54245 lon: 24.55747 facility: Cardiomed status: NOT_YET_RECRUITING city: Târgu Mureș state: Mureș zip: 540124 country: Romania name: Imre Benedek role: PRINCIPAL_INVESTIGATOR lat: 46.54245 lon: 24.55747 facility: Centrul Medical Mediab status: NOT_YET_RECRUITING city: Târgu-Mureș state: Mureș zip: 540142 country: Romania name: Carmen Crisan role: PRINCIPAL_INVESTIGATOR lat: 46.54245 lon: 24.55747 facility: Centrul Medical Mediab status: NOT_YET_RECRUITING city: Târgu-Mureș state: Mureș zip: 540142 country: Romania name: Adriana Cif role: PRINCIPAL_INVESTIGATOR lat: 46.54245 lon: 24.55747 facility: Private Practice - Dr. Cristian Podoleanu status: NOT_YET_RECRUITING city: Târgu-Mureș state: Mureș zip: 540143 country: Romania name: Cristian Podoleanu role: PRINCIPAL_INVESTIGATOR lat: 46.54245 lon: 24.55747 facility: Cabinet Medical Dr.Geru status: RECRUITING city: Timisoara state: Timiș zip: 300288 country: Romania name: Polina Geru role: PRINCIPAL_INVESTIGATOR lat: 45.75372 lon: 21.22571 facility: Institutul de Boli Cardiovasculare Timișoara status: NOT_YET_RECRUITING city: Timișoara state: Timiș zip: 300310 country: Romania name: Dan Gaita role: PRINCIPAL_INVESTIGATOR lat: 45.75372 lon: 21.22571 facility: C.M.D.T.A. Neomed status: NOT_YET_RECRUITING city: Brasov zip: 500283 country: Romania name: Sanziana Barbulescu role: PRINCIPAL_INVESTIGATOR lat: 45.64861 lon: 25.60613 facility: Spitalul Universitar de Urgență București status: NOT_YET_RECRUITING city: București zip: 050098 country: Romania name: DRAGOS VINEREANU role: PRINCIPAL_INVESTIGATOR lat: 44.42802 lon: 26.09665 facility: Milena Sante status: RECRUITING city: Galați zip: 800001 country: Romania name: Cristina-Victoria Mistodie role: PRINCIPAL_INVESTIGATOR lat: 45.45 lon: 28.05 facility: Diamed Obesity status: RECRUITING city: Galați zip: 800291 country: Romania name: Magdalena Morosanu role: PRINCIPAL_INVESTIGATOR lat: 45.45 lon: 28.05 facility: Centrul Medical Consultmed status: NOT_YET_RECRUITING city: Iași zip: 700547 country: Romania name: Delia Reurean-Pintilei role: PRINCIPAL_INVESTIGATOR lat: 47.16667 lon: 27.6 facility: Cardiomed Iași status: NOT_YET_RECRUITING city: Iași zip: 700687 country: Romania name: Sirona Lupu role: PRINCIPAL_INVESTIGATOR lat: 47.16667 lon: 27.6 facility: Clinica Korall status: RECRUITING city: Satu Mare zip: 440055 country: Romania name: Adriana Filimon role: PRINCIPAL_INVESTIGATOR lat: 47.79926 lon: 22.86255 facility: Policlinica Astra Sibiu status: RECRUITING city: Sibiu zip: 550371 country: Romania name: Georgiana Nicolescu role: PRINCIPAL_INVESTIGATOR lat: 45.8 lon: 24.15 facility: IN-DIA status: NOT_YET_RECRUITING city: Lucenec state: Banskobystrický Kraj zip: 984 01 country: Slovakia name: Livia Tomasova role: PRINCIPAL_INVESTIGATOR lat: 48.33249 lon: 19.66708 facility: ENRIN, s.r.o. status: NOT_YET_RECRUITING city: Rimavská Sobota state: Banskobystrický Kraj zip: 979 01 country: Slovakia name: Jana Horvath Bercikova role: PRINCIPAL_INVESTIGATOR lat: 48.38284 lon: 20.02239 facility: Cliniq s.r.o. status: NOT_YET_RECRUITING city: Bratislava state: Bratislavský Kraj zip: 81109 country: Slovakia name: Alena Ftacnikova role: PRINCIPAL_INVESTIGATOR lat: 48.14816 lon: 17.10674 facility: Sin Azucar status: NOT_YET_RECRUITING city: Malacky state: Bratislavský Kraj zip: 901 01 country: Slovakia name: Barbora Zobokova role: PRINCIPAL_INVESTIGATOR lat: 48.43604 lon: 17.02188 facility: Human Care s.r.o. status: NOT_YET_RECRUITING city: Kosice state: Košický Kraj zip: 04001 country: Slovakia name: Viera Donicova role: PRINCIPAL_INVESTIGATOR lat: 48.71395 lon: 21.25808 facility: Tatratrial s.r.o. status: NOT_YET_RECRUITING city: Rožňava state: Košický Kraj zip: 04801 country: Slovakia name: Beata Lachova role: PRINCIPAL_INVESTIGATOR lat: 48.66009 lon: 20.53758 facility: Areteus s.r.o. status: NOT_YET_RECRUITING city: Trebisov state: Košický Kraj zip: 075 01 country: Slovakia name: Dasa Skripova role: PRINCIPAL_INVESTIGATOR lat: 48.62858 lon: 21.71954 facility: Fakultná nemocnica Nitra status: NOT_YET_RECRUITING city: Nitra state: Nitriansky Kraj zip: 950 01 country: Slovakia name: Peter Minarik role: PRINCIPAL_INVESTIGATOR lat: 48.30763 lon: 18.08453 facility: IMCORE status: NOT_YET_RECRUITING city: Presov state: Prešovský Kraj zip: 080 01 country: Slovakia name: Luboslava Kocurova Frajtova role: PRINCIPAL_INVESTIGATOR lat: 48.99839 lon: 21.23393 facility: MEDISPOL status: NOT_YET_RECRUITING city: Presov state: Prešovský Kraj zip: 080 01 country: Slovakia name: Daniela Vinanska role: PRINCIPAL_INVESTIGATOR lat: 48.99839 lon: 21.23393 facility: MEDIKALS status: NOT_YET_RECRUITING city: Piešťany state: Trnavský Kraj zip: 921 01 country: Slovakia name: Slavka Kalinova role: PRINCIPAL_INVESTIGATOR lat: 48.59479 lon: 17.82591 facility: ENDIAMED s.r.o status: RECRUITING city: Dolny Kubin state: Žilinský Kraj zip: 026 01 country: Slovakia name: Jan Truban role: PRINCIPAL_INVESTIGATOR lat: 49.20983 lon: 19.30341 facility: JM-Interna s.r.o status: NOT_YET_RECRUITING city: Dolny Kubin state: Žilinský Kraj zip: 02601 country: Slovakia name: Jan Micik role: PRINCIPAL_INVESTIGATOR lat: 49.20983 lon: 19.30341 facility: NEDÚ - Národný endokrinologický a diabetologický ústav n.o. status: NOT_YET_RECRUITING city: Lubochna state: Žilinský Kraj zip: 034 91 country: Slovakia name: Emil Martinka role: PRINCIPAL_INVESTIGATOR lat: 49.12011 lon: 19.16891 facility: AMBORA s.r.o. Interna ambulancia status: NOT_YET_RECRUITING city: Martin state: Žilinský Kraj zip: 036 01 country: Slovakia name: Boris Raska role: PRINCIPAL_INVESTIGATOR lat: 49.06651 lon: 18.92399 facility: MediPrax, s.r.o. status: NOT_YET_RECRUITING city: Trstena state: Žilinský Kraj zip: 028 01 country: Slovakia name: Ivana Škerdová role: PRINCIPAL_INVESTIGATOR lat: 49.36101 lon: 19.61249 facility: CHUAC-Complejo Hospitalario Universitario A Coruña status: NOT_YET_RECRUITING city: A Coruña state: A Coruña [La Coruña] zip: 15001 country: Spain name: Jose Luis Diaz Diaz role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval status: NOT_YET_RECRUITING city: Ferrol state: A Coruña [La Coruña] zip: 15405 country: Spain name: DIEGO BELLIDO GUERRERO role: PRINCIPAL_INVESTIGATOR lat: 43.4896 lon: -8.21942 facility: CHUS - Hospital Clinico Universitario status: NOT_YET_RECRUITING city: Santiago de Compostela state: A Coruña [La Coruña] zip: 15706 country: Spain name: Jose Ramon Gonzalez-Juanatey role: PRINCIPAL_INVESTIGATOR lat: 42.88052 lon: -8.54569 facility: Hospital de Denia Marina Salud status: NOT_YET_RECRUITING city: Dénia state: Alicante zip: 03700 country: Spain name: ALFONSO VALLE role: PRINCIPAL_INVESTIGATOR lat: 38.84078 lon: 0.10574 facility: Hospital Universitario Reina Sofia status: NOT_YET_RECRUITING city: Cordoba state: Andalucía zip: 14004 country: Spain name: Jose Lopez Miranda role: PRINCIPAL_INVESTIGATOR lat: 37.89155 lon: -4.77275 facility: Hospital Unviersitario Virgen Nieves status: NOT_YET_RECRUITING city: Granada state: Andalucía zip: 18014 country: Spain name: Pablo González Bustos role: PRINCIPAL_INVESTIGATOR lat: 37.18817 lon: -3.60667 facility: Hospital Universitario Virgen de la Victoria status: NOT_YET_RECRUITING city: Malaga state: Andalucía zip: 29010 country: Spain name: Francisco Tinahones Madueno role: PRINCIPAL_INVESTIGATOR lat: 36.72016 lon: -4.42034 facility: Hospital de Cabueñes status: NOT_YET_RECRUITING city: Gijón state: Asturias zip: 33394 country: Spain name: Juan Rondán role: PRINCIPAL_INVESTIGATOR lat: 43.53573 lon: -5.66152 facility: Hospital Universitari Son Espases status: NOT_YET_RECRUITING city: Palma state: Balears [Baleares] zip: 07120 country: Spain name: Santiago Tofe Povedano role: PRINCIPAL_INVESTIGATOR lat: 39.56939 lon: 2.65024 facility: Hospital Germans Trias i Pujol status: NOT_YET_RECRUITING city: Badalona state: Barcelona [Barcelona] zip: 08916 country: Spain name: Núria Alonso Pedrol role: PRINCIPAL_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Parc de Salut Mar - Hospital del Mar status: NOT_YET_RECRUITING city: Barcelona state: Barcelona [Barcelona] zip: 08003 country: Spain name: Miguel Achirica role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Marqués de Valdecilla status: NOT_YET_RECRUITING city: Santander state: Cantabria zip: 39008 country: Spain name: Marta Martin Millan role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 facility: Hospital Clínic de Barcelona status: NOT_YET_RECRUITING city: Barcelona state: Catalunya [Cataluña] zip: 08036 country: Spain name: RAMON ESTRUCH role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital de la Santa Creu i Sant Pau status: NOT_YET_RECRUITING city: Barcelona state: Catalunya [Cataluña] zip: 08041 country: Spain name: Xavier Garcia-Moll role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Universitari de Bellvitge status: NOT_YET_RECRUITING city: L'Hospitalet de Llobregat state: Catalunya [Cataluña] zip: 08907 country: Spain name: Xavier Pintó role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 facility: Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí status: NOT_YET_RECRUITING city: Sant Joan Despí state: Catalunya [Cataluña] zip: 08970 country: Spain name: CARLOS JERICO ALBA role: PRINCIPAL_INVESTIGATOR lat: 41.36718 lon: 2.0574 facility: Hospital Virgen del Camino status: NOT_YET_RECRUITING city: Sanlúcar de Barrameda state: Cádiz zip: 11540 country: Spain name: Manuel Beltran Robles role: PRINCIPAL_INVESTIGATOR lat: 36.77808 lon: -6.3515 facility: Hospital Virgen de las Montañas status: NOT_YET_RECRUITING city: Villamartin state: Cádiz zip: 11650 country: Spain name: Enrique Garcia del Rio role: PRINCIPAL_INVESTIGATOR lat: 36.85979 lon: -5.64485 facility: Hospital Universitari de Girona Doctor Josep Trueta status: NOT_YET_RECRUITING city: Girona state: Girona [Gerona] zip: 17007 country: Spain name: Eduardo Esteve role: PRINCIPAL_INVESTIGATOR lat: 41.98311 lon: 2.82493 facility: Hospital Insular de Gran Canaria status: NOT_YET_RECRUITING city: Las Palmas de Gran Canaria state: Las Palmas zip: 35016 country: Spain name: Rosa María Sánchez Hernández role: PRINCIPAL_INVESTIGATOR lat: 28.09973 lon: -15.41343 facility: Hospital Universitario Fundacion ALcorcon status: NOT_YET_RECRUITING city: Alcorcón state: Madrid, Comunidad De zip: 28922 country: Spain name: Carlos Guijarro Herraiz role: PRINCIPAL_INVESTIGATOR lat: 40.34582 lon: -3.82487 facility: Hospital Universitario Ramón y Cajal status: NOT_YET_RECRUITING city: Madrid state: Madrid, Comunidad De zip: 28034 country: Spain name: Luis Manzano Espinosa role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Puerta de Hierro Majadahonda status: NOT_YET_RECRUITING city: Majadahonda state: Madrid, Comunidad De zip: 28220 country: Spain name: Juan Manuel Escudier Villa role: PRINCIPAL_INVESTIGATOR lat: 40.47353 lon: -3.87182 facility: Hospital Universitario Quironsalud Madrid status: NOT_YET_RECRUITING city: Pozuelo de Alarcón state: Madrid zip: 28223 country: Spain name: Esteban Jodar Gimeno role: PRINCIPAL_INVESTIGATOR lat: 40.43293 lon: -3.81338 facility: Hospital Clínico Universitario Virgen de la Arrixaca status: NOT_YET_RECRUITING city: El Palmar, Murcia state: Murcia, Región De zip: 30120 country: Spain name: Domingo Pascual Figal role: PRINCIPAL_INVESTIGATOR facility: Vithas Hospital Sevilla status: RECRUITING city: Seville state: Sevilla zip: 41950 country: Spain name: Cristobal Morales Portillo role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: Hospital Universitari Sant Joan de Reus status: NOT_YET_RECRUITING city: Reus state: Tarragona [Tarragona] zip: 43204 country: Spain name: Daiana Ibarretxe Gerediaga role: PRINCIPAL_INVESTIGATOR lat: 41.15612 lon: 1.10687 facility: Hospital Clinico de Valencia status: NOT_YET_RECRUITING city: Valencia state: Valenciana, Comunitat zip: 46010 country: Spain name: Julio Nunez Villota role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Hospital Arnau de Vilanova status: NOT_YET_RECRUITING city: Valencia state: Valenciana, Comunitat zip: 46015 country: Spain name: JUAN COSIN SALES role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Hospital General Universitario de Valencia status: NOT_YET_RECRUITING city: Valencia state: València zip: 46014 country: Spain name: Francesc Puchades role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Hospital Infanta Elena status: NOT_YET_RECRUITING city: Huelva zip: 21007 country: Spain name: Manuel Jesús Romero-Jiménez role: PRINCIPAL_INVESTIGATOR lat: 37.26638 lon: -6.94004 facility: Complejo Hospitalario de Jaén status: NOT_YET_RECRUITING city: Jaén zip: 23007 country: Spain name: Francisco Gomez Delgado role: PRINCIPAL_INVESTIGATOR lat: 37.76922 lon: -3.79028 facility: Hospital Lucus Augusti status: NOT_YET_RECRUITING city: Lugo zip: 27003 country: Spain name: Rosa Argüeso Armesto role: PRINCIPAL_INVESTIGATOR lat: 43.00992 lon: -7.55602 facility: Hospital Universitario La Paz status: NOT_YET_RECRUITING city: Madrid zip: 28029 country: Spain name: Jose Mostaza role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Clinico San Carlos status: NOT_YET_RECRUITING city: Madrid zip: 28040 country: Spain name: Manuel Mendez role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario 12 de Octubre status: NOT_YET_RECRUITING city: Madrid zip: 28041 country: Spain name: Agustin Blanco Echevarria role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca status: NOT_YET_RECRUITING city: Salamanca zip: 37007 country: Spain name: ARMANDO OTERINO MANZANAS role: PRINCIPAL_INVESTIGATOR lat: 40.96882 lon: -5.66388 facility: Hospital General de Segovia status: NOT_YET_RECRUITING city: Segovia zip: 40002 country: Spain name: FERNANDO Gomez PERALTA role: PRINCIPAL_INVESTIGATOR lat: 40.94808 lon: -4.11839 facility: Hospital Universitario Virgen Macarena status: NOT_YET_RECRUITING city: Sevilla zip: 41009 country: Spain name: Rafael Jesús Hidalgo Urbano role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: Hospital Universitario Virgen Del Rocio status: NOT_YET_RECRUITING city: Sevilla zip: 41013 country: Spain name: Luis Beltrán role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: Hospital Universitario Miguel Servet status: NOT_YET_RECRUITING city: Zaragoza zip: 50009 country: Spain name: Fernando Civeira role: PRINCIPAL_INVESTIGATOR lat: 41.65606 lon: -0.87734 facility: Changhua Christian Hospital status: NOT_YET_RECRUITING city: Changhua County state: Changhua zip: 50006 country: Taiwan name: Ching-Pei Chen role: PRINCIPAL_INVESTIGATOR facility: Chang Gung Memorial Hospital at Kaohsiung status: NOT_YET_RECRUITING city: Kaohsiung Niao Sung Dist state: Kaohsiung zip: 83301 country: Taiwan name: Chih-Yuan Fang role: PRINCIPAL_INVESTIGATOR facility: Chung Shan Medical University Hospital status: NOT_YET_RECRUITING city: Taichung City state: Taichung zip: 402 country: Taiwan name: Kwo-Chang Ueng role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 facility: Chi Mei Medical Center status: NOT_YET_RECRUITING city: Tainan City state: Tainan zip: 71004 country: Taiwan name: Chon Seng Hong role: PRINCIPAL_INVESTIGATOR lat: 22.99083 lon: 120.21333 facility: Cathay General Hospital status: NOT_YET_RECRUITING city: Taipei City state: Taipei zip: 106 country: Taiwan name: Chi-Hung Huang role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 facility: Shin Kong Wu Ho-Su Memorial Hospital status: NOT_YET_RECRUITING city: Taipei City state: Taipei zip: 111 country: Taiwan name: Kou-Gi Shyu role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 facility: Tri-Service General Hospital status: NOT_YET_RECRUITING city: Taipei City state: Taipei zip: 114 country: Taiwan name: WEI-HSIANG LIN role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 facility: National Yang Ming Chiao Tung University Hospital status: NOT_YET_RECRUITING city: Yilan City state: Yilan zip: 260006 country: Taiwan name: Hsuan-Ming Tsao role: PRINCIPAL_INVESTIGATOR lat: 24.757 lon: 121.753 facility: Kaohsiung Medical University Chung-Ho Memorial Hospital status: RECRUITING city: Kaohsiung zip: 807 country: Taiwan name: Tsung-Hsien Lin role: PRINCIPAL_INVESTIGATOR lat: 22.61626 lon: 120.31333 facility: Fu Jen Catholic University Hospital status: NOT_YET_RECRUITING city: New Taipei zip: 24352 country: Taiwan name: Shih-Chi Liu role: PRINCIPAL_INVESTIGATOR lat: 25.01111 lon: 121.44583 facility: National Cheng Kung University Hospital status: NOT_YET_RECRUITING city: Tainan zip: 704 country: Taiwan name: Yi-Ching Yang role: PRINCIPAL_INVESTIGATOR lat: 22.99083 lon: 120.21333 facility: National Taiwan University Hospital status: NOT_YET_RECRUITING city: Taipei zip: 10002 country: Taiwan name: Tzung-Dau Wang role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 facility: Taipei Medical University Hospital status: NOT_YET_RECRUITING city: Taipei zip: 110 country: Taiwan name: Chun-Yao Huang role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 facility: Taipei Veterans General Hospital status: NOT_YET_RECRUITING city: Taipei zip: 11217 country: Taiwan name: Chern-En Chiang role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 facility: Chang Gung Medical Foundation-Linkou Branch status: NOT_YET_RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Pao-Hsien Pao-Hsien Chu role: PRINCIPAL_INVESTIGATOR lat: 24.95233 lon: 121.20193 facility: Bristol Royal Infirmary status: NOT_YET_RECRUITING city: Bristol state: Bristol, City Of zip: BS2 8HW country: United Kingdom name: Paul Downie role: PRINCIPAL_INVESTIGATOR lat: 51.45523 lon: -2.59665 facility: Torbay Hospital status: NOT_YET_RECRUITING city: Torquay state: Devon zip: TQ2 7AA country: United Kingdom name: Jamie Smith role: PRINCIPAL_INVESTIGATOR lat: 50.46198 lon: -3.5252 facility: Royal Free London NHS Foundation Trust status: NOT_YET_RECRUITING city: London state: England zip: NW32QG country: United Kingdom name: Devaki Nair role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Lister Hospital status: RECRUITING city: Stevenage state: Hertfordshire zip: SG1 4AB country: United Kingdom name: Mary Lynch role: PRINCIPAL_INVESTIGATOR lat: 51.90224 lon: -0.20256 facility: Hull and East Yorkshire Hospitals NHS Trust status: RECRUITING city: Hull state: Kingston Upon Hull zip: HU3 2JZ country: United Kingdom name: Deepa Narayanan role: PRINCIPAL_INVESTIGATOR lat: 53.7446 lon: -0.33525 facility: Panthera Biopartners - Manchester status: RECRUITING city: Rochdale state: Manchester zip: OL11 4AU country: United Kingdom name: Krishnakumar Radhakrishnan role: PRINCIPAL_INVESTIGATOR lat: 53.61766 lon: -2.1552 facility: Salford Royal Hospital status: RECRUITING city: Salford state: Manchester zip: M6 8HD country: United Kingdom name: John Gibson role: PRINCIPAL_INVESTIGATOR lat: 53.48771 lon: -2.29042 facility: Panthera Biopartners - Glasgow status: RECRUITING city: Glasgow state: Scotland zip: G51 4TY country: United Kingdom name: Raghavendra Madimchetty role: PRINCIPAL_INVESTIGATOR lat: 55.86515 lon: -4.25763 facility: Sunderland Royal Hospital status: RECRUITING city: Tyne And Wear zip: SR4 7TP country: United Kingdom name: Peter Carey role: PRINCIPAL_INVESTIGATOR facility: Sandwell General Hospital status: RECRUITING city: West Bromwich zip: B71 4HJ country: United Kingdom name: Inessa Tracey role: PRINCIPAL_INVESTIGATOR lat: 52.51868 lon: -1.9945 hasResults: False

 nctId: NCT06292000 id: 23-1721 briefTitle: Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults With Prediabetes acronym: TExIS overallStatus: RECRUITING date: 2024-02-01 date: 2026-06 date: 2026-06 date: 2024-03-04 date: 2024-03-29 name: University of Colorado, Denver class: OTHER briefSummary: Purpose of the Study: This study is to learn more about how exercising at different times of the day (morning versus evening) affects metabolism of glucose in the body, sleep, activity outside of exercise, and other factors.

Procedures:

* 2 screening visits to make sure you are eligible to be in the study. This will include a fasting blood draw and heart tracing (EKG).
* If you are eligible, you will complete both exercise conditions in a random order. All participants in the study will complete the following separated by 3-4 weeks:

  * Baseline condition of NO exercise
  * Morning exercise for 3 days in a row
  * Evening exercise for 3 days in a row
* You will be provided with an example diet to follow for the days you are completing the baseline and exercise conditions (three days total for each condition). This diet will be a "traditional" diet with a controlled amount of carbohydrates, protein, and fat per day. The investigators will provide you with examples of meals to eat during this time.
* You will be asked questions and complete questionnaires about your health history, sleeping and awakening habits, and sleepiness levels.
* You will undergo one x-ray scan to measure your level of body fat.
* You will be asked to wear an activity monitor and sleep monitor for 6 days in a row three times during this study.
* You will be asked to wear a continuous glucose monitor (CGM) for 6 days in a row three times during this study.
* You will be asked to measure your saliva melatonin levels three times in the study. This will be done once per hour for 5 hours (a total of 6 saliva samples).
* You will be asked to complete a procedure called a "hyperinsulinemic-euglycemic clamp" where you will have an IV placed and insulin and glucose infused with frequent lab and finger stick blood sugars monitored closely. This will be done 3 times during the study. conditions: PreDiabetes conditions: Obesity conditions: Inactivity/Low Levels of Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: AM Exercise name: PM Exercise measure: Peripheral insulin sensitivity measure: Free Living Glucose measure: Melatonin offset measure: AM Cortisol measure: Physical activity and sedentary behavior measure: Sleep outcomes sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: University of Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Rebecca Rosenberg, DO role: CONTACT phone: 503-442-0762 email: rebecca.rosenberg@cuanschutz.edu name: Rebecca Rosenberg, DO role: PRINCIPAL_INVESTIGATOR name: Seth Creasy, PhD role: SUB_INVESTIGATOR name: Victoria Catenacci, MD role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06291987 id: IRB23-1681 briefTitle: Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation acronym: MPN overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2026-05 date: 2026-05 date: 2024-03-04 date: 2024-04-26 name: University of Chicago class: OTHER briefSummary: The purpose of this research is to gather information on the safety and effectiveness determining maximum tolerated dose (MTD) of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs while evaluate the efficacy of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs. conditions: Myeloproliferative Neoplasms studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Ivosidenib name: Ruxolitinib measure: Maximum tolerated dose measure: Overall Survival (OS) measure: Overall Response Rate (ORR) measure: Time to Response (TTR) measure: Duration of response (DOR) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago Medicine Comprehensive Cancer Center city: Chicago state: Illinois zip: 60637 country: United States name: Clinical Trials Intake role: CONTACT phone: 855-702-8222 email: cancerclinicaltrials@bsd.uchicago.edu name: Anand Patel role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06291974 id: delta2024 briefTitle: Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-10-15 date: 2024-11-30 date: 2024-03-04 date: 2024-03-07 name: Delta University for Science and Technology class: OTHER briefSummary: To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III). conditions: Cerebral Palsy Spastic Diplegia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: electromyography measure: muscle activity by Electromyography device sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06291961 id: CS-101-01 briefTitle: A Safety and Efficacy Study Evaluating CS-101 in Subjects With β-Thalassemia Major overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2025-07 date: 2024-03-04 date: 2024-03-06 name: CorrectSequence Therapeutics Co., Ltd class: INDUSTRY briefSummary: The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating patients with β-thalassemia major anemia. conditions: Beta-Thalassemia Major studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: CS-101 injection measure: AEs(Adverse Events) and SAEs(Serious Adverse Events) after CS-101 infusion measure: Overall survival rate measure: Proportion of subjects with engraftment measure: Time to neutrophil engraftment measure: Time to platelet engraftment measure: Incidence of transplant-related mortality measure: Change in fetal hemoglobin(HbF) concentration over time measure: Change in total hemoglobin(Hb) concentration over time measure: Chimerism level in Peripheral blood and bone marrow measure: Proportion of subjects achieving transfusion independence for at least 6 consecutive months measure: Proportion of subjects achieving fetal hemoglobin(HbF) increase≥2.0 g/dL measure: Proportion of subjects achieving fetal hemoglobin(HbF) increase≥7.0 g/dL sex: ALL minimumAge: 7 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi country: China name: Yongrong Lai, M.D. role: CONTACT name: Yongrong Lai, M.D. role: PRINCIPAL_INVESTIGATOR lat: 22.81667 lon: 108.31667 facility: Children's Hospital of Fudan University city: Shanghai state: Shanghai country: China name: Xiaowen Zhai, M.D. role: CONTACT name: Xiaowen Zhai, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Ruijin Hospital Shanghai JiaoTong University School of Medicine city: Shanghai state: Shanghai country: China name: Saijuan Chen, M.D. role: CONTACT name: Saijuan Chen, M.D. role: PRINCIPAL_INVESTIGATOR name: Weili Zhao, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06291948 id: 0225 briefTitle: A Clinical Study With Adalimumab Biosimilar overallStatus: COMPLETED date: 2022-08-01 date: 2023-01-10 date: 2023-10-20 date: 2024-03-04 date: 2024-03-04 name: Laboratorios Richmond S.A.C.I.F. class: INDUSTRY name: FP Clinical Pharma S.R.L. name: Custom Biologics briefSummary: The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) \[Test Product\] vs. Humira® AC Pen \[Reference Product\] conditions: Pharmacokinetics conditions: Safety Issues studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized, Double Blind, Parallel groups, Phase 1 Clinical Study comparing the Pharmacokinetic, Safety and Immunogenicity of Adalimumab in Healthy Subjects. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Study subjects, investigators, Sponsor, monitor, analytical center, and data analyst will be unaware of assigned treatments.

Each product in its original primary packaging will be blinded and labeled with a fantasy name "Product A" or "Product B".

The link between "Product A or B" with the Test Product or Reference Product will be kept in two separate copies in a sealed envelope. One copy will remain with the Sponsor and the other will be provided to the Principal Investigator. The envelope may only be opened in the event of a medical emergency. The investigator must follow the trial's randomization procedures, and must ensure that the code is broken only in accordance with the protocol. The investigator must promptly document and explain to the Sponsor should the identity of the investigational product be revealed (whether accidentally or due to a serious adverse event). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ACTUAL name: Humira® (adalimumab) AC Pen [Reference Product] name: Adalimumab Richmond [Test Product] measure: Peak Serum Concentration of adalimumab (Cmax) measure: Area Under the Serum Concentration-time Curve of adalimumab (ABC0-t) measure: Area Under the Serum Concentration- Time Curve ob adalimumab (ABC0-∞) measure: Number of samples with positive Anti-adalimumab serum antibodies measure: Adverse Events measure: Number of positive Anti-adalimumab serum samples with neutralizing capacity sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: FP Clinical Pharma S.R.L. city: Buenos Aires zip: C1425BAA country: Argentina lat: -34.61315 lon: -58.37723 hasResults: False

 nctId: NCT06291935 id: VG901-2021 A id: EU CT: 2023-504383-42-00 type: OTHER domain: EMA briefTitle: Safety and Tolerability of Intravitreal Administration of VG901 in Patients With Retinitis Pigmentosa Due to Mutations in the CNGA1 Gene overallStatus: RECRUITING date: 2023-09-01 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: ViGeneron GmbH class: INDUSTRY briefSummary: The goal of this phase 1 clinical trial is to learn about the safety and efficacy of a gene therapy, VG901, in patients with a rare disorder of the eye called Retinitis Pigmentosa. The main questions the study aims to answer are:

* What is the best tolerated dose and are there any side effects, in particular any inflammatory reactions post drug administration?
* Are there any early signs of efficacy on visual function?

Participants will be administered a single intravitreal dose of VG901 into the most affected eye through a syringe and followed up for a year to monitor safety and efficacy. There will be two cohorts of participants in this study. Study Cohort 1 will receive the low dose and Study Cohort 2 will receive the high dose as specified in the Protocol. conditions: Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: VG901 measure: Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Physical Examination measure: Pulse rate measure: Blood pressure measure: Body temperature measure: Respiratory rate measure: Slit lamp examination measure: Fundus biomicroscopy measure: Optical coherence tomography (OCT) measure: Fundus autofluorescence measure: Tonometry measure: Adeno-associated virus (AAV) spread measure: Immunopathology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Ophthalmology, University of Tuebingen status: RECRUITING city: Tuebingen zip: 72076 country: Germany name: Andrea Rindtorff role: CONTACT lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06291922 id: 853181 id: R01HL166621 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL166621 briefTitle: Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation acronym: MOVE-LVAD II overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-06 date: 2028-06 date: 2024-03-04 date: 2024-04-16 name: University of Pennsylvania class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Exercise Intervention name: Usual Care measure: Effects of exercise intervention on physical activity and capacity (step count) measure: Effects of exercise intervention on physical activity and capacity (distance) measure: Effects of exercise intervention on frailty and muscle mass (frailty status) measure: Effects of exercise intervention on frailty and muscle mass (muscle quantity) measure: Effects of exercise intervention on quality of life measure: Cost-effectiveness of the exercise intervention vs. usual care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291909 id: 205989 briefTitle: Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia overallStatus: RECRUITING date: 2024-04-03 date: 2026-12 date: 2027-01 date: 2024-03-04 date: 2024-03-29 name: University of South Australia class: OTHER name: Flinders University briefSummary: This is a randomised controlled study aiming to evaluate the implementation of a website ('Small Steps') to support the modification of participants' time-use behaviour to reduce the risk factors for dementia. 'Small Steps' website provides the tools for this with a visual representation of the participant's current use of time and allowing manipulation to demonstrate how small lifestyle changes may improve and meet sleep and physical activity needs. Participants will be assisted to make changes to current behaviours with the aim to reduce the time they spend sitting (sedentary behaviour), increase physical activity, and improve sleep duration and quality.

Participants (aged 65 or older) will be randomly allocated to one of two groups, the 'Extended Program' (intervention) group or the 'Condensed Program' (control) group.

There are 3 phases (Introductory, Maintenance and Follow-Up; each 12-weeks long) to this program and in total the program is 36-weeks long. Participants will use a tailored website to help support them in making progressive changes over the first 12 weeks. They will then try to maintain these behaviour changes for as long as possible. There will be in-person health testing during each phase and information about sleep habits, sleep quality, and motivation will be assessed using online surveys. Physical activity levels and sleep duration will also be assessed. conditions: Dementia conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Small Steps Program name: Comparator Program measure: Number of participant logins onto the "Small Steps" website measure: Number of participant check-ins on the "Small Steps" dashboard measure: Number of participant behavioural change choices on the "Small Steps" website during the Introduction Phase. The greater number of choices indicates a greater engagement with the intervention and use of the website. measure: Time participants spent on the "Small Steps" website measure: Duration of each participant behavioural change choice during the Introductory Phase measure: Holden's Simplified System Usability Scale measure: Health Care Climate Questionnaire measure: Behavioural Automaticity Questionnaire measure: (Behavioural Regulation in Exercise Questionnaire measure: Self-efficacy and Intention Questionnaire measure: Perceived Competence Scale measure: Exit interview measure: Daily activity measure: Sleep quality measure: Sleep Hygiene measure: Sleep quantity measure: Addenbrooke's Cognitive Exam III measure: Trail Making Test measure: Digit Span Test sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of South Australia status: RECRUITING city: Adelaide state: South Australia zip: 5001 country: Australia name: Catherine Yandell, PhD role: CONTACT phone: +61 8 83022109 email: catherine.yandell@unisa.edu.au name: Emma Waters, BSc(Hon) role: CONTACT name: Ashleigh Smith, PhD role: PRINCIPAL_INVESTIGATOR name: Maddison Mellow, PhD role: SUB_INVESTIGATOR name: Dorothea Dumuid, PhD role: SUB_INVESTIGATOR name: Tyman Stanford, PhD role: SUB_INVESTIGATOR name: Timothy Olds, PhD role: SUB_INVESTIGATOR name: Hannah Keage, PhD role: SUB_INVESTIGATOR name: Ross Smith, PhD role: SUB_INVESTIGATOR name: Alison Coates, PhD role: SUB_INVESTIGATOR name: Michelle Rogers, PhD role: SUB_INVESTIGATOR name: Catherine Yandell, PhD role: SUB_INVESTIGATOR name: Emma Waters, BSc(Hon) role: SUB_INVESTIGATOR name: Kate Laver, PhD role: SUB_INVESTIGATOR name: Alexander Wade, PhD role: SUB_INVESTIGATOR lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06291896 id: UBT 2023-01 briefTitle: A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection overallStatus: RECRUITING date: 2024-03-15 date: 2026-02-15 date: 2026-12-15 date: 2024-03-04 date: 2024-03-08 name: Umbria Bioengineering Technologies class: INDUSTRY name: Toscana Life Sciences Sviluppo s.r.l. name: London South Bank University name: ELAROS 24/7 Limited (UK) name: Servicio De Salud De Castilla La Mancha (Spain) name: IMT School for Advanced Studies Lucca name: EVITA - Cancro Hereditário (Portugal) briefSummary: This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity\>75% and specificity\>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs. conditions: Women's Health: Neoplasm of Breast studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinical Investigation with class IIa medical device primaryPurpose: SCREENING masking: NONE count: 10000 type: ESTIMATED name: MammoWave measure: MammoWave® sensitivity measure: MammoWave® specificity measure: Detection rates by type of lesion measure: Recall rate measure: Positive-predictive value measure: Program screening rate measure: BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density measure: MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study measure: Agreement between different evaluator (i.e. local versus central) measure: Volunteers' satisfaction questionnaire sex: FEMALE minimumAge: 45 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Giovanni Battista - USL Umbria 2 status: NOT_YET_RECRUITING city: Foligno state: Perugia zip: 06034 country: Italy name: Riccardo Loretoni role: CONTACT email: riccardo.loretoni@uslumbria2.it name: Riccardo Loretoni role: PRINCIPAL_INVESTIGATOR lat: 42.95488 lon: 12.70268 facility: IRCCS Policlinico San Martino status: RECRUITING city: Genova zip: 16132 country: Italy name: Massimo Calabrese role: CONTACT email: massimo.calabrese@hsanmartino.it name: Massimo Calabrese role: PRINCIPAL_INVESTIGATOR name: Alberto Stefano Tagliafico role: SUB_INVESTIGATOR lat: 44.40478 lon: 8.94438 facility: Pomeranian Medical University Hospital status: NOT_YET_RECRUITING city: Szczecin country: Poland name: Jan Lubinsky role: CONTACT email: jan.lubinski@pum.edu.pl name: Jan Lubinsky role: PRINCIPAL_INVESTIGATOR lat: 53.42894 lon: 14.55302 facility: Champalimaud Foundation status: NOT_YET_RECRUITING city: Lisboa country: Portugal name: Filipa Lourenço Cardoso role: CONTACT email: filipa.cardoso@research.fchampalimaud.org name: Celeste Alves role: PRINCIPAL_INVESTIGATOR name: Maria Antónia Vasconcelos role: SUB_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: Clínica Dr. Passos Ângelo in Lisbon status: NOT_YET_RECRUITING city: Lisboa country: Portugal name: Ângelo Passos role: CONTACT email: epassosangelo@gmail.com name: Ângelo Passos role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: Hospital Universitario Reina Sofía- Córdoba status: NOT_YET_RECRUITING city: Córdoba country: Spain name: Marina Álvarez Benito role: CONTACT email: marinaalvarezbenito@telefonica.net name: Marina Álvarez Benito role: PRINCIPAL_INVESTIGATOR lat: 37.89155 lon: -4.77275 facility: Hospital General Universitario Morales Meseguer status: NOT_YET_RECRUITING city: Murcia country: Spain name: María Martínez Gálvez role: CONTACT email: martinezgalvez@gmail.com name: María Martínez Gálvez role: PRINCIPAL_INVESTIGATOR name: Este Correo role: SUB_INVESTIGATOR lat: 37.98704 lon: -1.13004 facility: Complejo Hospitalario Universitario de Toledo status: NOT_YET_RECRUITING city: Toledo country: Spain name: Daniel Alvarez Sánchez-Bayuela role: CONTACT email: danialsanba@gmail.com name: Cristina Romero Castellano role: PRINCIPAL_INVESTIGATOR lat: 39.8581 lon: -4.02263 facility: Diagnostic and Interventional Radiology, University Hospital Zurich status: NOT_YET_RECRUITING city: Zürich country: Switzerland name: Thomas Frauenfelder role: CONTACT email: thomas.frauenfelder@usz.ch name: Thomas Frauenfelder role: PRINCIPAL_INVESTIGATOR name: Jann Wieler role: SUB_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06291883 id: CHUH112-REC2-008 briefTitle: Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection. overallStatus: COMPLETED date: 2023-02-09 date: 2023-04-18 date: 2024-02-08 date: 2024-03-04 date: 2024-03-06 name: Sheng-Teng Huang class: OTHER briefSummary: These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19. conditions: Coronavirus Disease 2019 conditions: Severe Acute Respiratory Syndrome Coronavirus 2 Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 26 type: ACTUAL name: Kang Guan Recipe (Treat) name: Kang Guan Recipe (Placebo) measure: Serum Infection rate of pseudocells sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: China Medical University Hospital city: Taichung state: North District zip: 404 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06291870 id: F4396-P id: IRB-22-01-4294 type: OTHER domain: John D. Dingell VA Medical Center briefTitle: Predictors of Post-COVID Clinical and Cognitive Consequences acronym: SCLC overallStatus: RECRUITING date: 2023-01-19 date: 2025-07-30 date: 2025-12-30 date: 2024-03-04 date: 2024-04-01 name: VA Office of Research and Development class: FED name: John D. Dingell VA Medical Center briefSummary: The CDC describes Post-acute sequelae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function. conditions: Post Acute Sequelae of SARS CoV 2 Infection conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Neurocognitive function Trails A and Trails B measure: Neurocognitive function PASAT measure: Neurocognitive function Stroop color-word interference measure: Neurocognitive function DIGIT measure: Neurocognitive function WASI measure: Neurocognitive function WMS measure: Neurocognitive function PVT measure: Neurocognitive function HVLT-R measure: Sleepiness ESS measure: Sleep quality PSQI measure: Quality of life SF-36v2 measure: Quality of life FOSQ measure: Quality of life SGRQ measure: Fatigue Severity measure: PROMISE Sleep Disturbance measure: Horne and Osteberg Morningness/Eveningness Questionnaire measure: Mini Mental State Examination (MMSE) measure: Borg Scale measure: Dyspnea: Six-minute walk test (6MWT) distance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: John D. Dingell VA Medical Center, Detroit, MI status: RECRUITING city: Detroit state: Michigan zip: 48201-1916 country: United States name: Ruchi Rastogi, MS role: CONTACT phone: 313-576-4464 email: ruchi.rastogi@va.gov name: Susmita Chowdhuri, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 hasResults: False

 nctId: NCT06291857 id: CIC-E-301 briefTitle: A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine overallStatus: NOT_YET_RECRUITING date: 2024-08-30 date: 2025-03-15 date: 2025-04-09 date: 2024-03-04 date: 2024-03-20 name: Novavax class: INDUSTRY briefSummary: The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant. conditions: COVID-19 studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 4000 type: ESTIMATED name: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant name: Novavax COVID-19 Vaccine name: Comparator Influenza Vaccine - Fluarix name: Comparator Influenza Vaccine -Fluarix High Dose name: Placebo 0.9% sodium chloride for injection measure: Safety- Solicited AEs over 7 days post-vaccination, For both local injection site symptoms/signs and systemic symptoms/signs measure: Safety-Unsolicited AEs over 21 days post-vaccination and medically attended adverse events (MAAEs). measure: Safety-Treatment-related MAAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis) over 6 months measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as SCR measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMFR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as SCR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMTR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMT measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMFR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as SCR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMTR sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291844 id: Cohort-Mata-2023-1 briefTitle: Ocular Trauma and COVID-19 in Indonesia overallStatus: COMPLETED date: 2021-01-01 date: 2022-03-31 date: 2023-06-01 date: 2024-03-04 date: 2024-03-04 name: Prof. R. D. Kandou General Hospital class: OTHER briefSummary: Ocular injuries, a significant contributor to avoidable blindness globally, impact approximately 55 million individuals each year. Prompt initial treatment is vital for improving vision, yet the scarcity of skilled eye specialists often results in overcrowding at advanced medical centers. Moreover, the COVID-19 outbreak has introduced distinct factors into the management of ocular trauma. This research investigated the epidemiology of ocular injuries during the pandemic and offered observations on the distinctive hurdles and trends encountered. conditions: Ophthalmological Disorder conditions: Ocular Injury conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 13 type: ACTUAL measure: Ocular Trauma sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, Prof. R. D. Kandou General Hospital - Faculty of Medicine, Sam Ratulangi University city: Manado state: North Sulawesi country: Indonesia lat: 1.48218 lon: 124.84892 hasResults: False

 nctId: NCT06291831 id: C4671050 briefTitle: A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain. overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-13 date: 2024-05-13 date: 2024-05-13 date: 2024-03-04 date: 2024-04-09 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to collect information on the:

* general information of a group of people such as their age, sex
* clinical information of the patients such as any other illness before having COVID 19.
* the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations
* adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.

This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir.

This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.

The study will include patient information of those who:

* had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022.
* are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: nirmatrelvir, ritonavir name: Controls measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Age measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Gender measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Ethnicity measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Education measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Employment status measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Height measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Weight measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Body Mass Index (BMI) measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Smoking status measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Pre-existing Comorbidities measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Concomitant medications for comorbidities at index date measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Medications used to treat COVID-19 measure: Assessment of all Participants HRU: Inpatient setting measure: Assessment of all Participants HRU sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer Gulf FZ city: Busaiteen country: Bahrain hasResults: False

 nctId: NCT06291818 id: 2023-0917 briefTitle: Self-Adhering Magnetic Device to Treat Corneal Exposure overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-04-01 date: 2024-03-04 date: 2024-03-04 name: University of Illinois at Chicago class: OTHER briefSummary: Paralytic lagophthalmos can be difficult to treat and manage. It has a host of causes and effects, one of which (for the latter) is exposure keratopathy. Untreated, this can lead to corneal ulceration, inflammation, and potentially blindness. Despite a variety of attempts at treating this complex condition, none have satisfactorily reduced complications ranging from ease of use to aesthetics. With improvement in magnetic technology, however, that may change. Barmettler et al (2014) have demonstrated preliminary success of externally affixed magnets in closing both model and patient eyelids. As such, we hypothesize that magnetic devices can be used to treat corneal exposure by controlling eyelid position. conditions: Paralytic Lagophthalmos conditions: Corneal Exposure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: temporary magnetic system for tarsorrhaphy (MST) primaryPurpose: OTHER masking: NONE count: 25 type: ESTIMATED name: temporary magnetic system for tarsorrhaphy (MST) measure: Number of participants with success of a temporary magnetic system for tarsorrhaphy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois - Specialty Care Building city: Chicago state: Illinois zip: 60612 country: United States name: Pete Setabutr, MD role: CONTACT phone: 312-996-9120 email: psetabut@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06291805 id: 1-10-72-189-23 briefTitle: Phenotyping and Characterization of wtATTR-CM (TRACE 1) overallStatus: RECRUITING date: 2024-02-20 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: Steen Hvitfeldt Poulsen class: OTHER name: Novo Nordisk A/S briefSummary: Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity. conditions: Transthyretin Amyloidosis conditions: Transthyretin Amyloid Cardiomyopathy conditions: Wild-Type Transthyretin-Related (ATTR)Amyloidosis conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED measure: Investigation of cardiac amyloidosis severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy. measure: Investigation of the relations between cardiac amyloid severity and patient quality of life in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy. measure: Assessment of transthyretin and pathogenic fragments and relation to cardiac amyloid severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy measure: Validation of a new amyloid specific questionnaire (ATTR-QoL) in comparison with Kansas City Cardiomyopathy Questionnaire (KCCQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital status: RECRUITING city: Aarhus state: Arrhus N zip: 8200 country: Denmark name: Sie Kronborg Fensman role: CONTACT phone: +45 30 48 88 85 email: siefensman@gmail.com lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06291792 id: FTR001 briefTitle: Otago Exercise Program Applied By Telerehabilitation acronym: OEPABT overallStatus: RECRUITING date: 2023-11-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-04 date: 2024-03-04 name: Sinop University class: OTHER briefSummary: The aim of this study is to examine the effects of Otago Exercise Program (OEP) on pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life and balance with the telerehabilitation method in individuals with a history of falling, which is frequently seen in elderly individuals due to aging.

45 people between the ages of 65 and 78 participated in the study. They were randomly divided into 3 groups as control, telerehabilitation otago exercise program (TOEG) and face-to-face otago exercise program (FOEG). 45 minutes of OEP was applied 3 times a week for 8 weeks. Pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life, and balance were evaluated before the Otago Exercise Program, at the 4th week, at the 8th week, and 4 weeks after the end of the exercise program. Significance was evaluated at the p\<0.05 level in the study. conditions: Older People--Abuse of conditions: Falling conditions: Balance; Distorted studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: telerehabilitation otago exercise program name: face to face otago exercise program measure: Numerical Pain Scale measure: Walking Speed measure: lower extremity muscle strength measure: Fall effectiveness scale measure: Beck anxiety scale measure: Tinetti balance and walking test measure: World Health Organization Quality of Life Scale: sex: ALL minimumAge: 65 Years maximumAge: 90 Years stdAges: OLDER_ADULT facility: Bahçeşehir University research application center status: RECRUITING city: Istanbul country: Turkey name: Sefa Haktan Hatık, PhD role: CONTACT email: haktanhtk@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06291779 id: SNUBH-GS- HBP5 id: E-2211-792-350 (local IRB) type: OTHER domain: Seoul National University Bundang Hospital briefTitle: Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine overallStatus: RECRUITING date: 2022-11-30 date: 2024-02-26 date: 2024-05-31 date: 2024-03-04 date: 2024-03-04 name: Ho-Seong Han class: OTHER name: Seoul National University Bundang Hospital briefSummary: * This study aim to develope a diagnostic method of pancreatic cancer by using a reagent for analyzing purine metabolite (Hypoxanthine, Xanthine) in urine.
* It is safe and cost effective compare to radiologic or blood test. It can be used for initial screening test for healty population. conditions: Pancreas Cancer conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio measure: Urine sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ho-Seong Han status: RECRUITING city: Seongnam state: Gyeonggi-do country: Korea, Republic of lat: 37.43861 lon: 127.13778 hasResults: False

 nctId: NCT06291766 id: 2022-05498-01 briefTitle: Gestational Diabetes After Gastric Bypass Surgery overallStatus: RECRUITING date: 2024-01-01 date: 2028-12 date: 2035-12 date: 2024-03-04 date: 2024-03-04 name: Region Skane class: OTHER briefSummary: The goal of this trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery.

The main question it aims to answer is:

How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women.

Participants will be randomized to either continous glucose monitoring or regular capillary glucose measurements during the last trimester of their pregnancy. Researchers will compare the glucose measurement outcomes, the glucose lowering treatment given and pregnancy outcomes between groups. conditions: Diabetes, Gestational conditions: Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium conditions: Pregnancy in Diabetic conditions: Blood Glucose Self Monitoring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: FreeStyle Libre 2, continous glucose monitoring measure: Adverse Pregnancy Outcome measure: Glucose values measure: Glucose values measure: Glucose values measure: Glucose values measure: Glucose values measure: Pharmacological treatment measure: Pharmacological treatment measure: Pharmacological treatment measure: Pharmacological treatment measure: Birthweight measure: Week of delivery sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Region Skane status: RECRUITING city: Lund zip: 221 85 country: Sweden name: Ulrika Moll, MD, PhD role: CONTACT lat: 55.70584 lon: 13.19321 hasResults: False

 nctId: NCT06291753 id: SL-B2023-478-01 briefTitle: Characteristics and Tumor Staging Proposal for Primary Malignant Melanoma of the Esophagus overallStatus: COMPLETED date: 2023-09-22 date: 2024-02-18 date: 2024-02-18 date: 2024-03-04 date: 2024-03-04 name: Sun Yat-sen University class: OTHER briefSummary: Background: Primary malignant melanoma of the esophagus (PMME) is a malignant tumor originating from esophageal melanocytes with a poor prognosis. No international clinical guidelines or tumor staging systems have been proposed for PMME. This study aimed to analyze the clinical characteristics and treatment outcomes of patients with PMME and propose a tumor staging system in PMME.

Materials and Methods: The clinical characteristics of 25 patients with PMME at our cancer center were summarized, and 21 patients were enrolled in a pooled analysis with 162 cases (extracted from 74 eligible articles in PubMed) for further survival analysis and proposal of PMME tumor staging. conditions: Primary Malignant Melanoma of the Esophagus studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: RETROSPECTIVE count: 25 type: ACTUAL measure: Overall Survival(OS) measure: Disease-free survival (DFS) sex: ALL minimumAge: 23 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qianwen Liu city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06291740 id: MTU-EC-EM-2-008/67 id: Faculty of Medicine type: OTHER domain: Thammasat University, Thailand briefTitle: Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-05 date: 2024-03-04 date: 2024-03-04 name: Thammasat University class: OTHER briefSummary: The goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ED). Participants will random assign to either continuous or intermittent nebulization. In the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. In the intermittent group, the same medications are administer every 20 minutes for an hour. Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge. Adverse events are documented. conditions: Asthma Exacerbation conditions: Emergency Department conditions: Nebulization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial (RCT) primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: continuous nebulization name: Intermittent nebulization measure: Length of ED stay measure: pulmonary function test measure: Hospital admission measure: ED revisit within 48 hours sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291727 id: Prisma Upstate briefTitle: Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA overallStatus: RECRUITING date: 2024-02-16 date: 2025-07-01 date: 2025-07-01 date: 2024-03-04 date: 2024-03-04 name: Prisma Health-Upstate class: OTHER briefSummary: This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.

Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization. conditions: Anesthesia, Spinal conditions: Arthroplasty, Replacement, Knee studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized 1:1 to one of two groups; one receiving Mepivacaine spinal anesthesia and the other receiving Bupivacaine spinal anesthesia for total knee arthroplasty (TKA). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigators and participants will not know which anesthetic agent they receive. Anesthesia providers will be aware in order to provide correct randomization. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 138 type: ESTIMATED name: Mepivacaine name: Bupivacaine measure: Same day discharge rate measure: Post-operative pain score as assessed by numeric rating scale (NRS) measure: Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively measure: Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity measure: Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively measure: Pain Medications as evaluated by medical morphine equivalents measure: Patient satisfaction levels as assessed by a 5-item Likert response scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prisma Health Patewood Hospital status: RECRUITING city: Greenville state: South Carolina zip: 29615 country: United States name: Kyle Adams role: CONTACT phone: 864-455-3449 email: Kyle.Adams@prismahealth.org lat: 34.85262 lon: -82.39401 hasResults: False

 nctId: NCT06291714 id: Clearsight briefTitle: Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension acronym: Clearsight overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2026-03-31 date: 2024-03-04 date: 2024-03-15 name: University of Giessen class: OTHER name: Edwards Lifesciences briefSummary: In order to reduce the incidence of IOH, various goal-directed therapy (GDT) protocols have already been introduced with success regarding the reduction of postoperative AKI and MINS. However, these studies used an invasive hemodynamic monitoring which offered a continuous surveillance of the blood pressure. In contrast, standard non-invasive blood pressure monitoring results in a blind gap between two measurements (mostly three or five minutes). In order to address this limitation, different continuous non-invasive blood pressure monitoring devices have been introduced. The next evolutional step of non-invasive cardiac output monitoring was to prevent IOH before their onset by using the Hypotension Prediction Index (HPI). Based on the Edward ́s monitoring platform, HPI is a monitoring tool which aims to predict IOH (defined as MAP\<65 mmHg for at least one minute) up to 15 min before its onset. The underlying machine learning based algorithm uses analyses features from the pressure waveform and was first calculated from a large retrospective data set of surgical patients and subsequently validated in a prospective cohort. In this study HPI showed a sensitivity of 88% and specificity of 87% for predicting IOH 15 min before its onset. Since then, own and studies of other working groups confirmed the effective prevention of IOH by the use of HPI-based GDT. Until today the arterial waveform analysis was dependent on invasive arterial measurement but since Edwards Lifesciences already promoted the start of the HPI on the ClearSight platform a non-invasive measurement will soon be possible.

Further, until now it has not yet been proven that the perioperative use of a continuous non-invasive blood pressure monitoring has a beneficial effect on the patient´s outcome.

Study objectives The aim of the study is to investigate whether a hemodynamic protocol based on continuous non-invasive cardiac output monitoring (ClearSight system) compared to standard care can reduce the incidence of IOH, postoperative AKI, and MINS in patients undergoing major trauma and orthopedic surgery. conditions: Intraoperative Hypotension conditions: Acute Kidney Injury conditions: Myocardial Injury After Non-cardiac Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Management of interventional group patients Prior to the surgery the rest cardiac index and contractility (dp/dt) must be quantified. For this purpose, the cardiac index will be measured in the preoperative night by applicating the HPI ClearSight system through a study team member. If the rest cardiac index is not available throughout the night because the patient´s sleep is altered by the measurements, the awake cardiac index will be quantified until the monitoring is stopped for the night sleep of the patient. This mean baseline measurements (CI and dp/dt) will then be the target cardiac index throughout the study algorithm (figure 1). In case no sleep measurement was achievable, the awake measurement will be accounted as baseline value. The perioperative study intervention period starts with the beginning of anesthesia and ends at the end of surgery. Intraoperative mean arterial pressure will be maintained at least at 65 mmHg and cardiac index and dp/dt will be individually primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: All patients are connected to the Clearsight device but the interface is masked in the control group. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: GDT-based hemodynamic management based on Clearsight device measure: Change of the frequency of intraoperative hypotension measure: Change of the absolute duration of of intraoperative hypotension measure: Change of the relative duration of intraoperative hypotension measure: AKI measure: MINS sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291701 id: ODUSBFFTR-ELIFAYGUNPOLAT-002 briefTitle: The Relationship Between Scapular Endurance, Core Endurance, and Functional Performance in Adolescent Tennis Players overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-15 date: 2024-04-01 date: 2024-04-15 date: 2024-03-04 date: 2024-04-04 name: T.C. ORDU ÜNİVERSİTESİ class: OTHER briefSummary: This study aims to examine the relationship between scapular endurance, core endurance, and upper extremity performance in adolescent tennis players. The hypothesis of this study is that better scapular/core endurance in adolescent tennis players is associated with better upper extremity performance. Establishing this relationship will contribute to identifying the exercise training necessary to improve upper extremity performance in tennis players. conditions: Athletic Injuries conditions: Sports Physical Therapy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 35 type: ESTIMATED name: Assessment of scapular endurance name: Prone Bridge Test name: Side Bridge Test name: Closed Kinetic Chain Upper Extremity Stability Test name: Seated Medicine Ball Throw Test measure: Prone Bridge Test measure: Side Bridge Test measure: Scapular Endurance Values measure: Closed Kinetic Chain Upper Extremity Stability Test measure: Seated Medicine Ball Throw Test sex: ALL minimumAge: 11 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ordu University city: Ordu zip: 52200 country: Turkey lat: 40.97782 lon: 37.89047 hasResults: False

 nctId: NCT06291688 id: 202312004RIND briefTitle: Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability overallStatus: RECRUITING date: 2024-01-26 date: 2025-12-31 date: 2026-01-31 date: 2024-03-04 date: 2024-03-04 name: National Taiwan University Hospital class: OTHER briefSummary: The goal of this clinical interventional study is to compare the efficacy of mobile healthcare education in two ways (game-based or text-based) to improve cutaneous self-care capability in cancer patients receiving EGFR-based target therapy. The main questions it aims to answer are:

Impact of different mobile healthcare education ways on cutaneous self-care capability of patients Impact of different mobile healthcare education ways on learning motivation of patients towards cutaneous self-care knowledge and skills

Participants will be randomly divided into two groups. Both groups will download a healthcare education application on their phone. One group will accept the education about the knowledge and self-care skills of cutaneous adverse drug reaction by playing game. In contrast, the other group will accept the same education content by reading text on the phone. Subjects will be asked to use the application at home for two weeks after giving consent to participate this study, and then completed questionnaire three times during study period. The timepoints of completing questionnaire are listed following:

Baseline / pre-intervention test (after signing informed consent form, D1) First post-intervention test (after finishing intervention, D15) Second post-intervention test (D30) Researchers will compare game group and text group to see if game group has better performance on cutaneous self-care capability and learning motivation. conditions: EGFR Gene Mutation conditions: Drug-Related Side Effects and Adverse Reactions conditions: Cancer, Treatment-Related conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 110 type: ESTIMATED name: Mobile healthcare education game name: Mobile healthcare education application measure: Change from baseline in the score of cutaneous adverse drug reaction (CADR) knowledge on researcher-designed questionnaire at Day 15 and Day 30. measure: Investigate the learning motivation towards CADR by self-designed questionnaire at Day 15 measure: Change from baseline in the score of the quality of life on DLQI questionnaire at Day 15 and Day 30 measure: Investigate the user-experience of the mobile healthcare education APP by researcher-designed questionnaire at Day 15. measure: Change from baseline in the score of the self-care measurement adherence on researcher-designed questionnaire at Day 15 and Day30. measure: The correlation among APP usability, learning motivation and self-care capability. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100225 country: Taiwan name: XinYi Lin, Bs role: CONTACT phone: +886988619601 email: r11426019@ntu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06291675 id: 2083/2022 briefTitle: Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content overallStatus: RECRUITING date: 2023-03-03 date: 2026-03-03 date: 2033-03-03 date: 2024-03-04 date: 2024-03-04 name: Medical University of Vienna class: OTHER briefSummary: Background: Gender affirming hormone therapy (GAHT) leads to profound changes in sex hormone levels, carrying a wide range of implications for major physiological processes in the body. GAHT has been shown to be associated with changes in cardiovascular parameters, the insulin system, body composition, and the psychological state. However, despite the fact that GAHT is usually a long-term intervention, the majority of the research concerns itself with an overall short duration of the therapy and the data on the mid- to long-term effects of GAHT is scarce.

Objectives: The study aims to investigate the effects of gender affirming hormone therapy on the cardiovascular risk profile, insulin system, body composition, various metabolic parameters, and the psychological state after 2, 5, and 10 years of the treatment.

Study design: The study is designed as an observational longitudinal monocentric study, which includes transgender men and transgender women who have been taking gender affirming hormone therapy during the past 2 years and took part in our pilot study. Our probands will undergo a magnetic resonance scan, extensive bloodwork, an oral glucose tolerance test, and a psychological self-assessment after 2, 5, and 10 years of the treatment.

Materials and methods: The magnetic resonance imaging and spectroscopy will be performed with a 3-Tesla magnetic resonance device. We will also perform an extensive blood analysis and an 75g- 2h oral glucose tolerance test. Additionally, the psychological state of the probands will be assessed with 3 questionnaires.

Study population: 30 transgender men 30 transgender women who participated in our pilot study and have been taking the gender affirming hormone therapy for the past 2 years.

Relevance and implications of the study: The majority of previous research has focused on the short-term effects of gender affirming hormone therapy. Contrastingly, our study aims to focus on the effects of hormone therapy at 2, 5 and 10 years after the beginning of the treatment. Moreover, our study group utilizes measurements of myocardial, hepatic, and pancreatic fat content as well as an MR-assisted measurement of cardiac function, which is a topic that has not been present in research into the effects of gender affirming hormone therapy outside of our pilot study. conditions: Gender Dysphoria conditions: Hormone Therapy Induced Morphologic Change studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: gender-affirming hormone therapy measure: Myocardial mass measure: Cardiac function - LVEF measure: cardiac function - cardiac output index measure: Organ lipid content measure: Subcutaneous to visceral fat ratio sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chiari Stoffwechselambulanz, Medical University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Carola Deischinger, MD PhD role: CONTACT phone: +43140400 phoneExt: 20690 email: carola.deischinger@meduniwien.ac.at name: Alexandra Kautzky-Willer, Prof, MD role: CONTACT email: alexandra.kautzky-willer@meduniwien.ac.at name: Alexandra Kautzky-Willer, Prof, MD role: PRINCIPAL_INVESTIGATOR name: Carola Deischinger, MD PhD role: SUB_INVESTIGATOR lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06291662 id: PRECISE_IC briefTitle: Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-04 date: 2024-03-04 name: Kathleen McGreevy class: OTHER briefSummary: Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3D printing. In fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. This new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. conditions: Sarcoma conditions: Intracranial Neoplasm conditions: Pelvic Bone Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Oncologic patients primaryPurpose: OTHER masking: NONE count: 12 type: ESTIMATED name: 3D printer applications measure: 3D model feasibility for pre-surgical making decisions measure: Surgical time measure: Device feasibility sex: ALL minimumAge: 7 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria Careggi (AOUC) status: ACTIVE_NOT_RECRUITING city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Federico Mussa, MD role: CONTACT email: federico.mussa@meyer.it lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Senese (AOUS) status: ACTIVE_NOT_RECRUITING city: Siena country: Italy lat: 43.31822 lon: 11.33064 hasResults: False

 nctId: NCT06291649 id: AMIETOX briefTitle: Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age overallStatus: RECRUITING date: 2023-04-05 date: 2033-04-05 date: 2033-08-05 date: 2024-03-04 date: 2024-03-04 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings.

The primary objective of the study is to assess the epidemiology of acute intoxications in paediatric age with respect to the social and care factors associated with it in order to then implement in the future a better diagnostic-therapeutic management modality on a national level.

Thi is a prospective non-profit multicentre observational cohort study on acute intoxications in the paediatric age, conducted by AMIETOX, aimed at CAVs (Poison Control Centres) and PSPs (Paediatric emergency room). conditions: Acute Intoxication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Determination of Incidence of intoxication in paediatric children measure: Determination of Prevalence of intoxication in paediatric children sex: ALL minimumAge: 1 Month maximumAge: 16 Years stdAges: CHILD facility: Ospedale Santa Maria Annunziata status: RECRUITING city: Bagno A Ripoli state: Firenze zip: 50139 country: Italy name: Anna Chiara Azzali role: CONTACT phone: 055 69361 email: annachiara.azzali@uslcentro.toscana.it lat: 43.75115 lon: 11.32252 facility: Ospedale Del Mugello status: RECRUITING city: Borgo San Lorenzo state: Firenze zip: 50139 country: Italy name: Rosalia Emidia Di Silvio role: CONTACT email: rosaliaemidia.disilvio@uslcentro.toscana.it lat: 43.95548 lon: 11.38561 facility: Ospedale G B Morgagni status: RECRUITING city: Forlì state: Forlì-Cesena country: Italy name: Melodie Aricò role: CONTACT email: melodieolivialoredanarosa.arico@auslromagna.it lat: 44.22177 lon: 12.04144 facility: Mater Salutis status: RECRUITING city: Legnago state: Verona country: Italy name: Anna Maria Colombaria role: CONTACT email: annamaria.colombari@aulss9.veneto.it lat: 45.19365 lon: 11.30227 facility: Ospedale Maggiore status: RECRUITING city: Bologna country: Italy name: Chiara Ghizzi role: CONTACT email: chiara.ghizzi@ausl.bologna.it lat: 44.49381 lon: 11.33875 facility: Ospedale Centrale Bolzano status: RECRUITING city: Bolzano country: Italy name: Ylenia Girtler role: CONTACT email: ylenia.girtler@sabes.it lat: 46.49067 lon: 11.33982 facility: Ospedale Brotzu status: RECRUITING city: Cagliari country: Italy name: Gabriella Cherchi role: CONTACT email: gacherchi@gmail.com lat: 39.23054 lon: 9.11917 facility: Ospedale San Giuseppe status: RECRUITING city: Empoli zip: 50053 country: Italy name: Antonino Francesco Capizzi role: CONTACT email: antoninofrancesco.capizzi@uslcentro.toscana.it lat: 43.71795 lon: 10.94758 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence zip: 50139 country: Italy name: Marco De Luca role: CONTACT phone: 0555662051 email: marco.deluca@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedale Misericordia status: RECRUITING city: Grosseto zip: 58100 country: Italy name: Francesca Bonsignori role: CONTACT email: francesca.bonsignori@uslsudest.toscana.it lat: 42.76296 lon: 11.10941 facility: Policlinico Messina status: RECRUITING city: Messina country: Italy name: Laura Colavita role: CONTACT email: lauracol85@gmail.com lat: 38.19394 lon: 15.55256 facility: Ospedale San Francesco status: RECRUITING city: Nuoro country: Italy name: Antonio Cualbu role: CONTACT email: antonio.cualbu@atssardegna.it lat: 40.31991 lon: 9.32568 facility: Ao Padova status: RECRUITING city: Padova country: Italy name: Francesco Corazza role: CONTACT email: francesco.corazza@aopd.veneto.it lat: 45.40797 lon: 11.88586 facility: Nuovo Ospedale Dei Bambini status: RECRUITING city: Parma country: Italy name: Monica Rubini role: CONTACT email: rubinim@ao.pr.it lat: 44.79935 lon: 10.32618 facility: Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Thomas Foiadelli role: CONTACT email: thomas.foiadelli@gmail.com lat: 45.19205 lon: 9.15917 facility: Policlinico Pescara status: RECRUITING city: Pescara country: Italy name: Giorgia Carlone role: CONTACT email: giorgia.carlone@asl.pe.it lat: 42.4584 lon: 14.20283 facility: Ospedale Santa Chiara - Cisanello status: RECRUITING city: Pisa country: Italy name: Alessandro Orsini role: CONTACT email: aorsini.md@gmail.com lat: 43.70853 lon: 10.4036 facility: Ospedale San Jacopo status: RECRUITING city: Pistoia zip: 51100 country: Italy name: Francesca Mangiantini role: CONTACT email: francesca.mangiantini@usl.toscana.it lat: 43.93064 lon: 10.92365 facility: Ospedale Civile Santa Maria Degli Angel status: RECRUITING city: Pordenone country: Italy name: Daniele Santori role: CONTACT email: daniele.santori@asfo.sanita.fvg.it lat: 45.95689 lon: 12.66051 facility: Ospedale Santo Stefano status: RECRUITING city: Prato zip: 59100 country: Italy name: Francesca Grisolia role: CONTACT email: francesca.grisolia@uslcenntro.toscana.it lat: 43.8805 lon: 11.09699 facility: Ospedale Infermi status: RECRUITING city: Rimini country: Italy name: Gianluca Vergine role: CONTACT email: gianluca.vergine@auslromagna.it lat: 44.05755 lon: 12.56528 facility: CAV Gemelli status: RECRUITING city: Roma country: Italy name: Maurizio Paolo Soave role: CONTACT email: centro.antiveleni@policlinicogemelli.it lat: 41.89193 lon: 12.51133 facility: Policlinico Gemelli status: RECRUITING city: Roma country: Italy name: Antonio Gatto role: CONTACT email: antonio.gatto@policlinicogemelli.it lat: 41.89193 lon: 12.51133 facility: Ospedale Regina Margherita status: RECRUITING city: Torino country: Italy name: Claudia Bondone role: CONTACT email: claudiabondone@virgilio.it lat: 45.07049 lon: 7.68682 facility: Santa Chiara status: RECRUITING city: Trento country: Italy name: Stefania Ielo role: CONTACT email: stefania.ielo@apss.tn.it lat: 46.06787 lon: 11.12108 facility: Ulss 2 Marca Trevigiana status: RECRUITING city: Treviso country: Italy name: Valentina Brugnarolo role: CONTACT email: valentina.brugnolaro@aulss2.veneto.it lat: 45.66673 lon: 12.2416 facility: Burlo Garofalo status: RECRUITING city: Trieste country: Italy name: Alessandro Amaddeo role: CONTACT email: alessandro.amaddeo@burlo.trieste.it lat: 45.64953 lon: 13.77679 facility: Clinica Pediatrica Udine status: RECRUITING city: Udine country: Italy name: Chiara Pilotto role: CONTACT email: chiara.pilotto@asufc.sanita.fvg.it lat: 46.0693 lon: 13.23715 facility: CAV Veneto status: RECRUITING city: Verona country: Italy name: Giorgio Ricci role: CONTACT email: centroantiveleno@aovr.veneto.it lat: 45.4299 lon: 10.98444 facility: Ospedale Della Donna E Del Bambino status: RECRUITING city: Verona country: Italy name: Pietro Soloni role: CONTACT email: pietro.soloni@aovr.veneto.it lat: 45.4299 lon: 10.98444 facility: Ospedale San Bortolo status: RECRUITING city: Vicenza country: Italy name: Ilaria Tosetto role: CONTACT email: ilaria.tosetto@aulssl8.veneto.it lat: 45.54672 lon: 11.5475 hasResults: False

 nctId: NCT06291636 id: R.24.01.2451 briefTitle: Re- Admission Rate Among Survived Patients With Acute Respiratory Failure overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2024-01-20 date: 2024-03-04 date: 2024-03-04 name: Mansoura University class: OTHER briefSummary: Readmission to the intensive care unit (ICU) results in increased consumption of medical resources and costs, and has been proposed as a marker for quality of care. ICU readmission rates have been estimated at 4 to 14% and different risk factors have been proposed by various studies Readmitted patients mostly carry poor prognosis compared to newly admitted ones, in addition to the bad psychological impact for both patient and his family conditions: Respiratory Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 994 type: ACTUAL measure: Length of hospital and ICU stay and Cause of readmission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tamer Awad Elsayed city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06291623 id: Molecular Analysis briefTitle: Molecular Analysis of Intracanal Microbes After Chemomechanical Procedure and Root Canal Medication: Clinical Study overallStatus: COMPLETED date: 2022-05-03 date: 2023-12-20 date: 2024-01-15 date: 2024-03-04 date: 2024-03-04 name: Mansoura University class: OTHER briefSummary: This study aimed to evaluate clinically the intracanal microbes at molecular level after using established root canal medicament Calcium hydroxide and potential root canal medicament Glycyrrhizin.and Decontamination Analysis of Controls samples. conditions: Bacterial Viability of Necrotic Pulp With Asymptomatic Apical Periodontitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ACTUAL name: Glycyrrhizin measure: minimizing of viable bacteria which showed by Real time PCR sex: ALL minimumAge: 19 Years maximumAge: 60 Years stdAges: ADULT facility: Mansoura University city: Mansoura state: Dakahliya zip: 35511 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06291610 id: Aarhus University Hospital briefTitle: Feasibility Testing a Decision-support Intervention for Clinical Trials overallStatus: RECRUITING date: 2024-02-19 date: 2025-12-31 date: 2026-12-31 date: 2024-03-04 date: 2024-03-04 name: University of Aarhus class: OTHER briefSummary: A decision-support intervention are developed for a Danish nationwide randomised controlled trial (RCT) among patients with laryngeal and pharyngeal cancer referred to curative intended radiotherapy. The primary endpoints in this RCT are levels of dysphagia and xerostomia.

The decision-support intervention consists of three components, including (1) a patient decision aid tailored to clinical trial participation and (2) decision coaching consultations carried out by trained healthcare professionals. Finally, (3) a training program in decision coaching will be an integrated part of the intervention.

To feasibility test (beta test) the intervention, 60 patient participants will be included, separated into pre- (n=30) and post- (n=30) intervention groups. Pre-intervention to complete the survey based on current clinical practice. Post-intervention to complete the survey following engagement in the decision support intervention.

A total of 12 physicians will be recruited and trained in decision coaching. To assess the acceptability of the intervention, the physicians will be interviewed. Additionally, they will be asked to audio-record two decision coaching sessions to test the fidelity of the intervention. conditions: Head and Neck Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre- and post-intervention measures in two consecutive groups. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Patients are recruited anonymous count: 60 type: ESTIMATED name: Clinical trial decision support intervention measure: Decisional conflict scale measure: The decision preparation scale measure: The stages of decision making measure measure: Items on health literacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital status: RECRUITING city: Aarhus zip: 8200 country: Denmark name: Anne Kristensen role: CONTACT phone: +4530315605 email: annkrs@rm.dk name: Cai Grau role: CONTACT email: cai.grau@rm.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06291597 id: 22071 briefTitle: Vaping Adverse Lung and Heart Events Cohort acronym: VapALERT overallStatus: RECRUITING date: 2021-10-14 date: 2031-12 date: 2032-06 date: 2024-03-04 date: 2024-03-04 name: Laval University class: OTHER name: Ministere de la Sante et des Services Sociaux briefSummary: This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up. conditions: Vaping conditions: Electronic Cigarette Use studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Vaping measure: Number of participants who vape daily with impaired lung volumes. measure: Number of participants who vape daily with impaired lung diffusion capacity. measure: Number of participants who vape daily with impaired spirometry. measure: Number of participants who vape daily with airway hyperresponsiveness. measure: Number of participants who vape daily with changes in blood cell count. measure: Number of participants who vape daily with changes in sputum cell count. measure: Vaping, tobacco and cannabis smoking habits of participants. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IUCPQ-UL status: RECRUITING city: Québec zip: G1V 4G5 country: Canada name: Ariane Lechasseur, PhD role: CONTACT phone: 418-656-8711 phoneExt: 2652 email: ariane.lechasseur@criucpq.ulaval.ca name: Mathieu C Morissette, PhD role: PRINCIPAL_INVESTIGATOR name: Andréanne Côté, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06291584 id: P20230001 briefTitle: Effects of Exercises on Functional Capacity overallStatus: RECRUITING date: 2023-10-01 date: 2024-05-01 date: 2024-10-01 date: 2024-03-04 date: 2024-03-08 name: Kırklareli University class: OTHER briefSummary: In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity. conditions: Nicotine Addiction conditions: Respiratory Disease conditions: Sedentary Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study consists of three groups. Groups to be formed: Group 1: face-to-face exercise group; Group 2: Online (Telehealth) Exercise Group; Group 3: Control Group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: First of all, the randomization of exercise groups will be performed according to the closed envelope procedure. The student who selects one of the envelopes with the names of the three groups will be included in the group written in the envelope he selected. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Exercise measure: International Physical Activity Questionnaire - Short Form measure: Six-Minute Walk Test- (6MWT) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Kirklareli University status: RECRUITING city: Kırklareli state: Kayalı zip: 39000 country: Turkey name: Fulya DEMIRHAN, Res. Ass. role: CONTACT phone: +90-532-353-2208 email: fulyademirhan@klu.edu.tr lat: 41.73508 lon: 27.22521 hasResults: False

 nctId: NCT06291571 id: 324543 briefTitle: Assessment of Microorganisms and Host Response In Liver Diseases acronym: MILD overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2029-02-28 date: 2030-03-01 date: 2024-03-04 date: 2024-03-04 name: University of Aberdeen class: OTHER briefSummary: The normal human gut is home to millions of microbes including bacteria, fungi, and viruses, collectively forming the gut microbiota, which exists in harmony within us. Much research is still required to fully understand the contribution of microbes resident in the large intestine in liver diseases. The liver receives blood from the gut carrying all the necessary nutrients needed for our body but also has to deal with toxins derived from the microbes residing in the intestines. The gut microbiota is altered in liver disease. We still do not know clearly how this change impacts liver function and the health of liver patients. The purpose of our study is to answer this question by assessing the gut microbiota using modern microbiological and molecular methods. By studying the alterations in the gut microbiota in patients with liver disease we can understand how they affect our immune system and metabolism. This will help design novel medicinal products to prevent and treat liver disease. conditions: Gut Microbiome conditions: Liver Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: To identify the bacterial, fungal, and virological agents present in patients with liver disease as opposed to controls measure: To assess the host immune response against specific microbes isolated from patients with liver disease and controls measure: To characterise the changes in the liver immune microenvironment by analysing liver biopsies from patients sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291558 id: P202200027 briefTitle: Exercise Training for Smoking Students overallStatus: RECRUITING date: 2023-10-01 date: 2024-05-01 date: 2024-10-01 date: 2024-03-04 date: 2024-03-04 name: Kırklareli University class: OTHER briefSummary: Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. In the studies, it has been seen that smoking may reduce the oppression and exercise ability. conditions: Nicotine Dependence conditions: Smoking conditions: Physical Inactivity conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The participants will be informed that the study was carried out for scientific purposes and the information will not be shared with third parties. Randomization of exercise groups will be performed according to the closed envelope procedure. The student who selects one of the envelopes with the names of the 3 groups will be included in the group written in the envelope he selected. Information about other groups will not be shared. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Exercise measure: International Physical Activity Questionnaire (Short) measure: Six-Minute Walk Test measure: Scoring the Fagerstrom Test for Nicotine Dependence (FTND) measure: Beck's Depression Inventory (BDI) measure: Lung Function Test sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Kirklareli University status: RECRUITING city: Kırklareli state: Kayalı zip: 39000 country: Turkey name: Fulya DEMIRHAN, Res. Ass. role: CONTACT phone: +90-532-353-2208 email: fulyademirhan@klu.edu.tr lat: 41.73508 lon: 27.22521 hasResults: False

 nctId: NCT06291545 id: JW-SBC202202 briefTitle: Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-12-31 date: 2025-06-30 date: 2024-03-04 date: 2024-03-05 name: JW Medical Systems Ltd class: INDUSTRY briefSummary: This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） name: ScoreFlex NC Coronary Dilatation Catheter measure: Rate of successful device usage measure: Rate of success of the surgery measure: Incidence of in-hospital MACE measure: Incidence of PoCE within 30 days after surgery measure: The lumen is obtained immediately sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291532 id: VRRS01 briefTitle: Feasibility and Usability of a Virtual Reality System overallStatus: ENROLLING_BY_INVITATION date: 2023-04-01 date: 2025-09-30 date: 2025-09-30 date: 2024-03-04 date: 2024-03-04 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: Intellectual disability (ID) and autism spectrum disorder (ASD) are often co-occurring neurodevelopmental disorders that require composite intervention. However, standardized rehabilitation programs presented several limitations due to behavioral problems and poor engagement in proposed activity. The Virtual Reality Rehabilitation System (VRRS) is a medical device is recognized as one of the most advanced systems to rehabilitate patients with motor, cognitive, linguistic and behavioral disorders. The use of VRRS offers the opportunity to adapting task parameters according to the patient's performance and the virtual system increases engagement and avoids boredom and frustration. the patients underwent a two months experimental intervention integrated into the regular activity of a semi-residential center for autistic adolescents and young adults. conditions: Autism Spectrum Disorder conditions: Intellectual Disability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Rehabilitation with VRRS measure: Usability questionnaire measure: Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time measure: Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: the number of repetitions of the exercises. measure: Virtual Reality Rehabilitation System (VRRS) electromedical device parameters:global scores for exercise. sex: ALL minimumAge: 6 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Centro Neurolesi Bonino Pulejo city: Messina zip: 98124 country: Italy lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06291519 id: SHN50343434 briefTitle: The Effect of Multisensory Stimulus Method on Pain and Physiological Parameters in Infants overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-30 date: 2023-12-30 date: 2024-03-04 date: 2024-03-04 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This study aimed to investigate the impact of employing the multi-sensory stimulation technique by both the mother and the nurse on the pain and physiological responses of infants aged 2-6 months during vaccination. The significance of pain experienced during vaccination in children is emphasized, potentially leading to avoidance behaviors toward healthcare services. There is growing evidence supporting the efficacy of non-pharmacological interventions. Multi-sensory stimulation, which integrates various stimuli such as taste, touch, and speech, alleviates infant pain. However, there has been a lack of studies assessing the effectiveness of this approach during vaccination administered by different healthcare providers. Hence, this study sought to explore the effects of multi-sensory stimulation by both mother and nurse applied to pain and physiological parameters. It is anticipated that the findings of this study will contribute to both pain management strategies and healthcare practices. conditions: Multisensory Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled experimental design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 96 type: ACTUAL name: Multi-sensory Stimulation Method-Mother Applying the Method to the Baby name: Multi-sensory Stimulation Method-Nurse Applying the Method to the Baby name: Breastfeeding Applied Group measure: The Effect of Multiple Sensory Stimulus Method measure: Comparison of the group in which the mother applied multiple sensory stimuli and the group in which the nurse applied multiple sensory stimuli sex: ALL minimumAge: 2 Months maximumAge: 6 Months stdAges: CHILD facility: Istanbul University-Cerrahpasa city: Istanbul state: None Selected zip: 34381 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06291506 id: 6270 briefTitle: SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER). acronym: SUPAFER overallStatus: RECRUITING date: 2023-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-03-04 date: 2024-03-04 name: Hospital Universitario La Paz class: OTHER briefSummary: Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.

Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic. conditions: Persistent and Long Lasting or Chronic Atrial Fibrillation conditions: Atrial Fibrillation Ablation conditions: Linear Left Atrial Ablation conditions: Daily Transtelephonic Electrocardiogram studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 randomization primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Radiofrequency ablation of heart atrial tissue. measure: Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter. measure: Acute intraprocedure efficacy. measure: Complications. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: La Paz University Hospital - IdiPaz status: RECRUITING city: Madrid country: Spain name: José Luis Merino, MD role: CONTACT phone: +34 912071301 email: lapaz@arritmias.net name: Sergio Castrejón Castrejón role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06291493 id: CS-2024-0002 briefTitle: Precision Study Measuring Potassium (K) in Capillary Specimens overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-10 date: 2024-12 date: 2024-03-04 date: 2024-03-22 name: Abbott Point of Care class: INDUSTRY briefSummary: Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer. conditions: Precision of Potassium (K) Test in Capillary Whole Blood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Capillary precision analysis will be performed for Potassium K. primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Fingerstick blood draw measure: Precision for Potassium (K) Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291480 id: NL78853.058.22 / STRUM briefTitle: Music Therapy After Stroke (Subacute Phase) overallStatus: RECRUITING date: 2023-01-01 date: 2024-08 date: 2024-12 date: 2024-03-04 date: 2024-03-04 name: Universiteit Leiden class: OTHER name: Amstelring briefSummary: The goal of this longitudinal, single-subject study is to investigate the role of motivation in music therapy for stroke patients within the subacute phase, who experience upper limb and/or attention deficits. The main questions it aims to answer are:

* Does music therapy increase patient's motivation to rehabilitate?
* Do increases in motivation correlate with functional improvements, in particular upper limb and/or attention skills?

Participants will receive up to 9 music therapy sessions within 3-5 weeks, with functional assessments before and after each period. Each participant serves as their own comparison: researchers will compare a period with standard care only (control phase) to a period with music therapy plus standard care (intervention phase), the order of which will be randomized in advance. conditions: Stroke (CVA) or TIA conditions: Stroke/Brain Attack studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Neurologic Music Therapy measure: Motivation: Brain Injury Rehabilitation Trust Motivation Questionnaire (BMQ-S) [self-reported] measure: Motor Function: Action Research Arm Test (ARAT) measure: Motor Function: Barthel Index (BI) measure: Cognition: Cancellation Wechsler Adult Intelligence Scale (WAIS-IV) measure: Cognition: Color-Word Interference Test, also known as Stroop test measure: Cognition: WAIS IV Digit Span Test - Forward and Backward measure: Cognition: Verbal Fluency Test measure: Cognition: Trail Making Test (TMT) measure: Motivation to engage in musical activities: Barcelona Music Reward Questionnaire (BMRQ) measure: Quality of Life: EuroQol-5 (EQ-5D-5L) measure: Mood: Depression Anxiety Stress Scale-21 (DASS-21) measure: Mood: Visual Analogue Mood Scale (VAMS) measure: Personality Traits: The Big Five Index-Extra Short Form (BFI-2-XS) measure: Optimism: Life Orientation Test- Revised (LOT-R) measure: Brief self-report of therapy expectations and satisfaction with treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leo Polak Rehabilitation centre status: RECRUITING city: Amsterdam state: Nederland zip: 1069BW country: Netherlands name: Theo Dimitriadis, MSc role: CONTACT email: tdimitriadis@amstelring.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06291467 id: RECHMPL23_0121 briefTitle: Plasma Beta-endorphin Levels and Suicidal Behavior acronym: BEST overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Montpellier class: OTHER name: Institut de Génomique Fonctionnelle (IGF) de Montpellier briefSummary: It is an interventional research, monocentric, which involves only minimal risks and constraints.

Psychological pain is closely associated with suicidal ideation (SI) and suicidal behavior, regardless of the severity of the depression. The psychological pain being regulated by the opioidergic system, it seems that a dysfunction of this system exists in suicidal attempters. The aim of this study is to explore the association between levels of β-endorphin and suicidal behavior.

The research team will measure plasma levels of β-endorphin in patients hospitalized for suicide attempt (SA) within 72 hours and compare them to those of patients hospitalized for current major depressive episode (EDC) without any lifetime history of SA. In order to follow the kinetics of β endorphin levels, The research team will carry out two measurements: at inclusion and on day 7 (+/- 2 days) of inclusion.

The main objective is to compare plasma β-endorphin levels in patients hospitalized following a recent SA (≤72 hours) and in patients hospitalized for an EDC without lifetime history of SA. conditions: Suicide conditions: Depression conditions: Beta Endorphin studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 104 type: ESTIMATED name: Blood samples name: questionnaires measure: Comparison of plasma β-endorphin levels between patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any lifetime history of suicide attempt. measure: - The kinetics of β-endorphin levels between two measurement points (inclusion and D7+/-2 days) in patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any history of suicide attempt. measure: The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS) measure: The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16) measure: To assess the association between β-endorphin levels and and Suicidal ideation and history of suicidal behavior in the last week before inclusion, measure: To assess the association between β-endorphin levels and Anhedonia measure: To assess the association between β-endorphin levels and Current psychological and physical pain as well as usual and maximum over the 15 days before inclusion measure: To assess the association between β-endorphin levels and Anxiety, sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University hospital city: Montpellier zip: 34295 country: France name: Jessica DALAUDIERE role: CONTACT email: jessica.dalaudiere@chu-montpellier.fr lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06291454 id: 741100 briefTitle: GCF Levels of Chemokines in Periodontitis overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-01 date: 2023-12-01 date: 2024-03-04 date: 2024-03-08 name: T.C. ORDU ÜNİVERSİTESİ class: OTHER briefSummary: This study aimed to determine CCL19/MIP3beta(β) and CCL20/MIP3alpha(α) in the gingival crevicular fluid (GCF) of the patients with different periodontitis phenotypes.

A total of 72 individuals, 24 with Stage III Grade B periodontitis (Group 1), 24 with Stage III Grade C periodontitis (Group 2), and 24 periodontally healthy (control group) (Group 3), were included in the study. GCF and clinical periodontal parameters were obtained at baseline. MIP3β and MIP3α levels in GCF were determined by ELISA. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 72 type: ACTUAL name: Routine periodontal examination measure: CCL19/MIP3beta(β) levels measure: CCL20/MIP3alpha(α) levels measure: CCL19/MIP3beta(β) levels and clinical parameters measure: CCL20/MIP3alpha(α) levels and clinical parameters sex: ALL minimumAge: 22 Years maximumAge: 55 Years stdAges: ADULT facility: Ordu University, Faculty of Dentistry city: Ordu zip: 52100 country: Turkey lat: 40.97782 lon: 37.89047 hasResults: False

 nctId: NCT06291441 id: WUIPS briefTitle: Women Urinary Incontinence Prevalence Study (WUIPS) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: IRCCS San Raffaele class: OTHER name: Università Vita-Salute San Raffaele briefSummary: The goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of Urinary Incontinence (UI) among female patients, female caregivers and female personnel in four hospitals in Northern Italy: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG). conditions: Female Urinary Incontinence studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1842 type: ESTIMATED name: No intervention measure: Prevalence of middle-aged women with urinary incontinence measure: Predictors of urinary incontinence in middle-aged women measure: Quality of life of middle-aged women with urinary incontinence measure: Social impact of middle-aged women with urinary incontinence measure: Costs of urinary incontinence for middle-aged women sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Policlinico San Marco Zingonia city: Osio Sotto state: Bergamo zip: 24040 country: Italy name: Elisabetta Bagnato role: CONTACT email: elisabetta.bagnato@grupposandonato.it name: Giulia Villa role: CONTACT phone: 0291751779 email: villa.giulia@hsr.it lat: 45.61608 lon: 9.58905 facility: Policlinico San Pietro Ponte San Pietro city: Bergamo zip: 24036 country: Italy name: Elisabetta Bagnato role: CONTACT email: elisabetta.bagnato@grupposandonato.it name: Giulia Villa role: CONTACT phone: 0291751779 email: villa.giulia@hsr.it lat: 45.69601 lon: 9.66721 facility: San Raffaele Turro Hospital (MI) city: Milan zip: 20127 country: Italy lat: 45.46427 lon: 9.18951 facility: San Raffaele Hospital (MI) city: Milan zip: 20132 country: Italy name: Sara Trapani role: CONTACT phone: +39 3389879403 email: trapani.sara@hsr.it name: Giulia Villa role: CONTACT phone: 0291751779 email: villa.giulia@hsr.it name: Stefania Rinaldi role: SUB_INVESTIGATOR name: Caglioni Martina role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-08-23 uploadDate: 2024-02-15T07:26 filename: Prot_000.pdf size: 544090 hasResults: False

 nctId: NCT06291428 id: F-CNIC-2024-007 briefTitle: Raman Spectroscopy Compared to Flow Cytometry overallStatus: NOT_YET_RECRUITING date: 2024-10-15 date: 2026-12-30 date: 2026-12-30 date: 2024-03-04 date: 2024-03-04 name: Hospital Regional de Alta Especialidad del Bajio class: OTHER name: Optics research center briefSummary: The detection of MRD is associated with an increased risk of relapse and adverse prognosis in all patient groups diagnosed with acute lymphoblastic leukemia (ALL). However, it has a sensitivity level that detects one leukemic cell in 10,000 normal cells, along with other disadvantages such as the need for a panel of fluorescent antibodies for MRD detection, and its measurement is not standardized in many centers. New determination techniques may be necessary for MRD evaluation. Raman spectroscopy is proposed as a potential technique for MRD measurement, which is based on the inelastic scattering of light that occurs when it interacts with matter, causing optical scattering, where a portion of the radiation changes its wavelength (by Raman effect).

Objectives:

MAIN OBJECTIVE:

To evaluate the presence of MRD in patients with ALL by comparing a standard evaluation method using flow cytometry with a new proposed method using Raman spectroscopy.

SPECIFIC OBJECTIVES:

* To assess the presence of MRD using flow cytometry in patients with ALL.
* To assess the presence of MRD using Raman spectroscopy in patients with ALL.
* To perform a comparison between the MRD measurement techniques by determining sensitivity, specificity, positive predictive value, and negative predictive value.
* To establish the validation of using Raman spectroscopy as a method for MRD evaluation.

Study Design:

An observational, cross-sectional, comparative, and diagnostic test study will be conducted on bone marrow aspirate samples from adult and pediatric ALL patients to evaluate the presence of MRD using Raman spectroscopy, comparing the results of this technique with those obtained using flow cytometry. As a diagnostic test study, sensitivity, specificity, positive predictive value, and negative predictive value will be evaluated. The study will be conducted on adult and pediatric patients diagnosed with acute lymphoblastic leukemia treated at the hemato-oncology department of the UMAE No. 1 National Medical Center Bajio and the UMAE Hospital Gynecology-Pediatrics No. 48.

Inclusion Criteria:

Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study. Their results will be evaluated using the gold standard, flow cytometry, and compared with results obtained through Raman spectroscopy. conditions: Acute Lymphoblastic Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Raman spectroscopy measure: measurable residual disease sex: ALL minimumAge: 2 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291415 id: 2022-523-GLOB1 briefTitle: The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) overallStatus: RECRUITING date: 2024-04-02 date: 2026-04 date: 2026-11 date: 2024-03-04 date: 2024-04-19 name: Hutchmed class: INDUSTRY briefSummary: This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP. conditions: Immune Thrombocytopenia conditions: Blood Platelet Disorder conditions: Hematologic Diseases conditions: Purpura, Thrombocytopenic conditions: Purpura conditions: Blood Coagulation Disorder conditions: Thrombotic Microangiopathies conditions: Hemorrhagic Disorders conditions: Autoimmune Diseases conditions: Immune System Diseases conditions: Hemorrhage conditions: Pathologic Processes conditions: Skin Manifestations conditions: Thrombocytopenia conditions: Purpura, Thrombocytopenic, Idiopathic conditions: Primary Immune Thrombocytopenia conditions: ITP - Immune Thrombocytopenia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Part 1: Dose escalation stage - subjects will receive one of 3 dose levels of HMPL-523 to determine the recommended dose of HMPL-523 for the randomized dose optimization- stage (Part 2)

Part 2: subjects will be randomized in a 1:1 ratio between the 2 dose levels recommended by the SRC to better understand the exposure/efficacy/toxicity relationship. At the end of Part 2, the SRC will evaluate the safety, tolerability, preliminary efficacy, and PK data to determine the Recommended Phase 3 dose (RP3D) of HMPL-523. primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: HMPL-523 measure: Safety and tolerability of HMPL-523 in adult subjects with primary ITP measure: Dose Limiting Toxicities measure: Cmax (maximum plasma drug concentration) measure: AUCtau (area under the concentration-time curve over a dosage interval) measure: Tmax (time to reach maximum plasma drug concentration) measure: Cmin (minimum plasma drug concentration) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Cancer and Blood Disorders status: RECRUITING city: Bethesda state: Maryland zip: 20817 country: United States name: Ralph V Boccia, MD role: CONTACT name: Ralph V Boccia, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98067 lon: -77.10026 facility: Massachusetts General Hospital status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: David J Kuter, MD role: CONTACT name: David J Kuter, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Taussig Cancer Institute status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Alan Lichtin, MD role: CONTACT name: Alan Lichtin, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: Peninsula Private Hospital status: NOT_YET_RECRUITING city: Frankston state: Victoria country: Australia name: Huy Tran, MD role: CONTACT name: Huy Tran, MD role: PRINCIPAL_INVESTIGATOR lat: -38.14458 lon: 145.12291 facility: The Perth Blood Institute (PBI) Hollywood Specialist Centre status: NOT_YET_RECRUITING city: West Perth state: Western Australia country: Australia name: Ross Baker, MD role: CONTACT name: Ross Baker, MD role: PRINCIPAL_INVESTIGATOR lat: -31.94896 lon: 115.84199 facility: Marien Hospital Dusseldorf status: NOT_YET_RECRUITING city: Düsseldorf zip: 40479 country: Germany name: Stefanie Groepper, MD role: CONTACT name: Stefanie Groepper, MD role: PRINCIPAL_INVESTIGATOR lat: 51.22172 lon: 6.77616 facility: Sykehuset Ostfold Kalnes (fosta) / Osfold Hospital Trust (MSL) status: NOT_YET_RECRUITING city: Grålum zip: 1714 country: Norway name: Waleed Ghanima, MD role: CONTACT name: Waleed Ghanima, MD role: PRINCIPAL_INVESTIGATOR lat: 59.29048 lon: 11.06668 facility: Hospital del Mar Barcelona status: NOT_YET_RECRUITING city: Barcelona zip: 08003 country: Spain name: Blanca Gonzalez, MD role: CONTACT name: Blanca Gonzalez, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Universitari Vall d'Hebron status: NOT_YET_RECRUITING city: Barcelona country: Spain name: David Ferreiras, MD role: CONTACT name: David Ferreiras, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: University de Burgos status: NOT_YET_RECRUITING city: Burgos zip: 09001 country: Spain name: Jose Gonzalez Lopez, MD role: CONTACT name: Jose Gonzalez Lopez, MD role: PRINCIPAL_INVESTIGATOR lat: 42.34106 lon: -3.70184 facility: Hospital Gregorio Maranon Madrid status: NOT_YET_RECRUITING city: Madrid zip: 28007 country: Spain name: Cristina Izquierdo, MD role: CONTACT name: Cristina Izquierdo, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Clinica Universidad de Navarra status: NOT_YET_RECRUITING city: Madrid zip: 28027 country: Spain name: Carlos Garcia Grande, MD role: CONTACT name: Carlos Garcia Grande, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Infanta Leonor status: NOT_YET_RECRUITING city: Madrid zip: 28031 country: Spain name: Angeles Foncillas, MD role: CONTACT name: Angeles Foncillas, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Fundacion Jimenez Diaz status: NOT_YET_RECRUITING city: Madrid zip: 28040 country: Spain name: Pilar Llamas Sillero, MD role: CONTACT name: Pilar Llamas Sillero, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Morales Meseguer status: NOT_YET_RECRUITING city: Murcia zip: 30008 country: Spain name: Maria Lozano, MD role: CONTACT name: Maria Lozano, MD role: PRINCIPAL_INVESTIGATOR lat: 37.98704 lon: -1.13004 hasResults: False

 nctId: NCT06291402 id: RC 34-1-2024 briefTitle: Nasal Packing Duration and Development of Pharyngitis After Septorhinoplasty Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-06-15 date: 2024-06-15 date: 2024-03-04 date: 2024-03-04 name: Al-Azhar University class: OTHER name: Benha University briefSummary: Septoplasty or septal reconstruction is a corrective surgical procedure performed to straighten the nasal septum. It may be associated with numerous complications. To minimize these complications, both nasal cavities are frequently packed with different types of nasal packing. In our study we will try to find relationship between duration of nasal packing and postrhinoplasty sore throat and pharyngitis. conditions: Rhinitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Sore throat measure: Dysphagia measure: Throat irritation sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Neveen Kohaf city: Tanta zip: 11865 country: Egypt name: Neveen Kohaf, Ph.D role: CONTACT phone: +201060383012 email: nevenabdo@azhar.edu.eg name: Haney Bauiomy, M.D role: PRINCIPAL_INVESTIGATOR name: Ahmed Abosakaya, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06291389 id: RC.2.8.2023 briefTitle: Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-05-15 date: 2024-05-15 date: 2024-03-04 date: 2024-03-04 name: Al-Azhar University class: OTHER name: Benha University briefSummary: An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function. conditions: Abdominal Compartment Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Intraoperative peak airway pressure (PAP) measure: Duration of oxygen therapy measure: Post operative Tidal Volume (Vt) (Measured by spirometer) measure: Post operative Respiratory Rate (RR) measure: Hospital stay. sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Neveen Kohaf city: Tanta zip: 11865 country: Egypt name: Haney Bauiomy role: PRINCIPAL_INVESTIGATOR name: Ahmed Abosakaya role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06291376 id: D928FC00001 briefTitle: Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) acronym: ICAN overallStatus: RECRUITING date: 2024-03-29 date: 2026-02-23 date: 2029-10-25 date: 2024-03-04 date: 2024-04-29 name: Alexion Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression. conditions: Immunoglobulin A Nephropathy conditions: IgAN studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 470 type: ESTIMATED name: Ravulizumab name: Placebo measure: Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34 measure: Glomerular Filtration Rate (eGFR) Over 106 Weeks measure: Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106 measure: Change From Baseline in eGFR at Weeks 34, 50, and 106 measure: Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106 measure: Reduction in 24-hour UPCR ≥ 50% From Baseline to Weeks 10, 26, 34, 50, and 106 measure: Number of Participants With Partial Remission at Weeks 34, 50, and 106 measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106 measure: Number of Participants With Composite Kidney Failure Endpoint measure: Reduction in 24-hour UPCR ≥ 50% From Baseline at both Weeks 34 and 106 measure: Number of Participants With Kidney Hierarchical Composite Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: 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30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chengdu zip: 610072 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chongqing zip: 400010 country: China lat: 29.56278 lon: 106.55278 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510080 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510100 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510280 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Hangzhou zip: 310003 country: China lat: 30.29365 lon: 120.16142 facility: Research Site status: NOT_YET_RECRUITING city: Hangzhou zip: 310009 country: China lat: 30.29365 lon: 120.16142 facility: Research Site status: NOT_YET_RECRUITING city: Jinan zip: 250012 country: China lat: 36.66833 lon: 116.99722 facility: 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zip: 09121 country: Italy lat: 39.23054 lon: 9.11917 facility: Research Site status: NOT_YET_RECRUITING city: Firenze zip: 50134 country: Italy lat: 43.77925 lon: 11.24626 facility: Research Site status: NOT_YET_RECRUITING city: Milano zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site status: NOT_YET_RECRUITING city: Milano zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy lat: 45.40797 lon: 11.88586 facility: Research Site status: NOT_YET_RECRUITING city: Parma zip: 43126 country: Italy lat: 44.79935 lon: 10.32618 facility: Research Site status: NOT_YET_RECRUITING city: Piacenza zip: 29121 country: Italy lat: 45.05242 lon: 9.69342 facility: Research Site status: NOT_YET_RECRUITING city: Torino zip: 10154 country: Italy lat: 45.07049 lon: 7.68682 facility: Research Site status: NOT_YET_RECRUITING city: Torrette zip: 60126 country: Italy facility: Research Site status: NOT_YET_RECRUITING city: Verona zip: 37126 country: Italy lat: 45.4299 lon: 10.98444 facility: Research Site status: WITHDRAWN city: Ashikaga zip: 326-0843 country: Japan lat: 36.33333 lon: 139.45 facility: Research Site status: NOT_YET_RECRUITING city: Bunkyo-ku zip: 113-8431 country: Japan lat: 35.37517 lon: 139.92991 facility: Research Site status: NOT_YET_RECRUITING city: Chiba-Shi zip: 260-0877 country: Japan lat: 35.6 lon: 140.11667 facility: Research Site status: RECRUITING city: Chiba-shi zip: 260-8712 country: Japan lat: 35.6 lon: 140.11667 facility: Research Site status: RECRUITING city: Fukuoka-shi zip: 815-8555 country: Japan lat: 33.6 lon: 130.41667 facility: Research Site status: RECRUITING city: Kamakura zip: 247-8533 country: Japan lat: 35.30889 lon: 139.55028 facility: Research Site status: RECRUITING city: Kasugai-shi zip: 486-8510 country: Japan lat: 35.24762 lon: 136.97229 facility: Research Site status: NOT_YET_RECRUITING city: Kitakyushu-shi zip: 802-8555 country: Japan lat: 33.85181 lon: 130.85034 facility: Research Site status: RECRUITING city: Matsumoto-shi zip: 390-8621 country: Japan lat: 36.23333 lon: 137.96667 facility: Research Site status: NOT_YET_RECRUITING city: Matsuyama-shi zip: 790-8524 country: Japan lat: 33.83916 lon: 132.76574 facility: Research Site status: NOT_YET_RECRUITING city: Nagoya zip: 466-8650 country: Japan lat: 35.18147 lon: 136.90641 facility: Research Site status: NOT_YET_RECRUITING city: Osaka-shi zip: 534-0021 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site status: NOT_YET_RECRUITING city: Osaka-shi zip: 545-8586 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site status: NOT_YET_RECRUITING city: Sapporo-shi zip: 060-8604 country: Japan lat: 43.06667 lon: 141.35 facility: Research Site status: SUSPENDED city: Toyota-Shi zip: 471-8513 country: Japan lat: 35.08333 lon: 137.15 facility: Research Site status: NOT_YET_RECRUITING city: Urayasu-shi zip: 279-0021 country: Japan lat: 35.67054 lon: 139.88862 facility: Research Site status: RECRUITING city: Anyang-si zip: 14068 country: Korea, Republic of lat: 37.3925 lon: 126.92694 facility: Research Site status: NOT_YET_RECRUITING city: Busan zip: 49241 country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Research Site status: NOT_YET_RECRUITING city: Deagu zip: 41944 country: Korea, Republic of facility: Research Site status: NOT_YET_RECRUITING city: Gwangju zip: 61469 country: Korea, Republic of lat: 35.15472 lon: 126.91556 facility: Research Site status: NOT_YET_RECRUITING city: Gyeonggi-do zip: 13620 country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Research Site status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 05278 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Suwon-si zip: 16499 country: Korea, Republic of lat: 37.29111 lon: 127.00889 facility: Research Site status: NOT_YET_RECRUITING city: Ipoh zip: 30990 country: Malaysia lat: 4.5841 lon: 101.0829 facility: Research Site status: NOT_YET_RECRUITING city: Johor Bahru zip: 80100 country: Malaysia lat: 1.4655 lon: 103.7578 facility: Research Site status: NOT_YET_RECRUITING city: Kuala Lumpur zip: 59100 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site status: NOT_YET_RECRUITING city: Seremban zip: 70300 country: Malaysia lat: 2.7297 lon: 101.9381 facility: Research Site status: NOT_YET_RECRUITING city: Taiping zip: 34000 country: Malaysia lat: 4.85 lon: 100.73333 facility: Research Site status: NOT_YET_RECRUITING city: Chihuahua zip: 31000 country: Mexico lat: 28.63528 lon: -106.08889 facility: Research Site status: NOT_YET_RECRUITING city: Culiacan zip: 80020 country: Mexico lat: 24.79032 lon: -107.38782 facility: Research Site status: NOT_YET_RECRUITING city: Guadalajara zip: 44280 country: Mexico lat: 20.66682 lon: -103.39182 facility: Research Site status: NOT_YET_RECRUITING city: Juriquilla zip: 76320 country: Mexico lat: 20.71277 lon: -100.45568 facility: Research Site status: NOT_YET_RECRUITING city: Mexico zip: 14080 country: Mexico lat: 19.42847 lon: -99.12766 facility: Research Site status: NOT_YET_RECRUITING city: Zapopan zip: 45138 country: Mexico lat: 20.72356 lon: -103.38479 facility: Research Site status: NOT_YET_RECRUITING city: Amsterdam zip: 1105 AZ country: Netherlands lat: 52.37403 lon: 4.88969 facility: Research Site status: NOT_YET_RECRUITING city: Groningen zip: 9700 RB country: Netherlands lat: 53.21917 lon: 6.56667 facility: Research Site status: NOT_YET_RECRUITING city: Nijmegen zip: 6500 HB country: Netherlands lat: 51.8425 lon: 5.85278 facility: Research Site status: NOT_YET_RECRUITING city: Białystok zip: 15-276 country: Poland lat: 53.13333 lon: 23.16433 facility: Research Site status: NOT_YET_RECRUITING city: Białystok zip: 15-540 country: Poland lat: 53.13333 lon: 23.16433 facility: Research Site status: NOT_YET_RECRUITING city: Kraków zip: 31-513 country: Poland lat: 50.06143 lon: 19.93658 facility: Research Site status: NOT_YET_RECRUITING city: Lublin zip: 20-954 country: Poland lat: 51.25 lon: 22.56667 facility: Research Site status: NOT_YET_RECRUITING city: Olsztyn zip: 10-561 country: Poland lat: 53.77995 lon: 20.49416 facility: Research Site status: NOT_YET_RECRUITING city: Poznań zip: 60-355 country: Poland lat: 52.40692 lon: 16.92993 facility: Research Site status: NOT_YET_RECRUITING city: Szczecin zip: 70-111 country: Poland lat: 53.42894 lon: 14.55302 facility: Research Site status: NOT_YET_RECRUITING city: Warszawa zip: 02-006 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site status: NOT_YET_RECRUITING city: Warszawa zip: 02-507 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site status: NOT_YET_RECRUITING city: Łódź zip: 92-213 country: Poland lat: 51.75 lon: 19.46667 facility: Research Site status: NOT_YET_RECRUITING city: Riyadh zip: 11211 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: Research Site status: NOT_YET_RECRUITING city: Banská Bystrica zip: 974 01 country: Slovakia lat: 48.73946 lon: 19.15349 facility: Research Site status: NOT_YET_RECRUITING city: Bratislava zip: 831 01 country: Slovakia lat: 48.14816 lon: 17.10674 facility: Research Site status: NOT_YET_RECRUITING city: Martin zip: 03659 country: Slovakia lat: 49.06651 lon: 18.92399 facility: Research Site status: NOT_YET_RECRUITING city: Alcalá de Henares zip: 28805 country: Spain lat: 40.48205 lon: -3.35996 facility: Research Site status: NOT_YET_RECRUITING city: La Coruña zip: 15006 country: Spain lat: 43.37135 lon: -8.396 facility: Research Site status: NOT_YET_RECRUITING city: Lérida zip: 25198 country: Spain lat: 41.61674 lon: 0.62218 facility: Research Site status: NOT_YET_RECRUITING city: Madrid zip: 28031 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site status: NOT_YET_RECRUITING city: Madrid zip: 28040 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site status: NOT_YET_RECRUITING city: Madrid zip: 28046 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site status: NOT_YET_RECRUITING city: Málaga zip: 29010 country: Spain lat: 36.72016 lon: -4.42034 facility: Research Site status: NOT_YET_RECRUITING city: Oviedo zip: 33011 country: Spain lat: 43.36029 lon: -5.84476 facility: Research Site status: WITHDRAWN city: Sant Joan Despí zip: '08970 country: Spain lat: 41.36718 lon: 2.0574 facility: Research Site status: NOT_YET_RECRUITING city: Sevilla zip: 41013 country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site status: NOT_YET_RECRUITING city: Tarragona zip: 09-43005 country: Spain lat: 41.11667 lon: 1.25 facility: Research Site status: SUSPENDED city: Valencia zip: 46014 country: Spain lat: 39.46975 lon: -0.37739 facility: Research Site status: NOT_YET_RECRUITING city: Zaragoza zip: 50009 country: Spain lat: 41.65606 lon: -0.87734 facility: Research Site status: NOT_YET_RECRUITING city: Kaohsiung City zip: 83301 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site status: NOT_YET_RECRUITING city: Kaohsiung zip: 80756 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site status: NOT_YET_RECRUITING city: New Taipei City zip: 220 country: Taiwan lat: 25.01111 lon: 121.44583 facility: Research Site status: NOT_YET_RECRUITING city: Taichung City country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site status: NOT_YET_RECRUITING city: Taichung zip: 40705 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site status: NOT_YET_RECRUITING city: Tainan City zip: 70403 country: Taiwan lat: 22.99083 lon: 120.21333 facility: Research Site status: NOT_YET_RECRUITING city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: RECRUITING city: Taipei zip: 23561 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Taoyuan City zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10400 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10700 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Chaingmai zip: 50200 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Khlong Luang zip: 12120 country: Thailand lat: 14.06467 lon: 100.64578 facility: Research Site status: NOT_YET_RECRUITING city: Khon Kaen zip: 40002 country: Thailand lat: 16.44671 lon: 102.833 facility: Research Site status: NOT_YET_RECRUITING city: Ankara zip: 06230 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site status: NOT_YET_RECRUITING city: Ankara zip: 06560 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site status: NOT_YET_RECRUITING city: Bursa zip: 16059 country: Turkey lat: 40.19559 lon: 29.06013 facility: Research Site status: NOT_YET_RECRUITING city: Istanbul zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site status: NOT_YET_RECRUITING city: Istanbul zip: 34452 country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site status: NOT_YET_RECRUITING city: Kayseri zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 facility: Research Site status: NOT_YET_RECRUITING city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site status: NOT_YET_RECRUITING city: Konya zip: 42080 country: Turkey lat: 37.87135 lon: 32.48464 facility: Research Site status: NOT_YET_RECRUITING city: Cambridge zip: CB2 0QQ country: United Kingdom lat: 52.2 lon: 0.11667 facility: Research Site status: NOT_YET_RECRUITING city: Doncaster zip: DN2 5LT country: United Kingdom lat: 53.52285 lon: -1.13116 facility: Research Site status: NOT_YET_RECRUITING city: Leicester zip: Le5 4PW country: United Kingdom lat: 52.6386 lon: -1.13169 facility: Research Site status: NOT_YET_RECRUITING city: London zip: E1 1BB country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE1 9RT country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE5 9NU country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Salford zip: M6 8HD country: United Kingdom lat: 53.48771 lon: -2.29042 hasResults: False

 nctId: NCT06291363 id: 2024-3612 briefTitle: Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception. acronym: ESMONOL overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2025-03-03 date: 2025-03-04 date: 2024-03-04 date: 2024-03-25 name: Ciusss de L'Est de l'Île de Montréal class: OTHER briefSummary: This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit. conditions: Opioid Use, Unspecified conditions: Anesthesia conditions: Nociceptive Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of patients randomized into Group "ESMOLOL" for esmolol and group "Standard of Care" for a total of 64 participants. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization will be done prior to the entrance in the OR, the day of the surgery. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Esmolol Hydrochloride name: Saline measure: Intra operative remifentanil administration measure: The NOL Index variation before and after orotracheal intubation and first surgical incision measure: The mean intraoperative blood pressure and heart rate measure: doses and time weighted of norepinephrine (mg); ephedrine (mg), glycopyrrolate (mg) and atropine (mg) measure: Total time with NOL value above > 25 measure: The total time and time weighted average of hypotension and/or bradycardia measure: The time to first analgesic requirement in PACU measure: The amount of morphine equivalent consumption measure: The intensity of pain at rest and under stress measure: Postoperative nausea and vomiting (PONV) and antiemetics use measure: The time spent in PACU sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal city: Montréal-Est state: Quebec zip: H1T2M4 country: Canada name: Pascal Laferrière-Langois, MD FRQS role: CONTACT phone: +1-819-432-5847 email: pascal.laferriere-langlois@umontreal.ca name: Pascal Laferrière-Langois, MD FRQS role: PRINCIPAL_INVESTIGATOR lat: 45.63202 lon: -73.5075 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-26 uploadDate: 2024-03-21T17:38 filename: Prot_000.pdf size: 732855 hasResults: False

 nctId: NCT06291350 id: 23-AOI-05 briefTitle: Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid acronym: MICROPC overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-09-15 date: 2024-03-04 date: 2024-03-15 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa.

Indeed, the dysbiotic periodontal microbiota could aggravate the gingival damage specific to MMP, either directly by activating inflammatory pathways, or indirectly by degrading cellular and matrix components. On the other hand, areas of erosive gingiva generated by the autoimmune process could increase the virulent power of periodontal pathobionts, by representing accessible, nutrient-rich connective surfaces. Moreover, in recent years, bacterial studies based on a high-throughput metagenomic approach have suggested the existence of a relationship between the oral and intestinal microbiota in patients with degraded periodontal conditions and suffering from autoimmune inflammatory diseases (inflammatory bowel disease, acute graft-versus-host disease). This relationship can also be envisaged in MMPg patients who meet the conditions that allow this type of pathological process to occur: autoimmune disease; disruption of the gingival epithelial barrier in erosive gingival areas (increasing the risk of antigen exposure); large amounts of thick plaque; degraded periodontal condition with the presence of numerous periodontal pockets from which periodontopathogenic bacteria can translocate intra-tissularly and cause distant adverse consequences.

The main aim of this observational, multicentre, case-control, matched study is to compare the composition of the periodontal microbiota between MMPg patients and control patients (arm 2 and arm 3). The secondary objectives are to compare the composition of periodontal and intestinal microbiota in cases and control patients (arm 2 and arm 3), to compare periodontal microbiota composition in cases and control patients (arm 2) according to periodontitis severity, and to compare gut microbiota composition between cases and control patients (arm 2 and arm3). To date, no such study exists. conditions: Pemphigoid, Benign Mucous Membrane conditions: Gingivitis Hyperplastic studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Plaque sampling and stool collection name: periodontal examination measure: composition of the periodontal microbiota measure: Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3). measure: Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3). measure: Compare (name and number of bacterial colonies) periodontal microbiota composition in MMP and control patients (arm 2) according to periodontitis severity (non-severe/severe) measure: Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nice University Hospital city: Nice zip: 06000 country: France name: Sophie DRIDI, PUPH role: CONTACT phone: 04 92 03 30 07 email: dr.sm.dridi@free.fr name: Rachida Yatimi role: CONTACT phone: 04 92 03 30 07 email: yatimi.r@chu-nice.fr name: Sophie DRIDI role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Paris hospital Pitié Salpetrière (APHP) city: Paris zip: 75013 country: France name: Juliette ROCHEFORT role: CONTACT phone: 0142178416 email: juliette.rochefort@aphp.fr name: Juliette ROCHEFORT role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Paris hospital Bretonneau (APHP) city: Paris zip: 75018 country: France name: Anne-Laure AJEIL role: CONTACT phone: 0153111800 email: anne-laure.ejeil@aphp.fr name: Anne-Laure AJEIL role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06291337 id: Pro2019001483 id: 10-204Mc type: OTHER domain: Rutgers IRB briefTitle: Ibuprofen Inhibits Human Sweet Taste overallStatus: COMPLETED date: 2020-06-01 date: 2023-09-01 date: 2023-09-30 date: 2024-03-04 date: 2024-03-04 name: Rutgers, The State University of New Jersey class: OTHER name: Monell Chemical Senses Center briefSummary: The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Recently, ibuprofen and naproxen have been identified to inhibit human T1R3 when heterologously expressed in cells. In the present study, the initial objective was to determine if ibuprofen and naproxen inhibit interactions of sugars with human sweet taste receptor under normal, physiological conditions. Ten healthy participants were asked to rate sweetness intensity for a range of sweet stimuli (sucrose, fructose, sucralose) after a prerinse of ibuprofen, naproxen or water. Both ibuprofen and naproxen inhibited sweet taste intensity in a dose-dependent manner. In association studies, ibuprofen use has been linked to preserved metabolic function, as its use is correlated with lower rates of Alzheimer's disease, diabetes and colon cancer. Here the investigators present a potential novel pathway for systemic ibuprofen to impact these metabolic diseases. conditions: Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants conditions: Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy Participants studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We are testing individual sin a within subject control for their sweet taste ratings of sugars without and with oral rinses of ibuprofen and naproxen. primaryPurpose: BASIC_SCIENCE masking: NONE count: 32 type: ACTUAL name: Inhibition of Sweet Taste by Ibuprofen Oral Rinses name: Inhibition of Sweet Taste by Naproxen Oral Rinses measure: Sweet taste ratings measure: Sugar detection thresholds sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Food Science and Nutritional Sciences city: New Brunswick state: New Jersey zip: 08901 country: United States lat: 40.48622 lon: -74.45182 hasResults: False

 nctId: NCT06291324 id: IRB00103472 id: LCI-SUPP-CRF-WATD-001 type: OTHER domain: Atrium Health briefTitle: WATD and Cancer-Related Fatigue: A Study For Patients Undergoing Anti-Cancer Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12-15 date: 2025-12-15 date: 2024-03-04 date: 2024-03-04 name: Wake Forest University Health Sciences class: OTHER name: Atrium Health Levine Cancer Institute briefSummary: The purpose of this study is to evaluate the feasibility of using a commercial WATD (Wearable Activity Tracker Device) to collect HRV (Heart Rate Variability) data from pancreatic and breast cancer patients. conditions: Pancreatic Cancer conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 46 type: ESTIMATED measure: Adherence and acceptability measure: Theme measure: Heart rate variability (HRV) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Alicia Patrick role: CONTACT phone: 980-292-1746 email: alicia.patrick@atriumhealth.org name: Dori Beeler, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 hasResults: False

 nctId: NCT06291311 id: MT_NIPP-HPV_ERBE briefTitle: Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants overallStatus: RECRUITING date: 2023-12-27 date: 2024-06 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: University Hospital Tuebingen class: OTHER briefSummary: This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen. conditions: HPV Infection conditions: Cervical Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Cold physical Plasma name: Control group measure: HPV eradication rate measure: Correlation of HPV Genotyping measure: HPV-Quality-of-Life (HPV-QoL) measure: Tissue Tolerance and Compatibility of NIPP Treatment measure: Detection of Intracellular Molecular Plasma Mechanisms sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen, Department of Women's Health status: RECRUITING city: Tuebingen zip: 72076 country: Germany name: Martin Weiss, Dr. med. role: CONTACT phone: +4970712982211 email: martin.weiss@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06291298 id: STUDY006542 briefTitle: Novel Adaptive Cognitive Training in Autistic Adults With Co-occurring Insomnia overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-03-04 date: 2024-03-04 name: University of South Florida class: OTHER briefSummary: The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- AUT). Participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. Weekly check-ins will be conducted by study staff over Teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. During these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (GENEActiv). GENEActiv is a watch-like device that monitors light and movement activity. conditions: Autism Spectrum Disorder conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot test COGMUSE-AUT in a small sample of autistic adults with co-occurring insomnia on primary and secondary outcomes. primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: COGMUSE-AUT measure: Objective Cognition-National Institute of Health Toolbox measure: Objective Slee-Daily Actigraphy measure: Subjective Sleep- Electronic Daily Sleep Diaries measure: Insomnia Severity Index measure: Sleep Habits Questionnaire measure: Pre-Sleep Arousal measure: WHO Quality of Life-BREF measure: Mood measure: Depression measure: Adaptive Behavior Assessment System (ABAS-III) measure: Game-related experience (completed during intervention) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291285 id: NN7533-7587 id: U1111-1285-7491 type: OTHER domain: World Health Organization (WHO) briefTitle: A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People overallStatus: NOT_YET_RECRUITING date: 2024-02-27 date: 2024-07-11 date: 2024-07-11 date: 2024-03-04 date: 2024-03-04 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease, a rare blood disease. The purpose of the study is to compare the absorption of two different NDec versions (a tablet and a capsule). Participant will either get first the tablet and then the capsule, or the other way around. The order in which participant get them is decided by chance. The study will last for about 12 to 45 days depending on the wash-out period between the two stays in the clinic and from recruitment to the first study day. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: Decitabine-THU name: Decitabine-THU measure: AUC0-inf,DEC,SD: Area under the plasma decitabine concentration-time curve after a single dose measure: AUC0-inf,THU,SD: Area under the plasma tetrahydrouridine concentration-time curve after a single dose measure: Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose measure: Cmax,THU,SD: Maximum plasma concentration of tetrahydrouridine after a single dose measure: t½,DEC,SD: Terminal half-life for decitabine after a single dose measure: t½,THU,SD: Terminal half-life for tetrahydrouridine after a single dose measure: tmax,DEC,SD: Time to maximum observed plasma decitabine concentration after a single dose measure: tmax,THU,SD:: Time to maximum observed plasma tetrahydrouridine concentration after a single dose measure: Maximum change from pre dose in dNA methyltransferase 1 (DNMT1) protein expression after a single dose measure: Maximum change from pre dose in cytidine deaminase (CDA) activity after a single dose sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: ICON-Salt Lake City city: Millcreek state: Utah zip: 84124 country: United States lat: 40.68689 lon: -111.87549 facility: Profil Institut für Stoffwechselforschung GmbH city: Neuss zip: 41460 country: Germany lat: 51.19807 lon: 6.68504 hasResults: False

 nctId: NCT06291272 id: FMHS 328-0723 briefTitle: Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI acronym: RUFUS overallStatus: RECRUITING date: 2023-10-15 date: 2024-06-30 date: 2024-10-30 date: 2024-03-04 date: 2024-03-04 name: University of Nottingham class: OTHER name: Quadram Institute Bioscience briefSummary: Our challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of FODMAPs. We will exploit the recent availability of a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances (4). We are currently performing the COCOA2 study using a modified methylcellulose (results awaited). We now wish to perform a pilot study to image what happens in the colon when methylcellulose is ingested to enable us to plan the next step in our research programme. conditions: Colon, Irritable studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 3 way cross -over primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Opaque plastic bags containing test meals prepared by some one not involved in analysis pf results whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Psyllium name: Methylcellulose name: Inulin name: Maltodextrin measure: colonic gas volume measure: colonic gas volume at 6 hours measure: Breath hydrogen measure: Oro-cecal transit time measure: 24 hour breath hydrogen sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nottingham Digestive Disease Centre status: RECRUITING city: Nottingham state: Nottinghamshire zip: NG7 2UH country: United Kingdom name: Alaa Alhasani, BSc role: CONTACT phone: 01159429924 email: alyaa11@exmail.nottingham.ac.uk name: Robin Spiller role: CONTACT phone: +447824328319 email: robin.spiller@nottingham.ac.uk lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06291259 id: CTO 4081 briefTitle: Mpox Prospective Observational Cohort Study acronym: MPOCS overallStatus: RECRUITING date: 2022-06-21 date: 2024-09 date: 2024-09 date: 2024-03-04 date: 2024-03-04 name: Unity Health Toronto class: OTHER briefSummary: The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:

1. The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.
2. The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada
3. The transmissibility of Mpox infection
4. Viral shedding over time in infected individuals

The study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):

1. Collection of clinical data through chart review and research staff interviews with study participants
2. Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
3. Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.

Other optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies. conditions: Monkeypox studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED measure: Description of clinical manifestation measure: Psychosocial impact measure: Transmission-related aspects of mpox infection measure: Virologic aspects of mpox infection over time sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: BC Centre For Excellence status: RECRUITING city: Vancouver state: British Columbia zip: V6Z 1Y6 country: Canada name: Brody Lyon role: CONTACT phone: 604-682-2344 phoneExt: 66230 email: blyons@bccfe.ca name: Mark Hull, MD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 facility: Unity Health Toronto status: RECRUITING city: Toronto state: Ontario zip: M5B 1T8 country: Canada name: Shreya Shah role: CONTACT phone: 416-360-4000 phoneExt: 77312 email: shreya.khera@unityhealth.to name: Darrell HS Tan role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: University Health Network status: RECRUITING city: Toronto state: Ontario country: Canada name: Asmaa Mabrouk role: CONTACT phone: 416-340-4800 phoneExt: 2240 email: Asmaa.mabrouk@uhn.ca name: Sharon Walmsley, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06291246 id: 23-1823 id: K12TR004416-01 type: NIH link: https://reporter.nih.gov/quickSearch/K12TR004416-01 briefTitle: Expediting Access to Services for Equity (EASE) acronym: EASE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-06-30 date: 2024-03-04 date: 2024-03-04 name: University of North Carolina, Chapel Hill class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 3 after their initial diagnosis of autism.

The main questions it aims to answer are:

* Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism?
* Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?
* Does Family Navigation improve caregiver well-being?

Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.

Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 86 type: ESTIMATED name: Virtual Family Navigation name: Educational Materials measure: Time to initiation of autism specific intervention measure: Caregiver Well-Being Score measure: Child's Developmental Functioning Score measure: Child's Adaptive Functioning Score measure: Appropriateness of Intervention Score measure: Feasibility of Intervention Score measure: Acceptability of Intervention Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Carolina Institute for Developmental Disabilities city: Carrboro state: North Carolina zip: 27510 country: United States lat: 35.91014 lon: -79.07529 hasResults: False

 nctId: NCT06291233 id: HUM00236812 id: 1R01MH132656-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH132656-01 briefTitle: A Hybrid Effectiveness-Implementation Randomized Clinical Trial (RCT) of Virtual Interview Training for Autistic Transition-Age Youth overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-04 date: 2024-04-05 name: University of Michigan class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs.

Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group). conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Virtual Interview Training (VIT) name: Services-as-usual measure: Competitive Employment based on self-report employment surveys measure: Change in Job Interview Skills from Mock Interview Rating Scale (MIRS) measure: Change in Job Interview Skills from Measure of Job Interview Skills (MOJO-iSkills) measure: Time to Employment measure: Vocational Index Score measure: Vocational Index Score measure: Change in Interview Anxiety using a modified version of the brief Personal Report of Public Speaking Apprehension (PRSPA) measure: Change in Interview Motivation measure: Change in Social Responsiveness using the Social Responsiveness Scale 2nd version (SRS-2) measure: Change in Job Search Behavior using the Job Search Behavior Scale (JSBS) measure: Change in Work Readiness using the Work Readiness Scale (WRS) measure: Change in Work Motivation using the Work Motivation Scale (WMS) measure: Change in Social Cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) measure: Change in Interview Knowledge sex: ALL minimumAge: 16 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: The San Diego State University city: San Diego state: California zip: 92182 country: United States lat: 32.71533 lon: -117.15726 facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Disability Network Wayne County city: Detroit state: Michigan zip: 48235 country: United States lat: 42.33143 lon: -83.04575 facility: Lincoln Park city: Lincoln Park state: Michigan zip: 48146 country: United States lat: 42.25059 lon: -83.17854 hasResults: False

 nctId: NCT06291220 id: M24-291 id: 2023-507637-19 type: OTHER domain: EU CT briefTitle: A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) overallStatus: NOT_YET_RECRUITING date: 2024-06-02 date: 2029-07-21 date: 2029-07-21 date: 2024-03-04 date: 2024-03-04 name: AbbVie class: INDUSTRY briefSummary: Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed.

ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 28 sites across the world.

Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. Participants in part B will be place in one of 2 cohorts. Participants in cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. Participants in cohort 2.2 will receive no treatment during the the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. The estimated study duration is 5 years.

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, and checking for side effects. conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Obinutuzumab name: ABBV-453 measure: Part A and B: Percentage of Participants With Adverse Events (AEs) measure: Part A: Maximum Administered Dose (MAD) of ABBV-453 measure: Part A: Maximum Tolerated Dose (MTD) of ABBV-453 measure: Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453 measure: Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453 measure: Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453 measure: Part A and B: Overall Response Rate (ORR) measure: Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better measure: Part A and B: Complete response rate (CRR) measure: Part A and B: Duration of Complete Response (DOCR) measure: Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Response among Participants Achieving a PR, nPR, CR, or CRi measure: Part A and B: Progression-free survival (PFS) measure: Part A and B: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291207 id: AD-224P3 briefTitle: A Study to Evaluate the Efficacy and Safety of AD-224 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-04 date: 2024-03-06 name: Addpharma Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of AD-224 conditions: Hypertension,Essential studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 252 type: ESTIMATED name: AD-224A name: AD-224B name: AD-224C name: Placebo of AD-224A name: Placebo of AD-224B name: Placebo of AD-224C measure: Change rate of MSSBP sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291194 id: 22DE30902 briefTitle: Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients overallStatus: RECRUITING date: 2023-11-10 date: 2024-05 date: 2024-05 date: 2024-03-04 date: 2024-04-08 name: AJU Pharm Co., Ltd. class: INDUSTRY name: GL Pharm Tech Corporation briefSummary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 396 type: ESTIMATED name: AJU-S56 5% name: Placebo Group(Vehicle) measure: Total corneal staining score (TCSS) measure: LGCSS measure: TFBUT sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AJU Pharm Co., Ltd. status: RECRUITING city: Seoul country: Korea, Republic of name: JUNGMIN LEE role: CONTACT phone: +82-02-2630-0700 email: ajuf13001@ajupharm.co.kr lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06291181 id: Soh-Med-24-01-05MD briefTitle: Studying the Distribution of Accessory Gene Regulator (Agr) Quorum Sensing System and the Prevalence of Linezolid and Mupirocin Resistance in Biofilm Producer/Non Producer Staphylococcus Aureus in Sohag University Hospitals overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-30 date: 2023-06-30 date: 2024-03-04 date: 2024-03-04 name: Sohag University class: OTHER briefSummary: Staphylococcus aureus is an important pathogen causing a wide spectrum of infections . The organism usually colonizes the skin and mucous of humans and several animal species. Multiple body sites can be colonized in humans, however, the anterior nares of the nose are the most frequent carriage site for S. aureus. Other sites for carriage include the skin, perineum, and pharynx . It has been shown that there is an increased prevalence of staphylococcus infections, which may be attributed to its carriage in anterior nares and hands of health care workers and patients .

The pathogenic mechanisms enabling S. aureus to cause serious infections could include: biofilm which protects organisms from host immune response; opsonophagocytosis and antimicrobial agents, thus leading to chronic and persistent infections.

Antibiotic resistance associated with S.aureus infections is a great concern for the clinicians to prevent spread of infections. Methicillin was commonly used for these infections before the emergence of MRSA which is developed due to irrational use of antibiotics, prolonged hospital stay, nasal and hand carriage in health care staff. Also vancomycin, linezolid and mupirocin are used in treating infections,as well as decolonization of carriers .

Mupirocin act by inhibiting the protein synthesis of bacteria by binding specifically to isoleucyl-tRNAsynthetase enzyme. The irrational use of Mupirocin among patients and its carriage in health care staff has led to the emergence of resistance to this antibiotic. .

MupA, plasmid mediated gene, has a great role in mupirocinresistence as it had a supplementary modified isoleucyltRNAsynthetase which leads to the high level resistance to Mupirocin. The mupA gene has the ability to facilitate and disseminate the resistance mechanism in different patterns .

Linezolid,theﬁrstoxazolidinonedrug,waslaunchedin2001andis still displaying excellent in vitro activity against Staphylococcus epidermidis on a global scale,although outbreaks of linezolidresistant S. epidermidis (LRSE) are occasionally reported..

Linezolid resistance is mediated by, mutations in the 23S rRNA gene, altering the drug-binding site, and/or the 50S ribosomal proteins L3, L4 and L22, impairing linezolid binding;,Oracquisition of the primarily plasmid-encoded genes cfr, encoding a methyltransferase, or optrA, encoding an ABC transporter, or the cfr homologues cfr(B) and cfr(C).

While cfr can mediate the PhLOPSA phenotype (resistance to phenicols, lincosamides,oxazolidinones, pleuromutilins and streptogramin A compounds), optrA confers oxazolidinone and phenicolresistance only..

Pathogenecity of S. aureus is regulated by various factors ,one of them is the accessory gene regulatory (agr) system. It consists of 2 divergently transcribed loci (3 kb) controlled by means of 2 promoters P2 and P3. Most of clinical isolates of acute infections have a functional agr system and all, like strains, produce RNAIII in vitro and in vivo.

Agr deficiency has been related to increased biofilm formation because RNAIII reduces the expression of surface adhesins and increases the production of capsule, toxins, and proteases. The agr system is supposed to regulate over 70 genes, 23 of which are renowned virulence factors.

There are 2 classes of virulence factors regulated by agr. The first class includes virulence factors implicated in attachment to the host and immune evasion, whereas the second class contains genes engaged in the production of exoproteins related to invasion and toxin production . The activation of the agr system switches the bacterium from an adhesive, colonizing commensal into an invasive and aggressive pathogen(Roux A et al; 2009).

Major virulence factors in S. aureus, exfoliative toxins (ETs), toxic shock syndrome toxin (TSST-1), and staphylococcal enterotoxins (SEs) are involved in host colonization, invasion of damaged skin and mucus, gastrointestinal infection, and prevarication of host defense mechanisms. Indeed, agr operon including agrA, agrB, agrC, and agrD genes regulate over 70 genes in S. aureus 23 of which control its pathogenicity and invasive infections .

Moreover, S. aureus can be stratified into 4 different groups (agr I, agr II, agr III, and agr IV) according to the sequences of agrC (auto inducing peptide) and agrD (cyclic AIP) genes. It is stated that agr types are different in their properties and prevalence in various geographical areas thus, identification of predominant types in each region may well be functional . conditions: Staphylococcus Aureus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 265 type: ACTUAL name: antibiotic sensitivity test measure: resistence of staphylococci to mupirocin and linezolid antibiotics sex: ALL minimumAge: 3 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06291168 id: CMT002 briefTitle: Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain acronym: CTESMYCLBP overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-06-01 date: 2024-03-04 date: 2024-03-04 name: SEFA HAKTAN HATIK class: OTHER briefSummary: The aim of our study was to compare the effectiveness of chiropractic manipulation and yoga-based exercise techniques on pain, functionality, depression and anxiety in patients with long-term low back pain. conditions: Low Back Pain conditions: Spinal Manipulation conditions: Yoga studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The 60 participants will be divided into three groups. These groups will be randomly divided into three groups as chiropractic manipulation group (n=20), yoga-based exercise group (n=20) and conventional exercise group (control group) (n=20). Exercise programs will be performed under the supervision of a physiotherapist. Chiropractic manipulation will be applied to the lumbar region and sacroiliac joint in the side lying position. Data will be analyzed in SPSS 29.0 IBM program. Kruskal-Wallis H test will be used for difference analysis between groups, Kruskal-Wallis H test will be used for comparisons between groups by taking the differences between measurement times and the significance level will be determined as p\<0.05. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chiropractic Manipulation (HVLA - High Velocity Low Amplitude) name: Yoga-Based Exercise Program name: Conventional Exercises measure: Numeric Rating Scale (NRS) measure: Roland-Morris Disability Questionnaire measure: Hospital Anxiety and Depression Scale (HADS) measure: Range of Motion (ROM) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291155 id: HUM00222335 briefTitle: Renal Mechanism of SGLT2 Inhibition overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2028-06-30 date: 2024-03-04 date: 2024-03-04 name: University of Michigan class: OTHER name: University of Colorado, Denver name: Renal Pre-Competitive Consortium (RPC3) briefSummary: The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.

Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study:

Consent and Screening:

* Laboratory tests to determine baseline health
* Ultrasound to measure kidney size and ensure presence of 2 functioning kidneys

Month 0:

* Study entry kidney MRI (day 0)
* Study entry kidney biopsy (within 30 days of MRI)
* Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supply

Month 3:

* Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication
* Review of systems

Month 6:

* Follow-up kidney MRI
* Follow-up kidney biopsy

Study participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs).

Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples. conditions: Type 2 Diabetes conditions: Diabetic Kidney Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open-label, non-randomized mechanistic trial of an FDA-approved drug primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: SGLT2 inhibitor measure: Glomerular basement membrane (GBM) width and mesangial expansion measure: Kidney Transcript Changes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Chrysta C Lienczewski, BS role: CONTACT phone: 734-615-5021 email: boridley@umich.edu name: Markus Bitzer, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06291142 id: R129030 id: IRAS 315004 type: OTHER domain: IRAS briefTitle: Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot overallStatus: ENROLLING_BY_INVITATION date: 2023-11-22 date: 2024-09 date: 2025-03 date: 2024-03-04 date: 2024-03-08 name: University of Manchester class: OTHER name: National Institute for Health Research, United Kingdom name: Royal Bolton Hospital NHS Foundation Trust name: Alder Hey Children's NHS Foundation Trust name: University Hospitals of Morecambe Bay NHS Trust name: Stockport NHS Foundation Trust name: Medway NHS Foundation Trust name: Northern Care Alliance NHS Foundation Trust name: Royal Free Hospital NHS Foundation Trust briefSummary: The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:

* Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?
* Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report
* Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content.

Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system.

Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report. conditions: Systemic Sclerosis conditions: Raynaud Phenomenon studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: Observation - Nailfold capillaroscopy measure: Pilot Image Acquisition measure: Qualitative Feedback measure: Skin tone sub-study data set sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Care Alliance NHS Foundation Trust city: Salford zip: M6 8HD country: United Kingdom lat: 53.48771 lon: -2.29042 hasResults: False

 nctId: NCT06291129 id: CAAE: 61347422.4.0000.5626 briefTitle: Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-30 date: 2023-10-30 date: 2024-10-30 date: 2024-03-04 date: 2024-03-04 name: Universidade Federal Fluminense class: OTHER briefSummary: Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test. conditions: Gingivitis conditions: Periodontal Diseases conditions: Diabetes conditions: Diabetes Mellitus, Type 1 conditions: Malocclusion conditions: Malocclusion in Children studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Periodontal therapy measure: Bleeding on probing sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universidade Federal Fluminense city: Nova Friburgo state: Rio De Janeiro zip: 28625650 country: Brazil lat: -22.28194 lon: -42.53111 hasResults: False

 nctId: NCT06291116 id: 2022/0345/HP briefTitle: Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease acronym: ETERNAL-PKD overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2029-05-01 date: 2029-05-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease linked to mutation of the PKD1 or PKD2 genes encoding polycystins 1 and 2. Patients develop renal cysts with progressive impairment of renal function leading to renal failure. terminal renal failure for 1/3 of them. These patients also present early with high blood pressure and cardiovascular complications, notably intracerebral aneurysms. This phenotype is linked to abnormal polycystins on the cilia of renal epithelial and vascular endothelial cells which no longer ensure the mechanotransduction of shear forces linked to urinary and blood flow leading to the modification of numerous cellular functions.

Experimental results suggested that stimulation of dopamine receptor type 5 (DR5) could restore the mechanosensitivity of endothelial cells, a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD. through restoration of endothelial NO release upon increased blood flow. Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine, a dopamine agonist administered via transdermal patches for 2 months at a low dose (4 mg/24h).

Dopaminergic stimulation could also prevent abnormalities linked to polycystin deficiency at the renal level and we therefore hypothesize that rotigotine could slow the progression of ADPKD both at the renal and cardiovascular levels.

This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact. conditions: Kidney Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: standard care + rotigotine at 4 mg/24h for 24 months. name: standard care for 24 months. measure: Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06291103 id: 2022/0342/HP briefTitle: Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) acronym: BELA-M-R overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2031-03-01 date: 2031-03-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs) (phenotype 2). Preexisting DSA-associated ABMR have superior graft survival compared with dnDSA-associated ABMR, which could partly be explained by the fact that patients with de novo DSA-associated ABMR have biopsy later, when graft dysfunction and/or proteinuria are already present. ABMR is a progressive process with an early stage called subclinical ABMR (sABMR), in which histological lesions are present in the kidney graft without clinical graft dysfunction. These early lesions are now well recognized as risk factors for transplant glomerulopathy and poor graft survival in phenotype 1 ABMR (ref 5). The impact of sABMR associated with dnDSA at any time post-transplant has been less studied and reported. Recently, we published a retrospective multicenter study within the Spiesser Group that included 123 patients without graft dysfunction who underwent graft biopsy because of the presence of dnDSA (One Lambda, MFI \> 1000). Performing a kidney graft biopsy after dnDSA indentification without renal dysfunction leads to the diagnosis of active sABMR in 35 % of cases. Nevertheless, we did not observe any effect of standard of care treatment in active sABMR. Very recently, an expert consensus for the recommended treatment for ABMR after KT was published. They concluded the clear lack of evidence but a standard of care for ABMR was nevertheless defined. Therefore, we propose to evaluate a new strategy for active sABMR, testing a conversion from calcineurin inhibitor (CNI) to belatacept associated with the recently recommended standard of care (SOC) compared to continuing CNI. Belatacept might help to manage nonadherence, decrease the toxicity of CNI on an endothelium already affected by microvascular inflammation, and reduce DSA titers.

The monitoring of dnDSA after KT and an indication graft biopsy in case of appearance, even in the absence of graft dysfunction, is not part of a routine clinical practice in all KT centers. This strategy could be a valuable option, in order to begin treatment of ABMR before graft dysfunction occurs, and therefore to improve prognosis associated with phenotype 2 ABMR. Parajuli et al.4 suggested that early diagnosis and treatment of sABMR with SOC, using DSA monitoring may improve outcomes after KT, but this is a retrospective and no-randomized study. This study will be the first prospective randomized study in the context of de novo DSA. We will evaluate a new combination of treatment for ABMR in the context of dnDSA with subclinical lesions and in the same time may help to determine the real incidence of sABMR in KT recipients with subclinical dnDSA. The use of belatacept in the context of sABMR to improve the non-adherence and to decrease the endothelial toxicity had never been evaluated in a prospective way. conditions: Kidney Transplant Rejection studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 290 type: ESTIMATED name: Conversion to Belatacep name: Standard of care treatment (SOC regimen) with Tacrolimus measure: The efficacy of belatacept combined with standard of care, compared to calcineurin inhibitors (CNI) combined with standard of care, among kidney transplant recipients with sABMR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291090 id: 22-0789 id: K08DA049905 type: NIH link: https://reporter.nih.gov/quickSearch/K08DA049905 briefTitle: A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision overallStatus: RECRUITING date: 2023-01-18 date: 2024-04-30 date: 2025-05-01 date: 2024-03-04 date: 2024-03-29 name: University of Colorado, Denver class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This intervention will be implemented across 12 hospitals primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 400 type: ESTIMATED name: OUD treatment intervention measure: Change in buprenorphine prescribing at hospital discharge measure: Change in rates of methadone prescribing during hospitalization measure: Change in average (mean) COWS score over time measure: Change in naloxone prescribing at hospital discharge sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medicl Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Susan L Calcaterra, MD role: CONTACT phone: 248-703-5947 email: susan.calcaterra@cuanschutz.edu lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06291077 id: 2021/0391/HP briefTitle: Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO> acronym: BELAFENDO overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2028-01-01 date: 2028-01-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Kidney transplantation is the standard treatment for patients with end-stage renal failure.

However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction.

Belatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage. conditions: Kidney Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Belatacept name: anticalcineurins measure: Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291064 id: IRB23-0678 briefTitle: Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer acronym: TARMAC overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-06 date: 2032-06 date: 2024-03-04 date: 2024-03-04 name: University of Chicago class: OTHER briefSummary: The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).

All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis. conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: Cyclophosphamide name: Epirubicin name: Docetaxel name: Carboplatin name: Breast Surgery name: Capecitabine measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast) measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes) measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage) measure: Side Effects of the Study Pre-surgery Chemotherapy Regimen measure: Clinical Response measure: Progressive Disease measure: Invasive Disease Free Survival (iDFS) measure: Duration of Response measure: Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291051 id: 2021/0382/HP briefTitle: Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia acronym: CAMPTOSTIM overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2028-01-01 date: 2028-01-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Camptocormia is defined by abnormal flexion of the trunk, not fixed, present when standing and walking, resolves when lying down and often complicated by lower back pain. It can be observed in numerous neurological pathologies with a prevalence ranging between 5 and 19% in Parkinson's disease. The physiopathology of camptocormia associated with PD is not completely elucidated, however several mechanisms are discussed, including muscular hypertonia, abdominal muscle dystonia, proprioceptive deficit, iatrogenics linked to dopamine agonists, and focal myopathy. Although its impact is major and greater than the main symptoms of the disease, no specific treatment has been the subject of a marketing authorization request in this indication. Its management remains difficult and usually consists of: adjusting the antiparkinsonian treatment, reducing or even eliminating dopamine agonists, resorting to botulinum toxin injections and rehabilitation, sometimes with the use of a corset. However, the results observed are most often disappointing. The benefit of more invasive techniques, such as deep brain stimulation, classically proposed in advanced forms at the stage of motor complications of PD, is discussed by certain authors. Numerous studies thus suggest that bilateral stimulation of the NST could have a significant but moderate beneficial effect on postural disorders associated with PD, in particular on camptocormia. Likewise, the results of a retrospective study recently conducted in 36 Parkinson's patients discuss the effectiveness of bi-pallidal stimulation. Furthermore, surgical interventions by arthrodesis remain invasive and cause more frequent complications in Parkinson's patients with camptocormia compared to patients with isolated degenerative spinal pathology.

Electrical spinal cord stimulation (ESS) is a validated technique in the management of chronic neuropathic pain. Several publications suggest that it could be effective on postural disorders in PD. Thus, authors report the case of a Parkinson's patient afflicted with painful camptocormia refractory to drug treatments and deep brain stimulation who benefited from EMS with a remarkable effect on pain, walking and posture. This observation is corroborated by data collected in 3 Parkinson's patients with camptocormia subjected to EMS with a beneficial effect on painful and motor symptoms. The mechanism of action could be linked to the correction of the proprioceptive deficit via ascending stimulation of the basal ganglia. On the other hand, the effectiveness of repetitive spinal cord magnetic stimulation was evaluated in a study carried out in 37 patients with camptocormia associated with PD. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Electrical spinal cord stimulation measure: Evaluation of the safety of electrical spinal cord stimulation in Parkinson's patients with painful camptocormia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291038 id: 2021/0381/HP briefTitle: Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability acronym: MISSISIIPI overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2029-03-01 date: 2029-03-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.

One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.

Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).

Our working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric; prospective; randomized; double blind; interregional primaryPurpose: TREATMENT masking: SINGLE maskingDescription: double blind whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks name: • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. measure: Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291025 id: 2021/0374/HP briefTitle: Efficacy and Safety of Immunosuppression, Caplacizumab and Plasma Infusion Without Therapeutic Plasma Exchange in Immune-mediated Thrombotic Thrombocytopenic Purpura: Multicentric Non-inferiority Single-arm Study acronym: PEX-FREE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-08-01 date: 2026-08-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-adhesive treatment (Caplacizumab). Our group recently reported the outcome of 90 patients with iTTP treated with this triple association and when compared to historical patients, the triplet regimen prevented death, refractoriness and exacerbations. Likewise, plasma volumes were reduced by 2 to 3-fold and we could reduce the median number of PEX sessions from 13 to 6. PEX is an invasive and time-consuming procedure, associated with catheter and plasma-related complications ranging from 22% to 30%. Consequently, to alleviate the burden of care in iTTP, using a regimen without PEX would represent a major and topical goal. Attempts to treat patients with plasma infusion (PI) without PEX were previously reported and provided evidence that large volumes of PI (20-30 ml/kg/day) improved the initial outcome of iTTP. However, fluid overload occurred in most cases after 5-7 days, limiting the feasibility of this strategy. Nevertheless, the recent availability of caplacizumab opens the perspective of treating patients with plasma for a shorter period. Recently, strategies without PEX have been carried out in Jehovah's Witnesses with iTTP \[5\]. Impressively, improvement was rapid and comparable to those provided with a standard PEX-based treatment. Additionally, a treatment combining caplacizumab and immunosuppression only was successfully performed in six iTTP patients with severe neurologic and/or cardiac involvement. The rapid and durable improvement provides evidence that a regimen without plasma seems feasible. However, we consider that robust data are still lacking to completely remove plasmatherapy from iTTP management. Based on these statements, we wish here to address the efficacy and safety of a PEX-free regimen, combining PI only (15 ml/kg/day), corticosteroids/rituximab, and caplacizumab. conditions: Thrombotic Microangiopathies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This trial is prospective, non-comparative, non-inferiority, single-arm, multicentric, national. primaryPurpose: TREATMENT masking: NONE count: 131 type: ESTIMATED name: PEX-FREE measure: To evaluate the efficacy of a PEX-FREE regimen in adults with iTTP as assessed by the proportion of participants day-30 post-plasma therapy death, refractoriness, exacerbation or an ADAMTS13 activity < 20%. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06291012 id: RECHMPL22_0399 id: 2024-512236-30-00 type: REGISTRY domain: EUCT Number briefTitle: Stopping Pneumonia Antibiotherapy Regimen Early acronym: SPARE overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-05-01 date: 2027-09-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Montpellier class: OTHER name: Direction Générale de l'Offre de Soins briefSummary: The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days. conditions: Community-acquired Pneumonia conditions: Child, Only studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The randomization will be carried out by minimization with stratification on the investigating center and age (\< 1 year and ≥ 1 year) primaryPurpose: TREATMENT masking: SINGLE whoMasked: CARE_PROVIDER count: 1100 type: ESTIMATED name: Quick response: Amoxicillin for 3 days name: Delayed response: Amoxicillin for 5 days name: Quick response: Amoxicillin for 5 days name: Delayed response: Amoxicillin for 7 days measure: Therapeutic failure rate D7 measure: Therapeutic failure rate on D30 measure: Adverse effects measure: Compliance measure: Duration of antibiotic therapy sex: ALL minimumAge: 3 Months maximumAge: 59 Months stdAges: CHILD facility: CHU de Montpellier city: Montpellier zip: 34295 country: France name: Sarah DUTRON, MD role: CONTACT name: Sarah DUTRON, MD role: PRINCIPAL_INVESTIGATOR name: Eric JEZIORSKI, MD PhD role: SUB_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06290999 id: CHUBX 2023/80 briefTitle: Study of Multifrequential Impedancemetry in Pulsatile Tinnitus acronym: MADMAN overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-09-15 date: 2025-12-15 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Bordeaux class: OTHER briefSummary: This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus. conditions: Pulsatile Tinnitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: multifrequential admittancemetry measure: Multifrequency admittancemetry measure: compression maneuvers measure: Evaluation of the effect of interventional radiology measure: success of radiointerventional treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bordeaux University Hospital city: Bordeaux zip: 33000 country: France name: Balthazar CROC role: CONTACT email: balthazar.croc@chu-bordeaux.fr name: Valérie FRANCO-VIDAL, Pr role: CONTACT phone: 0556795609 email: valerie.vidal@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 hasResults: False

 nctId: NCT06290986 id: Pyrocardan® RCT briefTitle: Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis overallStatus: RECRUITING date: 2022-09-26 date: 2025-09-30 date: 2025-09-30 date: 2024-03-04 date: 2024-03-04 name: Herlev and Gentofte Hospital class: OTHER briefSummary: This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be considered for participation in the trial. The following exclude from participation in the study: Below 40 years of age; cognitive or linguistic impairment; osteoarthritis of other carpal bones; previous surgery in the carpometacarpal joint; patients with rheumatoid arthritis. A total of 64 patients will be included. The primary outcome is the patient reported outcomes questionnaire; Quick-DASH. The secondary outcomes are patient-reported outcomes, functional outcomes, radiographic outcomes, readmission, complications, revisions. The patients are examined before surgery and 3, 6, 12 and 24 months after the operation. The patients are also contacted after 5 and 10 years. conditions: CMC-1 Osteoarthritis conditions: Trapeziometacarpal Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Pyrocardan® implant name: Ligament reconstruction and tendon interposition (LRTI) measure: Patient-reported outcome: QuickDASH measure: Patient-reported outcome measure: Strength measurements measure: Radiographs measure: Return to occupation sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Herlev and Gentofte Hospital status: RECRUITING city: Hellerup zip: 2900 country: Denmark name: Jens Jørgsholm, MD role: CONTACT phone: +4551339705 email: Jens.bertel.joergsholm.01@regionh.dk name: Rasmus Wejnold Jørgensen, MD, PhD role: CONTACT phone: +4538673315 email: rasmus.wejnold.joergensen@regionh.dk lat: 55.73204 lon: 12.57093 hasResults: False

 nctId: NCT06290973 id: PI-23-3017 briefTitle: Quality of Life and Health Perception After Surgery of Varicose Veins overallStatus: COMPLETED date: 2023-01-02 date: 2023-02-28 date: 2023-11-14 date: 2024-03-04 date: 2024-03-04 name: Hospital Clínico Universitario de Valladolid class: OTHER briefSummary: The aim of this study is to analyze changes in health perception and quality of life in patients after surgery for varicose veins using clinical score VCSS and QoL scores SF12 as general health questionary and Veines QoL/Sym as disease specific questionary. conditions: Quality of Life conditions: Varicose Veins studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 58 type: ACTUAL name: surgery of varicose veins measure: changes in qol questionarie SF-12 after surgery of varicose veins measure: changes in qol questionarie Veines QoL/Sym after surgery of measure: changes in VCSS after surgery of varicose veins sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital CLínico Universitario de Valladolid city: Valladolid country: Spain lat: 41.65518 lon: -4.72372 hasResults: False

 nctId: NCT06290947 id: BFR-AE-DT2-2023-01 id: IRB 2022/C/20/N type: OTHER_GRANT domain: AAUP briefTitle: BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes acronym: BRAID overallStatus: COMPLETED date: 2022-03-06 date: 2023-12-20 date: 2024-01-08 date: 2024-03-04 date: 2024-03-04 name: Arab American University (Palestine) class: OTHER briefSummary: This clinical trial examines the impact of Blood-Flow Restriction Walk Training (BFRw) on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes (T2D).

The primary objectives of the study are to determine: If Blood-Flow Restriction Walk Training (BFRw) can improve insulin sensitivity in individuals with Type 2 Diabetes (T2D).

Whether Blood-Flow Restriction Walk Training (BFRw) enhances aerobic capacity in individuals with Type 2 Diabetes (T2D).

Participants in the study are divided into two groups. One group undergoes Blood-Flow Restriction Walk Training (BFRw), and the other serves as a control. Both groups attend three treadmill walking sessions weekly for eight weeks. The BFRw group has a restriction cuff placed around both thighs during their sessions, while the control group participates in the walking sessions without any blood flow restriction.

Hemoglobin A1c (HbA1c) levels and maximal oxygen consumption (VO2 max) are monitored as indicators of insulin sensitivity and aerobic capacity, respectively. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study employs a randomized controlled trial model with a parallel assignment to evaluate the efficacy of Blood-Flow Restriction Walk Training compared to a control condition. Participants are randomly allocated into two groups: one receiving the intervention (BFR walk training) and the other serving as a control (usual walk training). This design allows for the direct comparison of outcomes between the intervention and control groups over the study period. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: None (Open Label) count: 60 type: ACTUAL name: BFR Cuffs for Intervention Group name: Standard Walking Training Program measure: Improvement in Insulin Sensitivity measure: Improvement in Aerobic Capacity measure: Change in Body Mass Index (BMI) sex: MALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arab American University - Palestine city: Jenin zip: P.O Box 24 country: Palestinian Territory, occupied lat: 32.45943 lon: 35.30086 hasResults: False

 nctId: NCT06290934 id: GS-US-409-5704 id: 2023-508304-38 type: OTHER domain: European Medicines Agency briefTitle: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis acronym: SWIFT overallStatus: RECRUITING date: 2024-03-27 date: 2027-05 date: 2028-03 date: 2024-03-04 date: 2024-04-23 name: Gilead Sciences class: INDUSTRY briefSummary: The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2).

The primary objectives of this study are:

Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12

Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12 conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 423 type: ESTIMATED name: GS-1427 name: Ustekinumab name: Placebo-to-match GS-1427 measure: Parts 1 and 2: Proportion of Participants Achieving Clinical Response at Week 12 measure: Part 2: Proportion of Participants Achieving Clinical Response at Week 24 measure: Parts 1 and 2: Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths. measure: Parts 1 and 2: Incidence of Treatment-emergent Lab Abnormalities measure: Parts 1 and 2: Proportion of Participants Achieving Clinical Remission at Week 12 measure: Part 1: Proportion of Participants Achieving Clinical Remission at Week 52 measure: Part 2: Proportion of Participants Achieving Clinical Remission at Week 24 measure: Part 2: Proportion of Participants Achieving Partial Modified Mayo Score Remission at Week 52 measure: Parts 1 and 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12 measure: Part 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 24 measure: Parts 1 and 2: Proportion of Participants Achieving Mucosal Healing at Week 12 measure: Part 2: Proportion of Participants Achieving Mucosal Healing at Week 24 measure: Parts 1 and 2: Proportion of Participants Achieving Endoscopic Improvement at Week 12 measure: Part 2: Proportion of Participants Achieving Endoscopic Improvement at Week 24 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Om Research LLC status: RECRUITING city: Camarillo state: California zip: 93010 country: United States lat: 34.21639 lon: -119.0376 facility: VVCRD Research status: RECRUITING city: Garden Grove state: California zip: 92845 country: United States lat: 33.77391 lon: -117.94145 facility: Om Research LLC status: RECRUITING city: Lancaster state: California zip: 93534 country: United States lat: 34.69804 lon: -118.13674 facility: United Medical Doctors status: RECRUITING city: Murrieta state: California zip: 92563 country: United States lat: 33.55391 lon: -117.21392 facility: Encore Medical Research. LLC status: RECRUITING city: Hollywood state: Florida zip: 33021 country: United States lat: 26.0112 lon: -80.14949 facility: Encore Medical Research of Weston, LLC status: RECRUITING city: Weston state: Florida zip: 33331 country: United States lat: 26.10037 lon: -80.39977 facility: Clinical Research Institute of Michigan, LLC. status: RECRUITING city: Chesterfield state: Michigan zip: 48047 country: United States lat: 42.66281 lon: -82.84242 facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center. status: RECRUITING city: Wyoming state: Michigan zip: 49519 country: United States lat: 42.91336 lon: -85.70531 facility: Quality Medical Research status: RECRUITING city: Nashville state: Tennessee zip: 37211 country: United States lat: 36.16589 lon: -86.78444 facility: Southwest Clinical Trials status: RECRUITING city: Houston state: Texas zip: 77074 country: United States lat: 29.76328 lon: -95.36327 facility: Southern Star Research Institute, LLC. status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 facility: Tyler Research Institute, LLC. status: RECRUITING city: Tyler state: Texas zip: 75701 country: United States lat: 32.35126 lon: -95.30106 hasResults: False

 nctId: NCT06290921 id: 3472 briefTitle: Ovulation Triggering 2 vs 3 Follicles overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-22 date: 2024-12-31 date: 2025-02-20 date: 2024-03-04 date: 2024-03-04 name: Clinique Ovo class: INDUSTRY briefSummary: Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists. Although poor responders tend to have sub-optimal fertility treatment outcomes, many of these patients wish to attempt at least one IVF cycle. Traditionally, IVF cycles producing less than 3 to 4 mature follicles (measuring at least 14 mm) have either been cancelled or converted to intra-uterine insemination (IUI) due to the low pregnancy rates associated with these cycles. The minimal number of follicles required to proceed with egg collection is based on clinical experience, having been determined by weighing the probability of implantation and pregnancy versus the risk of not obtaining quality oocytes or reaching embryo transfer when fewer mature follicles are present. This retrospective quality control study aims to compare pregnancy rates in IVF cycles producing 3 follicles measuring 14 mm and more on trigger day, versus 2 or fewer follicles. conditions: Infertility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Ovulation triggering measure: Clinical Pregnancy Rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT facility: Clinique Ovo city: Montréal state: Quebec zip: H4P 2S4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06290908 id: TF2018-001-01 briefTitle: RPE-P/TLIF for Lumbar Spinal Stenosis With Instability overallStatus: COMPLETED date: 2018-09-04 date: 2022-04-30 date: 2024-02-01 date: 2024-03-04 date: 2024-03-04 name: Wen-xi Sun class: OTHER name: Guangdong Provincial Hospital of Traditional Chinese Medicine briefSummary: Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films. conditions: Spinal Stenosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 26 type: ACTUAL name: RPE-P/TLIF measure: Pain visual analog scale (VAS) measure: Oswestry disability index (ODI) measure: MacNab criteria measure: intervertebral space height measure: lumbar physiological curvature measure: fusion rate measure: pedicle screw accuracy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial Hospital of Traditional Chinese Medicine city: Guangzhou country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06290895 id: 3465 briefTitle: Artificial Oocyte Activation overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-22 date: 2024-12-31 date: 2025-02-19 date: 2024-03-04 date: 2024-03-04 name: Clinique Ovo class: INDUSTRY briefSummary: Studies reported that calcium signal deficiency or insufficiency during oocyte activation are related with embryo arrest and blastocyst quality. The utilization of Artificial Oocyte Activation (AOA) is safe and does not increase birth defects, cognition, language and motor skills. AOA is the first line of treatment in patients with globozoospermia (round headed spermatozoa). Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists and comprises about 10-15% of patients undergoing controlled ovarian hyperstimulation. The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. The European Society of Human and REproduction (ESHRE) recommends AOA in cases with failed fertilization/ low fertilization. conditions: Infertility conditions: Ovarian Insufficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 54 type: ACTUAL name: women having had a second IVF cycle with AOA measure: Blastocyst rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT facility: Clinique Ovo city: Montréal state: Quebec zip: H4P 2S4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06290882 id: ERMA trial briefTitle: Endoscopic Versus Robotic Myotomy for Treatment of Achalasia acronym: ERMA overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2026-01-31 date: 2027-01-01 date: 2024-03-04 date: 2024-03-05 name: Germans Trias i Pujol Hospital class: OTHER briefSummary: Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, resulting in impaired relaxation of the esophagogastric junction (EGJ), along with loss of peristalsis in the esophageal body. The standard criteria for diagnosing achalasia is high-resolution esophageal manometry, which shows incomplete relaxation of the EGJ along with absence of esophageal body peristalsis. These anomalies usually cause dysphagia and regurgitation as the main symptoms of this pathology. Different treatment options have been described for this pathology, with pneumatic dilation (PD) and myotomy being considered first-line, whether surgical (laparoscopic Heller myotomy, LHM) or endoscopic (peroral endoscopic myotomy, POEM). The arrival of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the point that it has become a routine procedure in many centers around the world. In recent years, a large amount of data examining the effectiveness of POEM have appeared, including several meta-analyses. The success rate of POEM in prospective cohorts has been greater than 90%. Two randomized studies have been published comparing POEM with LHM, providing a framework to evaluate the comparative efficacy and safety of these two interventions and to determine which should be first-line for the treatment of these patients. According to these data, it seems that the two procedures offer the same clinical results in the medium term. On the other hand, in recent years, there has been a growing expansion of the application of robot-assisted technology. Robotic Heller myotomy (RHM) has been proposed as an alternative minimally invasive approach to traditional laparoscopy with a lower complication rate. Based on the evidence, POEM and RHM could have comparable results in short term, but there is no clear certainty about the results in medium-long term. Likewise, there is a lack of studies that confirm postoperative reflux results in both procedures.

The purpose of the study is to evaluate the clinical and quality of life results of the RHM and compare them with the results of POEM in treatment of achalasia. conditions: Achalasia Cardia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 144 type: ACTUAL name: Robotic Heller Myotomy name: Peroral Endoscopic Myotomy measure: Eckhard symptom scores measure: GERD-Q score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elisenda Garsot Savall city: Badalona state: Barcelona zip: 08016 country: Spain lat: 41.45004 lon: 2.24741 hasResults: False

 nctId: NCT06290869 id: STUDY00006070 briefTitle: Tobacco Education and Lung Health Study (TEAL) acronym: TEAL overallStatus: RECRUITING date: 2024-02-22 date: 2026-02 date: 2026-04 date: 2024-03-04 date: 2024-03-06 name: Georgetown University class: OTHER briefSummary: Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.

Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1188 type: ESTIMATED name: Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention name: E-Referral to the Tobacco Quitline measure: Biochemically verified smoking abstinence- MHS vs. QL-E arms measure: Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care measure: self-reported smoking status measure: cigarettes per day measure: readiness to quit measure: Patient reach and patient engagement measure: Costs per arm from the health system perspective sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Georgetown University Medical Center status: RECRUITING city: Washington state: District of Columbia zip: 20007 country: United States name: Kathryn L Taylor, PhD role: CONTACT phone: 202-215-9402 email: taylorkl@georgetown.edu lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06290856 id: 651397 briefTitle: Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy overallStatus: RECRUITING date: 2024-01-15 date: 2025-12-15 date: 2025-12-15 date: 2024-03-04 date: 2024-03-07 name: Oslo University Hospital class: OTHER briefSummary: Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making. conditions: Metastatic Colorectal Cancer conditions: Pancreas Adenocarcinoma conditions: Cholangiocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Multiplex PCR-test for circulating tumor DNA measure: Clinical validity of ctDNA tests measure: Resources needed for ctDNA assays in routine diagnostics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo university Hospital status: RECRUITING city: Oslo country: Norway name: Ragnhild Nome, MD, PhD role: CONTACT lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06290843 id: AWFiS/2024_1_PE briefTitle: Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-05-30 date: 2024-05-30 date: 2024-03-04 date: 2024-04-04 name: Gdansk University of Physical Education and Sport class: OTHER briefSummary: The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group. conditions: Idiopathic Scoliosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Schroth method measure: Analysis of body balance on the AMTI force platform measure: Analysis of body balance on the AMTI force platform measure: Analysis of body balance on the AMTI force platform measure: Analysis of body balance on the AMTI force platform measure: Photographic analysis of body posture measure: Analysis of x-ray in the frontal plane measure: Analysis of x-ray in the frontal plane measure: Analysis of x-ray in the frontal plane measure: Analysis of x-ray in the frontal plane measure: Analysis of x-ray in the sagittal plane measure: Analysis of x-ray in the sagittal plane sex: FEMALE minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Gdansk University of Physical Education and Sport city: Gdańsk state: Pomorskie zip: 80-336 country: Poland lat: 54.35205 lon: 18.64637 hasResults: False

 nctId: NCT06290830 id: OMUŞükranBaşgöl01 briefTitle: Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-05-31 date: 2024-06-01 date: 2024-03-04 date: 2024-03-12 name: Ondokuz Mayıs University class: OTHER briefSummary: In this prospective, randomized controlled study, n=140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. Between 15.03.2024 and 31.05.2024, n=140 (35=control group, 35=kegel exercise group, 35=abdominal exercise group, 35=abdominal and kegel exercise group) volunteered to participate in the study. Female students with functional constipation will be randomly divided into four groups as intervention and control groups. Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used in this study. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Descriptive statistics, Pearson, and Spearman's correlation analyses will be used in the analysis of research data. conditions: Functional Constipation conditions: Constipation conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Abdominal massage group name: Kegel Exercises group name: Both abdominal massage and kegel exercises to gether measure: Constipation severity change measure: Quality of Life change measure: Bristol stool form score change sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06290817 id: 2023-0724 briefTitle: Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI overallStatus: RECRUITING date: 2023-03-30 date: 2025-03-30 date: 2026-03-20 date: 2024-03-04 date: 2024-03-04 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University name: Huizhou Municipal Central Hospital name: Ningbo Medical Center Lihuili Hospital name: Affiliated Hospital of Jiaxing University name: The Second Affiliated Hospital of Jiaxing University briefSummary: This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen. conditions: Diffuse Large B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 62 type: ESTIMATED name: Orelabrutinib combined with R-CDOP regimen measure: 2-year central nervous system relapse rate measure: Complete Response Rate measure: Overall Response Rate (ORR) measure: 2-year Overall survival (OS) rate measure: 1-year Overall survival (OS) rate measure: 2-year progression-free survival (PFS) rate measure: 1-year progression-free survival (PFS) rate measure: Occurrence of hematologic adverse events and non-hematologic adverse events according to CTCAE V4.03 measure: Occurrence of adverse events and serious adverse events according to CTCAE V4.03 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital, School of Medicine, Zhejiang University status: RECRUITING city: Zhejiang state: Zhejiang country: China name: Wenbin Qian role: CONTACT name: Xibin Xiao role: SUB_INVESTIGATOR facility: Huzhou Central Hospital status: RECRUITING city: Huzhou country: China name: Lihong Shou role: CONTACT phone: 13362216921 email: SLH077@126.COM lat: 30.8703 lon: 120.0933 facility: Affiliated hospital of Jiaxing University , the First Hospital of Jiaxing status: RECRUITING city: Jiaxing country: China name: Hui Zeng role: CONTACT phone: 13957330440 email: zhwuhqn@163.com lat: 30.7522 lon: 120.75 facility: Affiliated hospital of Jiaxing University , the Second Hospital of Jiaxing status: RECRUITING city: Jiaxing country: China name: Beili Hu role: CONTACT phone: 0573-82080930 email: 87718916@qq.com lat: 30.7522 lon: 120.75 facility: Ningbo Medical Center LiHuili Hospital status: RECRUITING city: Ningbo country: China name: Jing Le role: CONTACT phone: 13566511755 email: nblejing@aliyun.com lat: 29.87819 lon: 121.54945 facility: Taizhou Hospital of Zhejiang status: RECRUITING city: Taizhou country: China name: Yiqun Guo role: CONTACT phone: 13515861286 email: guoqunyi@163.com lat: 32.49069 lon: 119.90812 hasResults: False

 nctId: NCT06290804 id: drezgiyucel0000000193593877 briefTitle: Assessing Sustainable Behaviors and Health Impacts of Climate Change overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-03 date: 2024-07 date: 2024-03-04 date: 2024-03-04 name: Eskisehir Osmangazi University class: OTHER briefSummary: The relationship between climate change, sustainability and child health is complex and important. These three concepts are interacting factors and have significant impacts on children's health. Sustainability measures are vital to protect child health by mitigating the impacts of climate change. At the same time, children's education and awareness is an important factor that will contribute to future generations living in a sustainable world. As a society, tackling climate change and striving for a sustainable future is crucial to ensure that children live healthy and safe lives. The aim of this study is to evaluate the effectiveness of the education program and educational videos to be applied to children in terms of environmentally sustainable behaviors and awareness of the health effects of climate change in 60-72-month-old children studying in Eskişehir Odunpazarı Municipality Day Care Center and Nurseries. In addition, in this study, it was aimed to measure the level of global climate change awareness of parents and to evaluate the relationship with children's environmentally sustainable behaviors. conditions: Climate Change conditions: Child Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ESTIMATED name: education measure: increasing sustainable behaviors measure: raising awareness of the health impacts of climate change measure: raising awareness of global climate change sex: ALL minimumAge: 60 Months maximumAge: 72 Months stdAges: CHILD facility: Ezgi Yücel city: Odunpazarı state: Eskişehir zip: 553 723 43 57 country: Turkey lat: 39.76821 lon: 30.53538 hasResults: False

 nctId: NCT06290791 id: K2020214 briefTitle: Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery? overallStatus: COMPLETED date: 2020-12-31 date: 2023-12-31 date: 2024-02-10 date: 2024-03-04 date: 2024-03-04 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis. conditions: Drain Tube Influence the Postoperative Epidural Haematoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 89 type: ACTUAL name: two level lumbar decompression with BESS procedure received one drain. name: two level lumbar decompression with BESS procedure received two drain. measure: the cross-sectional area of POSEH measure: the volume of drain output sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhonglin Zhong city: Yiwu state: Zhejiang zip: 322000 country: China lat: 29.31506 lon: 120.07676 hasResults: False

 nctId: NCT06290778 id: Baylor IRB #023-445 briefTitle: Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees acronym: PEER UP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-08 date: 2027-08 date: 2024-03-04 date: 2024-03-05 name: Baylor Research Institute class: OTHER name: University of Pittsburgh name: Boston University name: Texas A&M University briefSummary: The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are:

* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation?
* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation?
* Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes?

Participants will:

* Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training.
* Complete a questionnaire and clinical interview prior to the workshop.
* Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy.

Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms. conditions: PTSD conditions: Alcohol Use Disorder conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 480 type: ESTIMATED name: Brief Unified Protocol name: Psychoeducation measure: PTSD Symptoms measure: Alcohol Use Disorder symptoms measure: Depression symptoms measure: Anxiety symptoms measure: Functional Impairment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06290765 id: A23-401 briefTitle: Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera acronym: PV overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-12-31 date: 2027-02-28 date: 2024-03-04 date: 2024-03-04 name: PharmaEssentia class: INDUSTRY briefSummary: This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks). conditions: Polycythemia Vera conditions: Myeloproliferative Neoplasm studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Ropeginterferon alfa-2b name: Phlebotomy measure: The proportion of patients with treatment response evaluated. Treatment response is defined as the maintenance of the median HCT values <45% over time, without progression of disease, and no need of any extra-protocol cytoreductive drugs. sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False

 nctId: NCT06290752 id: KY-2024-030 briefTitle: Determining the Learning Curve for Ultrasound-guided Caudal Epidural Block overallStatus: RECRUITING date: 2024-03-01 date: 2024-11-30 date: 2024-12-31 date: 2024-03-04 date: 2024-03-12 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: mastering ultrasound-guided sacral canal block entails traversing a multifaceted learning curve characterized by anatomical intricacies, technical challenges, and patient variability. Through systematic education, deliberate practice, and clinical experience, clinicians can ascend this learning curve and harness the full potential of this innovative technique in pain management. As the landscape of regional anesthesia continues to evolve, a commitment to ongoing learning and proficiency attainment is paramount for delivering safe, effective, and patient-centered care. conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 6 type: ESTIMATED measure: operation time sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dongmei Ma status: RECRUITING city: Yiwu state: Zhejiang zip: 322000 country: China name: Zhu Xinqiang role: CONTACT phone: +8657989935052 lat: 29.31506 lon: 120.07676 hasResults: False

 nctId: NCT06290739 id: JHuang886 briefTitle: A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma overallStatus: RECRUITING date: 2024-02-07 date: 2024-03-07 date: 2024-03-27 date: 2024-03-04 date: 2024-03-04 name: West China Hospital class: OTHER briefSummary: The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND. conditions: Intrahepatic Cholangiocarcinoma conditions: Machine Learning studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: lymph nodes dissection measure: Overall survival measure: Disease free survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: fengmin Luo, Doctor role: CONTACT phone: +86 028-85582944 email: hxyyhfb@163.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06290726 id: 202001927B0 briefTitle: Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients overallStatus: COMPLETED date: 2002-02 date: 2016-02 date: 2024-01 date: 2024-03-04 date: 2024-03-05 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The goal of this observational study is to compare in anti-HBc (+) grafts/ anti-HBc (-) grafts. The main question it aims to answer is the long-term efficacy of active vaccination and graft/patient outcomes of anti-HBc (+) grafts have yet to be comprehensively investigated. Researchers will compare anti-HBc (+) grafts/ anti-HBc (-) to see if it would affect the long-term survival. conditions: Living Donor Liver Transplantations With Anti-HBc (+) Grafts studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 204 type: ACTUAL measure: Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts sex: ALL minimumAge: 4 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06290713 id: IRB202301491 id: 1R21AR079755-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AR079755-01 id: PRO00050023 type: OTHER domain: UFIRST briefTitle: Vasodilator and Exercise Study for DMD (VASO-REx) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-03-04 date: 2024-03-21 name: University of Florida class: OTHER name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) briefSummary: Examining two strategies as potential adjuvant therapies for Duchenne muscular dystrophy (DMD); aerobic exercise training (to induce adaptations in skeletal muscle and improve cardiovascular health) and tadalafil, an FDA-approved vasodilator (to optimize blood flow and muscle perfusion which is impaired and often overlooked in DMD). Target: improved muscle function, vascular health, and DMD treatment. conditions: Duchenne Muscular Dystrophy conditions: Duchenne Disease conditions: Muscular Dystrophy conditions: Muscular Dystrophy in Children conditions: Vasodilation conditions: Exercise conditions: DMD studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned to receive interventions based on their completion and results of Aim 1 (responsiveness to study drug). If participants are found to be Tadalafil-responsive after one dose, they will be included in Aim 2 of the study and will be asked to participate in the double-blinded, randomized, placebo-controlled longitudinal medication \& exercise 6-month study program. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Tadalafil name: Placebo name: Exercise Training measure: Vascular responsiveness after muscle contraction to a single dose of tadalafil. measure: Cycling time to fatigue measure: Quadriceps muscle Fat Fraction measure: Metabolic recovery measure: cardiopulmonary exercise testing (CPET) - Peak aerobic capacity (VO2max) measure: cardiopulmonary exercise testing (CPET) - Minute Ventilation (VE) measure: cardiopulmonary exercise testing (CPET) - Ventilatory Equivalent for Oxygen (VE/VO2) measure: cardiopulmonary exercise testing (CPET) - Gas Exchange Threshold (GET) measure: cardiopulmonary exercise testing (CPET) - Workload at Anaerobic Threshold (W at AT) measure: The 100-meter timed test (100m) measure: the North Star Ambulatory Assessment (NSAA) measure: The 4-stair climb measure: The Physical activity questionnaire (PAQ-C) measure: Pulmonary function testing - vital capacity (FVC) measure: Pulmonary function testing - forced expiratory volume in 1 second (FEV1) measure: Neurology Quality of Life (NeuroQoL) pediatric lower extremity function measure: Patient Reported Outcomes Measurement Information System (PROMIS) pediatric fatigue measure: PROMIS parent proxy for physical activity measure: PROMIS pediatric physical activity measure: Physical Activity Monitoring - Daily Step Rate measure: Physical Activity Monitoring - Time in Low-Level Activity measure: Physical Activity Monitoring - Time in Moderate-Level Activity measure: Physical Activity Monitoring - Time in High-Level Activity sex: MALE minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06290700 id: MCBU_2880 briefTitle: Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life overallStatus: COMPLETED date: 2022-11-01 date: 2024-02-01 date: 2024-02-01 date: 2024-03-04 date: 2024-03-04 name: Celal Bayar University class: OTHER briefSummary: This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life. conditions: Life Quality conditions: Functional Status studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 126 type: ACTUAL name: Neonatal Care education measure: severity of maternal function by Barkin Index of Maternal Functioning measure: Maternal Postpartum Quality of Life Instrument sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Yonca ÇIÇEK OKUYAN city: Manisa country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False

 nctId: NCT06290687 id: CASE5824 briefTitle: Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-01-29 date: 2027-01-29 date: 2024-03-04 date: 2024-03-06 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy. conditions: Malignant Neoplasm of Bladder conditions: Muscle Invasive Bladder Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single-center, prospective, phase II trial. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Neoadjuvant Chemotherapy name: Partial cystectomy with Extended pelvic lymph node dissection name: Adjuvant systemic therapy measure: Recurrence-Free Survival (RFS) measure: Presence of Post-operative Complications measure: Median Bladder RFS measure: Median Muscle-Invasive Bladder RFS measure: Median Bladder-Intact Survival measure: Median Cancer-Specific Survival measure: Changes in Genitourinary-specific HRQoL sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44195 country: United States name: Nima Almassi, MD role: CONTACT phone: 216-444-1825 email: almassn2@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06290674 id: P.T.REC/012/004043 briefTitle: Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile overallStatus: COMPLETED date: 2022-09-11 date: 2024-01-01 date: 2024-02-01 date: 2024-03-04 date: 2024-03-07 name: Adly A Adam class: OTHER briefSummary: Almost postmenopausal women store significant extra visceral adipose tissue with unexplained mechanism, yet. Postmenopausal obese women with excess abdominal obesity have raised metabolic risk of numerous cardiovascular diseases, which negatively influence health policy concern. Therefore, actual need to recommend non-invasive approach that cover this lack of quantitative knowledge in clinical management of obese postmenopausal women. conditions: Obesity, Abdominal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clinical randomized controlled study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double masking (Investigator and Participant) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Extracorporeal Shockwave therapy name: Balanced low-calorie diet measure: Waist/ hip ratio measure: Skin fold caliper measure: Lipid profile sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Helwan General Hospital city: Cairo state: Helwan, Cairo Governate zip: 02 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06290661 id: UHCT-IEC-SOP-016-03-01 briefTitle: Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Postherpetic Neuralgia. overallStatus: RECRUITING date: 2023-02-09 date: 2024-12-31 date: 2025-06-30 date: 2024-03-04 date: 2024-03-04 name: Wuhan Union Hospital, China class: OTHER name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine name: The Second People's Hospital of GuangDong Province name: Xiamen Hospital of Traditional Chinese Medicine briefSummary: The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia. The main questions it aims to answer are:

1. The efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia
2. The safety of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.

Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with postherpetic neuralgia. conditions: Neuropathic Pain conditions: Postherpetic Neuralgia 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 electrostimulation name: Placebo electrostimulation measure: Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period measure: Visual simulation assessment scale collects pain scores after peripheral electrode placement measure: Proportion of subjects whose pain relief more than 30% measure: Proportion of subjects of ideal pain state measure: Sleep-related assessment after electrostimulation measure: Change of life quality after electrostimulation measure: Analgesic medications measure: Stability of external assistant devices measure: Questionnaire survey equipment satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji medical college, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Dong Yang, PHD role: CONTACT phone: 13871230491 phoneExt: 86 email: dongyang118@sina.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06290648 id: 22-0868 id: 5R34MH130555 type: NIH link: https://reporter.nih.gov/quickSearch/5R34MH130555 briefTitle: Forging New Paths: Building Interventions to Treat Criminogenic Needs in Community Based Mental Health Settings acronym: FNP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: University of North Carolina, Chapel Hill class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question\[s\] it aims to answer are:

1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure).
2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes)

Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records. conditions: Mental Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 72 type: ESTIMATED name: Forging New Paths measure: Change in Levels of Aggression Score from Baseline to Month 3 measure: Change in Levels of Aggression Score From Baseline to Month 6 measure: Community Tenure measure: Change in Overall Criminal Attitudes Score measure: Change in Overall Impulsivity Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Amy Wilson, PhD role: CONTACT lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06290635 id: Pro00119668 briefTitle: Edmonton Dyspnea Inventory- Validation Study overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-11 date: 2024-05-30 date: 2024-12-30 date: 2024-03-04 date: 2024-04-11 name: University of Alberta class: OTHER briefSummary: Breathlessness is a common problem for many patients with Interstitial lung disease (ILD). ILD is a group of lung diseases that cause inflammation (swelling) and scarring in the lung tissue where gas exchange (oxygen and carbon dioxide) occurs. Unfortunately, there is no cure for these conditions and as a result many patients decline over time with worsening breathlessness. This limits their ability to live a good life. Clinicians do not often recognize, assess, or treat breathlessness appropriately. Breathlessness, being a subjective experience, cannot be fully understood through objective measurements such as lung function tests, the arterial blood gas test etc. The objective and subjective measures of breathlessness are frequently disconnected. Clinicians who often rely on these types of objective tests do not directly enquire into its nature and severity of breathlessness from patients themselves. As a result, they remain unaware of this disabling symptom and the extent of its impact on patients. While there are many tools to measure breathlessness, they are not consistently used in routine care or have impacted care in a meaningful way. Many such tools are also complex with intricate response systems with possibility of errors and user fatigue. As a result, easy to use tools like modified MRC or MRC are frequently used even though they do not assess severity of breathlessness. No tool has been effective at helping clinicians identify the problem and prescribe appropriate treatments. This results in needless suffering for patients and their families and prevents them from receiving timely and appropriate therapies. Investigators propose to test an easy-to-use tool that combines the subjective and objective aspects of breathlessness. Investigators hope that the tool will help clinicians quickly identify the patient's breathlessness severity and provide them with an algorithm of what to do next. The tool was developed by clinicians with +15 years of experience in ILD and dyspnea. Early analysis already suggests the tool is useful to patients and helps improve care. conditions: ILD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Breathlessness Assessment Tool measure: Validate Edmonton Dyspnea Inventory (EDI; formerly known as multidimensional dyspnea scale-MDDS) measure: To perform time-motion observation of care providers or patients using the scale measure: Calculate MCID for Edmonton Dyspnea Inventory measure: Feasibility of Questionnaire measure: To assess day-to-day variability in dyspnea scores sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaye Edmonton Clinic city: Edmonton state: Alberta zip: T6G 2G3 country: Canada lat: 53.55014 lon: -113.46871 facility: Aarhus University city: Aarhus country: Denmark lat: 56.15674 lon: 10.21076 facility: Bristol ILD Service; North Bristol NHS Trust city: Bristol country: United Kingdom lat: 51.45523 lon: -2.59665 hasResults: False

 nctId: NCT06290622 id: IRB300012414 (UAB23136) briefTitle: PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-06-30 date: 2028-01-31 date: 2024-03-04 date: 2024-04-24 name: University of Alabama at Birmingham class: OTHER briefSummary: This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses. conditions: Diffuse Large B Cell Lymphoma conditions: Lymphoma, B-Cell conditions: Lymphoma, Follicular studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Retifanlimab, INCAGN02385, INCAGN02390 measure: Identify the optimal biological dose (OBD) for Retifanlimab in combination with INCAGN02385 and INCAGN02390 in relapsed/refractory DLBCL. 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: Margaret Thomas role: CONTACT email: margaretannthomas@uabmc.edu name: Mayur Narkhede, MD role: PRINCIPAL_INVESTIGATOR name: Amitkumar Mehta, MD role: SUB_INVESTIGATOR name: Lauren Shea, MD role: SUB_INVESTIGATOR name: Gaurav Goyal, MD role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06290609 id: 72799 briefTitle: Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-15 date: 2024-06-15 date: 2024-03-04 date: 2024-03-04 name: Stanford University class: OTHER briefSummary: The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study. conditions: Spasticity, Muscle conditions: Spinal Cord Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A single group of participants who will receive active treatment with the experimental stimulation device will be studied. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Vibrotactile Coordinated Reset measure: Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University city: Stanford state: California zip: 94305 country: United States name: Peter Tass, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06290596 id: MSR/AZAST/AIP029/21/222/8/2023 briefTitle: Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-04 date: 2024-03-06 name: Al-Azhar University class: OTHER briefSummary: To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions. conditions: Uterine Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 387 type: ESTIMATED name: Vasopressin name: Tranexamic acid name: Saline measure: blood loss sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06290583 id: Prilocaine in cesarean section briefTitle: Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-12 date: 2024-03-04 date: 2024-03-05 name: South Valley University class: OTHER briefSummary: one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes. conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Bupivacaine name: Prilocaine measure: Maternal arterial blood pressure measure: Evaluation of duration of motor block measure: Total dose of ephedrine sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06290570 id: 23-007685 briefTitle: A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's Heart overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-09 date: 2024-03-04 date: 2024-04-03 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's heart using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices. conditions: Hypertrophic Cardiomyopathy conditions: Athlete Heart studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: 12-Lead ECG name: Apple Smart Watch Single Lead ECG name: AliveCor KardiaMobile 6-Lead ECG measure: Distribution of AI-ECG probabilities in HCM measure: Comparative diagnostic performance between tracings obtained from different devices measure: Distribution of AI-ECG probabilities in Athlete's Heart measure: Correlation with false negative AI ECG result 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: Heart Rhythm Services Research Team role: CONTACT phone: 507-255-0774 name: Konstantinos Siontis, MD role: CONTACT phone: (507) 255-1051 email: Siontis.Konstantinos@mayo.edu name: Konstantinos Siontis, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06290557 id: 2023-507737-17-00 briefTitle: First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133 acronym: HY-133 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-01 date: 2026-07-01 date: 2024-03-04 date: 2024-03-05 name: University Hospital Tuebingen class: OTHER briefSummary: In this clinical trial we will test a new approach for decolonization of S. aureus.

As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned. conditions: Staphylococcus Aureus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: HY_133 name: Placebo measure: ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06290544 id: CCM 1552 briefTitle: Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1) acronym: CARDT1 overallStatus: RECRUITING date: 2021-11-29 date: 2026-07 date: 2026-07 date: 2024-03-04 date: 2024-03-04 name: Centro Cardiologico Monzino class: OTHER briefSummary: This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria. conditions: Diabetes Mellitus, Type 1 conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients. primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Standard of care plus additional examinations measure: Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines. measure: Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE). measure: Prevalence of cardiovascular disease in type 1 diabetes patients measure: Prevalence of diabetic retinopathy measure: Prevalence of diabetic nephropathy measure: Prevalence of diabetic neuropathy measure: CT-derived calcium score measure: Carotid intima-media thickness measure: Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method) measure: Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ) measure: Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS) measure: Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires. measure: Stratify type 1 patient cohort by lipid profile measure: Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Centro Cardiologico Monzino status: RECRUITING city: Milan zip: 20138 country: Italy name: Stefano Genovese, MD role: CONTACT phone: 0258002327 email: stefano.genovese@cardiologicomonzino.it lat: 45.46427 lon: 9.18951 facility: Policlinico di Monza status: NOT_YET_RECRUITING city: Monza zip: 20900 country: Italy name: Gianluca Perseghin, MD role: CONTACT phone: +390392810430 email: gianluca.perseghin@policlinicodimonza.it lat: 45.58005 lon: 9.27246 hasResults: False

 nctId: NCT06290531 id: CEBD-CU-2023-11-12 briefTitle: Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain overallStatus: COMPLETED date: 2022-01-16 date: 2023-09-28 date: 2023-09-28 date: 2024-03-04 date: 2024-03-04 name: Cairo University class: OTHER briefSummary: Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.

The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.

Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients. conditions: Dental Caries in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE maskingDescription: The statistician was only blinded for data analysis. But it was not feasible to blind the participant, investigator or the outcome assessor due to the nature of the study. count: 96 type: ACTUAL name: Buzzy device (cold and vibration) name: Buzzy device (vibration only) name: precooling name: Flavored Benzocaine topical anesthetic gel 20% measure: Patient reported pain during needle injection measure: Child behaviour during needle injection measure: Heart rate measure: Oxygen saturation measure: Child and parent satisfaction sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University city: Cairo zip: 11559 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06290518 id: PROBIFERT P051 briefTitle: Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713 overallStatus: COMPLETED date: 2020-09-01 date: 2023-05-03 date: 2024-01-29 date: 2024-03-04 date: 2024-03-04 name: Biosearch S.A. class: INDUSTRY name: Hospital San Carlos, Madrid name: Universidad Complutense de Madrid briefSummary: The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation. conditions: Infertility Unexplained studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Volunteers are classified into 2 groups. All women in the probiotic group consume (oral route) a daily capsule with \~50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin). All women in the placebo group consume (oral route) a daily capsule with \~50 mg of maltodextrin. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Triple (Participant, Care Provider, Investigator) Only one person of the collaborator that provides the capsules (Biosearch Life) know the correspondecs between each reference (one reference per each subject) and the arm (probiotic or placebo). The codes are blinded for the participant, the care provider and the investigator. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 72 type: ACTUAL name: Ligilactobacillus salivarius CECT5713 name: Placebo measure: Successful pregnancies measure: Modification of the vaginal microbiota measure: Vaginal immunomodulation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biosearch S.A.U. city: Granada zip: 18004 country: Spain lat: 37.18817 lon: -3.60667 facility: Hospital Clínico San Carlos city: Madrid zip: 28040 country: Spain lat: 40.4165 lon: -3.70256 facility: Universidad Complutense de Madrid city: Madrid zip: 28040 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06290505 id: PALEO briefTitle: A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study acronym: PALEO overallStatus: RECRUITING date: 2021-12-08 date: 2027-07-31 date: 2028-01-31 date: 2024-03-04 date: 2024-03-04 name: Australasian Gastro-Intestinal Trials Group class: NETWORK briefSummary: The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another are of the body (metastasised). conditions: Oesophageal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Durvalumab measure: Progression free survival rate is the proportion of patients alive and progression free (the cancer has not worsened) assessed by CT Scan and clinical review. measure: Duration of dysphagia relief measure: Nutritional status measure: Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30 measure: Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18 measure: Response rate in metastatic lesions measure: Physician graded toxicity measure: SAE Rate measure: Overall survival. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Border Medical Oncology status: RECRUITING city: Albury state: New South Wales zip: 2640 country: Australia name: Jacqui McBurnie role: CONTACT email: jacqui.mcburnie@bordermedonc.com.au lat: -36.07482 lon: 146.92401 facility: Calvary Mater Newcastle status: RECRUITING city: Newcastle state: New South Wales zip: 2298 country: Australia name: Kim Adler role: CONTACT email: paleo@calvarymater.org.au lat: -32.92715 lon: 151.77647 facility: Royal Brisbane and Women's Hospital status: RECRUITING city: Herston state: Queensland zip: 4029 country: Australia name: Jacqui Keller role: CONTACT email: jacqui.keller@health.qld.gov.au lat: -27.44453 lon: 153.01852 facility: Flinders Medical Centre status: RECRUITING city: Bedford Park state: South Australia country: Australia name: Aleksandra Kuruni, Dr role: CONTACT email: Aleksandra.Kuruni@sa.gov.au lat: -35.03333 lon: 138.56667 facility: St Vincent's Hospital status: RECRUITING city: Fitzroy state: Victoria zip: 3065 country: Australia name: Nadia Ranieri role: CONTACT email: Nadia.RANIERI@svha.org.au lat: -37.79839 lon: 144.97833 facility: Peter MacCallum Cancer Centre status: RECRUITING city: Melbourne state: Victoria zip: 3000 country: Australia name: Shandelle Norman role: CONTACT email: Shandelle.Norman@ctaust.org lat: -37.814 lon: 144.96332 facility: Sir Charles Gairdner Hospital status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Aylin Yahya role: CONTACT email: Aylin.Yahya@health.wa.gov.au lat: -31.98184 lon: 115.8073 facility: Auckland Hospital status: RECRUITING city: Grafton state: Auckland zip: 1023 country: New Zealand name: Sophie Goodger role: CONTACT email: SophieGo@adhb.govt.nz lat: -36.86029 lon: 174.76566 hasResults: False

 nctId: NCT06290492 id: AHMU-tDCS-insomnia briefTitle: Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia overallStatus: RECRUITING date: 2023-05-01 date: 2023-12-30 date: 2024-11-01 date: 2024-03-04 date: 2024-03-04 name: WANG KAI class: OTHER briefSummary: To investigate the intervention effect of transcranial direct current stimulation (tDCS) on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients. conditions: Chronic Insomnia conditions: Transcranial Direct Current Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: transcranial direct current stimulation name: sham transcranial direct current stimulation measure: subjective sleep quality assessed by the PSQI measure: subjective sleep quality assessed by the ISI measure: daytime sleepiness assessed by the FFS measure: daytime sleepiness assessed by the ESS measure: objective sleep quality assessed by the PSG measure: emotional symptoms assessed by the HAMA measure: emotional symptoms assessed by the HAMD sex: ALL minimumAge: 15 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Medical University status: RECRUITING city: Hefei state: Anhui country: China name: Kai Wang, PhD role: CONTACT phone: +86-0551-62923704 email: wangkai1964@126.com name: Chengjuan Xie role: CONTACT phone: +8615656989777 email: xie_chengjuan@126.com lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06290479 id: 20358 briefTitle: A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-30 date: 2024-06-30 date: 2024-03-04 date: 2024-03-04 name: air up GmbH class: INDUSTRY name: Citruslabs briefSummary: A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks. conditions: Water Intake studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Masking: Triple (Participant, Care Provider, Investigator) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Air Up® Peach Pod name: Air Up® Orangeade Pod measure: Change in Hydration Habits and Health Outcomes as Measured by the Water Intake Questionnaire and the Hydration-Related Quality of Life Scale measure: Blood Biomarkers sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Citruslabs status: RECRUITING city: Santa Monica state: California zip: 90404 country: United States name: Patrick Renner, MSc role: CONTACT email: hello@citruslabs.com lat: 34.01945 lon: -118.49119 hasResults: False

 nctId: NCT06290466 id: FCN-437c-CP-004 briefTitle: Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects overallStatus: COMPLETED date: 2022-11-11 date: 2023-02-08 date: 2023-02-08 date: 2024-03-04 date: 2024-03-04 name: Ahon Pharmaceutical Co., Ltd. class: OTHER briefSummary: This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule.

This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control.

This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ACTUAL name: Low dose group name: High dose group measure: ΔΔQTcF measure: adverse events measure: Physical examination measure: Axillary temperature measure: blood pressure measure: pulse measure: Ecg monitoring and electrocardiogram measure: laboratory examination measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06290453 id: AOGR briefTitle: The Regulatory Role of miRNA 27 Follistatin Like Protein-1 Gene in Multiple Scelerosis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-03-04 date: 2024-03-04 name: Assiut University class: OTHER briefSummary: Multiple sclerosis (MS) is a neurodegenerative disease characterized by demyelination of the central nervous system. Young women between the ages of 20 and 40 are primarily targeted by this disabling disorder. Till now there are no sufficient mechanisms to explain the pathophysiology of multiple sclerosis. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: micro RNA 27- FLP1 gene expression name: The Expanded Disability Status Scale (EDSS) name: Electrophysiological assessment: name: MRI examination MRI brain: measure: • To measure the levels of miR-27 expression and its target gene (FSTL1) in progressive MS and relapsing-remitting multiple sclerosis (RRMS) patients. measure: To correlate the levels of expression of miR-27 expression and its target gene (FSTL1) relative to the severity of symptoms of MD patients. sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06290440 id: 28/NDGD-HDDD briefTitle: MEdication Counselling Models for Outpatient oRal antIcoaguLation acronym: MEMORIAL overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-03-04 date: 2024-03-06 name: Gia Dinh People Hospital class: OTHER briefSummary: The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants. conditions: Anticoagulants; Circulating, Hemorrhagic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: Telepharmacy-led counselling name: Pharmacist-led counselling measure: Medication adherence measure: Knowledge of oral anticoagulants measure: All-cause hospitalisation measure: VTE-related hospitalisation measure: Bleeding-related hospitalisation measure: All-cause mortality measure: VTE-related mortality measure: Bleeding-related mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06290427 id: COMPAR-K briefTitle: Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K) acronym: COMPAR-K overallStatus: RECRUITING date: 2024-02-01 date: 2024-06 date: 2024-12 date: 2024-03-04 date: 2024-03-04 name: Azienda Ospedaliera Universitaria Integrata Verona class: OTHER briefSummary: The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using three currently available platforms:

* DaVinci®;
* Hugo®;
* Versius®.

The questions it aims to answer are:

Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?

Participants will be invited to join one of these three experimental group:

1. surgery with the DaVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform. conditions: Renal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 45 type: ESTIMATED name: DaVinci RAPN name: Hugo RAS RAPN name: Versius® RAPN measure: Number of participants with postoperative complications measure: Number of participants with moderate to major postoperative complications measure: Number of participants with major postoperative complications measure: Overall duration of the surgery measure: Number of intraoperative complications measure: Type of intraoperative complications measure: Number of intraoperative technical malfunctions measure: Type of intraoperative technical malfunctions measure: Estimated Blood Loss measure: Postoperative hospitalization measure: Postoperative pain measure: Positive Surgical Margins measure: Serum Creatinine dosage for renal function assessment measure: Estimated Glomerular Filtration Rate for renal function assessment measure: Time taken for platform related timings measure: Procedure-related costs sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Urology Unit, AOUI Verona status: RECRUITING city: Verona state: VR zip: 37126 country: Italy name: Alessandro AA Antonelli, MD role: CONTACT phone: +39 0458127701 email: alessandro.antonelli@aovr.veneto.it name: Unità Ricerca Clinica role: CONTACT phone: +39 0458122844 email: unita.ricerca.clinica@aovr.veneto.it lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06290414 id: FDASU-Rec IM 112318 briefTitle: The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status overallStatus: RECRUITING date: 2023-11-30 date: 2024-03-30 date: 2024-07-30 date: 2024-03-04 date: 2024-03-04 name: Ain Shams University class: OTHER briefSummary: The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 45 type: ESTIMATED name: infrared thermal camera measure: Determine the agreement of thermographic images for diagnosis of periodontal diseases measure: The temperature ranges for healthy periodontium, gingivitis and periodontitis sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of dentistry Ain Shams University status: RECRUITING city: Cairo country: Egypt name: Shrouk N. Elboray, BDS role: CONTACT phone: +201065433857 email: shrouk.elboraay@dent.asu.edu.eg name: Mahetab M. AbdalWahab, lecturer role: CONTACT phone: +201115554490 email: mahetabmohamed@dent.asu.edu.eg name: Ola M. Ezzatt, professor role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06290401 id: 2023-0671 briefTitle: A Socio-ecological Approach for Improving Self-management in Adolescents With SCD acronym: SC-Thrive overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-01-31 date: 2028-06-30 date: 2024-03-04 date: 2024-03-04 name: Children's Hospital Medical Center, Cincinnati class: OTHER name: Nemours Children's Health System name: Emory University name: Children's Hospital of Philadelphia briefSummary: The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.

The main question\[s\]it aims to answer are:

* Does SCThrive improve patient activation?
* Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?
* Are any improvements maintained 3 months after treatment?

Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).

Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits. conditions: Anemia, Sickle Cell studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be allocated to SCThrive or SCHealthED (uniform standard care) using a randomized block design for age group (13-17 years of age or 18-21 years of age) with a predefined block size of 4. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcomes assessors will not know the condition to which participants have been randomized. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 310 type: ESTIMATED name: SCThrive name: SCHealthED measure: Patient Activation measure: Self-Management Behaviors measure: Daily Functioning measure: Emergency Room (ER) Visits measure: Self-Management Skills measure: Health-related quality of life sex: ALL minimumAge: 13 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06290388 id: 23ME-01473-CLIN-001 briefTitle: Study of 23ME-01473 in Patients With Advanced Solid Malignancies overallStatus: RECRUITING date: 2024-03-07 date: 2026-06-30 date: 2026-06-30 date: 2024-03-04 date: 2024-03-22 name: 23andMe, Inc. class: INDUSTRY briefSummary: This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: 23ME-01473 measure: Phase 1:Incidence and severity of dose-limiting toxicities (DLTs) measure: Phase 1: Incidence and severity of adverse events (AEs) measure: Phase 1 Incidence and severity of serious adverse events (SAEs) measure: ORR based on investigator assessment against RECIST 1.1 criteria measure: Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473 measure: Phase 1: Objective response rate (ORR) measure: Duration of response (DoR) measure: Disease Control Rate (DCR) measure: Progression free survival (PFS) measure: Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473 measure: Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473 measure: Last measurable serum concentration (Clast) following a single dose of 23ME-01473 measure: Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473 measure: Terminal half-life (T1/2) following a single dose of 23ME-01473 measure: Maximum serum concentration (Cmax) following multiple doses of 23ME-01473 measure: Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473 measure: Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-01473 measure: Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473 measure: Terminal half-life (T1/2) following multiple doses of 23ME-01473 sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Center for Cancer Care status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06290375 id: HSK21542-T-202 briefTitle: A Study of HSK21542 in a Peritoneal Dialysis Pruritus Population. overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2024-03-08 date: 2025-04-11 date: 2024-03-04 date: 2024-03-04 name: Xizang Haisco Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: This is a two- stage study. Stage I is a multicenter, open-label trial；Stage II was a multi-center, randomized, double-blind, placebo-controlled trial. About 250 maintenance peritoneal dialysis patients with moderate or above pruritus are planned to be enrolled. conditions: Pruritus studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 250 type: ESTIMATED name: HSK21542 tablet name: Placebo measure: Proportion of subjects with an improvement of ≥ 4points from baseline in the weekly average of the daily Worst Itch Numeric Rating Scale (WI-NRS) after 12 weeks of treatment. measure: Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment. measure: Change from baseline in subjects' quality of life (evaluated using the 5-D itch scale) after 12 weeks of treatment. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06290362 id: EgeTrial4 briefTitle: Exploring Digitalized Interventions for Stress and Problem Solving overallStatus: COMPLETED date: 2021-04-16 date: 2021-07-30 date: 2021-11-28 date: 2024-03-04 date: 2024-03-07 name: Ege University class: OTHER briefSummary: Excessive and prolonged stress can have detrimental effects on both psychological and physiological health, compromising overall well-being and functioning. This study examines the impact of telepsychiatric group consultation using Instagram as an unexplored online social media platform on stress levels and problem-solving skills among young adults. conditions: Stress conditions: Problem-solving studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The current 8-week randomized, single-blind factorial trial was conducted with a control group and one intervention group. Over eight weeks, participants received cognitive behavioral-based intervention through online sessions. Pre-/post-test and follow-up assessments employed. primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 54 type: ACTUAL name: Cognitive Behavioural Theory-based group consultation measure: Perceived Stress Scale (first evaluation with posttest) measure: Problem Solving Inventory (first evaluation with posttest) measure: Perceived Stress Scale (second evaluation with follow up) measure: Problem Solving Inventory (second evaluation with follow up) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: İzmir zip: 35100 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06290349 id: DA5221_DM_III briefTitle: Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2025-05-31 date: 2025-11-30 date: 2024-03-04 date: 2024-03-04 name: Dong-A ST Co., Ltd. class: INDUSTRY briefSummary: This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 162 type: ESTIMATED name: DA5221-T1 name: DA5221-T2 name: Placebo name: DA5221-B1 name: DA5221-B2 measure: Change from the baseline in HbA1c (%) after 24 weeks measure: Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks measure: Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks measure: Change from the baseline in weight after 24 weeks sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Severance Hospital, Yonsei University college of Medicine city: Seoul country: Korea, Republic of name: Cha Bong Soo, Ph.D role: CONTACT email: BSCHA@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06290336 id: PROTEKT briefTitle: Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement acronym: PROTEKT overallStatus: RECRUITING date: 2023-12-20 date: 2025-12-30 date: 2026-12-30 date: 2024-03-04 date: 2024-03-04 name: Linkoeping University class: OTHER_GOV name: Region Östergötland name: Region Jönköping County briefSummary: The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.

The main questions it aims to answer are:

* Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?
* Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?
* Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?
* Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?

Participants will be randomized stratified by age (≤ 67 years, \> 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-center randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessor blinded to group allocation whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Pre-operative exercise therapy and education name: Standardized pre-operative information session measure: Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery measure: Patient satisfaction at 1 year after surgery measure: Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery measure: Change in active knee range of motion from baseline to 6 weeks after surgery measure: Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery measure: Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery measure: Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery measure: Change in Knee Osteoarthritis Outcome Score (KOOS) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery measure: : Change in EuroQol 5 Dimensions 3 Levels (EQ5D-3L) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery measure: Change in International Physical Activity Questionnaire - short form (IPAQ-sf) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery measure: Change in Mod-PEI-2 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery measure: Change in FJS-12 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery and 6 weeks and 3 months after surgery sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Linkoping University status: RECRUITING city: Linkoping state: Ostergotland zip: 58183 country: Sweden name: Joanna Kvist, Professor role: CONTACT phone: +46 (0) 13 284664 email: joanna.kvist@liu.se name: Joanna Kvist, Professor role: PRINCIPAL_INVESTIGATOR lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06290323 id: 11/05/2022-9/VIII briefTitle: Effects of Quadratus Lumborum Block on Lower Urinary System Symptoms overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-25 date: 2024-05-15 date: 2024-05-30 date: 2024-03-04 date: 2024-03-04 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: The most common reason for applying to a hospital in the postoperative period due to the double J stent inserted during operations of the uteroscopic lithotripsy is reflected pain (T11-L2). The posterior approximation QL block (QL-P) is known to extend more easily to the thoracic paravertebral cavity or thoracolumbar plane, creating analgesia from T 7' to L 1'. The effects of double J catheter in patients are followed by 'Ureteral Stent Symptom Scoring Survey'. QL-P for postoperative analgesia after URS operations Our primary hypothesis in this prospective, randomized, controlled study is that the symptoms of the sub-urinary system associated with the DJS of the QL-P block will decrease. Our secondary hypotheses in the study are to investigate the effects of the unilateral QL-P block, made under ultrasound guidance, on pain scores that occur after ureteroscopic lithotripsy operations due to unilateral ureteral stones made under spinal anesthesia. conditions: Lower Urinary Tract Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with double J catheter inserted into ureteroscopic lithotripsy surgeries due to urethral stones primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The researcher evaluating the survey does not know which group the patients are. whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: Quadratus lumborum block name: Placebo measure: Quadratus posterior block measure: Pain Score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mugla Sitki Kocman Training and Research Hospital city: Mugla zip: 48000 country: Turkey lat: 37.21807 lon: 28.3665 hasResults: False

 nctId: NCT06290310 id: PAVELA briefTitle: Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography acronym: PAVELA overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2024-09-01 date: 2024-09-01 date: 2024-03-04 date: 2024-03-04 name: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged class: OTHER_GOV name: Hochschule Furtwangen University name: Budapest University of Technology and Economics name: Szeged University briefSummary: Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony. conditions: Acute Lung Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: EIT name: patient-ventilator asynchrony assessment measure: distribution measure: connecting asysnchrony cycles with electric impedance tomography measurements measure: identifying unic electric impedance tomography signs of asynchrony sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kiskunhalas Semmelweis Hopsital the Teaching Hospital of the University of Szeged city: Kiskunhalas zip: 6400 country: Hungary name: András Lovas, M.D. Ph.D. role: CONTACT phone: 003677522000 phoneExt: 2045 email: landras@halasi-korhaz.hu lat: 46.43402 lon: 19.48479 hasResults: False

 nctId: NCT06290297 id: Progetti di Rete (RIN-IDEA) briefTitle: Assessment and Telerehabilitation of Cognitive and Motor Skills in Children With Neurodevelopmental Disabilities (Tablet Project) overallStatus: RECRUITING date: 2020-09-30 date: 2024-06-30 date: 2024-06-30 date: 2024-03-04 date: 2024-03-04 name: IRCCS Fondazione Stella Maris class: OTHER name: Fondazione Don Carlo Gnocchi Onlus name: IRCCS Eugenio Medea name: Oasi Research Institute-IRCCS name: Ospedale Pediatrico Bambin Gesù name: IRCCS San Raffaele Roma name: IRCCS National Neurological Institute "C. Mondino" Foundation name: IRCCS Centro Neurolesi "Bonino-Pulejo" name: Istituto Giannina Gaslini name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta name: IRCCS Ospedale San Raffaele name: IRCCS Istituto delle Scienze Neurologiche di Bologna briefSummary: The development and application of new technologies to support functional assessment and rehabilitation pathways for neurodevelopmental disabilities allow the evaluation and enhancement of cognitive, motor, and speech abilities within a more playful and motivating context. In fact telerehabilitation programs foster access to rehabilitative services and permit the delivery of a wide range of neuropsychological, motor, speech and communication interventions, even for patients unable to frequently attend a clinical institution (distance from the hospital, parental work employment, etc.), by overcoming geographic barriers. In this scenario, new technologies guarantee significant time- and cost-saving, shortening hospitalization and delivering the rehabilitative process at home, in a more ecological context (American Telemedicine Association, 2017) therefore enforcing the generalization of the achieved competences. Another great advantage provided by using innovative technologies in clinical practice to foster therapies tailored to patient's needs concerns both the possibility of collecting comprehensive and accurate quantitative data, thus supporting a better intervention monitoring, and of offering multi domain activities, also integrating peripheral devices (i.e. sensors). Using innovative technologies in clinical practice also give the possibility to propose neuropsychological and motor activities in a playful and motivating context, thus enhancing participation and enjoyment, especially for the pediatric population, while maintaining high levels of efficiency. Such telerehabilitation pathways allow to increase dosage and intensity of the intervention and ensure caregivers' involvement in the rehabilitation process. This multicenter study aims to assess the feasibility of using technological systems, primarily validated in the adult population, in children with congenital and acquired disabilities by administering ad-hoc questionnaires. conditions: Neurodevelopmental Cognitive, Motor and Speech-language Disabilities studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 350 type: ESTIMATED name: Telerehabilitation VRRS measure: Scores of One shot feasibility questionnaire (5-point likert scale) measure: Tele-rehabilitation feasibility measures: Adherence to the study measure: Tele-rehabilitation feasibility measures: Adherence to the training measure: Tele-rehabilitation feasibility measures: Number of dropouts measure: Tele-rehabilitation feasibility measures: Number of sessions completed in the target time measure: Tele-rehabilitation feasibility measures: Technical problems encountered that prevent the program from running measure: Scores of training feasibility questionnaire (5-point likert scale) measure: Changes in the Sustained attention subtest of Leiter 3 measure: Changes in the visual attention subtest (CP) of Italian battery for ADHD (BIA) measure: Changes in the Conners' Parent Rating Scale - Brief version measure: Changes in the Visuo-motor precision subtest of NEPSY II measure: Changes in the Developmental Test Of Visuo-Motor Integration (VMI) measure: Changes in the digit span forwards and backward subtests of BVN both for children aged 5-11 and for children aged 12-18 measure: Changes in the Corsi Block Tapping test subtest of BVS-Corsi measure: Changes in the Behaviour Rating inventory of executive function (BRIEF 2/P ) for parents measure: Changes in the route finding subtest of NEPSY II measure: Changes in the arrow subtest of NEPSY II measure: Changes in the Gross Motor Function Measure 88 (GMFM-88) measure: Changes in the Assisting Hand Assessment (AHA) measure: Changes in Both Hand Assessment (BoHA) measure: Changes in the Melbourne Assessment of Unilateral Upper Limb Function o Melbourne Assessment 2 (MUUL o MA2) measure: Changes in the Abilhand Kids measure: Changes in the Box and Block test (BBT) measure: Changes in the Movement Disorders - Childhood Rating Scale 4-18 revised (MD-CRS 4-18 R) measure: Changes in the 6 minutes walk test (6MWT) measure: Changes in the Functional Reach Test (FRT) measure: Changes in the Pediatric Berg Balance Scale (PBS) measure: Changes in the Timed up and go (TUG) sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Pisa state: PI zip: 56128 country: Italy name: Giuseppina Sgandurra, MD, PhD role: CONTACT phone: 050 886233/224 phoneExt: +39 email: g.sgandurra@fsm.unipi.it lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06290284 id: 6322 briefTitle: Comparison Between Mini-midline and the Peripheral Intravenous Catheter acronym: INSERT/2022 overallStatus: COMPLETED date: 2023-09-25 date: 2023-11-17 date: 2023-12-28 date: 2024-03-04 date: 2024-03-04 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.

The main questions it aims to answer are:

* Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures;
* Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.

Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms. conditions: Vascular Access Devices conditions: Venous Puncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The statistician will be provided an anonymized dataset. whoMasked: OUTCOMES_ASSESSOR count: 294 type: ACTUAL name: Long Peripheral Catheter name: Peripheral Intra-Venous Catheter measure: Difference in proportion measure: Adverse events associated with use of LPC and PIVC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06290271 id: CISTAR briefTitle: Arterial Wall Shear Stress After Intracranial Artery Recanalization overallStatus: RECRUITING date: 2023-08-01 date: 2024-06 date: 2024-12 date: 2024-03-04 date: 2024-03-04 name: Chonbuk National University Hospital class: OTHER name: Seoul National University Hospital name: Chungnam National University Hospital name: Asan Medical Center name: Chonnam National University Hospital name: Korea University Ansan Hospital name: SMG-SNU Boramae Medical Center briefSummary: There has been consistent research on the cerebral blood flow features in ischemic stroke patients with acute occlusion of major intracranial arteries. However, studies analyzing the overall features of the major intracranial artery blood flow in the periods of pre and post-recanalization are still lacking. Time-of-flight magnetic resonance angiography (TOF-MRA) is extensively utilized to evaluate the intracranial arteries. The arterial signal intensity from MRA-TOF varies across subjects and arterial subtypes, leading to the development of the Signal Intensity Gradient (SIG) concept. SIG has demonstrated a strong correlation with Computational Fluid Dynamics (CFD), a known method for reflecting wall shear stress. SIG could be associated with the pathophysiology of wall shear stress. We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG. conditions: Intracranial Artery Occlusion studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 160 type: ESTIMATED name: Intracranial artery flow pattern measure: Neurological Severity at discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Korea University Ansan Hospital status: NOT_YET_RECRUITING city: Ansan state: Gyeonggi-do zip: 15355 country: Korea, Republic of name: Sang-Heon Lee, Prof. role: CONTACT email: huny0029@naver.com lat: 37.32361 lon: 126.82194 facility: Jeonbuk National University Hospital status: NOT_YET_RECRUITING city: Jeonju state: Jeollabuk Do zip: 54907 country: Korea, Republic of name: Hyo Sung Kwak, Prof. role: CONTACT email: kwakhs8140@gmail.com lat: 35.82194 lon: 127.14889 facility: Chungnam National University Hospital status: RECRUITING city: Daejeon zip: 35015 country: Korea, Republic of name: Hee Jung Song, Prof. role: CONTACT email: nrsono@naver.com lat: 36.32139 lon: 127.41972 facility: Chonnam National University Hospital status: RECRUITING city: Gwangju zip: 61469 country: Korea, Republic of name: Man-Seok Park, Prof. role: CONTACT email: mspark@chonnam.ac.kr lat: 35.15472 lon: 126.91556 facility: Seoul National University Hospital status: NOT_YET_RECRUITING city: Seoul zip: 03080 country: Korea, Republic of name: Keun-Hwa Jung, Prof. role: CONTACT email: jungkh@gmail.com lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: RECRUITING city: Seoul zip: 05505 country: Korea, Republic of name: Beom-Jun Kim, Prof. role: CONTACT email: medicj80@hanmail.net lat: 37.566 lon: 126.9784 facility: SMG-SNU Boramae Medical Center status: NOT_YET_RECRUITING city: Seoul zip: 07061 country: Korea, Republic of name: Yong-Seok Lee, Prof. role: CONTACT email: mercades@snu.ac.kr lat: 37.566 lon: 126.9784 facility: Ulsan University Hospital status: RECRUITING city: Ulsan zip: 44033 country: Korea, Republic of name: Chan-Hyuk Lee, Prof. role: CONTACT email: bluewave0210@gmail.com lat: 35.53722 lon: 129.31667 hasResults: False

 nctId: NCT06290258 id: 202202143A0 briefTitle: Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-07-31 date: 2024-03-04 date: 2024-03-04 name: Chang Gung Memorial Hospital class: OTHER briefSummary: This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis. conditions: Autism Spectrum Disorder conditions: Gastrointestinal Diseases conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Fecal microbiota transplantation measure: Changes of gastrointestinal symptoms of patients with ASD after FMT measure: Changes of autistic symptoms of patients with ASD after FMT measure: Changes of the diversity of intestinal microbiota of patients with ASD after FMT measure: Changes of cytokine levels of patients with ASD after FMT measure: Changes of repetitive behavior symptoms of patients with ASD after FMT measure: Changes of autistic behavior symptoms of patients with ASD after FMT measure: Changes of emotion and behavior symptoms of patients with ASD after FMT measure: Changes of inattention and hyperactivity of patients with ASD after FMT measure: Changes of quality of life of patients with ASD after FMT measure: Changes of objective sleep of patients with ASD after FMT by actigraphy recording measure: Changes of subjective sleep of patients with ASD after FMT measure: Changes of intelligence of patients with ASD after FMT measure: Changes of attention and impulse control of patients with ASD after FMT sex: ALL minimumAge: 7 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Wei-Chih Chin city: Taoyuan city zip: 333423 country: Taiwan name: Wei-Chih Chin role: CONTACT phone: +886 3 3281200 phoneExt: 3836 email: auaug0327@cgmh.org.tw lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06290245 id: P.T.REC/012/005045 briefTitle: PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients overallStatus: RECRUITING date: 2024-03 date: 2024-10 date: 2024-12 date: 2024-03-04 date: 2024-03-04 name: Cairo University class: OTHER briefSummary: Exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which less costly devices could offer, could reduce DH.

A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD.

PEP buddy is an adjunct to current COPD therapies, such as inhalers and pulmonary rehabilitation. It provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life. conditions: Pulmonary Disease, Chronic Obstructive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: PEP Buddy name: aerobic exercise measure: dyspnea measure: pulmonary function measure: exercise capacity measure: Sleep quality measure: Health-related quality of life (HRQoL) sex: ALL minimumAge: 55 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Giza state: Dokki zip: 11432 country: Egypt name: Ebtesam N Nagy role: CONTACT phone: +201278141946 email: Dr.EbtesamNagy2@outlook.com lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06290232 id: IRB-P00044498 briefTitle: Fetoscopic Laser Photocoagulation in Management of Vasa Previa acronym: FLUMEN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-12-31 date: 2024-03-04 date: 2024-03-12 name: Boston Children's Hospital class: OTHER briefSummary: In this research study, the investigators want to learn more about the safety and effectiveness of a fetal surgery, known as fetoscopic laser photocoagulation (FLP), for the treatment of a pregnancy condition called vasa previa (VP). Vasa previa is a pregnancy complication that happens when blood vessels from the fetus grow over the entrance to the womb. In a VP pregnancy, natural vaginal birth is deadly for the baby in more than half of cases due to the bursting of VP vessels and severe blood loss. Currently, VP patients are recommended to be closely monitored and often hospitalized once they reach the third trimester of pregnancy. An early delivery by C-section would typically be performed in order to avoid breaking the exposed fetal vessels.

Fetoscopic laser photocoagulation is a minimally invasive surgery in the womb to remove or correct abnormal blood vessels and tissues. In the FLP procedure, the surgeon uses a fetoscope (a tiny telescope) and a laser device to seal off unprotected vessels. While this surgery has been used to treat other pregnancy conditions, it has not yet been proven to be safe and/or effective for the treatment of vasa previa. This treatment aims to eliminate the VP, and, if successful, may have the potential to minimize the risk of bleeding, thereby enabling patients to avoid long hospitalization before delivery. This procedure may enable VP patients to have a vaginal delivery instead of C-section. conditions: Vasa Previa conditions: Pregnancy Complications conditions: Maternal; Procedure conditions: In Utero Procedure Affecting Fetus or Newborn studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Fetoscopic Laser Photocoagulation measure: Mode of delivery measure: Gestational age at delivery measure: Successful visualization and mapping of vasa previa measure: The rate of successful coagulation of the vasa previa - intraoperative imaging measure: The rate of successful coagulation of the vasa previa - postoperative imaging measure: The rate of successful coagulation of the vasa previa - pathology measure: Placental function measure: GA at hospital admission measure: Duration of hospital stay measure: Cause for hospital admission measure: The rate of spontaneous preterm labor measure: The rate of preterm premature rupture of membranes (PPROM) measure: The rate of placental abruption measure: The rate of chorioamnionitis measure: The rate of chorioamniotic separation measure: Interval from procedure to delivery measure: The rate of fetal growth restriction measure: Fetal brain structure measure: The rate of NICU admission measure: NICU length of stay measure: Short term neonatal morbidity measure: Neonatal survival measure: Maternal mental health score measure: Postnatal examination of the placenta sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06290219 id: CF23509A briefTitle: The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction acronym: PRP overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-30 date: 2024-12-31 date: 2024-03-04 date: 2024-03-04 name: Taichung Veterans General Hospital class: OTHER briefSummary: The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia. conditions: Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis) conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: platelet-rich plasma combined with hyaluronic acid name: Zinc Gluconate 10 MG Oral Tablet name: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil measure: phenyl ethyl alcohol odor detection threshold test measure: traditional Chinese version of University of Pennsylvania Smell Identification Test (TC-UPSIT) measure: Visual Analogue Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital city: Taichung zip: 40705 country: Taiwan name: Rong-San Jiang, MD, PhD role: CONTACT phone: 800-555-5555 phoneExt: 4088 email: rsjiang@vghtc.gov.tw name: Kai-Li Liang, MD role: CONTACT phone: +886423592525 phoneExt: 82620 email: kellyliang1107@gmail.com name: Rong-San Jiang, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06290206 id: UU_IRB_00161649 id: 1R01CA279973-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01CA279973-01 id: DSS_10065815 type: OTHER domain: University of Utah, Document Summary Sheet (DSS) Number briefTitle: PREVENT HPV-Related Cancers acronym: PREVENT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-12-30 date: 2027-06-01 date: 2024-03-04 date: 2024-03-29 name: University of Utah class: OTHER name: Kaiser Permanente name: University of Arizona name: Sea Mar Community Health Centers name: National Cancer Institute (NCI) briefSummary: This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States. The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. The proposed study includes the following: (1) boot camp translation to tailor messaging based on patient and provider input; (2) PREVENT randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention; and (3) qualitative interviews with parents/caregivers, providers, and other healthcare team members and development of best practices, implementation guides and dissemination of findings for other clinics to implement the program on a broader scale. At the end of the trial, personal interviews with parents/caregivers, clinical staff, and providers will be conducted to understand reactions to the program and persistent barriers to initiating and completing HPV vaccination. conditions: Vaccine Hesitancy conditions: HPV Vaccination conditions: Vaccine; Uptake conditions: Vaccination; Series Completion conditions: Vaccine Refusal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The investigators will use intervention mapping (IM) to plan each intervention step. The investigators will apply IM to develop and test HPV vaccination reminders for parents/caregivers (P/C). Bootcamp Translation (BCT) will engage diverse stakeholders using an iterative schedule of meetings. The BCT process will define the format and content of vaccination messages.

Intervention: The investigators propose a 3-arm RCT to compare rates of completing the next step in the HPV vaccination series at six months and completing the HPV vaccination series at 13 months between Auto, Auto-Plus, and UC arms. P/C of children/adolescents (C/A) who have not completed the series will be randomized 1:1:1 to study arms. Participants will be assessed for eligibility and enrolled, with a total participant time in the study of 13 months, for a total of 25 months of enrollment, participation, and follow-up. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Clinic analysts will create a real-time list of patients due for an initial HPV vaccine dose. P/C of remaining C/A patients will be individually randomized to either Auto or Auto-Plus intervention or usual care (UC) in a 1:1:1 ratio. The PREVENT study will only target one child/adolescent per parent/caregiver (siblings will be excluded from intervention assessments). The investigators will use automated codes to manage interventions so that eligible patients get initial HPV vaccines on time and P/C are prompted to repeat vaccination, as recommended. The investigators will select a cohort of approximately 1,038 P/C patients from the 4 clinics, randomized to intervention arms (UC, Auto, and Auto-Plus). Intervention activities largely mimic clinic processes, and clinicians and participants will be unaware of which intervention study arm the P/C has been assigned. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 519 type: ESTIMATED name: PREVENT measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sea Mar Community Health Centers city: Seattle state: Washington zip: 98108 country: United States name: PREVENT Sea Mar CHC, Study Medical Coordinator, MsPH, MS role: CONTACT phone: 206-764-5504 email: LudyVillegas@seamarchc.org name: PREVENT Research Assistant role: CONTACT phone: 801-587-4565 email: Kepka-Research@hci.utah.edu name: Amanda Petrik, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06290193 id: 23-392 briefTitle: Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery overallStatus: RECRUITING date: 2024-02-23 date: 2029-02-23 date: 2029-02-23 date: 2024-03-04 date: 2024-03-04 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution/ANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic blood transfusion/ABT in people having primary cytoreductive surgery. conditions: Ovarian Cancer conditions: Fallopian Tube Carcinoma conditions: Ovarian Carcinoma conditions: Peritoneal Carcinoma conditions: Ovarian Cancer Stage IIIC conditions: Fallopian Tube Cancer Stage IIIC conditions: Ovarian Cancer Stage IV conditions: Fallopian Tube Cancer Stage IV conditions: Fallopian Tube Cancer conditions: Peritoneal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 86 type: ESTIMATED name: Acute Normovolemic Hemodilution/ANH measure: Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 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: Dennis Chi, MD role: CONTACT phone: 212-639-5016 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: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 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: Dennis Chi, MD role: CONTACT phone: 212-639-5016 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: Dennis Chi, MD role: CONTACT phone: 212-639-5016 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: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 40.70038 lon: -73.59291 hasResults: False

 nctId: NCT06290180 id: 13632 id: 1S06GM146095 type: NIH link: https://reporter.nih.gov/quickSearch/1S06GM146095 briefTitle: Healing Lodge First Face Training Evaluation Study overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2025-03-31 date: 2025-03-31 date: 2024-03-04 date: 2024-03-04 name: Cambridge Health Alliance class: OTHER name: National Institute of General Medical Sciences (NIGMS) briefSummary: The purpose of this study is to evaluate a culturally grounded training program, xaʔtus (meaning First Face) for Mental Health. This program will train community members in how to recognize and respond to youth and adults experiencing mental health crises and ways to serve as a bridge between these individuals and the help they need. All Healing Lodge staff are being asked to complete First Face training.

To evaluate First Face, the investigators will ask all trainees to complete surveys before and after training, and again 3 months later. These surveys will measure knowledge about mental health and addiction, as well as the ability and confidence to respond appropriately to mental health crises. The study will help the investigators understand whether the First Face training program influences mental health and attitudes, as well as responses to mental health crisis situations. conditions: Addiction conditions: Depression/Anxiety conditions: Trauma, Psychological conditions: Self-harm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre/post/3-month follow-up model primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: First Face for Mental Heatlh measure: Attitudes Towards Serious Mental Illness - Adolescent Version measure: First Face knowledge assessment measure: Perceived Competence to Respond measure: Satisfaction with Training measure: Use of First Face learnings in professional/personal life measure: Intended Use of First Face learnings in professional/personal life sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Healing Lodge of the Seven Nations city: Spokane Valley state: Washington zip: 99212 country: United States name: Melinda Bowman, EdD role: CONTACT phone: 509-795-8342 email: melindab@healinglodge.org name: Michelle Zuckerman, EdD role: CONTACT phone: 509-533-6910 email: michellez@healinglodge.org name: Melinda Bowman, EdD role: PRINCIPAL_INVESTIGATOR lat: 47.67323 lon: -117.23937 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-21 uploadDate: 2024-02-21T11:51 filename: SAP_000.pdf size: 52477 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-28 uploadDate: 2024-02-28T13:20 filename: ICF_001.pdf size: 251558 hasResults: False

 nctId: NCT06290167 id: 30M201 briefTitle: A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab acronym: DUAL-Rehab overallStatus: RECRUITING date: 2023-07-03 date: 2026-04-10 date: 2026-04-10 date: 2024-03-04 date: 2024-03-04 name: Istituto Auxologico Italiano class: OTHER briefSummary: The main objective of this project is two-fold

1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.

Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.

Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments. conditions: Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: 360° media name: Treatment As Usual (TAU) name: In hospital sessions name: at home sessions name: Mild Cognitive Impairment name: Subjective Memory Complain measure: Cognitive functions measure: Motor functions sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan state: MI zip: 20149 country: Italy name: Elisa Pedroli, PsyD role: CONTACT phone: 02 61911 2707 email: e.pedroli@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06290154 id: RG2024-022-02 briefTitle: Factors Associated With Posttransplant Cardiac Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-12-31 date: 2024-03-04 date: 2024-03-05 name: Sun Yat-sen University class: OTHER briefSummary: Cardiovascular disease has become the leading cause of death early after liver transplantation (LT). The aging LT population is accompanied with the increasing prevalence of cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Furthermore, cirrhosis has been known to cause alterations in the systemic haemodynamic system and cardiac muscle dysfunction, systolic and/or diastolic, known as Cirrhotic cardiomyopathy (CCM). Hence, transthoracic echocardiography is required in all LT candidates for preprocedural evaluation and risk stratification. However, traditional echocardiographic indices of cardiac function have low sensitivity. It is unclear whether comprehensive echocardiographic multiparameters, including speckle tracking echocardiograph (STE) and tissue doppler imaging (TDI) can help improve preoperative risk stratification. Therefore, we sought to analyze the ability of clinical and comprehensive echocardiography variables to predict intraoperative and perioperative cardiac events and cardiac mortality in our LT patient experience up to early post-liver transplant. conditions: Cardiovascular Diseases conditions: Liver Transplantation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: a composite outcome of new cardiovascular disease after liver transplantation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06290141 id: EFC18156 id: U1111-1295-3363 type: REGISTRY domain: ICTRP id: 2023-508338-33 type: REGISTRY domain: CTIS briefTitle: A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) acronym: VITALIZE overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-11-05 date: 2027-05-19 date: 2024-03-04 date: 2024-03-29 name: Sanofi class: INDUSTRY briefSummary: The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. conditions: Chronic Inflammatory Demyelinating Polyneuropathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Part A is a double-blind treatment period and Part B is an open-label period. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: riliprubart name: Placebo name: riliprubart name: Placebo name: IVIg name: Placebo name: IVIg premedication measure: Percentage of participants experiencing a response measure: Percentage of participants randomized to riliprubart who responded during the double-blind period and had a lasting response during the open-label period measure: Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score measure: Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score measure: Change from baseline in grip strength (kilopascals, dominant hand) measure: Change from baseline in Medical Research Council Sum Score (MRC-SS) measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS) measure: Percentage of participants experiencing a relapse measure: Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L) measure: Number of participants with TEAEs, including SAEs and AESIs measure: Number of participants with treatment-emergent ADA in participants treated with riliprubart measure: Number of participants with TEAEs, including SAEs and AESIs measure: Percentage of participants randomized to riliprubart experiencing a relapse measure: Percentage of participants randomized to IVIg continuation experiencing a relapse measure: Number of participants and titer of anti-drug antibodies (ADA) measure: Change from baseline in I-RODS measure: Change from baseline in adjusted INCAT score measure: Change from baseline in grip strength (kilopascals; dominant hand) measure: Change from baseline in MRC-SS measure: Change from baseline in RT-FSS measure: Change from baseline in EQ-5D-5L score measure: Percentage of participants randomized to riliprubart who experience a response during the open-label period without prior response in the double-blind period (delayed response) measure: Percentage of participants randomized to IVIg continuation who experience a response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06290128 id: EFC17236 id: U1111-1295-5755 type: REGISTRY domain: ICTRP id: 2023-506503-26 type: REGISTRY domain: CTIS briefTitle: A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work acronym: MOBILIZE overallStatus: RECRUITING date: 2024-04-09 date: 2026-02-03 date: 2027-10-12 date: 2024-03-04 date: 2024-03-28 name: Sanofi class: INDUSTRY briefSummary: The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double-blind treatment in part A and open-label treatment in Part B. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Riliprubart name: Placebo name: Riliprubart name: Placebo measure: Percentage of participants refractory to standard of care (SOC) experiencing a response measure: Percentage of participants randomized to riliprubart with lasting response measure: Percentage of participants randomized to placebo who experience a response measure: Percentage of participants randomized to riliprubart who experience a response measure: Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score measure: Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score measure: Change from baseline in grip strength (kilopascals; dominant hand) measure: Change from baseline in Medical Research Council Sum Score (MRCSS) measure: Percentage of participants refractory to immunoglobulins experiencing a response measure: Change from baseline in the EuroQol 5 Dimension, 5Level Health Scale (EQ5D5L) measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS) measure: Number of participants with treatmentemergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) measure: Incidence and titer of anti-riliprubart antibodies (ADA) measure: Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) measure: Incidence and titer of anti-riliprubart antibodies measure: Change from baseline in I RODS score measure: Change from baseline in adjusted INCAT score measure: Change from baseline in grip strength (kilopascals; dominant hand) measure: Change from baseline in MRC-SS measure: Change from baseline in EQ-5D-5L score measure: Change from baseline in RT-FSS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alabama Neurology Associates Site Number : 8400019 status: RECRUITING city: Birmingham state: Alabama zip: 35209 country: United States lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06290115 id: 202301 briefTitle: Adolescents' Non-suicidal Behavior and Perception of Parents' Negative Emotional Expression and Family Communication overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-31 date: 2024-12-31 date: 2024-03-04 date: 2024-03-13 name: Sun Yat-sen University class: OTHER briefSummary: The starting point of this project is to study young people and adolescents, aiming to explore the correlation between non-suicidal behavior of young people and adolescents and the negative emotional expression of their parents and family communication. The purpose of this project is to investigate the non-suicidal self-injury behavior of teenagers aged 15-25 years by issuing questionnaires (sample size: 327 people). In order to find out whether there is any connection between family communication and non-suicidal self-injury behavior of young people and adolescents. conditions: Adolescents studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 324 type: ESTIMATED name: Questionnaires set 1 name: Questionnaires set 2 name: Questionnaires set 3 measure: Non-suicidal self-injury behavior of young people and adolescents measure: Expression of negative emotions of parents measure: Parent-Adolescent communication scale measure: Childhood Trauma Questionnaire measure: Parental Bongding Instrument measure: The parent-child relationship intimacy scale sex: ALL minimumAge: 15 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06290102 id: TV56248-RES-10204 briefTitle: Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old overallStatus: RECRUITING date: 2024-05-02 date: 2024-10-02 date: 2024-11-09 date: 2024-03-04 date: 2024-04-24 name: Teva Branded Pharmaceutical Products R&D, Inc. class: INDUSTRY briefSummary: The primary objectives of this study are:

* To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants with asthma
* To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)
* To compare the PK profiles of ABS between the 2 different strengths of TEV-56248

The secondary objective is:

• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI conditions: Asthma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: TEV-56248 name: Fp MDPI measure: Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp) measure: Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS) measure: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp measure: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS measure: Last Measurable Concentration Above the Quantification Limit (Clast) of Fp measure: Last Measurable Concentration Above the Quantification Limit (Clast) of ABS measure: Time of Last Measurable Concentration (tlast) of Fp measure: Time of Last Measurable Concentration (tlast) of ABS measure: Number of Participants with Adverse Events (AEs) measure: Number of Participants with Serious Adverse Events (SAEs) measure: Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 4 Years maximumAge: 11 Years stdAges: CHILD facility: Teva Investigational Site 12001 status: RECRUITING city: Boerne state: Texas zip: 78006 country: United States lat: 29.79466 lon: -98.73197 hasResults: False

 nctId: NCT06290089 id: OEV-131 briefTitle: Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose overallStatus: RECRUITING date: 2024-02-12 date: 2024-06 date: 2024-09 date: 2024-03-04 date: 2024-04-12 name: Scandinavian Biopharma AB class: INDUSTRY name: Johns Hopkins Bloomberg School of Public Health briefSummary: This is an open label study with the aim to estimate the incidence of moderate and severe diarrhea among participants challenged with an enterotoxigenic E. coli (ETEC) strain. This strain is planned to be used in a subsequent challenge study on the efficacy of an oral inactivated ETEC vaccine.

The study will be conducted at one site; the Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, United States. conditions: ETEC Diarrhea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Enterotoxigenic E. coli (ETEC) strain measure: The incidence of moderate and severe diarrhea sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health status: RECRUITING city: Baltimore state: Maryland zip: 21205 country: United States name: Kawsar R. Talaat, MD role: CONTACT phone: 410-502-9627 email: ktalaat@jhu.edu name: Kawsar R. Talaat, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06290076 id: IAT-PROACT briefTitle: A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy overallStatus: COMPLETED date: 2020-01-01 date: 2023-06-30 date: 2023-09-30 date: 2024-03-04 date: 2024-03-04 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials. conditions: Acute Ischemic Stroke conditions: Endovascular Thrombectomy conditions: Symptomatic Intracranial Hemorrhage conditions: Malignant Cerebral Edema studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1500 type: ACTUAL measure: Rate of severe complications measure: Rate of mRS score of 3-6 measure: Rate of mRS score of 5-6 measure: Rate of symptomatic intracranial hemorrhage measure: Rate of malignant cerebral edema measure: Change of NIHSS score measure: Rate of modified Rankin Scale (mRS) score of 0-2 measure: All-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06290063 id: 22-08-0138 briefTitle: Cannabidiol and Older Adult Cannabis Users acronym: QUARTz overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-08-31 date: 2028-08-31 date: 2024-03-04 date: 2024-03-04 name: University of Colorado, Boulder class: OTHER briefSummary: Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market. conditions: Sleep conditions: Anxiety conditions: Depression conditions: Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 385 type: ESTIMATED name: fsCBD Cannabidiol name: bsCBD Cannabidiol name: Placebo measure: Subjective Motor Function measure: Balance measure: Anxiety measure: Depression measure: Blood Cytokine Levels measure: Depression/Anxiety measure: Drug Effects measure: Inhibitory Control measure: Cognitive Function measure: Pain Intensity and Interference measure: Cognitive Ability measure: Pain Intensity measure: Change in Condition measure: Sleep Disturbance measure: Sleep-Related Impairment measure: Memory measure: Polypharmacy-Pain Medications measure: Polypharmacy-Psychiatric Medications measure: Polypharmacy-Sleep Medications measure: Strength and Endurance measure: Sleep Quality sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado at Boulder city: Boulder state: Colorado zip: 80309 country: United States name: Ellie Sundali, BA role: CONTACT email: ellie.sundali@colorado.edu lat: 40.01499 lon: -105.27055 hasResults: False

 nctId: NCT06290050 id: TAK-279-1006 briefTitle: A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults overallStatus: RECRUITING date: 2024-03-29 date: 2024-05-03 date: 2024-05-16 date: 2024-03-04 date: 2024-04-24 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide.

During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally). conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Midazolam name: Repaglinide name: TAK-279 measure: Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279 measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279 measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279 measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States name: Study Contact role: CONTACT phone: 480-415-7404 email: mara.baier@celerion.com name: Mara Baier, DO role: PRINCIPAL_INVESTIGATOR lat: 33.41477 lon: -111.90931 hasResults: False

 nctId: NCT06290037 id: 2024-01-003 briefTitle: Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers. overallStatus: RECRUITING date: 2024-03-15 date: 2024-12-31 date: 2024-12-31 date: 2024-03-04 date: 2024-03-04 name: Seoul National University Hospital class: OTHER briefSummary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities of elderly drivers.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function, general physical function and cognitive function of elderly drivers. to identify the correlation between their outcomes and the VR driving simulator's result conditions: Automobile Driving studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: VR Driving Simulator name: Computerized Neurocognitive Function Test name: Driver Test Station name: Short Physical Performance Battery name: On-road field driving Test measure: Feasibility of VR driving simulator measure: Driving performance in simulator, measured by driving errors sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Ja-Ho Leigh, M.D. Msc. role: CONTACT email: mazican@gmail.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06290024 id: XH-23-013 briefTitle: A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data overallStatus: RECRUITING date: 2023-08-15 date: 2024-08-15 date: 2024-08-15 date: 2024-03-04 date: 2024-04-02 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function conditions: Pain studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 2000 type: ESTIMATED name: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function measure: Visual Analogue Scale/Score（VAS） measure: digital pain grading method (NRS) measure: neuropathic pain assessment scale (DN4) measure: sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale) measure: EEG measure: Barrett impulse scale (BIS) measure: (Generalized Anxiety Disorder,GAD-7) measure: (Patient Health Questionnaire-9 measure: Montreal cognitive assessment scale (MoCA) measure: ocial support assessment scale (SSQ) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ke Ma status: RECRUITING city: Shanghai state: Yangpu zip: 200092 country: China name: Ke NA Ma, PHD role: CONTACT phone: 13361879260 email: marke72@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06290011 id: XH-23-014 briefTitle: A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR overallStatus: RECRUITING date: 2023-10-11 date: 2024-10-11 date: 2024-10-11 date: 2024-03-04 date: 2024-03-04 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain conditions: Pain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 132 type: ESTIMATED name: Pain key group measure: Visual Analogue Scale/Score（VAS） sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ke Ma status: RECRUITING city: Shanghai state: Yangpu zip: 200092 country: China name: Ke NA Ma, PHD role: CONTACT phone: 13361879260 email: marke72@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06289998 id: RP014-01 briefTitle: Study of Tamibarotene in Patients With ADPKD overallStatus: RECRUITING date: 2023-12-22 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: Rege Nephro Co., Ltd. class: INDUSTRY briefSummary: Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: Tamibarotene name: Placebo measure: Changes in TKV from baseline measure: Changes in TLV from baseline measure: Changes in eGFR from baseline measure: Incidence of adverse events sex: ALL minimumAge: 26 Years maximumAge: 55 Years stdAges: ADULT facility: Kurume University Hospital status: RECRUITING city: Kurume state: Fukuoka zip: 830-0011 country: Japan lat: 33.31667 lon: 130.51667 facility: Hokkaido University Hospital status: RECRUITING city: Sapporo state: Hokkaido zip: 060-8648 country: Japan lat: 43.06667 lon: 141.35 facility: Shonan Kamakura General Hospital status: RECRUITING city: Kamakura state: Kanagawa zip: 247-8533 country: Japan lat: 35.30889 lon: 139.55028 facility: Toranomon Hospital Kajigaya status: RECRUITING city: Kawasaki state: Kanagawa zip: 213-8587 country: Japan lat: 35.52056 lon: 139.71722 facility: Juntendo University School of Medicine Juntendo Hospital status: RECRUITING city: Bunkyo-ku state: Tokyo zip: 113-8431 country: Japan lat: 35.37517 lon: 139.92991 facility: Toranomon Hospital status: RECRUITING city: Minato-ku state: Tokyo zip: 105-8470 country: Japan lat: 34.2152 lon: 135.1501 facility: Tokyo Women's Medical University Hospital status: RECRUITING city: Shinjukuku state: Tokyo zip: 162-8666 country: Japan lat: 35.2946 lon: 139.57059 facility: Kyoto University Hospital status: RECRUITING city: Kyoto zip: 606-8507 country: Japan lat: 35.02107 lon: 135.75385 hasResults: False

 nctId: NCT06289985 id: STEP id: 1OT2NS129366-01 type: NIH link: https://reporter.nih.gov/quickSearch/1OT2NS129366-01 briefTitle: StrokeNet Thrombectomy Endovascular Platform acronym: STEP overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-09 date: 2024-03-04 date: 2024-03-04 name: Medical University of South Carolina class: OTHER name: National Institute of Neurological Disorders and Stroke (NINDS) name: University of Cincinnati name: University of Virginia name: Berry Consultants name: University of California, Los Angeles name: MOUNT SINAI HOSPITAL name: The Cooper Health System name: University of Pittsburgh Medical Center name: Stony Brook University name: University at Buffalo briefSummary: STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO). conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 2000 type: ESTIMATED name: Endovascular thrombectomy with any FDA-approved category POL or NRY device name: Medical Management measure: Global disability measured by Modified Rankin Score measure: Global disability measured by Modified Rankin Score measure: Neurological deficit as measured by the National Institutes of Health Stroke Scale (NIHSS) measure: Symptomatic intracranial hemorrhage measure: Any radiologic intracranial hemorrhage measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289972 id: HUvbayraktaroglu1 briefTitle: Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire overallStatus: RECRUITING date: 2024-02-20 date: 2025-02-20 date: 2025-02-20 date: 2024-03-04 date: 2024-03-06 name: Halic University class: OTHER briefSummary: The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis. conditions: Cystic Fibrosis conditions: Parents studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 22 type: ESTIMATED measure: The Breathlessness Beliefs Questionnaire (Caregiver Version) (BBQ-C) measure: Cystic Fibrosis Questionnaire Revised (CFQ-R) for parent version measure: Parent Attitude Scale (PAS) measure: Perceived Social Support Scale (PSS) measure: Parent Attitude Scale sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haliç University status: RECRUITING city: Istanbul state: Eyup zip: 34060 country: Turkey name: Vildan Bayraktaroglu, PT, MSc role: CONTACT phone: (0212) 924 24 44 email: vildanbayraktaroglu@halic.edu.tr name: Seda Saka, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06289959 id: JD-LC2023006-I01 briefTitle: Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2029-01-01 date: 2029-01-01 date: 2024-03-04 date: 2024-03-04 name: Second Affiliated Hospital of Soochow University class: OTHER briefSummary: A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients. conditions: Lymphoma, Large B-Cell, Diffuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: cfDNA measure: Progression-free survival（PFS） measure: Sensitivity, and specificity of plasma cfDNA in DLBCL patients measure: Overall survivals(OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215000 country: China name: Bingzong Li, Professor role: CONTACT phone: 0086-13776054037 email: lbzwz0907@hotmail.com lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06289946 id: NitroRadialLHC briefTitle: Topical Nitro or Placebo Pre-Cath overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-31 date: 2024-03-04 date: 2024-03-04 name: Thomas Jefferson University class: OTHER briefSummary: Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 256 type: ESTIMATED name: NitroBid name: Placebo measure: Crossover rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289933 id: BR-EMC-CT-103 briefTitle: A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult Volunteers overallStatus: RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-03-04 date: 2024-03-04 name: Boryung Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers conditions: Type2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: BR3005 name: BR3005-1 name: BR3005-2 measure: AUCτ measure: Cmax sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center, H PLUS Yangji Hospital status: RECRUITING city: Seoul state: Gwanakgu zip: 08779 country: Korea, Republic of name: Seunghyun Kang role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06289920 id: BR-EMC-CT-102 briefTitle: A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers overallStatus: RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-03-04 date: 2024-03-04 name: Boryung Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: BR3005 name: BR3005-1 name: BR3005-2 measure: AUCτ measure: Cmax sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center, H PLUS Yangji Hospital status: RECRUITING city: Seoul state: Gwanakgu zip: 08779 country: Korea, Republic of name: Seunghyun Kang role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06289907 id: LH-BH-ADV-01 briefTitle: Hot Flash and Night Sweat Virtual Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-09 date: 2024-05-30 date: 2024-07-30 date: 2024-03-04 date: 2024-03-04 name: Bonafide Health class: INDUSTRY name: Lindus Health briefSummary: The purpose of this research study is to evaluate the effectiveness of the study product on vasomotor symptoms (VMS) and overall menopause symptoms in healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65. conditions: Menopause studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Decentralized, double-blind, placebo-controlled, randomized primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Bonafide-HF3.0 name: Placebo measure: To determine the effects of the Study Product (SP) compared to placebo on hot flash symptoms measure: To determine the effects of the SP compared to placebo on hot flash symptoms measure: To determine the effects of the SP compared to placebo on hot flash symptoms measure: To determine the effects of the SP compared to placebo on vasomotor symptoms measure: To determine the effects of the SP compared to placebo on overall menopausal symptoms measure: To determine the effects of the SP compared to placebo on overall menopausal symptoms measure: To determine the effects of the SP compared to placebo on quality of life sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lindus Health, Inc. city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06289894 id: BRY805-101 briefTitle: A Study of BRY805 in Participants With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-05 date: 2027-09 date: 2024-03-04 date: 2024-03-04 name: BioRay Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This is a phase 1 open label multicenter study to evaluate safety, tolerance and the maximum tolerance of BRY805 administered intravenously (IV) once every three weeks in participants with advanced solid tumors, so as to confirm the recommended phase 2 dose of BRY805 and obtain the preliminary efficacy information of participants with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: BRY805 injection measure: Occurrence of Drug Limited Toxicities (DLTs) measure: Type and incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs) measure: BRY805 Serum Concentrations measure: Number of Participants with BRY805 Antibodies measure: Overall Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Progression-Free Survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Tumor hospital city: Jinan state: Shandong zip: 250117 country: China name: Jinming Yu, MD role: CONTACT phone: (+86)0531-67627156 email: sdyujinming@126.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06289881 id: SIL-026-21 briefTitle: Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets overallStatus: NOT_YET_RECRUITING date: 2025-02-04 date: 2025-03-11 date: 2025-03-25 date: 2024-03-04 date: 2024-03-04 name: Bio-innova Co., Ltd class: INDUSTRY briefSummary: The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 3 days washout period between the doses. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 36 type: ESTIMATED name: Sildenafill-Test product name: Sildenafill-Reference product measure: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) measure: Maximal measured plasma concentration (Cmax) measure: Number of subjects with adverse events sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06289868 id: DC-TR23-0222 id: HAV-EU-11-23 type: OTHER domain: Beckman Coulter, Inc briefTitle: Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23) overallStatus: NOT_YET_RECRUITING date: 2024-02-27 date: 2024-05-27 date: 2024-08-27 date: 2024-03-04 date: 2024-03-04 name: Beckman Coulter, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection, on the DxI 9000 Access Immunoassay Analyzer.

This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays. conditions: HAV studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1150 type: ESTIMATED name: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays name: Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays measure: Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity measure: Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cerba Xpert city: Frepillon zip: 95740 country: France name: Chloé Puisney, PhD role: CONTACT phone: 06.30.15.34.65 email: cpuisney@cerbaresearch.com lat: 49.05216 lon: 2.20528 facility: Eurofins Biomnis city: Ivry-sur-Seine zip: 94208 country: France name: Catherine Coignard, MD role: CONTACT phone: +33 149 59 63 37 email: catherine.coignard@biomnis.eurofinseu.com lat: 48.81568 lon: 2.38487 hasResults: False

 nctId: NCT06289855 id: Parkinson's disease briefTitle: Impulse Control Disorder Among Parkinson's Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2025-03-31 date: 2024-03-04 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: The goal of this observational study is to learn about impulse control disorders in Parkinson's disease patients.

The main question: it aims to answer:

* Detect Relative frequency of impulse control disorder among Parkinson's disease patients
* Detect Relation between impulse control disorders, and other non motor and motor symptoms in Parkinson's disease patients, using clinical, neurophysiological and radiological assessment conditions: Parkinson's Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 56 type: ESTIMATED name: MDS-UPDRS measure: number of patients with impulse control disorder among Parkinson's disease patients measure: percent of cognition affection, gait affection among patients with impulse control disorder among Parkinson's disease patients measure: volume of cortex and basal ganglia in patients with impulse control disorder among Parkinson's disease patients measure: cortical excitability and inhibition inpatients with impulse control disorder among Parkinson's disease patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289842 id: ZU-IRB #9697 briefTitle: Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients overallStatus: RECRUITING date: 2024-02-01 date: 2025-01 date: 2026-01 date: 2024-03-04 date: 2024-03-04 name: Zagazig University class: OTHER_GOV briefSummary: The objective of this study is to investigate efficacy of accelerated theta burst stimulation (TBS) in suicidal reduction in patients with unipolar and bipolar depression conditions: Suicide and Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) measure: Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS) measure: Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zagazig University status: RECRUITING city: Zagazig zip: 44519 country: Egypt name: Medhat M Bassiony, Professor role: PRINCIPAL_INVESTIGATOR name: Usama M Youssef, Professor role: SUB_INVESTIGATOR name: Ghada M Salah El-Deen, Professor role: SUB_INVESTIGATOR name: Hayam M El-Gohary, Professor role: SUB_INVESTIGATOR name: Alaa E Zayed, Ass.Lecturer role: SUB_INVESTIGATOR lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06289829 id: 4-2023-1605 briefTitle: The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam. overallStatus: RECRUITING date: 2024-03-02 date: 2025-07-29 date: 2025-07-29 date: 2024-03-04 date: 2024-03-04 name: Yonsei University class: OTHER briefSummary: The laryngeal mask airway (LMA) is an airway maintenance device that is easy to insert and has the advantage of causing less sore throat and autonomic nervous system stimulation. To appropriately insert the LMA, an adequate depth of anesthesia is essential. Various drugs have been studied for inducing anesthesia to achieve the appropriate depth for LMA insertion, and the newly developed benzodiazepine, remimazolam, is gaining attention as one of them. Remimazolam has rapid onset and recovery times, hemodynamic stability, and is often co-administered with opioids like remifentanil for more effective LMA insertion. This study aims to find the optimal dose of remifentanil for the proper insertion of the Ambu Auragain, one of the recently developed LMAs, during induction of anesthesia using remimazolam and the Biased-Coin Up-and-Down method will be used for this purpose. Starting with an initial concentration of remifentanil of 3.0 μg/mL, the success or failure of LMA insertion will determine the dosage for the next subject. Data will be collected from a total of 60 patients, and subsequent analysis will be conducted. conditions: Adult, Laryngeal Masks, Remimazolam, Remifentanil studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 67 type: ESTIMATED name: remifentanil of the assigned dose name: Ambu Auragain for airway management measure: Success/failure of LMA insertion on the first attempt measure: Difficulty of LMA insertion measure: Optimality of the LMA insertion based on the administered remifentanil dose measure: The number of attempts required for successful LMA insertion and whether intubation was performed. measure: Air leak volume during positive-pressure ventilation measure: Systolic blood pressure measure: Heart rate measure: Patient State Index (PSI) measure: Severity of hoarseness measure: Severity of coughing measure: Severity of sore throat measure: Diastolic blood pressure sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT facility: Severance Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Darhae Eum, Assistant Clinical Professor role: CONTACT phone: 82-2-2228-2431 email: deum@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06289816 id: 28/01/2023 briefTitle: Spleen Preserving Surgery for Splenic Hydatidosis: A Cohort Study on Short and Long-Term Outcomes overallStatus: COMPLETED date: 2015-01-01 date: 2021-06-30 date: 2021-06-30 date: 2024-03-04 date: 2024-03-04 name: Yarmouk University class: OTHER briefSummary: This retrospective cohort study examines the effectiveness of minimally invasive spleen-preserving surgeries compared to total splenectomy for treating primary splenic hydatidosis in Jordan. Covering 18 patients from January 2015 to June 2021, the research highlights similar recurrence rates between both surgical approaches, emphasizing the benefits of spleen preservation in maintaining immune function and reducing septic risks, particularly in pediatric patients. conditions: Spleen-Preserving Surgery conditions: Echinococcus Granulosus Infection conditions: Hydatid Disease conditions: Minimally Invasive Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 18 type: ACTUAL name: Minimally Invasive Surgery measure: Incidence of Postoperative Short-Term Complications measure: Incidence of Postoperative Long-Term Complications sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anas Aljaiuossi city: Irbid zip: 22110 country: Jordan lat: 32.55556 lon: 35.85 hasResults: False

 nctId: NCT06289803 id: Huadong Hospital of FudanU briefTitle: The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery overallStatus: RECRUITING date: 2023-09-01 date: 2025-01-31 date: 2025-06-30 date: 2024-03-04 date: 2024-03-04 name: Fudan University class: OTHER briefSummary: Aim of the study: To evaluate the value of Probe Confocal Laser Endomicroscopy (PCLE) in surgery for pancreatic tumor.

Methods:

Patients who are diagnosed with pancreatic tumor based on preoperative radiographic findings and will undergo radical resection are included in this clinical study. PCLE will be used in surgery to identify tumor is malignant or not, and surgeons will decide procedures of surgery based on outcomes of PCLE. In this present study, clinical trials will be divided into two phases. In the first phase, based on the definitive postoperative pathologic diagnosis, characteristic imaging structures that were collected by PCLE will be identified and primary diagnostic imaging criteria for pancreatic cancer would be developed. In the second phase, this criterion will be used for rapid intraoperative diagnosis of pancreatic cancer and predicting status of resection margin. In addition, accuracy of PCLE will be verified based on postoperative pathologic reports. conditions: Pancreatic Cancer conditions: Diagnosis conditions: Pancreatoduodenectomy conditions: Distal Pancreatectomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients diagnosed with pancreatic tumours will undergo surgical resection, and PCLE will be used for identifying the behaviour of tumours (benign or malignant neoplasms) and predicting the status of resection margin. primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: probe confocal laser endomicroscopy measure: diagnostic efficacy measure: Rate of R0 resection sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huadong Hospital affiliated to Fudan University status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China name: Chunjing Li, M.S role: CONTACT phone: 14790068967 email: Lcj1479006@163.com name: Chongyi Jiang, M.D role: CONTACT phone: +8618101802916 email: jiangzhongyi9@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06289790 id: 16/BW/2023' briefTitle: Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS) overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2024-11-07 date: 2024-11-07 date: 2024-03-04 date: 2024-03-04 name: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland class: OTHER briefSummary: The goal of this clinical trial is to compare analgesic efficacy of erector spinae plane (ESP) block vs intravenous lignocaine infusion in video- assisted thoracoscopy (VATS. The main goals are to compare post- operative pain scores and cumulative post- operative opioid doses in both groups conditions: Thoracic Surgery, Video-Assisted studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patient and nursing staff will be blinded to the performed intervention. PI and performing anaesthesiologist will not be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Erector Spinae Plane (ESP) block name: Lignocaine measure: pain score on numerical rating score measure: cumulative opioid dose measure: incidence of severe hypotension measure: incidence of nausea and vomiting measure: incidence of priuritis measure: incidence of local anaesthetic systemic toxicity symptoms measure: intra-operative cumulative opioid dose measure: time to discharge from hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Medical Institute of the Ministry of the Interior and Administration city: Warsaw state: Mazowieckie zip: 02-507 country: Poland role: CONTACT phone: 722 14 50 phoneExt: (47) email: anestezja@cskmswia.gov.pl name: Antoni Okniński, MD role: PRINCIPAL_INVESTIGATOR name: Iwona Pikto-Pietkiewicz, MD role: SUB_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06289777 id: aortic remodeling briefTitle: Aortic Remodeling After Endovascular Management of Type B Aortic Dissection. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-04-01 date: 2024-03-04 date: 2024-03-04 name: Assiut University class: OTHER briefSummary: Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair. conditions: Type B Aortic Dissection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: TEVAR measure: Analysis of aortic remodeling measure: technical success sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine city: Asyut zip: 71515 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06289764 id: 7/02/2024/131 briefTitle: The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on PMS acronym: Aromatherapy overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-20 date: 2024-05-30 date: 2024-03-04 date: 2024-03-04 name: Esra ÖZER class: OTHER name: KTO Karatay University briefSummary: Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being.

Premenstrual syndrome (PMS) is a health problem characterized by the periodic occurrence of physical, cognitive, emotional and behavioral symptoms during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is reported that approximately 80-95% of women complain of PMS complaints.

Although the use of aromatherapy in womens health is widespread, there is no study comparing bergamot and grapefruit essential oils. The aim of this study was to determine the effect of aromatherapy with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms. conditions: Premenstrual Syndrome-PMS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Bergamot Essential Oil name: Grapefruit Essential Oil name: Sweet almond oil measure: Premenstrual syndrome scale (PMS) measure: Menstrual Symptom Scale sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ankara Medipol Unıversty status: RECRUITING city: Ankara state: Altındağ zip: 06000 country: Turkey name: Esra ÖZER, Asisst. Prof. role: CONTACT phone: +905433630475 email: esraozellllll@gmail.com name: Şerife İrem DÖNER, research assistant role: SUB_INVESTIGATOR name: Hafize DAĞ TÜZMEN, lecturer role: PRINCIPAL_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06289751 id: NACI-CerV-004 briefTitle: Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2031-01-01 date: 2024-03-04 date: 2024-03-04 name: Tongji Hospital class: OTHER name: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial) name: Women Hospital, School of Medicine, Zhejiang University name: Southwest Hospital, China name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: Sichuan Cancer Hospital and Research Institute name: Qilu Hospital of Shandong University name: Beijing Friendship Hospital name: Tianjin Medical University name: West China Second University Hospital name: Xiangya Hospital of Central South University name: Gansu Provincial Maternal and Child Health Care Hospital name: Zhejiang Cancer Hospital name: Shengjing Hospital briefSummary: This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients. conditions: Cervical Cancer conditions: Neoadjuvant Chemoimmunotherapy conditions: Radical Hysterectomy conditions: Fertility Preservation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: a multicentre, single-arm, phase 2 trial primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Cadonilimab name: Paclitaxel-albumin name: Cisplatin name: Extrafascial hysterectomy measure: Percentage of patients meeting ConCerV criteria measure: Objective Response Rate, ORR measure: Proportion of patients requiring postoperative adjuvant therapy measure: Number of Participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.0 measure: the surgical complication measure: Pathologic Complete Response measure: Overall survival, OS measure: progression-free survival, PFS sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Gang Chen role: CONTACT phone: 086-027-8362 email: gumpc@126.com name: Jing Chen role: CONTACT phone: 086-027-8362 email: chenjing3223@126.com name: Gang Chen role: PRINCIPAL_INVESTIGATOR name: Kezhen Li role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06289738 id: ICF in Takayasu Arteritis briefTitle: ICF in Takayasu Arteritis overallStatus: RECRUITING date: 2024-02-21 date: 2024-03-20 date: 2024-03-25 date: 2024-03-04 date: 2024-03-04 name: Pamukkale University class: OTHER briefSummary: The aim was to analyze the problem in patients with Takayasu Arteritis based on the International Classification of Functioning, Disability and Health.The sample of our study will consist of individuals between the ages of 18-65 who have been diagnosed with Takayasu Arteritis by rheumatologists and are followed by Pamukkale University Rheumatology Clinic. conditions: Takayasu Arteritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: ICF measure: 6 open-ended questions sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elif Gur Kabul status: RECRUITING city: Uşak country: Turkey name: Elif Gur Kabul, Assistant Professor role: CONTACT phone: 00.90.2582964282 phoneExt: 4282 email: elifgur1988@hotmail.com lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06289725 id: IRB-VN01002-23932 briefTitle: Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-04 date: 2024-03-18 name: Ly Hoa Anh Minh class: OTHER briefSummary: The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response. conditions: Chronic Hepatitis b studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 84 type: ESTIMATED name: antiviral treatment measure: Serological response for HBeAg measure: Virological response measure: Biochemical response sex: ALL minimumAge: 2 Years maximumAge: 16 Years stdAges: CHILD facility: Children's Hospital 1 status: RECRUITING city: Ho Chi Minh City country: Vietnam name: Minh Hoa Anh Ly role: CONTACT phone: 0902352622 email: lhaminh.ncs.nhi23@ump.edu.vn lat: 10.82302 lon: 106.62965 facility: City Children's Hospital status: RECRUITING city: Ho Chi Minh City country: Vietnam name: Minh Hoa Anh Ly role: CONTACT email: lhaminh.ncs.nhi23@ump.edu.vn lat: 10.82302 lon: 106.62965 hasResults: False

 nctId: NCT06289712 id: APHP231660 briefTitle: Evaluation of the Ablation of Hepatic Lesions by Electroporation acronym: EVALHEP overallStatus: RECRUITING date: 2023-11-23 date: 2025-05-23 date: 2025-05-23 date: 2024-03-04 date: 2024-03-04 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Inria Team MONC briefSummary: Irreversible electroporation is a curative treatment for cancerous liver lesions, performed on deep-seated tumors that are not eligible for surgical resection or percutaneous thermal ablation.

The EVALHEP project aims to develop criteria for evaluating the effectiveness of the treatment based on imaging, mathematical models, and numerical simulations to assist radiologists who perform these complex procedures. conditions: Liver Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED measure: Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up measure: Calculation of the tumor coverage rate by the various electric field isolines at different relevant values (for example, three-dimensional isolines between 300 and 700V.cm-1 will be simulated numerically). measure: Correlation of recovery rate with treatment outcome and local recurrence during clinical follow-up measure: Identification and assessment of imaging biomarkers (radiomics-based) using numerical simulation and post-therapeutic imaging for treatment response evaluation. measure: Digital resolution of electrical potential and tissue conductivity values from test pulses at the start of the procedure. measure: Develop software solutions potentially usable in real-time and tailored for clinical use. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service d'imagerie diagnostique et interventionnelle tri-site des HUPSSD status: RECRUITING city: Bobigny zip: 93009 country: France name: Olivier SUTTER role: CONTACT phone: 01 72 40 00 12 email: olivier.sutter@aphp.fr lat: 48.9 lon: 2.45 hasResults: False

 nctId: NCT06289699 id: WARD-CSS international 1251 briefTitle: Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures overallStatus: RECRUITING date: 2024-02-26 date: 2024-08-01 date: 2024-12-31 date: 2024-03-04 date: 2024-03-04 name: Christian S. Meyhoff class: OTHER name: Rigshospitalet, Denmark briefSummary: The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction. conditions: User Experience conditions: Postoperative Complications conditions: Acute Medical Conditions studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data measure: Technical feasibility measure: Alert relay to smartphones measure: Response to alerts measure: Patients experiences from being monitored with wCSVM. measure: Relevance of alarms measure: Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day measure: Frequency of delivered alarms on respiration rate (RR) pr patient pr day measure: Frequency of delivered alarms on heart rate (HR) pr patient pr day measure: Frequency of delivered alarms on blod pressure (BP) pr patient pr day measure: Overall score of user satisfaction from use of WARD24/7 app measure: Subscale MAUQ scores measure: Monitoring practices prior to the wCVSM measure: Cumulative duration of SpO2<88% and SpO2 < 85% measure: Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1 measure: Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1 measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o measure: Cumulative duration of Circulatory failure measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o measure: Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88% sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation, General Anesthesiology status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Daniel Sessler, MD role: CONTACT name: Daniel Sessler, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie status: NOT_YET_RECRUITING city: Hamburg zip: 20246 country: Germany name: Bernd C Saugel, MD, Dr. Med. role: CONTACT name: Bernd C Saugel, MD, Dr. Med. role: PRINCIPAL_INVESTIGATOR lat: 53.57532 lon: 10.01534 facility: University Medical Center Groningen, Department of Anesthesiology status: NOT_YET_RECRUITING city: Groningen zip: 9700 country: Netherlands name: Marjolein Haveman, TP role: CONTACT name: Marjolein Haveman, TP role: PRINCIPAL_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin status: RECRUITING city: Trondheim zip: 7006 country: Norway name: Erlend Skraastad, MD, PhD role: CONTACT name: Erlend Skraastad, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 63.43049 lon: 10.39506 facility: Liverpool University Hospitals NHS Foundation Trust status: NOT_YET_RECRUITING city: Liverpool zip: L7 8YE country: United Kingdom name: Ingeborg Welters, Dr. Med. role: CONTACT name: Ingeborg Welters, Dr. Med. role: PRINCIPAL_INVESTIGATOR lat: 53.41058 lon: -2.97794 hasResults: False

 nctId: NCT06289686 id: C.2023.080 briefTitle: MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation overallStatus: RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-05 name: Brooke Army Medical Center class: FED name: Sparta Biopharma name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness briefSummary: Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair. conditions: Rotator Cuff Tears conditions: Rotator Cuff Injuries conditions: Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Rotator cuff repairs with BioEnthesis augmentation name: Rotator cuff repairs without BioEnthesis augmentation measure: Rates of re-tear measure: Change in the Visual Analogue Scale (VAS) from before surgery to after surgery measure: Change in the return to activities of daily living (ADL) from before surgery to after surgery measure: Change in the Concomitant medications (ConMeds) from before surgery to after surgery measure: Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery measure: Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery measure: Change in the Constant-Murley Score from before surgery to after surgery measure: Change in the shoulder immobilization status from before surgery to after surgery measure: Change in strength measurements from before surgery to after surgery measure: Change in range of motion measurements from before surgery to after surgery measure: Number of medical events/adverse events after surgery measure: Cumulative number of steroid injections after surgery measure: Number of unscheduled visits after surgery measure: Number of for-cause imaging procedures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center status: NOT_YET_RECRUITING city: Bethesda state: Maryland zip: 20889 country: United States name: Kelly Kilcoyne, MD role: CONTACT phone: 301-295-2441 email: Kelly.G.Kilcoyne.mil@health.mil lat: 38.98067 lon: -77.10026 facility: Brooke Army Medical Center status: RECRUITING city: San Antonio state: Texas zip: 78234 country: United States name: Andrew Sheean, MD role: CONTACT phone: 210-916-1280 email: Andrew.J.Sheean.mil@health.mil lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06289673 id: INITIALL id: NCI-2024-01659 type: REGISTRY domain: NCI Clinical Trial Registration Program briefTitle: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2034-05 date: 2039-05 date: 2024-03-04 date: 2024-03-15 name: St. Jude Children's Research Hospital class: OTHER briefSummary: The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.

Primary Objectives

* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.
* To develop a central database of genomic and clinical findings.

Secondary Objectives

* To assess event free and overall survival data of patients enrolled on this study. conditions: Acute Lymphoblastic Leukemia conditions: Lymphoblastic Lymphoma conditions: Mixed Phenotype Acute Leukemia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 850 type: ESTIMATED name: Dexamethasone name: Vincristine name: Daunorubicin name: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) name: Methotrexate name: Cytarabine measure: Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy). measure: Complete data within the INITIALL database measure: Event Free Survival (EFS) measure: Overall Survival (OS) sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: United States, Tennessee St. Jude Children's Research Hospital city: Memphis state: Tennessee zip: 38105 country: United States name: Seth E. Karol, MD role: CONTACT phone: 866-278-5833 email: referralinfo@stjude.org name: Seth E. Karol, MD role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False

 nctId: NCT06289660 id: PED-TB22 briefTitle: Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age overallStatus: RECRUITING date: 2022-12-22 date: 2033-01-02 date: 2033-03-01 date: 2024-03-04 date: 2024-03-04 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide. conditions: Tuberculosis Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Epidemiology of Tuberculosis sex: ALL minimumAge: 1 Week maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence state: Firenze zip: 50139 country: Italy name: Luisa Galli role: CONTACT email: luisa.galli@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedale Pediatrico Giovanni XXIII status: RECRUITING city: Bari country: Italy name: Desiree Caselli role: CONTACT email: desiree.caselli@policlinico.ba.it lat: 41.11148 lon: 16.8554 facility: Ospedale di Belluno status: RECRUITING city: Belluno country: Italy name: Giangiacomo Nicolini role: CONTACT email: gnicolini@gmail.com lat: 46.14262 lon: 12.2156 facility: Università di Bologna status: RECRUITING city: Bologna country: Italy name: Marcello Lanari role: CONTACT email: marcello.lanari@unibo.it lat: 44.49381 lon: 11.33875 facility: IRCCS Istituto Giannina Gaslini status: RECRUITING city: Genova country: Italy name: Elio Castagnola role: CONTACT email: eliocastagnola@gaslini.org lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico status: RECRUITING city: Milano country: Italy name: Samantha Bosis, MD role: CONTACT email: samantha.bosis@policlinico.mi.it lat: 45.46427 lon: 9.18951 facility: Ospedale Luigi Sacco status: RECRUITING city: Milano country: Italy name: Vania Giacomet role: CONTACT email: vania.giacomet@unimi.it lat: 45.46427 lon: 9.18951 facility: Policlinico di Modena status: RECRUITING city: Modena country: Italy name: Barbara Maria Bergamini role: CONTACT email: bergamini.barbaramaria@unimo.it lat: 44.64783 lon: 10.92539 facility: Università Federico II status: RECRUITING city: Napoli country: Italy name: Andrea Lo Vecchio role: CONTACT email: andrea.lovecchio@unina.it lat: 40.85216 lon: 14.26811 facility: Ospedale dei Bambini "G.Di Cristina" status: RECRUITING city: Palermo country: Italy name: Claudia Colomba, MD role: CONTACT email: claudia.colomba@unipa.it lat: 38.13205 lon: 13.33561 facility: Ospedale di Parma status: RECRUITING city: Parma country: Italy name: Susanna Maria Roberta Esposito role: CONTACT email: susannamariaroberta.esposito@unipr.it lat: 44.79935 lon: 10.32618 facility: IRCCS Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Gian Luigi Marseglia role: CONTACT email: gl.marseglia@smatteo.pv.it lat: 45.19205 lon: 9.15917 facility: Azienda Ospedaliero Universitaria Pisana status: RECRUITING city: Pisa country: Italy name: Diego Peroni role: CONTACT email: diego.peroni@unipi.it lat: 43.70853 lon: 10.4036 facility: Azienda USL Toscana Centro status: RECRUITING city: Prato country: Italy name: Per Luigi Vasarri role: CONTACT email: pvasarri@usl4.toscana.it lat: 43.8805 lon: 11.09699 facility: IRCCS Ospedale Pediatrico Bambin Gesù status: RECRUITING city: Roma country: Italy name: Laura Lancella role: CONTACT email: laura.lancella@opbg.net lat: 41.89193 lon: 12.51133 facility: Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Roma country: Italy name: Danilo Buonsenso, MD role: CONTACT email: danilo.buonsenso@policlinicogemelli.it lat: 41.89193 lon: 12.51133 facility: Ospedale Regina Margherita status: RECRUITING city: Torino country: Italy name: Silvia Garazzino role: CONTACT email: silvia.garazzino@unito.it lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06289647 id: 19-28923B id: 5UG1EY030833 type: NIH link: https://reporter.nih.gov/quickSearch/5UG1EY030833 briefTitle: Azithromycin Reduction to Reach Elimination of Trachoma B acronym: ARRET overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2029-08-31 date: 2029-08-31 date: 2024-03-04 date: 2024-03-04 name: University of California, San Francisco class: OTHER name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo name: National Eye Institute (NEI) briefSummary: The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution. conditions: Trachoma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double (Investigator, Outcomes Assessor) whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100000 type: ESTIMATED name: Azithromycin measure: Ocular chlamydia measured in a population-based sample of 0-9 year-old children measure: Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia measure: Conjunctival inflammation sex: ALL minimumAge: 1 Month maximumAge: 9 Years stdAges: CHILD facility: University of California, San Francisco city: Kindu state: Maniema country: Congo, The Democratic Republic of the lat: -2.94373 lon: 25.92237 hasResults: False

 nctId: NCT06289634 id: Pending briefTitle: The Influence of Sound on Stress, Anxiety, and Mood overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-04 date: 2024-03-04 name: Medgar Evers College, The City University of New York class: OTHER briefSummary: Multiple studies have highlighted music's ability to evoke diverse emotional states. Past research reveals that factors like musical elements, and the environment impact how people respond emotionally to music. For instance, faster tempos tend to heighten arousal, while minor key compositions evoke more arousal compared to major key compositions. In efforts to induce specific emotions post-stress, the research found that both pleasant and sad music aided stress recovery. Similarly, other researchers noted that positively rated music was more effective in reducing stress than negatively rated music, especially low arousal compositions over high arousal ones. Several studies focused on applying music to reduce stress and anxiety. In addition to man-made musical tones, the positive impact of natural surroundings on emotional state has been widely explored. A psycho-evolutionary viewpoint was offered, suggesting that humans have evolved in natural settings, making us inherently attuned to them physically and psychologically. A non-threatening natural environment, rich in aesthetically pleasing elements like visible escape routes, greenery, and water, tends to reduce stress and generate interest. In this study, the researchers are exploring how different sounds-man-made instrumental music versus natural sounds-affect stress, anxiety, and mood among the students of Medgar Evers College. Using an experimental approach, the researchers will assess pretest stress levels (via the perceived stress scale (PSS), anxiety (generalized anxiety disorder (GAD-7), and mood (four-dimensional mood scale (4DMS) among a sample of students. After randomly dividing them into two groups, each group will listen to one of the designated sounds (man-made music or nature sounds) for 30 minutes daily over 15 days. The researchers will then have them retake the stress, anxiety, and mood scales for post-test comparison. Statistical analysis (mixed ANOVA) will help to compare scores within and between groups. Ultimately, this study aims to determine the influence of tonal input on stress and anxiety levels among students, crucial given the significant stress they often experience. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Man-made sounds name: Natural sounds measure: Stress measure: Anxiety measure: Mood sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289621 id: 2024P000420 id: K01TW012180 type: NIH link: https://reporter.nih.gov/quickSearch/K01TW012180 briefTitle: Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-07-31 date: 2026-12-31 date: 2024-03-04 date: 2024-03-15 name: Massachusetts General Hospital class: OTHER name: University of Stellenbosch name: Fogarty International Center of the National Institute of Health name: Harvard Medical School (HMS and HSDM) briefSummary: The purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (PTSD) in South Africa. The intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. The brief intervention group will be compared to an enhanced standard care control group. conditions: Anxiety Disorders conditions: Post-traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a Type 1 hybrid-effectiveness implementation trial. Study participants are randomized into the brief transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD) or an enhanced standard care control group. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: False Safety Behavioral Elimination Treatment (FSET) name: Enhanced Standard Care measure: Structured Clinical Interview for the DSM-5 (SCID-5) measure: Clinician-Administered PTSD Scale for the DSM-5 (CAPS) measure: Work Social Adjustment Scale (WSAS) measure: General Anxiety Disorder-7 (GAD-7) measure: Beck Anxiety Inventory (BAI) measure: Safety Aid Scale (SAS) measure: Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5) measure: Patient Health Questionnaire - 9 (PHQ-9) measure: Beck Depression Inventory (BDI) measure: Anxiety Sensitivity Index -3 measure: Life Events Checklist (LEC) measure: Alcohol Use Disorders Identification Test (AUDIT) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289608 id: ID_2024 briefTitle: Bruxism and Underlying Psichological Factors overallStatus: RECRUITING date: 2023-02-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-04 date: 2024-03-04 name: University of Salamanca class: OTHER briefSummary: The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory. conditions: Bruxism conditions: Muscular Disorders, Atrophic conditions: Temporomandibular Joint Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: No intervention measure: Depression Level measure: Stress Level measure: Anxiety sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Odontológica de la Universidad de Salamanca status: RECRUITING city: Salamanca zip: 37007 country: Spain name: JAVIER MONTERO, DDS role: CONTACT phone: 619429971 email: javimont@usal.es lat: 40.96882 lon: -5.66388 hasResults: False

 nctId: NCT06289595 id: Pro00134382 briefTitle: Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment overallStatus: COMPLETED date: 2023-10-03 date: 2024-02-20 date: 2024-02-20 date: 2024-03-04 date: 2024-03-04 name: PBM Healing International Limited class: INDUSTRY briefSummary: Orthodontic treatment can cause pain. Research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment. In this study, data was collected from the medical charts of patients who had orthodontic treatment and recorded their pain levels for 1 week at the beginning of orthodontic treatment while they used a light therapy device or did not use at device. This collected information was used to see if the light therapy device could lessen orthodontic pain. conditions: Orthodontic conditions: Pain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 32 type: ACTUAL name: PBM Ortho device measure: Level of Pain sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bio Dental Clinic Ashiya city: Ashiya country: Japan lat: 34.72807 lon: 135.30264 facility: Sawa Dental Clinic city: Kasugai country: Japan lat: 35.24762 lon: 136.97229 facility: Soejima Dental Clinic city: Kitakyushu country: Japan lat: 33.85181 lon: 130.85034 facility: Higashimachigran Dental Clinic city: Kumamoto country: Japan lat: 32.80589 lon: 130.69182 facility: Tsujimura Dental Clinic city: Tanabe country: Japan lat: 33.73333 lon: 135.36667 facility: IXI Family Dental Clinic city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Miki Dental Clinic city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 hasResults: False

 nctId: NCT06289582 id: R24-004 briefTitle: Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-06 date: 2024-03-04 date: 2024-03-04 name: University of Alabama at Birmingham class: OTHER name: Michael J. Fox Foundation for Parkinson's Research briefSummary: The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval.

Primary Objectives

* To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers.
* To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.

Secondary Objectives

* To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes.
* To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes
* To acquire safety data following injection of \[18F\]DPA-714 conditions: Parkinson Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: [F-18]DPA714 administration IV measure: Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD. sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UAB city: Birmingham state: Alabama zip: 35294 country: United States name: Evan Hudson, BS role: CONTACT phone: 205-934-6499 email: evanhudson@uabmc.edu name: Jonathan McConathy, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06289569 id: PRO00037243 briefTitle: Home Tele Rehabilitation Therapy for Vascular Dementia overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2026-03-14 date: 2026-04-01 date: 2024-03-04 date: 2024-03-04 name: The Methodist Hospital Research Institute class: OTHER briefSummary: To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD) conditions: Dementia, Vascular conditions: Stroke Sequelae studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE maskingDescription: Self-report measures will be not blinded, assessors will be blinded to treatment phase (SOC or telerehabilitation) count: 120 type: ESTIMATED name: Home telerehabilitation therapy measure: Burden Scale for Family Caregivers measure: Adverse events measure: Fugl-Meyer Upper extremity assessment measure: Wolf Motor Function Test (WMFT) measure: Exercise log measure: Stroke Impact Scale sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289556 id: TEMP0001 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-04 date: 2024-03-20 name: [Redacted] hasResults: False

 nctId: NCT06289543 id: BVU-ESTELOGLU briefTitle: Preoperative Oral Carbohydrate on Gastric Emptying overallStatus: RECRUITING date: 2023-01-01 date: 2024-04-01 date: 2024-04-15 date: 2024-03-04 date: 2024-03-04 name: Bezmialem Vakif University class: OTHER briefSummary: The current preoperative fasting guidelines recommend, applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort. Fasting after midnight before the operation day is a widespread practice. The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product; which is proven safe and efficient, and unavailable in several countries. In this study, our objective is to analyze the gastric volume, preoperative anxiety, stress response, postoperative insulin resistance, and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa. conditions: Vomit Aspiration conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Preoperative carbohydrate solution measure: Gastric volume measure: preoperative anxiety measure: postoperative nausea and vomiting measure: thirst, hunger, fatigue, dry mouth measure: Postoperative Pain Score measure: postoperative insulin resistance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem University status: RECRUITING city: Istanbul state: Fatih country: Turkey name: Kazim Karaaslan role: CONTACT phone: +905055213865 email: kazimkaraslan@gmail.com lat: 41.01384 lon: 28.94966 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-01-01 uploadDate: 2024-01-24T06:51 filename: Prot_SAP_000.pdf size: 439034 hasResults: False

 nctId: NCT06289530 id: 2023XAGG0070-1 briefTitle: Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries acronym: CR-POPF overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-04 date: 2024-04-01 name: Peking Union Medical College Hospital class: OTHER briefSummary: This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions:

1. What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries?
2. What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries？

Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed. conditions: Postoperative Pancreatic Fistula studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Clinically relevant postoperative pancreatic fistula measure: Bile leakage measure: Chyle leak measure: Postpancreatectomy hemorrhage measure: Abdominal infection measure: Delayed gastric emptying sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: LING LAN, MD role: CONTACT email: lanling_1988@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06289517 id: 68Ga-Her2-affibody briefTitle: PET Imaging of 68Ga-Her2-affibody in Tumors With High Her2 Expression overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-30 date: 2025-06-30 date: 2024-03-04 date: 2024-03-04 name: Peking University First Hospital class: OTHER briefSummary: This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors. conditions: Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: 68Ga-Her2-affibody measure: The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer measure: The dosimetry of 68Ga-Her2-affibody measure: Quantitative evaluation of 68Ga-Her2-affibody measure: Correlation with pathological expression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital city: Beijing state: Beijing zip: 100034 country: China name: Lei Yin, Dr. role: CONTACT phone: +861083575252 email: jack-yin@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06289504 id: NN9838-4694 id: U1111-1295-4056 type: OTHER domain: World Health Organization (WHO) briefTitle: A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight overallStatus: RECRUITING date: 2024-02-27 date: 2024-11-16 date: 2024-11-16 date: 2024-03-04 date: 2024-03-19 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cagrilintide name: Semaglutide name: Atorvastatin name: Warfarin measure: AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state measure: AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state measure: Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state measure: tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state measure: AUC0-∞,S-war,SD: Area under the S-warfarin plasma concentration curve from time 0 to infinity after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: Rac,0-168hours,Cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose measure: Rac,0-168hours,Sema: The ratio of the area under the semaglutide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose measure: AUC0-168hours, 4th dose Cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema measure: AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Altasciences Company Inc. status: RECRUITING city: Mount-Royal state: Quebec zip: H3P 3P1 country: Canada lat: 45.51675 lon: -73.64918 hasResults: False

 nctId: NCT06289491 id: 2024P000544 briefTitle: Randomized Trial of Hydrus Microstent Versus Goniotomy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2029-04 date: 2024-03-04 date: 2024-03-04 name: Massachusetts Eye and Ear Infirmary class: OTHER briefSummary: The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:

* How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
* How do the safety profiles of these three microinvasive glaucoma surgeries compare?

Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery. conditions: Glaucoma conditions: Glaucoma, Open-Angle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 243 type: ESTIMATED name: Hydrus Microstent name: Incisional goniotomy name: Excisional goniotomy measure: Intraocular pressure measure: Intraocular pressure-lowering medications measure: Surgical complications sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289478 id: 0151/67 briefTitle: Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Cementless Bipolar Hemiarthroplasty - a Randomized Controlled Trial acronym: TXA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-03-04 date: 2024-03-04 name: King Chulalongkorn Memorial Hospital class: OTHER briefSummary: The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:

* The efficacy in reducing blood transfusion for topical tranexamic acid administration
* The safety of tranexemic acid, topically used

As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.

Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion. conditions: Femoral Neck Fracture conditions: Bipolar Hemiarthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Topical tranexamic acid administration measure: Rate of blood transfusion measure: Volume of blood transfusion measure: Calculated blood loss measure: Any adverse events measure: In-hospital mortality sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine city: Bangkok zip: 10330 country: Thailand name: Kanyakorn Riewruja role: CONTACT phone: +66-95-864-4447 email: kanyakorn.riew@gmail.com name: Kanyakorn Riewruja, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06289465 id: IstanbulBU briefTitle: Examination of Pain, Posture, Physical and Mental Status in Seasonal Hazelnut Workers overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2024-11-01 date: 2024-12-01 date: 2024-03-01 date: 2024-03-04 name: Istanbul Bilgi University class: OTHER briefSummary: The collection of hazelnuts grown in our country provides a great source of employment for local people and seasonal workers. However, geographical conditions in hazelnut growing areas, challenging variable weather conditions in August and insufficient number of workers create a disadvantageous environment for seasonal workers.

In this study, it was aimed to investigate the effects of working conditions on mental status, fatigue, pain severity and postures (posture disorders, developmental delays, etc.) of young adults working in Giresun during the hazelnut picking season in comparison with the group living in the same sociodemographic and cultural environment but not working as seasonal workers. conditions: Agricultural Workers' Diseases conditions: Posture conditions: Pain conditions: Depression conditions: Fatigue studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Observation measure: McGill Melzack Questionnaire measure: PhysioPrint Mobile Application measure: Checklist Individual Strength Questionnaire measure: Beck Depression Inventory sex: ALL minimumAge: 18 Years maximumAge: 34 Years stdAges: ADULT facility: Istanbul Bilgi University city: Istanbul zip: 34060 country: Turkey name: Furkan Çakır, M.Sc. role: CONTACT phone: 2123115432 phoneExt: +90 email: furkan.cakir@bilgi.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06289452 id: IVB102-101 briefTitle: Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis overallStatus: NOT_YET_RECRUITING date: 2024-03-06 date: 2025-12-31 date: 2029-12-31 date: 2024-03-01 date: 2024-03-01 name: InnoVec Biotherapeutics Inc. class: INDUSTRY name: Peking Union Medical College Hospital briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS. conditions: Retinoschisis conditions: Retinal Disease conditions: Retinal Degeneration conditions: Eye Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: IVB102 Injection name: IVB102 Injection name: IVB102 Injection measure: Incidence of DLTs measure: Incidence of AEs measure: Incidence of SAEs measure: Visual function measure: OCT imaging measure: ERG parameters sex: MALE minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100142 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06289439 id: 2024.05.25 briefTitle: Effect of Green Tea Supplementation in Older Adult Women acronym: GTAW overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-20 date: 2025-04-01 date: 2024-03-01 date: 2024-03-05 name: University of Valladolid class: OTHER name: Sanidad de Castilla y León name: Instituto de Neurociencia de Castillas y Leon briefSummary: Introduction: One of the consequences of aging is the decrease in physical performance which can affect the quality of life of older people. Although physical exercise is beneficial in improving this problem, older women do not seem to benefit as much as men. In this sense, the use of ergonomic aids by women could compensate for these issues. Thus, green tea has shown beneficial effects on physical performance in athletes through, among others, improving blood flow and vasodilation, mitochondrial respiration, calcium management, glucose and amino acid uptake, lipid oxidation, modulation of muscle damage, antioxidant effect, and anabolic and catabolic hormones, activation of the hypothalamic-pituitary-adrenal axis, etc. Therefore, the deterioration of physical performance and quality of life of green tea.

Objective: To analyze the effect of supplementation with 1 g/day green tea extract (500 mg of polyphenols) for 10 weeks on quality of life values, physical performance (grip strength, walking speed, and resistance), and health biomarkers (biochemical, hematological, and hormonal) in women over 60 years of age who follow a physical training program.

Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.9±4.58 years, BMI: 25.09±3.24 and body fat percentage: 32.54±6.39) who followed a physical activity adapted to their age and abilities are the members of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 1 g/day of green tea (GI; n = 10). Different physical tests were performed (grip strength, walking speed and resistance) and the quality of life questionnaire (WHOQOL-BREF) was passed and health biomarkers (biochemical, hematological, and hormonal) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2). conditions: Female conditions: Older Adults conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group placebo-controlled randomized clinical trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Green tea (Camellia sinensis) 1000 mg as extract name: Placebo measure: Creatine kinase (CK) measure: Lactate dehydrogenase (LDH) measure: Myoglobin (Mb) measure: Alanine Aminotransferase (ALT) measure: Aspartate Aminotransferase (AST) measure: Interleukin 6 (IL-6) measure: C-reactive protein (PCR) measure: Testosterone measure: Cortisol measure: Miostatin (GDF8) measure: advanced oxidation protein products (AOPP) measure: lipid peroxidation (LPO) measure: Oxygen radical absorption (ORAC) measure: Total antioxidant status (TAS) measure: Total antioxidant capacity (TAC) measure: Short Physical Performance Battery (SPPB) measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF) sex: FEMALE minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences, University of Valladolid Soria Campus status: RECRUITING city: Soria zip: 42004 country: Spain name: Diego Fernández Lázaro, Vice Dean role: CONTACT phone: +34658073375 email: diego.fernandez.lazaro@uva.es lat: 41.76401 lon: -2.46883 hasResults: False

 nctId: NCT06289426 id: KU3339 briefTitle: Online Yoga for Improving the Well-being of Desk-based Workers overallStatus: RECRUITING date: 2024-02-15 date: 2024-08-15 date: 2024-08-15 date: 2024-03-01 date: 2024-03-01 name: Kingston University class: OTHER briefSummary: The goal of this clinical trial is to evaluate the effectiveness of an 8-week online yoga intervention in improving the well-being and productivity of desk-based workers. The main questions it aims to answer are:

* How effective is an 8-week online yoga intervention in improving the well-being (mental and physical) and productivity (work engagement and job performance) of the yoga group compared with passive controls?
* Are there any differences in well-being and work-related measures between the yoga and control groups?

Participants in the yoga group will practice yoga three days a week for 8 weeks and will be compared with a wait-listed control group, which will continue with the usual routine for 8 weeks. Researchers will evaluate the impact of yoga on the well-being and productivity of desk-based workers. conditions: Perceived Stress conditions: Depression conditions: Anxiety conditions: Mindfulness conditions: Self-Compassion conditions: Compassion conditions: Work Engagement conditions: Productivity conditions: Heart Rate Variability conditions: Mental Wellbeing conditions: Musculoskeletal Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Yoga measure: Perceived Stress Scale measure: PROMIS-Anxiety Short form measure: The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) measure: The Mindful Attention Awareness Scale (MAAS) measure: The Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) measure: Self-Compassion Scale Short Form (SCS-SF) measure: The Compassion Scale (CS) measure: Uterecht Work Engagment Scale-Short Form (UWES -9) measure: Work Ability Index (WAI) measure: Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10) measure: Heart Rate Variability (HRV) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vipin Wadhen status: RECRUITING city: London zip: KT12EE country: United Kingdom name: VIPIN WADHEN, MPhil role: CONTACT phone: 07308468129 email: V.Wadhen@kingston.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06289413 id: KCHRRF_ADiPOSE_0027 briefTitle: Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study overallStatus: RECRUITING date: 2024-03 date: 2026-03 date: 2026-06 date: 2024-03-01 date: 2024-03-01 name: Kansas City Heart Rhythm Research Foundation class: OTHER name: Kansas City Heart and Rhythm Institute, Overland Park, KS name: Bariatric and Metabolic Specialists, Overland Park, KS briefSummary: Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS. conditions: Autonomic Dysfunction conditions: Orthostatic Intolerance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 400 type: ESTIMATED name: Development of AD/OI after BS measure: To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Menorah Medical Center status: RECRUITING city: Overland Park state: Kansas zip: 66209 country: United States name: Donita Atkins role: CONTACT lat: 38.98223 lon: -94.67079 facility: Bariatric and Metabolic Specialists status: RECRUITING city: Overland Park state: Kansas zip: 66211 country: United States name: Nicole Fearing, MD role: CONTACT lat: 38.98223 lon: -94.67079 facility: Kansas City Heart Rhythm Institute - Roe Clinic status: RECRUITING city: Overland Park state: Kansas zip: 66211 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 facility: Overland Park Regional Medical Center status: RECRUITING city: Overland Park state: Kansas zip: 66215 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: datkins@kchrf.com name: Naga Venkata K. Pothineni role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 facility: Centerpoint Medical Center Clinic status: RECRUITING city: Independence state: Missouri zip: 64057 country: United States name: Donita Atkins role: CONTACT lat: 39.09112 lon: -94.41551 facility: Centerpoint Medical Center status: RECRUITING city: Independence state: Missouri zip: 64057 country: United States name: Donita Atkins role: CONTACT lat: 39.09112 lon: -94.41551 facility: Research Medical Center Clinic status: RECRUITING city: Kansas City state: Missouri zip: 64032 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 facility: Research Medical Center status: RECRUITING city: Kansas City state: Missouri zip: 64032 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 hasResults: False

 nctId: NCT06289400 id: KaratayUOAS briefTitle: Magnetic Field Application in Patellofemoral Pain Syndrome overallStatus: RECRUITING date: 2024-02-26 date: 2024-05-01 date: 2024-05-31 date: 2024-03-01 date: 2024-03-04 name: KTO Karatay University class: OTHER briefSummary: The purpose of this study is to examine the effect of magnetic field application used in the treatment of patellofemoral pain. conditions: Pain, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Magnetic field application name: Conventional treatment measure: Visual Analogue Scale (VAS) measure: 36-Item Short Form Survey (SF-36) measure: Manual Muscle Test measure: The Lower Extremity Functional Scale (LEFS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KTO Karatay University status: RECRUITING city: Konya country: Turkey name: Osman Karaca, PhD role: CONTACT phone: +90 444 1251 phoneExt: 7845 email: osmankaracaftr@gmail.com lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06289387 id: MMDEF001 briefTitle: Combining Gene Variants to Improve Risk Prediction for Metabolic (Dysfunction)- Associated Fatty Liver Disease and Its Progression to Cirrhosis in Indian Individuals With Type 2 Diabetes overallStatus: RECRUITING date: 2024-01-20 date: 2025-01-01 date: 2025-01-10 date: 2024-03-01 date: 2024-03-05 name: Medanta, The Medicity, India class: OTHER briefSummary: Type 2 diabetes and metabolic (dysfunction)-associated fatty liver disease (MAFLD) often exist together. The prevalence of MAFLD is about 15-30% in healthy people and around 60-70% in people with type 2 diabetes. Moreover, type 2 diabetes accelerates the progression of liver disease in MAFLD.

MAFLD is a spectrum of liver conditions, ranging from simple fatty liver (low risk for progression), progressing to steatohepatitis (MASH) with no or mild fibrosis, advanced liver fibrosis, cirrhosis, and hepatocellular carcinoma. Although diabetes is the strongest predictor of advanced fibrosis in MAFLD, however, only a small proportion of people with type 2 diabetes and MAFLD (about 5-7%) develop a clinically significant liver disease, but the burden of MAFLD is such that even a small proportion of patients developing cirrhosis will lead to a huge strain on the health care system in India. MAFLD is predicted to be the leading indication for liver transplantation in coming years. At present, MAFLD/MASH is the second most common indication for liver transplantation in the USA as well as in India.

The question is why around 5-7% patients amongst MAFLD population develop fibrosis and cirrhosis. A growing body of evidence suggest that the disease develops because of a complex process in which several factors, including genetic susceptibility and environmental insults, are involved. There are several gene variants that have been incriminated in the development and progression of MAFLD. The most common genes associated with MAFLD are PNPLA3, TM6SF2, GCKR, and MBOAT7. The loss-of-function gene variant HSD17B13 seems to protect from NAFLD. There are a few studies from India about the role of PNPLA3 and TM6SF2 in MAFLD. However, these studies used USG for the diagnosis of MAFLD, which does not provide any information regarding fibrosis of the liver. The data regarding other three genetic variants are scarce from Indian individuals. conditions: Type2diabetes studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: Role of the PNPLA3, TM6SF2, GCKR, MBOAT7 and HSD17B13 genetic variants in the development and progression of MASLD. measure: Correlation between body fat percentage (DEXA-measured) and the genetic variants measure: Correlation between lean body mass (as measured by DEXA) and the genetic variants measure: Correlation between bone mineral content (DEXA-measured) and the genetic variants measure: Correlation between fibrosis-4 score (FIB-4) and the genetic variants measure: Correlation between MASLD fibrosis score (NFS) and the genetic variants measure: Correlation between serum creatinine levels (eGFR) and the genetic variants sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medanta Division of Endocrinology & Diabetes status: RECRUITING city: Gurgaon state: Haryana zip: 122001 country: India name: Surender, PhD role: CONTACT phone: 0124141414 phoneExt: 6596 email: yadavsurender89@gmail.com lat: 28.4601 lon: 77.02635 hasResults: False

 nctId: NCT06289374 id: 23HH8340 briefTitle: Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery acronym: LABS overallStatus: RECRUITING date: 2024-04 date: 2028-06 date: 2029-06 date: 2024-03-01 date: 2024-03-06 name: Imperial College London class: OTHER name: Cancer Research UK briefSummary: Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis. conditions: Oesophageal Adenocarcinoma conditions: Gastric Adenocarcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Biosample collection measure: Salivary microbial biomarkers to predict treatment response and long-term prognosis measure: Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment measure: Quality of life measure up to 2 years following cancer surgery using validated questionnaires sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London country: United Kingdom name: Bhamini Vadhwana role: CONTACT name: Professor George Hanna, PhD FRCS role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06289361 id: IMEA 070 briefTitle: Cohort IMEA 070 -Lenacapavir Compassional overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-15 date: 2024-07-30 date: 2024-03-01 date: 2024-03-22 name: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba class: OTHER name: Saint-Louis Hospital, Paris, France name: Bichat Hospital name: Saint Antoine University Hospital name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023 conditions: HIV Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 58 type: ESTIMATED measure: proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection measure: incidence of side effects and laboratory abnormalities on LEN treatment measure: evolution of HIV-1 or HIV-2 RNA over time measure: evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time measure: Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0) measure: Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Zobda Quitman city: Fort-de-France state: Martinique zip: 97261 country: France name: Ornella OC CABRAS, PhD role: CONTACT phone: +33.5.96.55.23.01 email: ornella.cabras@chu-fort-de-france.fr name: Ornella OC CABRAS, PhD role: PRINCIPAL_INVESTIGATOR facility: Hopital Avicenne city: Bobigny zip: 93000 country: France name: Frederic FM MECHAI, MD role: CONTACT phone: +33.1.48.95.54.21 email: frederic.mechai@aphp.fr name: Frederic FM MECHAI, MD role: PRINCIPAL_INVESTIGATOR lat: 48.9 lon: 2.45 facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses city: Bordeaux zip: 33000 country: France name: Pauline PP PERREAU role: CONTACT phone: 33.5.57.82.11.03 email: pauline.perreau@chu-bordeaux.fr name: Arnaud AD DESCLAUX, MD role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: Hopital Saint-Andre city: Bordeaux zip: 33075 country: France name: Sabrina SC CALDATO role: CONTACT phone: +33.5.56.79.57.33 email: sabrina.caldato@chu-bordeaux.fr name: Fabrice FB BONNET, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: Hopital Raymond Poincare city: Garches zip: 92380 country: France name: Rezak RM MAHREZ role: CONTACT phone: +33.1.47.10.46.65 email: rezak.mahrez@aphp.fr name: Pierre PT DE TRUCHIS, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.84226 lon: 2.18232 facility: C.H.D de Vendee city: La Roche Sur Yon zip: 85925 country: France name: Hélène HP PELERIN role: CONTACT phone: +33.2.51.44.65.72 email: helene.pelerin@ght85.fr name: Philippe PP PERRE, PhD role: PRINCIPAL_INVESTIGATOR lat: 46.66667 lon: -1.43333 facility: André Mignot Hospital city: Le Chesnay zip: 78150 country: France name: Marie-Charlotte MCDC DE CARNE, MD role: CONTACT phone: +33.1.39.63.88.56 email: mcdecarne@ght78sud.fr name: Marie-Charlotte MCDC DE CARNE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.8222 lon: 2.12213 facility: Centre Hospitalier Bretagne Sud - Hôpital du Scorff city: Lorient zip: 56100 country: France name: Jérémie JP PASQUIER, MD role: CONTACT phone: +33.2.97.06.74.86 email: j.pasquier@ghbs.bzh name: Jérémie JP PASQUIER, MD role: PRINCIPAL_INVESTIGATOR lat: 47.75 lon: -3.36667 facility: CHU de Nice city: Nice zip: 06200 country: France name: Sophie SB BREAUD role: CONTACT phone: +33 4 92 03 90 90 email: breaud.s@chu-nice.fr name: David DC CHIRIO, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Hôpital Hotel Dieu city: Paris zip: 75004 country: France name: Valérie VLB LE BAUT role: CONTACT phone: +33.1.42.34.81.65 email: valerie.le-baut@aphp.fr name: Jean-Paul JPV VIARD, PHD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hopital Saint Antoine city: Paris zip: 75012 country: France name: Rym RM MONARD role: CONTACT phone: +33 1 86 69 71 21 email: rym.monard@aphp.fr name: Karine KL LACOMBE, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales city: Paris zip: 75013 country: France name: Malikhone MC CHANSOMBAT role: CONTACT phone: +33.1.42.16.01.74 email: malikhone.chansombat@aphp.fr name: Sophie SS SEANG, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hopital Necker city: Paris zip: 75015 country: France name: Elisabete EGP GOMES PIRES role: CONTACT phone: +33.1.44.49.2719 email: elisabete.gomes-pires@aphp.fr name: Carole CL LOUISIN role: CONTACT phone: +33.1.44.49.55.72 name: Claudine CD DUVIVIER, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Bichat Hospital city: Paris zip: 75018 country: France name: ZELIE JULIA role: CONTACT phone: 40257057 phoneExt: 331 email: zelie.julia@aphp.fr name: ROLAND LANDMAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Delafontaine city: Saint-Denis zip: 93200 country: France name: Awa AN N'DIAYE role: CONTACT phone: +33.1.42.35.61.40 phoneExt: 6809 email: awa.ndiaye2@aphp.fr name: Naomie NS SAYRE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.93326 lon: 2.36666 facility: Hopital Foch city: Suresnes zip: 92150 country: France name: Amina AF FADLI role: CONTACT phone: +33.1.46.25.11.73 email: a.fadli@hopital.foch.org name: David DZ ZUCMAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.87143 lon: 2.22929 hasResults: False

 nctId: NCT06289348 id: APHP230240 id: 2023-A00970-45 type: REGISTRY domain: ID-RCB briefTitle: Announcement of Rare Metabolic Diseases in Systematic Newborn Screening: the Phenylketonuria Experience. acronym: ANNPHE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-03-01 date: 2024-03-01 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The aims of this collaborative, interdisciplinary research project are to understand and describe the psychological impact of the announcement of a rare, serious disease present since birth and detected in the context of the systematic neonatal screening (DNS), in terms of the parents' experience, but also on the part of the medical team, in order to improve its process and the support it provides for the announcement of the diagnosis. conditions: Phenylketonuria studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: socio-psychological questionnaire name: revised event impact scale (IER-S) name: Non directive interview name: Stern interview name: semi-directive interview measure: Psychological process linked to the announcement of inherited metabolic disease for the parents measure: Psychological impact of the announcement of an inherited metabolic disease on the doctors' experience measure: Measuring awareness of inherited metabolic diseases detected by midwives measure: Measure of the impact of the announcement on parents sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Pascale DELONLAY, MD, PhD role: CONTACT phone: +33 1 44 49 48 52 email: pascale.delonlay@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06289335 id: HCDrIMPrieto anaesthesia briefTitle: Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section overallStatus: COMPLETED date: 2020-08-05 date: 2021-09-05 date: 2022-01-03 date: 2024-03-01 date: 2024-03-01 name: Hospital Central "Dr. Ignacio Morones Prieto" class: OTHER briefSummary: Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia. conditions: Postanesthetic Excitement conditions: Cesarean Section studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: saline solution measure: Period of time measure: Adverse effects sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Hospital Central Dr. Ignacio Morones Prieto city: San Luis Potosí zip: 78290 country: Mexico lat: 22.14982 lon: -100.97916 hasResults: False

 nctId: NCT06289322 id: EU101136769-CLIN1 briefTitle: AI4HOPE Dementia Pain Assessment Pilot Study 1 acronym: AI4HOPE1 overallStatus: NOT_YET_RECRUITING date: 2025-07 date: 2026-12 date: 2026-12 date: 2024-03-01 date: 2024-03-05 name: University of Bonn class: OTHER name: University College Cork name: University of Leeds name: Fundacion Intras name: Universidade do Porto name: University Medical Centre Maribor briefSummary: The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia. conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: Digital toolkit for assessment measure: Feasibility and acceptability of toolkit measure: Accuracy of toolkit assessments measure: Effect of pain /distress interventions sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289309 id: N41/DBS/001142 briefTitle: NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-01 date: 2024-03-01 name: Marcin Barczynski class: OTHER briefSummary: The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury.

The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique.

A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each).

The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy. conditions: Thyroid Diseases conditions: Surgery conditions: Recurrent Laryngeal Nerve Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each). Patients referred to the Department of Endocrine Surgery, Jagiellonian University Medical College in Krakow, for first-time thyroid surgery from March 1, 2024 onwards will be registered. Eligible patients with either benign or malignant thyroid disease will be assessed for the study. The study protocole has been approved by the Institutional Review Board (Bioethics Committee of the Jagiellonian University). primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Both participants and outcomes assessor will be blinded to the respective group assignment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Neuromonitoring of the recurrent laryngeal nerves measure: Prevalence of recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy measure: Positive predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy measure: Negative predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy measure: Prevalence of permanent recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Endocrine Surgery, Jagiellonian University College of Medicine status: RECRUITING city: Krakow zip: 31-202 country: Poland name: Marcin Barczynski, MD, PhD role: CONTACT phone: +48602375939 email: marbar@mp.pl name: Marcin Barczynski, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06289296 id: MCT briefTitle: Medium Chain Fatty Acids and Ketones acronym: MCFA overallStatus: COMPLETED date: 2022-01-01 date: 2023-09-30 date: 2023-09-30 date: 2024-03-01 date: 2024-03-01 name: University of Copenhagen class: OTHER briefSummary: 16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil. Before and after each intervention, participants completed a five-hour experimental day evaluating the response to a first intake of the MCT or LCT oils (pre MCT or LCT), which was repeated after the intervention period of daily intake (post MCT or LCT) (Fig. The intervention periods were separated by a 2-4-week washout period. conditions: Diet, Healthy conditions: Health studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel crossover design, in which a group of lean and a group of obese participants are allocated to complete two seven-day intervention periods with twice daily consumption of either medium-chain fatty acids or long-chain fatty acids. primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ACTUAL name: Fatty acid intake in lean and obese males measure: Ketone bodies in plasma sex: MALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: University of Copenhagen city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06289283 id: Theodor Bilharz Research Ins. briefTitle: Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder acronym: Cancer bladder overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-12 date: 2026-04 date: 2026-12 date: 2024-03-01 date: 2024-03-01 name: Theodor Bilharz Research Institute class: OTHER briefSummary: Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis and new treatment strategies for bladder cancer. conditions: Urinary Bladder Neoplasms conditions: Microtia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 38 type: ACTUAL name: Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera measure: To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for bladder cancer sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Theodor Bilharz Research Institute city: Cairo zip: 12411 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06289270 id: Microbiota and bladder cancer briefTitle: Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Tissues From Egyptian Male Patients and Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder Cancer. acronym: Cancer bladder overallStatus: RECRUITING date: 2023-09-20 date: 2026-12 date: 2027-07 date: 2024-03-01 date: 2024-03-01 name: Theodor Bilharz Research Institute class: OTHER briefSummary: Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis, and new treatment strategies for bladder cancer. conditions: Microbiota in Patients With Urinary Bladder Carcinoma in Urine and Cancer Tissues studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 38 type: ESTIMATED measure: To characterize the microbiota in male patients with bladder cancer. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Theodor Bilharz Research Institute status: NOT_YET_RECRUITING city: Cairo state: Giza zip: 12411 country: Egypt name: Mohamed M Wishahi, MD role: CONTACT phone: +201222247437 email: wishahi@gmx.net lat: 30.06263 lon: 31.24967 facility: Theodor Bilharz Research Institute status: RECRUITING city: Cairo zip: 12411 country: Egypt name: Mohamed M Wishahi, MD role: CONTACT phone: +201222247437 email: wishahi@gmx.net lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06289257 id: VitDAndEndomet briefTitle: Association of Vitamin D Level and Its Receptor With Endometriosis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-09-30 date: 2024-03-01 date: 2024-03-01 name: Khon Kaen University class: OTHER briefSummary: Endometriosis, a condition where endometrial-like tissue grows outside the uterus, often occurs due to retrograde menstruation, where menstrual blood flows backward through the fallopian tubes into the pelvic cavity. This tissue can then implant and grow within the pelvic peritoneum. The survival of these ectopic implants leads to chronic inflammation, adhesion formation, and scarring of surrounding tissues, including the ovaries and fallopian tubes. Symptoms include cyclic pelvic pain, dysmenorrhea, dyspareunia, and infertility.

Ectopic endometrial tissue survival is not attributed to mutations but rather epigenetic changes. Studies have linked this phenomenon to genes such as KRAS (Kirsten Rat Sarcoma Virus Oncogene), involved in cell proliferation and survival. Dysregulated KRAS activity can lead to increased production of MMP-2 and MMP-9 proteins, implicated in angiogenesis and tissue invasion, facilitating the spread of endometrial tissue.

Vitamin D has been shown to modulate immune function and reduce inflammation. Studies suggest that vitamin D deficiency may exacerbate endometriosis symptoms and severity. However, evidence regarding the efficacy of vitamin D supplementation in managing endometriosis symptoms is mixed.

One study found that long-term intake of vitamin D-rich foods was associated with an 18% lower risk of developing endometriosis. Additionally, vitamin D deficiency has been correlated with increased expression of mutated KRAS in colorectal cancer patients, suggesting a potential link between vitamin D status and genetic abnormalities in disease progression.

Further research is needed to fully understand the relationship between vitamin D deficiency and endometriosis severity, particularly in specific populations like the Thai population. conditions: Endometriosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 108 type: ESTIMATED name: Vitamin D level name: Vitamin D receptor measure: Vitamin D level measure: rASRM measure: Vitamin D receptor sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University city: Khon Kaen zip: 40000 country: Thailand name: Vitet Layanun, Doctor of Medicine role: CONTACT phone: +66850663130 email: jockvitet@hotmail.com name: Vitet Layanun, Doctor of Medicine role: PRINCIPAL_INVESTIGATOR lat: 16.44671 lon: 102.833 hasResults: False

 nctId: NCT06289244 id: 6597 briefTitle: Correlation Between Muscle Strength and Thickness in Critically Ill Patients overallStatus: RECRUITING date: 2023-06-06 date: 2025-03-30 date: 2025-06-30 date: 2024-03-01 date: 2024-03-01 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Mechanical ventilation (MV) is associated with adverse outcomes in ventilated patients, and impact of MV-induced diaphragm changes are still unclear.

The objective of this prospective observational study is to assess muscle thickness and strength, specifically in limb muscles such as the quadriceps, among critically ill patients who undergo extended mechanical ventilation during their Intensive Care Unit (ICU) stay.

The primary inquiries this study seeks to address are:

* Is there an association between muscle thickness and strength in the limbs of critically ill patients undergoing prolonged MV?
* How much thickness and strength variation can be expected in respiratory and limb muscles in critically ill patients undergoing prolonged MV? conditions: Critical Illness conditions: Muscle Weakness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Ultrasound name: Muscle strength measurement measure: Correlation between quadriceps strength and thickness measure: Quadriceps strength measure: Quadriceps thickness measure: Diaphragm thickness measure: Diaphragm strength measure: Time to reach the sitting position sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Veronica Rossi, MSc role: CONTACT email: veronica.rossi@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06289231 id: AWFiS/2023_5_PE briefTitle: The Use of Artificial Intelligence (AI) for Gait Analysis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-08 date: 2024-03-01 date: 2024-03-04 name: Gdansk University of Physical Education and Sport class: OTHER briefSummary: The main purpose of this study will be to assess the consistency and reliability of measurements made using the Vicon three-plane gait analysis device (Vicon Motion Capture System Ltd, Oxford, UK) and a mobile application based on image recognition technology with the help of artificial intelligence. conditions: Gait studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Gait analysis by the Vicon system measure: Gait analysis by the mobile image recognition application sex: ALL minimumAge: 20 Years maximumAge: 25 Years stdAges: ADULT facility: Gdansk University of Physical Education and Sport city: Gdańsk state: Pomorskie zip: 80-336 country: Poland lat: 54.35205 lon: 18.64637 hasResults: False

 nctId: NCT06289218 id: Treating knee osteoarthritis briefTitle: Kinesio Taping Versus Interferential Current Therapy in Treating Knee Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-06-25 date: 2025-06 date: 2025-09 date: 2024-03-01 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The purpose of this study will be to compare the combined effect of using Kinesio taping versus interferential current with an exercise program on knee pain, function, knee range of motion, knee muscle strength, and functional mobility in chronic knee osteoarthritis. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: interferential current name: kinesio taping name: exercise measure: knee flexion range of motion measure: knee extension range of motion measure: quadriceps muscle strength measure: The Western Ontario and McMaster Universities Osteoarthritis Index measure: Timed up and go test sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289205 id: 60/IRB/SLMC/SWL briefTitle: "Comparing Methotrexate Usage Techniques to Prevent Proliferative Vitreoretinopaty After Retinal Detachment Vitrectomy" overallStatus: RECRUITING date: 2024-03 date: 2025-02 date: 2025-05 date: 2024-03-01 date: 2024-03-01 name: University of Health Sciences Lahore class: OTHER briefSummary: This clinical trial, involving participants with rhegmatogenous retinal detachment, aims to compare Methotrexate Usage Techniques in preventing Proliferative Vitreoretinopathy (PVR) after vitrectomy. The study will evaluate the development of PVR, retinal detachment recurrence, and improvement in visual acuity. Participants will undergo retinal detachment surgery using the vitrectomy technique and will be divided into two groups. One group will receive Methotrexate infusion during surgery, while the other will receive repeated Methotrexate injections post-surgery. The researcher will analyze and compare outcomes between the two groups. conditions: Proliferative Vitreoretinopathy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Using lottery methods patients will be divided into two groups with 60 subjects in each group. Group 1 will be regarded as control group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate into one litre of BSS solution. Group 2 will be regarded as the study group and will receive 500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd , 4th and 6th post operative weeks. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: This will be a single-blind study in which the subjects will be unaware of the intervention. Blinding will be maintained by ensuring that subjects are unaware of the dosing regimens they are receiving. whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Methotrexate measure: Development of Proliferative Vitreoretinopathy (PVR) measure: Recurrence of Retinal Detachment measure: Visual Acuity Improvement sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sahiwal Medical College & Teaching Hospital, Sahiwal, Pakistan status: RECRUITING city: Sahiwal state: Punjab zip: 57000 country: Pakistan name: Ahmad Z Jamil, FCPS,FRCS role: CONTACT phone: +923334853851 email: ahmadzeeshandr@gmail.com lat: 30.66667 lon: 73.1 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-24 uploadDate: 2024-02-24T14:05 filename: Prot_SAP_000.pdf size: 182492 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-24 uploadDate: 2024-02-24T14:06 filename: ICF_001.pdf size: 185782 hasResults: False

 nctId: NCT06289192 id: IRB00396489 briefTitle: Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-03-01 date: 2024-03-15 name: Johns Hopkins University class: OTHER name: Maryland Cigarette Restitution Fund briefSummary: To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT).

The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention. conditions: Tobacco Dependence studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: C-Raven Virtual Tobacco Cessation Counseling name: Nicotine Replacement Product name: Community Health Worker name: Lung Cancer Screening measure: Acceptability and Feasibility measure: Readiness to quit smoking as assessed by The Readiness Ruler measure: Number of Participants that Uptake nicotine replacement therapy measure: Continued use of nicotine replacement therapy measure: Number of quit attempts measure: Number of participants than maintain cessation measure: Number of participants that uptake Quit Line services measure: Participant engagement with community health worker as assessed by number of CHW interactions measure: Participant satisfaction as assessed by study team survey sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chase House Apartments city: Baltimore state: Maryland zip: 21201 country: United States name: Jeanne Clark, MD role: CONTACT phone: 410-614-1135 email: jmclark@jhmi.edu name: Alejandra Ellison-Barnes, MD role: CONTACT phone: 4106141135 email: aelliso6@jhmi.edu lat: 39.29038 lon: -76.61219 facility: Monument East city: Baltimore state: Maryland zip: 21202 country: United States name: Jeanne Clark, MD role: CONTACT phone: 410-614-1135 email: jmclark@jhmi.edu name: Alejandra Ellison-Barnes, MD role: CONTACT phone: 4106141135 email: aelliso6@jhmi.edu lat: 39.29038 lon: -76.61219 facility: Johns Hopkins University School of Medicine city: Baltimore state: Maryland zip: 21205 country: United States name: Jeanne Clark, MD role: CONTACT phone: 410-614-1135 email: jmclark@jhmi.edu name: Alejandra Ellison-Barnes, MD role: CONTACT phone: 4106141135 email: aelliso6@jhmi.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06289179 id: Thyroid and cortisol in sepsis briefTitle: Thyroid and Cortisol Hormone Response to Sepsis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-02-20 date: 2026-10-25 date: 2024-03-01 date: 2024-03-01 name: Assiut University class: OTHER briefSummary: Thyroid and cortisol hormone response to sepsis conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 114 type: ESTIMATED measure: Pattern of cortisol level and thyroid function response to sepsis in ICU sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289166 id: STSP-0601-04 briefTitle: Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor overallStatus: RECRUITING date: 2024-03-18 date: 2025-02 date: 2025-02 date: 2024-03-01 date: 2024-04-03 name: Staidson (Beijing) Biopharmaceuticals Co., Ltd class: INDUSTRY briefSummary: This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor. conditions: Hemophilia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: STSP-0601 for Injection measure: Incidence of adverse events measure: Proportion of successfully treated bleeding episodes measure: Proportion of successfully treated bleeding episodes measure: Proportion of bleeding episodes received salvage treatment sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital status: NOT_YET_RECRUITING city: Hefei state: Anhui zip: 230000 country: China name: Changcheng Zheng role: CONTACT phone: 13956961162 email: zhengchch1123@163.com lat: 31.86389 lon: 117.28083 facility: The Second Affiliated Hospital of Chongqing Medical University status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Shu Chen role: CONTACT phone: 13983420188 email: chenshu921@163.com lat: 29.56278 lon: 106.55278 facility: Fujian Medical University Affiliated Union Medical College Hospital status: NOT_YET_RECRUITING city: Fuzhou state: Fujian zip: 350005 country: China name: Fenge Yang role: CONTACT phone: 13635250168 email: 339694677@qq.com lat: 26.06139 lon: 119.30611 facility: Lanzhou University First Hospital status: NOT_YET_RECRUITING city: Lanzhou state: Gansu zip: 730000 country: China name: Yaming Xi role: CONTACT phone: 13919110815 email: ncuyfygcp2018@163.com lat: 36.05701 lon: 103.83987 facility: Southern Medical University Southern Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Jing Sun role: CONTACT phone: 13316202696 email: jsun-cn@qq.com lat: 23.11667 lon: 113.25 facility: Shenzhen Second People's Hospital status: NOT_YET_RECRUITING city: Shenzhen state: Guangdong zip: 518000 country: China name: Xin Du role: CONTACT phone: 13602523722 email: duxingz@medmail.com.cn lat: 22.54554 lon: 114.0683 facility: Guizhou Medical University Affiliated Hospital status: NOT_YET_RECRUITING city: Guiyang state: Guizhou zip: 550000 country: China name: Jishi Wang role: CONTACT phone: 13312233711 email: wjiayu1399@163.com lat: 26.58333 lon: 106.71667 facility: Harbin First Hospital Hematology Tumor Research Center status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Jun Ma role: CONTACT phone: 0451-84883471 lat: 45.75 lon: 126.65 facility: Henan Cancer Hospital status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450000 country: China name: Hu Zhou role: CONTACT phone: 13939068863 email: papertigerhu@163.com lat: 34.75778 lon: 113.64861 facility: Xiangya Hospital of Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410000 country: China name: Jie Peng role: CONTACT phone: 13974802938 email: pengjie-0728@csu.edu.cn lat: 28.19874 lon: 112.97087 facility: Nanjing University School of Medicine Affiliated Gulou Hospital status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Rongfu Zhou role: CONTACT phone: 13605142342 email: rfzhoucn@163.com lat: 32.06167 lon: 118.77778 facility: The First Affiliated Hospital of Nanchang University status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330038 country: China name: Ruibin Huang role: CONTACT phone: 13970006820 email: rbhuang69@163.com lat: 28.68396 lon: 115.85306 facility: The first hospital of Jilin University status: NOT_YET_RECRUITING city: Changchun state: Jilin zip: 130000 country: China name: Sujun Gao role: CONTACT phone: 158430732085 email: sujung1963@163.com lat: 43.88 lon: 125.32278 facility: Shengjing Hospital Affiliated to China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110000 country: China name: Wei Yang role: CONTACT phone: 18940259033 email: yangw@sj-hospital.org lat: 41.79222 lon: 123.43278 facility: Affiliated Hospital of Qingdao University status: NOT_YET_RECRUITING city: Qingdao state: Shandong zip: 266000 country: China name: Zhongguang Cui role: CONTACT phone: 18661809137 email: cuizhguang@163.com lat: 36.06488 lon: 120.38042 facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Xuefeng Wang role: CONTACT phone: 18917762601 email: 13641653074@139.com lat: 31.22222 lon: 121.45806 facility: Xi'an Central Hospital status: NOT_YET_RECRUITING city: Xi'an state: Shanxi zip: 710000 country: China name: Yanping Song role: CONTACT phone: 13572973308 email: xjtusyp@163.com lat: 34.25833 lon: 108.92861 facility: West China Hospital of Sichuan University status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Yuping Gong role: CONTACT phone: 15680990805 email: Liy1905@sina.com lat: 30.66667 lon: 104.06667 facility: Hospital of Hematology, Chinese Academy of Medical Sciences status: RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang role: CONTACT phone: 022-23909095 email: zhanglei1@ihcams.ac.cn lat: 39.14222 lon: 117.17667 facility: The Second Affiliated Hospital of Kunming Medical University status: NOT_YET_RECRUITING city: Kunming state: Yunnan zip: 650000 country: China name: Zeping Zhou role: CONTACT phone: 18788571605 email: zhouzeping@kmmu.edu.cn lat: 25.03889 lon: 102.71833 hasResults: False

 nctId: NCT06289153 id: 23-01182 briefTitle: Internal Bracing Following ACL Reconstruction overallStatus: RECRUITING date: 2024-03-01 date: 2025-02-26 date: 2025-08-26 date: 2024-03-01 date: 2024-03-12 name: NYU Langone Health class: OTHER briefSummary: The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with quadriceps graft with and without internal bracing. conditions: ACL Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Arthrex Internal Brace name: ACL Reconstruction measure: Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation measure: Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06289140 id: BIOPTERO2 briefTitle: Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2) acronym: BIOPTERO2 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-01 date: 2024-03-01 name: Fundació Eurecat class: OTHER name: Circe, S.L. briefSummary: The goal of this interventional study is to to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT) in healthy volunteers. The main question it aims to answer are:

• Do the crystallized forms of pterostilbene (ccPT) using two different encapsulation methods exhibit greater bioavailability than its commercial free base form (PT)?

Participants will attend to four visits: a preselection visit (V0), a visit for the first postprandial study (V1), a visit for the second postprandial study (V2) after one-week washing period and a visit for the third postprandial study (V3) after another one week washing period.

Researchers will analyze the three postprandial assays to determine which type of ccPT encapsulation provides the highest bioavailability compared to the commercial free base form (PT). conditions: Biological Availability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 6 type: ESTIMATED name: Pterostilbene cocrystal (ccPT) - Gelatin capsule name: Pterostilbene free form (PT) name: Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule measure: Bioavailability of Pterostilbene calculated by area under the curve (AUC 0-24) of plasma pterostilbene levels, both free and total. measure: Area under the curve (AUC 0-inf) of plasma pterostilbene levels, both free and total. measure: Relative bioavailability of plasma pterostilbene levels (Frel). measure: Maximum plasma concentration (Cmax) measure: Time for maximum plasma concentration (Tmax) measure: Half-life (T1/2). sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundació Eurecat city: Reus zip: 43204 country: Spain name: Antoni Caimari, PhD role: CONTACT phone: 0034 977 300 431 email: antoni.caimari@eurecat.org name: Anna Crescenti, PhD role: CONTACT phone: 0034 977 300 431 email: anna.crescenti@eurecat.org lat: 41.15612 lon: 1.10687 hasResults: False

 nctId: NCT06289127 id: GO 22/595 briefTitle: Test Properties of Lower Quarter Y-Balance Test: Effect of Verbal Instructions and Focus Techniques overallStatus: COMPLETED date: 2022-07-20 date: 2023-02-02 date: 2023-11-10 date: 2024-03-01 date: 2024-03-04 name: Hacettepe University class: OTHER briefSummary: The Lower Quadrant Y-Balance Test (LQYBT) is a landmark test used in assessing lower extremity performance, determining risk factors for injury, and making return-to-sport decisions. Studies have shown that the individual's focus of attention affects balance. The literature, has shown that the use of external focus is more effective than the use of internal focus in the execution of a movement.Consistent with these findings, the use of an external focus instruction during the LQYBT may lead to achieve more realistic and a higher performance outcome than the test result with standard instructions. The primary aim of this study was to investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT. The secondary aim was to investigate the reliability of the different instructions and focus tests we used for the LQYBT.

Hypothesis of the study that test performance can be further enhanced by differentiating the instructions and focus techniques. A more effective assessment of individual performance may help us to make a more realistic decision to return to sport. conditions: Healthy conditions: Attention Disturbances conditions: Physical Stress studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 2 type: ACTUAL name: Lower Quarter Y Balance Test measure: Investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT. measure: Investigate the reliability of the different instructions and focus tests we used for the LQYBT. sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Hacettepe University city: Ankara state: Sıhhıye zip: 06430 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06289114 id: S-20220005 briefTitle: Predictive Utility of a Short-term Improvement in Objectively Measured Physical Activity in Rheumatoid Arthritis (PUSIPA) acronym: PUSIPA overallStatus: RECRUITING date: 2023-09-01 date: 2025-09-01 date: 2025-09-01 date: 2024-03-01 date: 2024-03-01 name: Hospital of South West Jutland class: OTHER briefSummary: SUMMARY Background: Several studies have shown physical activity (PA) to be inversely correlated to disease activity in rheumatoid arthritis (RA) patients. However, it is unclear whether improved PA leads to lower disease activity or if low disease activity predicts improved PA in rheumatoid arthritis patients. Furthermore, it is unknown how fibromyalgia (FM) affects this interaction.

Objective(s): Our primary objective will be to compare the effect of an immediate improvement in physical activity after one week on the proportion of RA patients achieving low disease activity after 12 weeks of biological treatment. Furthermore, we will explore whether the presence of concomitant FM affects this clinical response (i.e., interaction between FM status and PA response).

Design: A prospective cohort study in the form of a target-trial attempting to address a causal question comparing the outcome among the participants with an immediate improvement in physical activity, relative to individuals without.

Setting and patients: Biologically naive RA patients initiating biological treatment are consecutively enrolled. PA is quantified by accelerometry one week prior to, one week after, and after 3 months of biological treatment.

Sample size: 100 RA patients starting biological therapy is planned enrolled in the study.

Measurements: RA patients will be divided into two groups depending on their improvement in physical activity after onset of biological treatment. The percentage of time spent in moderate-to-vigorously physical activity (MVPA) i.e., the percentage of time a patient is in motion \[walking, running, bicycling, or swimming\] is measured prior to, one week, and approximately 3 months after biological treatment onset, respectively. The MVPA ratio (MVPA After biological treatment/MVPA Before biological treatment) will divide patients enabling a contrast between two groups: Those with high improvement considering MVPA (after 1 week; the upper tertile of MVPA ratio of the sample) and those without. Treatment response (achieving a disease activity score \< 3.2) after approximately 3 months from baseline will be analyzed as the contrast between groups. conditions: Rheumatoid Arthritis conditions: Fibromyalgia, Secondary conditions: Fatigue conditions: Physical Inactivity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: MVPA ratio before and after biological therapy measure: Disease activity score (DAS) measure: Fibromyalgia measure: Fatigue measure: Physical activity scores on questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Esbjerg Hospital status: RECRUITING city: Esbjerg zip: 6700 country: Denmark name: Philip R Lage-Hansen, MD role: CONTACT phone: +4530114582 email: philip.rask.lage-hansen3@rsyd.dk lat: 55.47028 lon: 8.45187 hasResults: False

 nctId: NCT06289101 id: IRB00422008 id: R21HD112617 type: NIH link: https://reporter.nih.gov/quickSearch/R21HD112617 briefTitle: text4FATHER R21: Social Media - Efficacy Trial overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-03-01 date: 2024-03-01 name: Johns Hopkins University class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being. conditions: Fathers conditions: Mobile Health conditions: Nuclear Family studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 groups will be enrolled and randomized to receipt or not receipt of the intervention. primaryPurpose: PREVENTION masking: NONE count: 180 type: ESTIMATED name: text4FATHER measure: Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC) measure: Karitane Parenting Confidence Scale (KPCS) measure: Fathering Self-Efficacy Scale (FSES) measure: Father Engagement Scale (FES) measure: The Co-Parenting Relationship Scale 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: NCT06289088 id: E-10840098-772.02-4659 briefTitle: The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance acronym: lumbosacral overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-04 date: 2024-05-04 date: 2024-05-04 date: 2024-03-01 date: 2024-03-19 name: Istanbul Medipol University Hospital class: OTHER briefSummary: The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. conditions: Orthosis conditions: Low Back Pain, Postural studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single group, crossover study primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: First Intervention name: Second Intervention name: Third Intervention measure: Visual Analog scale measure: Orthosis comfort score measure: Functional Reach Test (FRT) measure: Pedobarographic evaluation measure: Y balance test sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06289075 id: 23-1096-retro briefTitle: PrognostICate- Study:Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040 acronym: PrognostICate overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-12-01 date: 2024-03-01 date: 2024-03-01 name: University Hospital of Cologne class: OTHER name: Johann Wolfgang Goethe University Hospital name: Monash University name: The Alfred name: Albert Einstein College of Medicine name: Montefiore Hospital briefSummary: The Objective of our retrospective multicenter- study is to forecast ICU length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models and historical, national and international ICU databases and population databases. conditions: ICU Admission studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 10000000 type: ESTIMATED name: Intensive Care Unit (ICU) treatment measure: Length of mechanical ventilation measure: Length of ICU stay sex: ALL minimumAge: 1 Day maximumAge: 120 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06289062 id: NACI-CERV-005 briefTitle: Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-01 date: 2030-12-01 date: 2024-03-01 date: 2024-03-01 name: Tongji Hospital class: OTHER name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: Women Hospital, School of Medicine, Zhejiang University name: Third Military Medical University name: Beijing Friendship Hospital name: Sichuan Cancer Hospital and Research Institute name: Tianjin Medical University name: West China Second University Hospital name: Xiangya Hospital of Central South University name: Qilu Hospital of Shandong University name: Gansu Cancer Hospital name: Zhejiang Cancer Hospital name: Shengjing Hospital name: Anhui Provincial Cancer Hospital briefSummary: This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, PFS and OS. conditions: Cervical Cancer conditions: Neoadjuvant Chemoimmunotherapy conditions: Fertility Preservation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Camrelizumab name: Cisplatin name: Nab paclitaxel name: biopsy measure: Pathologic complete response measure: The negative conversion of HPV measure: Pregnancy rate measure: Miscarriage rate measure: Live birth rate measure: Preterm birth rate measure: Adverse Event measure: Surgical complications measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score measure: Event-free survival (EFS) measure: Overall survival (OS) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Kezhen Li role: CONTACT phone: 086-027-8362 email: tjkeke@126.com name: Jing Chen role: CONTACT phone: 086-027-8362 email: chenjing3223@126.com name: Kezhen Li role: PRINCIPAL_INVESTIGATOR name: Gang Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06289049 id: HREBA.CC-24-0021 briefTitle: Heavy Strength Training in Head and Neck Cancer Survivors acronym: LIFTING2 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-04 date: 2024-03-01 date: 2024-03-05 name: University of Alberta class: OTHER briefSummary: Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS. conditions: Head and Neck Neoplasms conditions: Head and Neck Cancer conditions: Head and Neck Squamous Cell Carcinoma conditions: Head and Neck Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE maskingDescription: Participants and investigators will not be blinded to group assignment given the nature of the intervention. count: 60 type: ESTIMATED name: Experimental measure: Recruitment rate measure: Adherence to a heavy lifting strength training program measure: Completion of maximal strength testing measure: Followup assessment rate measure: Safety measure: Muscular Strength measure: Cancer Specific Quality of Life measure: Fear of Cancer Recurrence measure: Symptom Burden measure: Perceived Stress measure: Self-Esteem measure: Sleep Habits measure: Malnutrition Status measure: Swallowing Abilities measure: Shoulder Range of Motion measure: Body composition measure: Handgrip Strength measure: Physical Function sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alberta city: Edmonton state: Alberta country: Canada name: Stephanie Ntoukas role: CONTACT email: ntoukas@ualberta.ca name: Kerry Courneya role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False

 nctId: NCT06289036 id: H2020206632 briefTitle: Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging overallStatus: COMPLETED date: 2021-02-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-01 date: 2024-03-01 name: The First Hospital of Hebei Medical University class: OTHER briefSummary: We enrolled patients with subacute IS, associated with moderate-to-severe stenosis of the unilateral cervical internal carotid artery, who underwent 4D ASL. Perfusion levels and collateral circulation were compared between groups with favorable prognosis (modified Rankin scale \[mRS\] ≤ 2) and poor prognosis (mRS \> 2). conditions: The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 28 type: ACTUAL measure: Modified Rankin Scale（mRS） score after 3 months of onset sex: ALL minimumAge: 18 Years maximumAge: 88 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Hospital of Hebei Medical University city: Shijia Zhuang state: Hebei country: China lat: 34.17775 lon: 109.84894 hasResults: False

 nctId: NCT06289023 id: NCC1278 briefTitle: HA-WBRT-SIB for Brain Metastasis of Lung Cancer overallStatus: COMPLETED date: 2016-01-01 date: 2020-01-01 date: 2022-12-31 date: 2024-03-01 date: 2024-03-01 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, ﬁve times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment. conditions: Lung Neoplasm conditions: Brain Metastases conditions: Simultaneous Integrated Boost conditions: Hippocampal Avoidance conditions: Cognitive Function studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: HA-WBRT-SIB measure: OS measure: PFS measure: iPFS measure: HVLT-R learning score sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06289010 id: 7354E briefTitle: Neural Mechanisms of Family-Focused Treatment for Youth Depression overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-11 date: 2024-03-01 date: 2024-03-04 name: Boston University Charles River Campus class: OTHER name: Massachusetts Institute of Technology briefSummary: The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression (FFT-CD) outcomes. The main questions it aims to answer are:

* What are differences between depressed and non-depressed participants on baseline neural and parenting indicators?
* Do baseline neural and parenting indicators predict response to FFT-CD?
* Does change in parenting and neural functioning mediate change in depression from baseline to follow-up?

Participants will:

* complete baseline clinical measures
* complete neuroimaging tasks via Functional Magnetic Resonance Imaging (fMR)
* undergo a 12-session course of FFT-CD
* complete follow up evaluations and neuroimaging conditions: Childhood Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Family-Focused Treatment for Childhood-Depression (FFT-CD) measure: Depression Treatment Response measure: Children's Self Report of Depressive Symptoms measure: Depression Remission sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Boston University city: Boston state: Massachusetts zip: 02215 country: United States name: Martha C Tompson, PhD role: CONTACT phone: 617-358-4584 email: mtompson@bu.edu name: Natalie Marr, BS role: CONTACT phone: 6173539610 email: nmarr@bu.edu name: Martha C Tompson, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Athinoula A. Martinos Imaging Center at Massachusetts Institute of Technology city: Charlestown state: Massachusetts zip: 02129 country: United States name: John DE Gabrieli, PhD role: CONTACT phone: 617-253-8946 email: gabrieli@mit.edu name: John DE Gabrieli, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 hasResults: False

 nctId: NCT06288997 id: TFYuan_tACS briefTitle: tACS Intervention for Methamphetamine Addiction acronym: tACS for MUD overallStatus: COMPLETED date: 2021-11-21 date: 2023-05-09 date: 2023-11-09 date: 2024-03-01 date: 2024-03-01 name: Shanghai Mental Health Center class: OTHER briefSummary: A growing body of evidence suggests a wide range of brain areas are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial alternating current stimulation (tACS) over prefrontal cortex reduces craving for meth dependences. In this study, the investigators investigated whether a current level of 15mA with a patented frequency of 77.5Hz tACS intervention of prefrontal cortex cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities. conditions: Methamphetamine-dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 23 type: ACTUAL name: transcranial alternating current stimulation name: sham tACS measure: Changes of Cue-induced craving measure: Changes of cognition: behavioral inhibition measure: Changes of cognition: choice under ambiguity measure: changes of neural mechanism measure: Changes of depression status measure: Changes of anxiety status measure: Changes of sleep status measure: Changes of impulsivity measure: event-related potential in passive viewing task measure: side effect measurements sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantanghe Addiction Rehab Center city: Beijing state: Beijing zip: 100054 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06288984 id: NFEC-2024-061 briefTitle: Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-12-31 date: 2024-03-01 date: 2024-03-01 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Impaired respiratory function may occur after brain injury, and will progress to restricted respiratory dysfunction without early intervention. At present, there is a lack of effective treatment options for respiratory dysfunction. Repetitive Transcranial Magnetic Stimulation(rTMS) is a non-invasive, painless and non-invasive neuroregulatory technique. In healthy people, rTMS applied to the respiratory motor cortex induces a contralateral respiratory muscle response. However, whether rTMS can improve respiratory function in patients with brain injury remains unclear. gut microbiota can affect muscle function and mass, and animal experiments have shown that probiotics can increase skeletal muscle mass and grip strength in mice. On the other hand, studies have found that rTMS can improve the nutritional status of patients with vegetative state by regulating the structure of gut microbiota. However, it remains unclear whether rTMS can improve respiratory muscle function in patients with brain injury by regulating gut microbiota. Therefore, the investigators intend to apply rTMS to the respiratory motor cortex to observe whether rTMS can improve respiratory function and reduce the incidence of pneumonia in patients with brain injury, and to observe the role of gut microbiota in this process. conditions: Brain Injuries conditions: Respiratory Function Impaired conditions: Gut Microbiota studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: active rTMS name: sham rTMS measure: Diaphragm thickness measure: Thickening fraction measure: Diaphragm mobility measure: Surface EMG of diaphragm measure: Forced vital capacity(FVC) measure: Forced expiratory volume at one second（FEV1） measure: Peak expiratory flow (PEF) measure: Maximum voluntary ventilation (MVV) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288971 id: IRCCS FSM briefTitle: Personalized Innovative Intervention Pathways to Promote EF in Children With CP overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-01-31 date: 2027-03-01 date: 2024-03-01 date: 2024-03-01 name: IRCCS Fondazione Stella Maris class: OTHER name: University of Pisa name: University of Florence name: Anastasis Società Cooperativa Sociale briefSummary: Cerebral palsy (CP) is an umbrella term, covering a group of disorders of movement and posture. It is now accepted that CP represents much more than a disorder of movements considering the frequent association with a broad range of impairments, including cognitive impairments. In general, multiple clinical characteristics that define and determine different functional profiles. Several studies on children with unilateral and bilateral CP have been shown that, despite the overall preserved intellectual functioning, there are specific neuropsychological impairments distinguishing the two forms, including deficits in different Executive Functions (EF) components. Executive Functions (EFs) represent a complex cognitive domain consisting of a set of top-down functions essential for adaptive goal-directed behaviour, allowing to formulate, plan, and organise ideas, cope with challenges and novelties, resist temptations and stay focused. EF represents general domain abilities transversal to several cognitive processes and underling different daily life activities and school learning skills. Empowering EF becomes therefore crucial in children with CP both to strengthen specific functional EF weaknesses and to achieve far transfer effects on other compromised domains, such as motor planning, academic skills,and/or visuospatial processing. To pursue this, the EF training needs to be integrated into the complex and multidisciplinary care context promoting innovative intervention methodologies based on scientific evidence. Recent researches and clinical practice, carried out in our Institute, supports the effectiveness of innovative interventions on EF using new technologies in typical and atypical development, such as Self-adapting web based softwares, Game-based tools or Educational Robotics. Literature suggests these technologies allow to promote timely intervention within a user-friendly context, while respecting the key criteria of evidence-based neuropsychological rehabilitation, both reducing hospitalisation times and supporting interest and motivation for participation. The primary aim of this study is to evaluate the applicability of technological intervention integrated with psychomotor activities to promote EF and then secondary to measure the effect on the functional profile of children with CP, including motor planning, visuo-spatial processing and learning skills, evaluating both short-term (T2) and long-term changes (T3). conditions: Executive Functions in Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities name: Tele-rehabilitation of EF and specific cognitive processes underlying academic skills name: Game-based tools for the rehabilitation of EF and motor planning measure: changes in score of inhibition subtest at the NEPSY-II measure: changes in score of the sustained attention subtest at the Leiter-3 measure: changes in score of Developmental Test of Visual-Motor Integration (VMI) measure: changes in score of MOXO-continuous performance test measure: changes in score of Corsi block-tapping subtest at the BVS-corsi measure: changes in score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents measure: changes in score of RAN (rapid automatized naming) subtest at the rapid automatized naming and visual search of colours, figures and numbers test. measure: changes in score of reading and text comprehension task at the ALCE measure: changes in score of reading and writing task at the DDE-2 measure: changes in score of digit span forwards and backwards subtest at the BVN 5-11 and BVN 12-18 measure: changes in score of Go/No-Go and N-back 1 subtest at the teleFE measure: changes in score of verbal fluency subtest at the NEPSY-II measure: changes in score of Test of Visual Perception and Visuo-motor Integration (TPV) measure: changes in score of Praxic and Motor Coordination Skills-2nd Edition (APCM-2) measure: changes in score of Movement Assessment Battery for Children - Second Edition (Movement ABC-2) measure: changes in score of Synthetic scale for the evaluation of writing in developmental age (BHK test) sex: ALL minimumAge: 5 Years maximumAge: 13 Years stdAges: CHILD facility: IRCCS Fondazione Stella Maris city: Pisa zip: 56128 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06288958 id: Fondazione Stella Maris briefTitle: Quality of Life in Children With Cerebral Palsy overallStatus: COMPLETED date: 2019-04-01 date: 2020-12-31 date: 2021-12-31 date: 2024-03-01 date: 2024-03-01 name: IRCCS Fondazione Stella Maris class: OTHER briefSummary: Cerebral Palsy (CP) is an umbrella term that defines a group of permanent disorders of movement and posture, happening during the developing foetal or infant brain. In addition to the main motor symptoms, other clinical disturbances are associated. CP represents a clinical condition with an impact in Quality Of Life (QOL) and social participation, as reported in different countries. QOL is a multidimensional construct defined as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns" (WHOQOL, 1998).

In order to best capture the peculiarities of CP, specific questionnaires were carried out to analyse the QOL in this clinical population. The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) is an internationally recognized CP-specific instrument based on the International Classification of Functioning, Disability and Health (ICF) framework. Many studies have used this instrument, showing a lower QOL in children with CP compared to their typical developing peers. In literature, several studies have shown that children with CP are at risk of experiencing activity limitations and participation restriction and which can potentially affect their QOL. Participation in daily-life activities, defined as a person's "involvement in a life situation," and participation restriction, characterised as "problems an individual may experience in involvement in life situations" (ICF, World Health Organization, 2001). Studies aimed at describing participation in daily-life activities in CP have consistently found lower frequencies and fewer activities in children and adolescents with CP. In order to gain an overall picture of the QOL and participation of children and adolescents with CP, several studies underline the importance of analysing other background factors, such as motor and cognitive functioning, pain perception, and individual characteristics.

The present study aims to deeper understand the perception of QOL and social participation in a group of Italian children with CP, as reported by their parents, using two commonly used questionnaires in the CP population (CP-QOL and PEM-CY). In addition, this study aims to explore the roles of specific clinical variables, such as motor function and cognitive level, on parental perceptions of QOL, in the development of QOL and participation. conditions: Unilateral and Bilateral Cerebral Palsy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 80 type: ACTUAL name: Quality of Life and social participation in Italian children with CP measure: Score of CP-QOL Child questionnaire measure: Score of PEM-CY questionnaire measure: Scores of Wechsler Intelligence scales sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: IRCCS Fondazione Stella Maris city: Pisa zip: 56128 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06288945 id: Dry eye syndrome briefTitle: Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome overallStatus: COMPLETED date: 2023-01-15 date: 2023-09-14 date: 2023-09-14 date: 2024-03-01 date: 2024-03-01 name: Alexandria University class: OTHER briefSummary: Dry eye syndrome (DES) is a widespread ocular disease affecting the general population. It is a complex disorder affecting the surface of the eye, marked by an imbalance in the tear film and ocular symptoms. Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions conditions: Dry Eye Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Educational Program measure: ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Nursing, Alexandria university city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06288932 id: NIBD/IRB-263/08-2023 briefTitle: Outcome Study of Conventional Steroids vs. Steroids Combined With Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura. overallStatus: RECRUITING date: 2024-02 date: 2024-05 date: 2025-01 date: 2024-03-01 date: 2024-03-01 name: National Institute of Blood and Marrow Transplant (NIBMT), Pakistan class: OTHER_GOV briefSummary: Immune thrombocytopenia Purpura (ITP) is an autoimmune condition delineated by humoral as well as cell mediated immune response against thrombocyte surface proteins GPIIb/IIIa receptors, affecting primary homeostasis leading to mucocutaneous bleeding.ITP is characterized by platelet count \<100 x 109/L. The conventional line of treatment for newly diagnosed ITP is steroids but significant disadvantages have been associated with long term use and a high risk of relapse when reducing the dose. The addition of MMF to the first line treatment of ITP resulted in substantial response and a lower risk of refractory ITP with decreased financial burden and improved outcome. conditions: Immune Thrombocytopenia Purpura studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will comprise the newly diagnosed patients of Immune thrombocytopenia purpura aged 5-60 year. Patients will be included in this trial, with a 1:1 ratio among the two group patients will be in each group. One group will receive steroids alone and the other will receive steroids and MMF. primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Mycophenolate Mofetil (MMF) Treatment measure: Platelet count monitoring measure: Assessment of Health-Related Quality of Life questionnaire measure: Incidence of adverse events sex: ALL minimumAge: 5 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: National Institute of Blood Diseases and Bone Marrow Transplantation status: RECRUITING city: Karachi state: Sindh zip: 75300 country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06288919 id: 2023-IMPLHYGIENE briefTitle: Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Crowns Made by Different Materials overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2026-04-01 date: 2026-04-10 date: 2024-03-01 date: 2024-04-26 name: University of Pavia class: OTHER briefSummary: The aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts.

A randomized clinical trial will be conducted on the patient. Patients will be randomly divided into two groups:

* Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)
* Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) will be used.

Different subgroups will be defined according to the material of the dental crown of the related implant.

The oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Index. conditions: Dental Implant Failed conditions: Peri-implant Mucositis conditions: Peri-Implantitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Erythritol prophylactic powders name: Ultrasonic scaler with peek inserts measure: Probing Depth (PD) measure: Bleeding on Probing (BoP) measure: Plaque Index sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06288906 id: ASTER Study briefTitle: Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems acronym: ASTER overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2027-03 date: 2027-12 date: 2024-03-01 date: 2024-03-04 name: IRCCS San Raffaele class: OTHER briefSummary: This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging. conditions: Thrombosis, Venous studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 50 type: ESTIMATED name: mechanical thrombectomy of caval and iliofemoral veins measure: Rate of Technical success measure: Number of Participants presenting Bleeding sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Raffaele Hospital city: Milano zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06288893 id: DEU-2001 briefTitle: SHEN211 Tablets for the Treatment of Mild and Moderate Novel Corona Virus Infections (COVID-19) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2025-01-01 date: 2024-03-01 date: 2024-03-04 name: JKT Biopharma Co., Ltd. class: INDUSTRY briefSummary: Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets conditions: COVID-19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized 2:1 to experimental and placebo arms primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: SHEN211 Tablets name: Placebo for SHEN211 Tablets measure: Change from baseline in SARS-CoV-2 viral load at each time point measure: Time of recovery measure: Time to response measure: Time to negative measure: Percentage of subjects with disappearance of clinical symptoms measure: Change in COVID-19 symptom score measure: Ct value change from baseline measure: Change from baseline in chest CT scan (optional) measure: Percentage of Subjects Progressed measure: Percent of Subjects Who Died measure: Safety Assessment Results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shenzhen Third People 's Hospital city: Shenzhen state: Guangdong zip: 518112 country: China name: Hongzhou Lu, ph.D role: CONTACT phone: 0755-61232898 email: luhongzhou@fudan.edu.cn name: Ximin Meng role: CONTACT phone: 0755-61222333 phoneExt: 16565 email: szywjd2015@163.com name: Hongzhou Lu, ph.D role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 hasResults: False

 nctId: NCT06288880 id: kilis_4 briefTitle: Impact of Earthquake Trauma on Nurses' Compassion Fatigue: A Study From Kahramanmaraş, Turkey overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-01 date: 2024-05-01 date: 2024-03-01 date: 2024-03-01 name: Kilis 7 Aralik University class: OTHER name: Hasan Kalyoncu University briefSummary: This study investigates the impact of earthquake trauma on compassion fatigue among nurses working in emergency services following the devastating earthquakes on 6 February 2023, in Kahramanmaraş, Turkey. These earthquakes, with magnitudes of approximately 7.7 and 7.6, affected 11 provinces and resulted in over 50,000 deaths and 100,000 injuries, placing emergency service nurses at the forefront of dealing with the aftermath and trauma. The concept of compassion fatigue, characterised by a reduced capacity for empathy after repeated exposure to traumatic events, is a significant concern for nurses who have been directly involved in the care of earthquake victims. This study aims to explore the extent of earthquake trauma and compassion fatigue among these nurses, examining the relationship between these two conditions and their long-term effects. Given the limited research on post-traumatic stress disorder and compassion fatigue among emergency service nurses, this study seeks to contribute valuable insights into the psychological impacts of disaster response on healthcare professionals. The hypotheses tested aim to better understand the risks and psychological burdens faced by nurses in the wake of such natural disasters. conditions: Earthquake conditions: Compassion Fatigue studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: Section 1: Demographic Information Form measure: Section 2: Post-Earthquake Trauma Level Determination Scale measure: Section 3: Compassion Fatigue Short Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Islam Elagöz city: Kilis zip: 79100 country: Turkey name: islam elagöz role: CONTACT name: Aynur koyuncu role: CONTACT lat: 36.71611 lon: 37.115 hasResults: False

 nctId: NCT06288867 id: FMASU MD28/2024 briefTitle: A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-01 date: 2025-12-01 date: 2024-03-01 date: 2024-03-18 name: Ain Shams University class: OTHER briefSummary: This study aims to address hip labral tears and compare between arthroscopic labral repair versus debridement. conditions: Hip Injuries conditions: Acetabular Labral Tear conditions: Femoro Acetabular Impingement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Arthroscopic Labral Repair name: Arthroscopic Labral Debridement measure: Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS) measure: Change from baseline in Hip Function, as measured by Harris Hip Score (HHS) measure: Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ain Shams University city: Cairo country: Egypt name: Karim A Salem, MD role: CONTACT phone: 1000017388 phoneExt: +20 email: karimatefsalem@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06288854 id: 66222 briefTitle: Efficacy of Olanzapine on Weight Gain in Advanced Gynecologic Cancer With Paclitaxel and Carboplatin: a Double Blind, Placebo-controlled Randomized Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2025-03-31 date: 2025-06-30 date: 2024-03-01 date: 2024-03-12 name: Rajavithi Hospital class: OTHER_GOV briefSummary: * Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer
* Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo conditions: Weight Gain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: olanzapine vs placebo primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: weight gain each group measure: Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288841 id: TJMZ2023-008 briefTitle: Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study overallStatus: RECRUITING date: 2023-11-30 date: 2024-07-31 date: 2024-11-29 date: 2024-03-01 date: 2024-03-01 name: Tianjin Medical University General Hospital class: OTHER briefSummary: With the development of the concept of comfortable medicine and enhanced recovery surgery (ERAS), optimizing the perioperative management of patients, reducing surgical stress, and reducing postoperative pain can effectively reduce perioperative complications and achieve the purpose of accelerating recovery. As an important part of ERAS, multimodal analgesia is the core concept of perioperative analgesia management. As a kind of perioperative multimodal analgesia, quadratus lumbar muscle block (QLB) is a type of local anesthetic drug injected around the quadratus lumbar muscle to reduce or eliminate abdominal wall pain and visceral pain after abdominal surgery. QLB has been used successfully for pain control after laparoscopic and open surgery, reducing perioperative opioid use and improving prognosis-related measures such as PONV and length of hospital stay. Bupivacaine liposomes use DepoFoam technology to encapsulate the drug in polycystic liposomes, which can prolong the release time of bupivacaine due to the different rupture times of different vesicles, and the postoperative analgesia can be up to 72 hours. In this project, patients who undergo elective laparoscopic uterine and double adnexectomy were selected to be injected with lipososomes of bupivacaine at different concentrations under ultrasound guidance of bilateral posterior QLB before anesthesia induction, and the effect of liposomal bupivacaine on postoperative pain was investigated by evaluating the postoperative pain and incidence of adverse events. This study will greatly promote the clinical promotion and application of bupivacaine liposome, improve the postoperative comfort and satisfaction of patients, and accelerate the postoperative recovery of patients. conditions: Pharmacological Action studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Ropivacaine injection name: Bupivacaine liposome measure: NRS pain score within 72 hours after surgery sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University General Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300052 country: China name: Ning Luo role: CONTACT phone: 13622098703 email: ningluo1996@163.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06288828 id: IRB0569/66 briefTitle: The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients With Compensated Cirrhosis overallStatus: NOT_YET_RECRUITING date: 2024-03-05 date: 2024-08-01 date: 2025-12-31 date: 2024-03-01 date: 2024-03-01 name: King Chulalongkorn Memorial Hospital class: OTHER name: Chulalongkorn University briefSummary: The goal of this clinical trial is to explore the impact of a 16-week aerobic exercise regimen on the autonomic nervous system and endothelial function in patients with compensated cirrhosis who maintain sedentary lifestyles. The primary research question is:

1) What effect does 16 weeks of aerobic exercise have on changes in the autonomic nervous system and endothelial function in cirrhotic patients?

Additionally, the secondary research questions are:

1. How does a 16-week aerobic exercise program influence changes in muscle mass, muscle strength, and physical performance in cirrhotic patients?
2. Is there a correlation between muscle mass and parameters of the autonomic nervous system in cirrhotic patients?

Participants in the intervention group will undergo 150 minutes of moderate aerobic exercise per week for 16 weeks, accompanied by a personalized nutritional plan (1.2 grams of protein per kilogram of ideal body weight per day and a calorie intake of 35 kilocalories per kilogram of ideal body weight per day). The control group will solely receive nutritional guidance and maintain their sedentary lifestyle. The researchers will compare outcomes between these two groups. conditions: Cirrhosis conditions: Aerobic Exercises conditions: Lifestyle Modification conditions: Endothelial Function conditions: Autonomic Nervous System conditions: Autonomic Dysfunction conditions: Heart Rate Variability conditions: Flow Mediated Dilation conditions: Sarcopenia conditions: Physical Activity conditions: Physical Functional Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: Aerobic exercise name: Nutrition consultant measure: Autonomic function test: Heart rate variability (HRV) measure: Endothelial function test: Flow mediated dilation (FMD) in % FMD change measure: Physical function measure: Muscle mass change measure: Muscle strength change sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of medicine, King Chulalongkorn Memorial Hospital city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06288815 id: TUH oral fluid TKA briefTitle: Oral Fluid vs IV Fluid After Primary TKA overallStatus: RECRUITING date: 2024-01-10 date: 2024-12 date: 2025-06 date: 2024-03-01 date: 2024-03-04 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.

The main question it aims to answer is:

Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement? conditions: Osteoarthritis, Knee conditions: Total Knee Arthroplasty conditions: Oral Fluid Replacement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: Oral fluid name: IV fluid measure: Time to stand and walk measure: Time up and go measure: Incidence of oliguria measure: Incidence of nausea/vomiting measure: Urine specific gravity measure: the levels of certain electrolytes measure: the levels of creatinine measure: the levels of blood urea nitrogen (BUN). measure: Complications sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University status: RECRUITING city: Khlong Luang state: Pathum Thani zip: 12120 country: Thailand name: Yot Tanariyakul, M.D. role: CONTACT phone: 663930257 email: y.tanariyakul@gmail.com name: Nattapol Tammachote, M.D. role: PRINCIPAL_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False

 nctId: NCT06288802 id: 04-2023-200647 briefTitle: Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital overallStatus: RECRUITING date: 2020-06-15 date: 2024-06 date: 2024-12 date: 2024-03-01 date: 2024-03-01 name: South Egypt Cancer Institute class: OTHER name: Shefa Al-orman Children Cancer Hospital name: Assiut University briefSummary: The goal of this cross sectional observational study is to determine the percentage of Wilms tumors among pediatric cancers at Shefa Al-Orman Children Cancer Hospital from june 2020 to june 2024,to study the outcome of patients with Wilms tumor treated according to SIOP Umbrella protocol during the study period and to study the treatment related complications during therapy according to common terminology criteria of adverse events version 5.0 (CTCAE Version 5.0). conditions: Wilms Tumor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED measure: Overall-survival (OS) measure: Event-free survival (EFS) sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Shefa Al-orman Children Cancer Hospital status: RECRUITING city: Luxor country: Egypt name: Mahmoud Elzembely, MD role: CONTACT phone: +201146703107 email: elzimbily@aun.edu.eg lat: 25.69893 lon: 32.6421 hasResults: False

 nctId: NCT06288789 id: SFI-TR briefTitle: Turkish Validity and Reliability of the Social Frailty Index overallStatus: COMPLETED date: 2024-02-25 date: 2024-03-20 date: 2024-03-30 date: 2024-03-01 date: 2024-04-25 name: Pamukkale University class: OTHER briefSummary: The aim was to examine the validity and reliability of the Social Frailty Index in Turkish among older adults. 65 years and above older adults will be included included in the study. Older adults who agree to participate in the study will first be administered the Hodkinson Mental Test. Those who score 6 points and above will be included in the study. To evaluate the validity of the \&#34;Social Frailty Index\&#34;, Social Inclusion Scale, Older people\&#39;s quality of life-brief (OPQOL-brief) and Lubben Social Network Scale will be applied to the participants. To determine the reliability of the \&#34;Social Frailty Index\&#34;, older adults who do not receive any treatment will be tested and re-tested at one-week intervals. conditions: Elderly conditions: Frailty conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 186 type: ACTUAL name: Social Frailty Index measure: Social Frailty Index measure: Socıal Inclusıon Scale measure: Older people's quality of life-brief (OPQOL-brief) measure: Lubben Social Network Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Elif Gur Kabul city: Usak state: Merkez zip: 64200 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06288776 id: SOD/ERB/2023/22-04 briefTitle: Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity overallStatus: COMPLETED date: 2023-02-01 date: 2023-04-30 date: 2023-04-30 date: 2024-03-01 date: 2024-03-01 name: Pakistan Institute of Medical Sciences class: OTHER_GOV briefSummary: Type of study: Single-blinded clinical trial to evaluate the effectiveness of Azadirachta indica based Herbal mouthwash to treat the tooth sensitivity in patients.

Participants aged 20 years and above having Gingival Index score 3 will be included in the study. Their tooth sensitivity will be checked initially and then they will be given Herbal based mouthwash for 3 months. Again, their tooth sensitivity shall be checked after 3 months. conditions: Tooth Sensitivity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: In this study, participants will be selected by consecutive non-random sampling technique. primaryPurpose: TREATMENT masking: NONE maskingDescription: Single-blinded study where participant will be masked. count: 120 type: ACTUAL name: Herbal based mouthwash measure: Toothsensitivity declination with herbal based mouthwash sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Afsheen Mansoor city: Islamabad zip: 44080 country: Pakistan lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06288763 id: SC220192 briefTitle: Nerve Transfer to Improve Function in High Level Tetraplegia overallStatus: RECRUITING date: 2024-02-05 date: 2028-03-01 date: 2028-12-31 date: 2024-03-01 date: 2024-04-02 name: Washington University School of Medicine class: OTHER name: University of Michigan name: University of Calgary name: The Methodist Hospital Research Institute name: University of Pennsylvania name: University of Utah name: Stanford University name: University of Miami name: Johns Hopkins University name: University of Alberta briefSummary: The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.

Participants will:

* undergo standard of care pre- and post-op testing and study exams
* complete pre- and post-questionnaires
* undergo standard of care nerve transfer surgeries
* follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months
* attend therapy at local therapist for up to 2 years postop. conditions: Cervical Spinal Cord Injury conditions: Tetraplegia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Elbow Dynamometry measure: Spinal Cord Independence Measure measure: Motor strength in medical research council grade (MRC) measure: Electrodiagnosis (Nerve Conduction Study and Electromyography measure: Canadian Outcomes Performance Measure (COPM) measure: Capabilities of Upper Extremity Questionnaire (CUE-Q) measure: Modified Ashworth Scale (MAS) measure: Spinal Cord Injury Quality of LIfe Questionnaire measure: International SCI Pain Basic Dataset (ISCIPBDS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University status: NOT_YET_RECRUITING city: Stanford state: California zip: 94305 country: United States name: Adrian Valladarez role: CONTACT phone: 650-381-4257 email: adrian98@stanford.edu name: Anthony Bet role: CONTACT phone: 650-683-5823 email: abet0915@stanford.edu name: Thomas J Wilson, MD role: PRINCIPAL_INVESTIGATOR lat: 37.42411 lon: -122.16608 facility: University of Miami status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: George Jimsheleishvili, MD role: CONTACT phone: 305-243-4781 email: gxi150@med.miami.edu name: Patricia Graham role: CONTACT phone: 305-243-5119 email: pgraham1@med.miami.edu name: Stephen S Burks, MD role: PRINCIPAL_INVESTIGATOR name: Allan Levi, MD role: SUB_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Johns Hopkins University status: NOT_YET_RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Aston King role: CONTACT phone: 667-306-8862 email: aking64@jhu.edu name: Bronwyn Slobogean role: CONTACT email: bslobog1@jhmi.edu name: Sami Tuffaha, MD role: PRINCIPAL_INVESTIGATOR name: Allan Belzberg, MD role: SUB_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Savannah Solomon role: CONTACT phone: 734-936-7010 email: ssavanna@med.umich.edu name: Yamaan Saadeh, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Washington University in St. Louis status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Linda Koester role: CONTACT phone: 314-362-7368 email: koesterl@wustl.edu name: Wilson Z. Ray, MD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Lora Assi role: CONTACT phone: 267-254-4745 email: NCRDNeuroICU@uphs.upenn.edu name: Leah Coghlan role: CONTACT phone: 215-341-5864 email: NCRDNeuroICU@uphs.upenn.edu name: Eric Zager, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Houston Methodist status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Amber Behne role: CONTACT phone: 346-238-6424 email: abehne@houstonmethodist.org name: Sergio Ibarra Cortez role: CONTACT phone: 346-238-2494 email: shibarracortez@houstonmethodist.org name: Amir Faraji, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: University of Utah status: NOT_YET_RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Kirstianna Lombardi role: CONTACT phone: 801-585-9821 email: kirstianna.lombardi@utah.edu name: Douglas Gibula role: CONTACT email: douglas.gibula@hsc.utah.edu name: Mark Mahan, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 facility: University of Calgary - Alberta Health Services status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2N 2T9 country: Canada name: Ish Bains role: CONTACT phone: 403-944-4334 email: ish.bains@albertahealthservices.ca name: Rajiv Midha, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: University of Alberta status: NOT_YET_RECRUITING city: Edmonton state: Alberta zip: T6G 2E1 country: Canada name: Mith Rajshekar, PhD role: CONTACT email: rajsheka@ualberta.ca name: Andrew Jack, MD role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False

 nctId: NCT06288750 id: sdllycyyqx001 briefTitle: Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy overallStatus: RECRUITING date: 2024-02-01 date: 2025-06-01 date: 2025-06-30 date: 2024-03-01 date: 2024-03-05 name: Shandong Linglong Yingcheng Hospital class: NETWORK briefSummary: Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy. conditions: Total Thyroidectomy conditions: Parathyroid Function Low Adverse Event conditions: Parathyroid Glands--Diseases conditions: Indocyanine Green studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Indocyanine Green name: No indocyanine green measure: Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast measure: Central lymph node dissetion (CLND) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Shandong Linglong Yingcheng Hospital status: RECRUITING city: Yantai state: Shandong zip: 264000 country: China name: Xuan Qiu, MD role: CONTACT phone: 8618354280081 email: qiuxuan100@163.com name: Ni Wang, MD role: CONTACT phone: 8618705353551 email: wangni1989@163.com lat: 37.47649 lon: 121.44081 hasResults: False

 nctId: NCT06288737 id: 54335073 briefTitle: Assessing Patient Engagement in Keratoconus Clinical Research overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-03-01 date: 2024-03-01 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.

In essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition. conditions: Keratoconus studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Rate of patients who decide to join in a keratoconus clinical trial measure: Number of keratoconus patients who remain in clinical trial until completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-23 uploadDate: 2024-02-23T11:13 filename: ICF_000.pdf size: 73995 hasResults: False

 nctId: NCT06288724 id: NatIntensive briefTitle: MOdifiable facTors to Improve VentilAtion ThErapy in ICU acronym: MOTIVATE-ICU overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-09 date: 2024-03-01 date: 2024-03-01 name: Nat Intensive Care Surveillance - MORU class: OTHER name: D'Or Institute for Research and Education name: University of Oxford name: Wellcome Trust name: Makerere University briefSummary: ABSTRACT Introduction: Invasively ventilated patients in low and middle-income countries (LMICs) experience significantly higher mortality compared to those in High income countries (HICs). Direct application of HIC strategies to LMICs maybe ineffective due to context-specific challenges. This study aims to leverage the Intensive Care Registry of Uganda (ICRU) to identify ICU structural and process-related modifiable factors that impact patient outcomes in a low income country.

Methods: The MOTIVATE-ICU is a prospective multicentre observational study in invasively ventilated patients. It involves a registry-embedded component examining patient- and process-related factors and a cross-sectional survey on ICU organizational structures. Inclusion criteria encompass patients aged ≥ 15 years undergoing IMV in Ugandan ICUs. Primary outcomes are ICU mortality, ICU length of stay (LOS), and duration of ventilation. Secondary outcomes include ventilator-associated complications, non-pulmonary organ support. tTracheostomy outcomes will be explored in a pre-planned substudy. Factors potentially associated with outcomes will be categorized into two groups; non-modifiable factors and potentially modifiable. Non-modifiable factors will include patient-related factors like age, comorbidities and illness severity; potentially modifiable factors include processes of care (e.g. sedation levels) and ICU organizational structure (e.g. staffing patterns). Multilevel multivariable logistic regression will be utilized to study associations, with both patient and ICU level fixed effects considered.

Ethics and Dissemination: Given its observational nature, this study seeks a waiver for patient individual informed consent. Data anonymization ensures patient privacy. Following the principles of the Declaration of Helsinki, relevant ethical approvals will be acquired. Study findings will be disseminated through conferences and peer-reviewed journals. conditions: Critical Illness conditions: Invasive Mechanical Ventilation conditions: ICU Mortality conditions: Developing Countries conditions: Risk Factors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 625 type: ESTIMATED measure: ICU mortality measure: ICU Length of Stay measure: Duration of mechanical ventilation measure: Duration of non-pulmonary organ support measure: ICU-Free days measure: Ventilator-free days measure: Ventilator-associated Pneumonia measure: Tracheobronchitis measure: Non-infectious Pulmonary complication measure: Readmission measure: Unplanned extubations measure: Tracheostomy related outcomes sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288711 id: CHRBSS #STUDY00002538 id: R01DA057308 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA057308 briefTitle: Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD overallStatus: RECRUITING date: 2024-04-30 date: 2027-08-31 date: 2027-11-30 date: 2024-03-01 date: 2024-04-23 name: University of Vermont class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD. conditions: Opioid Use Disorder conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 135 type: ESTIMATED name: Prolonged exposure therapy name: Financial incentives name: Treatment as usual measure: Prolonged exposure therapy session attendance measure: Prolonged exposure therapy completion measure: Change in posttraumatic stress disorder symptom severity - clinician rated measure: Change in non-prescribed drug use - objective measure: Change in non-prescribed drug use - self-reported measure: Change in opioid craving measure: Medications for opioid use disorder treatment retention measure: Prolonged exposure therapy acceptability measure: Satisfaction with prolonged exposure therapy delivered via telemedicine measure: Prolonged exposure therapy homework adherence measure: Change in posttraumatic stress disorder symptom severity - self-reported sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vemont status: RECRUITING city: Burlington state: Vermont zip: 05401 country: United States name: Kelly R Peck, Ph.D. role: CONTACT phone: 802-656-9610 email: Kelly.Peck@uvm.edu lat: 44.47588 lon: -73.21207 hasResults: False

 nctId: NCT06288698 id: 53955721 briefTitle: Understanding Patient Engagement Trends in TBI Clinical Research overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-03-01 date: 2024-03-01 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.

The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients. conditions: TBI studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Number of TBI patients who decide to enroll in a clinical research measure: Rate of TBI patients who remain in clinical trial to trial completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-23 uploadDate: 2024-02-23T11:01 filename: ICF_000.pdf size: 69900 hasResults: False

 nctId: NCT06288685 id: 73/256 id: 73/256 type: OTHER domain: Police General Hospital briefTitle: Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone overallStatus: COMPLETED date: 2023-10-11 date: 2024-01-23 date: 2024-01-30 date: 2024-03-01 date: 2024-03-12 name: Police General Hospital, Thailand class: OTHER briefSummary: Background:

Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Corticosteroid injection is a common nonoperative treatment for trigger finger, providing favorable outcomes but associated with a notable risk of recurrence. Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection. However, to date, there is no report on early postoperative results.

Objective:

To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone.

Study Design \& Methods:

This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024. A total of 38 patients were enrolled, with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group. Postoperative assessments included pain scores using the Visual Analog Scale (VAS), evaluation of quality of life through the QuickDASH score (qDASH), patient satisfaction, and complications. conditions: Trigger Finger conditions: Percutaneous A1 Pulley Release conditions: Steroid Injection conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study \[ \]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Group allocation and Randomization:

Patients were enrolled and randomized into two groups, percutaneous A1 pulley release with steroid injection (Group A) and percutaneous A1 pulley release alone (Group B), by utilizing computer generate randomization and the results were put in opaque sealed envelopes. Informed consent was obtained from all participants, and surgeries were performed by the same surgeon (WJ). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 38 type: ACTUAL name: percutaneous A1 pulley release name: Triamcinolone measure: postoperative pain score measure: hand function by quickDASH measure: patients satisfaction sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Police General Hospital city: Bangkok state: Pathumwan zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06288672 id: 1002 briefTitle: IBS Skin Patch Test Food Allergy Study overallStatus: RECRUITING date: 2023-08-15 date: 2025-12 date: 2025-12 date: 2024-03-01 date: 2024-03-01 name: IBS-80, LLC class: INDUSTRY briefSummary: Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the \&#34;true\&#34; avoidance diet) or food(s) to which the testing did not show an allergy (this is called the \&#34;sham\&#34; avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants with IBS are patch tested to 80 type 4 food allergens. Those with questionable or positive patch test reactions are randomized to follow a patch test-directed avoidance diet or a sham diet (avoidance of foods to which the patch tests showed no reaction) for 16 weeks. Upon conclusion of the avoidance diet, participants complete a brief questionnaire to assess their response to the avoidance diet. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The true or sham avoidance diet for each participant is randomly assigned by the study administrator. Assignments will not be made available to participants until after their study completion or to investigators until all 250 participants have completed the study and the results have been analyzed. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: True avoidance diet name: Sham avoidance diet measure: Post-Avoidance Diet Relative IBS Symptom Global Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Adult and Pediatric Dermatology status: RECRUITING city: Marlborough state: Massachusetts zip: 01752 country: United States name: Christy Williams, MD role: CONTACT phone: 508-460-9613 email: cwilliams@apderm.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Christy Williams, MD role: PRINCIPAL_INVESTIGATOR lat: 42.34593 lon: -71.55229 facility: Adult and Pediatric Dermatology status: RECRUITING city: Westford state: Massachusetts zip: 01886 country: United States name: Christy Williams, MD role: CONTACT phone: 508-460-9613 email: cwilliams@apderm.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Christy Williams, MD role: PRINCIPAL_INVESTIGATOR lat: 42.57926 lon: -71.43784 facility: Allergy & Asthma Care of New York status: NOT_YET_RECRUITING city: New York state: New York zip: 10016 country: United States name: Clifford Bassett, MD role: CONTACT phone: 212-260-6078 email: cliffbassett1@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Clifford Bassett, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Modern Dermatology NYC status: RECRUITING city: New York state: New York zip: 10016 country: United States name: Kathryn Frew, MD role: CONTACT phone: 929-533-1797 email: kathrynfrew37@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Kathryn Frew, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: North Wales Dermatology, PLLC status: RECRUITING city: North Wales state: Pennsylvania zip: 19454 country: United States name: Michael B Stierstorfer, MD role: CONTACT phone: 215-699-1929 email: mbstierstorfer@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Michael B Stierstorfer, MD role: PRINCIPAL_INVESTIGATOR lat: 40.21094 lon: -75.27823 facility: Shepherd Allergy status: RECRUITING city: Barboursville state: West Virginia zip: 25504 country: United States name: Meagan Shepherd, MD role: CONTACT phone: 304-733-3333 email: allergy@shepherdallergy.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Meagan Shepherd, MD role: PRINCIPAL_INVESTIGATOR lat: 38.40953 lon: -82.29459 hasResults: False

 nctId: NCT06288659 id: KY2024-050 briefTitle: aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial acronym: ASTIM-MT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-12-30 date: 2024-03-01 date: 2024-04-23 name: Huashan Hospital class: OTHER briefSummary: ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage. conditions: Aneurysmal Subarachnoid Hemorrhage conditions: Intracranial Pressure Increase studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 368 type: ESTIMATED name: Intraventricular intracranial pressure monitoring measure: The rate of good neurological functional prognosis measure: The rate of good neurological functional prognosis measure: The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E) measure: Mortality measure: Incidence of VP shunt-related hydrocephalus measure: Incidence of Delayed Cerebral Ischemia measure: Incidence of epilepsy measure: Incidence of intracranial infection measure: Incidence of bleeding from puncture site measure: Incidence of poor healing in surgical incisions sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurosurgery, Huashan Hospital, Fudan University city: Shanghai state: Shanghai zip: 200000 country: China name: Xuehai Wu, Ph.D. role: CONTACT phone: +8613764880571 email: wuxuehai2013@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06288646 id: ROMEO 101712 briefTitle: Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer overallStatus: RECRUITING date: 2023-04-24 date: 2024-04-24 date: 2024-12-15 date: 2024-03-01 date: 2024-03-01 name: Picomole Inc class: INDUSTRY name: Vitalite Health Network briefSummary: The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.

Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history. conditions: Lung Cancer conditions: Non Small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls measure: Differences in breath spectra of patients with lung cancer before and after treatment sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vitalite Health Network status: RECRUITING city: Moncton state: New Brunswick zip: E1C 8X3 country: Canada name: Nada Hammami role: CONTACT phone: 506-869-7391 email: Nada.Hammami@Vitalitenb.ca name: Marcel Mallet, MD role: PRINCIPAL_INVESTIGATOR lat: 46.09454 lon: -64.7965 hasResults: False

 nctId: NCT06288633 id: FNWMRC briefTitle: Cardioneuroablation for Bradyarrhythmia acronym: CARDIOBOOST overallStatus: RECRUITING date: 2024-03-04 date: 2026-02-01 date: 2027-02-01 date: 2024-03-01 date: 2024-03-05 name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health class: OTHER name: Meshalkin National Medical Research Center, Ministry of Health of Russian Federation name: The Federal Centre of Cardiovascular Surgery, Russia name: Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare name: City Clinical Hospital No.52 of Moscow Healthcare Department name: National Medical Research Center for Therapy and Preventive Medicine name: Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan name: Tomsk National Research Medical Center of the Russian Academy of Sciences name: Vishnevsky Center of Surgery name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation briefSummary: This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation conditions: Bradycardia conditions: Syncope conditions: Sick Sinus Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 106 type: ESTIMATED name: Ganglionated plexi ablation name: Electrophysiological study measure: Implantation of a permanent cardiac pacemaker measure: Complications of cardioneuroablation measure: Presence of symptomatic or asymptomatic rhythm pauses >6 seconds measure: The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime measure: Transient or permanent atrioventricular block measure: Orthostatic hypotension and/or bradycardia during passive orthostasis test measure: Sinus tachycardia after cardioneuroablation measure: Implantation of a pacemaker by 24 months after randomization sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Almazov National Medical Research Centre status: RECRUITING city: Saint Petersburg country: Russian Federation name: Shlyakhto role: CONTACT phone: +78127023749 lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06288620 id: MA-EBC-II-024 briefTitle: Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer overallStatus: RECRUITING date: 2024-02-25 date: 2025-05-10 date: 2025-05-30 date: 2024-03-01 date: 2024-03-01 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 77 type: ESTIMATED name: Microwave Ablation measure: Complete ablation rate measure: Safety of microwave ablation sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China name: Wenbin Zhou, Professor role: CONTACT lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06288607 id: 2023-SR-708 briefTitle: Safety and Efficacy of High Intensity Focused Ultrasound in Solar Lentigo: A Self-controlled Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-16 date: 2024-04-18 date: 2024-04-18 date: 2024-03-01 date: 2024-03-06 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This trial is a single-center, prospective self-controlled study. The study proposes to recruit 30 patients with solar lentigo on both sides of the face. Patients are randomly assigned to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) on one side, and the other side is not treated. The Lab\* values of the lesion area and the area around the lesion are detected separately using 3nh HIGH-QUALITY COLORMETER colorimeter (Konica-Minolta Company, Japan), and skin lesion images are collected with dermatoscope and VISIA® (Canfield Company, USA). Measurements of Lab\* values and related images at the same location, along with adverse events, physician and subjective global aesthetic improvement scale scores are recorded before and at week2, week 4, week6. At the end of the follow-up on the treatment side, the same parameter treatment is provided for the untreated side, and the corresponding observation items are recorded for the patient before treatment, and at week2, week4, and week6 respectively. conditions: Solar Lentigo studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) measure: Lab* values measure: Physician Global Aesthetic Improvement Scale measure: Subjective Global Aesthetic Improvement Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06288594 id: DEU-PSI-HA-001 briefTitle: TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-09 date: 2024-12 date: 2024-03-01 date: 2024-03-06 name: Dokuz Eylul University class: OTHER briefSummary: The world experiences a high rate of traumatic events. Even if PTSD is not diagnosed, traumatic events can significantly affect people's lives. Traditional face-to-face therapies often face challenges, such as financial constraints, expensive therapy sessions, time restrictions, fear of stigma, and difficulties in accessing clinical psychologists. These challenges motivated us to develop new methods. Particularly in Turkey, there is neither sufficient infrastructure nor existing applications dedicated to addressing trauma-related complications. The development of the 'TraumaRelief' app is a pioneering initiative aimed at bridging this gap, targeting the resolution of these prevalent issues by introducing an accessible, innovative solution. The newly developed "TraumaRelief" app aims to provide solutions to these issues. This app contains eight modules: online video talks, psychoeducation, coping with symptoms, mindfulness-based relaxation exercises, imagery exposure, CBT (Cognitive Behavioral Therapy)-based daily exercises, therapist messaging, emergency contact access. The purpose of this study is to test the feasibility and acceptability of this newly developed application through a pilot randomized controlled trial. conditions: Post-Traumatic Stress Disorder (PTSD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a three-arm, parallel randomized controlled trial. Upon enrollment, participants are randomly assigned to one of three groups. The first group will use the "TraumaRelief" application in addition to weekly video calls with a psychologist. The second group will use the "TraumaRelief" mobile application exclusively. The third group will serve as a control and receive no intervention. The primary outcomes will be measured at baseline, five weeks, one month, and three months post-intervention to assess the efficacy and acceptability of the mobile application and the added benefit of psychological support. primaryPurpose: TREATMENT masking: NONE maskingDescription: In this pilot randomized controlled trial, no masking is applied, as the nature of the interventions makes it impractical. Participants are informed of their group assignment since those in the second group are aware of their additional video call sessions with psychotherapists. The therapists conducting the sessions also need to be aware of the intervention they are delivering to properly adhere to the treatment protocol. This open-label approach is necessary to facilitate the intended psychotherapeutic interactions and to ensure that the intervention is delivered with fidelity, as per the study design. count: 105 type: ESTIMATED name: Application Plus Online Therapist Support Group name: Application Only Group measure: PTSD Symptom Severity measure: Depression Anxiety and Stress Symptom Severity measure: Quality of Life Improvement measure: Feasibility: Attrition Rate measure: Feasibility: Recruitment Rate measure: Feasibility: Retention Rate measure: Feasibility: Adherence Rate to the Mobile Application measure: Feasibility: Consent Rate measure: Feasibility: Fidelity of Intervention Delivery measure: Acceptability: System Usability Scale (SUS) Score for Acceptability measure: Acceptability: Preferred and Least Preferred Module Components measure: Acceptability: Application Utilization Frequency measure: Acceptability: Likelihood to Recommend the Application sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288581 id: UDDS-Pedo-02-2024 briefTitle: U Shaped Toothbrush in Removing Plaque in Children overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-01 date: 2024-08-01 date: 2024-03-01 date: 2024-03-01 name: Damascus University class: OTHER briefSummary: The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.

Children accepted in the study will be randomly divided into two groups:

The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH) conditions: Dental Plaque studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Traditional toothbrush group name: U shaped toothbrush group measure: Changing in plaque index sex: ALL minimumAge: 4 Years maximumAge: 5 Years stdAges: CHILD facility: Damascus University status: RECRUITING city: Damascus zip: 20872 country: Syrian Arab Republic name: Kamar Abdulrahman, MSc. student role: CONTACT phone: 00963957510093 email: kamarabdulrahman1@gmail.com lat: 33.5102 lon: 36.29128 hasResults: False

 nctId: NCT06288568 id: Shift2Health briefTitle: Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers acronym: Shift2Health overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-01 date: 2028-05-31 date: 2024-03-01 date: 2024-03-05 name: University of Vienna class: OTHER name: Medical University of Vienna name: FH Joanneum Gesellschaft mbH name: Wageningen University and Research name: Wageningen University name: University of Bremen name: Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V. name: UNIVERSYTET MEDYCZNY W LODZI name: Københavns Universitet name: Charite University, Berlin, Germany name: Erasmus Medical Center briefSummary: Shift work is a well-known risk factor for the development of overweight and obesity, which may lead to downstream effects such as increased risk of cardiometabolic diseases and cancer. However, the biological and behavioral mechanisms underlying the obesogenicity of night shift work are not well understood. Population-based mechanistic studies in real life shift workers are needed to address how night shift work impacts metabolic health.

The investigators aim to characterize the behavioural, environmental, and biological mechanisms and pathways for the association of night shift work and obesity across Europe.

The investigators will conduct a cross sectional study in 5 European countries (Austria, Denmark, Germany, Netherlands and Poland) and recruit 1000 rotating night shift workers and day workers (200/country) from the health sector and different industries. Night and day workers will be age-frequency (3 age groups), gender and (where possible) working tasks matched. Participants will complete online questionnaires and report their diet habits in a mobile app. Body composition, dietary behavior and sensory preferences will be tested. Biologic specimens (blood, urine, saliva, hair and feces) will be collected at the workplace on a day where participants are working on a day shift (or a day off). In a subsample (Austria and Netherlands) shift workers will provide biological samples (spot blood, urine and saliva) both on a day shift and on a night shift. Biomarkers including hormones, cellular immunity and inflammation, parameters linked to gut health and metabolism of fat and sugar, appetite, oxidative stress, metabolomics and microbiota will be measured. The investigators hypothesize that compared to day workers, night shift workers will experience disrupted levels of pre-obesity markers. Higher circadian disruption, sleep disruption and mistimed eating patterns workers will be associated with more disrupted biomarker profiles. Among rotating shift workers, night shift will be associated with acute disrupted melatonin production, metabolomic profiles and composition of oral microbiota compared to a day shift. conditions: Obesity conditions: Shift-work Disorder conditions: Circadian Rhythm Disorders studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: No intervention measure: high-sensitive C-Reactive Protein (hs-CRP) measure: The investigators will consider levels of hormones in plasma measure: The investigators will consider levels of hormones in plasma measure: The investigators will consider levels of parameters linked to gut health in serum and in feces measure: The investigators will consider levels of parameters linked to gut health in serum and in feces measure: The investigators will consider levels of parameters linked to gut health in serum and in feces measure: The investigators will consider levels of parameters linked to gut health in serum and in feces measure: The investigators will consider parameters of cellular immunity and inflammation in plasma measure: The investigators will consider parameters of cellular immunity and inflammation in plasma measure: The investigators will consider parameters of cellular immunity and inflammation in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider levels of appetite markers in plasma measure: The investigators will consider levels of appetite markers in plasma measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS) measure: The investigators will consider microbiome analysis of feces samples and tongue swabs sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288555 id: 020/2566 briefTitle: Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care overallStatus: COMPLETED date: 2023-12-21 date: 2024-01-23 date: 2024-01-23 date: 2024-03-01 date: 2024-03-05 name: Ponlawat Hanchana, MD class: OTHER_GOV briefSummary: The goal of this observational study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.

The main question it aims to answer is:

How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test?

Participants underwent both the Ipswich touch test and the 10-g monofilament test. conditions: Diabetic Foot studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 274 type: ACTUAL name: Ipswich touch test measure: The accuracy of the Ipswich touch test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ponlawat Hanchana, MD city: Saraburi zip: 18120 country: Thailand lat: 14.53333 lon: 100.91667 hasResults: False

 nctId: NCT06288542 id: MD-250-2022 briefTitle: Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-01 date: 2024-03-01 name: Cairo University class: OTHER briefSummary: This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures conditions: Effect of Dextrose on Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 111 type: ESTIMATED name: group d name: group R measure: frequency of post-opertive nausea and vomiting in 24 hour measure: TOTAL AMOUNT OF ANTIEMETIC REQUIRED sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288529 id: 1 briefTitle: EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY overallStatus: COMPLETED date: 2023-07-15 date: 2023-12-31 date: 2024-01-31 date: 2024-03-01 date: 2024-03-01 name: University of Health Sciences Balikesir Hospital Eduation and Research class: OTHER_GOV briefSummary: Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking.

In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI. conditions: Chronic Kidney Diseases conditions: Type2diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 975 type: ACTUAL measure: Development of post-contrast acute kidney injury sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences Balikesir Education and Research Hospital city: Balıkesir zip: 10100 country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False

 nctId: NCT06288516 id: 7484 briefTitle: BenRalizumab Effect on Airway Remodeling in Severe asTHma acronym: BREATH overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-06-01 date: 2024-03-01 date: 2024-03-04 name: Aristotle University Of Thessaloniki class: OTHER name: Pulmonary Clinic, Aristotle University of Thessaloniki, Greece name: Pulmonary Clinic, University of Ioannina name: Pulmonary Clinic, Democritus University of Thrace name: 2nd Pulmonary Clinic, Kapodistrian University of Athens name: University Hospital of Crete name: Pulmonary and Respiratory Failure Department, National and Kapodistrian University of Athens name: University Hospital of Patras briefSummary: Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice.

Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment.

Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis.

Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients? conditions: Asthma; Eosinophilic conditions: Airway Remodeling studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Benralizumab (30mg) administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Benralizumab 30 mg/ml measure: Change in sub-basement membrane thickness measure: Change in airway smooth muscle area measure: Change in airway smooth muscle layer thickness measure: Change in submucosal eosinophil number measure: Change in epithelial integrity measure: Change in collagen thickness measure: Change of cytokine and protein levels measure: Change in exacerbation rate measure: Change in blood eosinophil levels measure: dentification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital status: RECRUITING city: Thessaloniki zip: 57010 country: Greece name: Kalliopi Domvri, Dr role: CONTACT phone: 00302313307258 email: kdomvrid@auth.gr name: Konstantinos Porpodis, Prof role: CONTACT phone: 00302313307179 email: kporpodis@yahoo.gr lat: 40.64361 lon: 22.93086 hasResults: False

 nctId: NCT06288503 id: HRF2023 briefTitle: Hydrolysed Rice Formula Study overallStatus: RECRUITING date: 2024-02-01 date: 2027-07 date: 2027-07 date: 2024-03-01 date: 2024-03-01 name: Nutricia UK Ltd class: INDUSTRY briefSummary: This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety. conditions: Cow's Milk Protein Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 86 type: ESTIMATED name: Hydrolysed Rice Protein Formula name: Cow's Milk Based Extensively Hydrolysed Formula measure: Growth measure: Gastrointestinal Tolerance measure: Stool frequency and consistency measure: Study Product Intake measure: Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD) measure: Patient Reported Atopic Symptoms measure: Cow's Milk Related Symptom Score measure: Food Allergy Quality of Life-Parental Burden (FAQL-PB) measure: Acceptability of the Study Formula measure: Nutrient Intake (Energy, Protein, Micronutrients) measure: Dietetic Goal measure: Overall Safety sex: ALL minimumAge: 0 Months maximumAge: 13 Months stdAges: CHILD facility: Gloucestershire Royal NHS Trust status: RECRUITING city: Gloucester state: Gloucestershire zip: GL1 3NN country: United Kingdom name: Victoria Bittle role: CONTACT phone: 0300 422 5506 email: v.bittle@nhs.net lat: 51.86568 lon: -2.2431 facility: Bristol Royal Hospital for Children status: RECRUITING city: Bristol state: Somerset zip: BS16 1TA country: United Kingdom name: Sarah Trace role: CONTACT phone: 0117 3428802 email: sarah.trace@uhbw.nhs.uk lat: 51.45523 lon: -2.59665 hasResults: False

 nctId: NCT06288490 id: AMCS-009 briefTitle: A Single Arm Study Comparing ACC Supplement to CCS in Management of Hypoparathyroidism acronym: AMCS009 overallStatus: TERMINATED date: 2013-04 date: 2014-06 date: 2014-06-25 date: 2024-03-01 date: 2024-03-01 name: Amorphical Ltd. class: INDUSTRY briefSummary: Primary objective:

Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).

Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).

Secondary objectives:

Phase I

* ACC dose selection - to confirm the conversion factor of ACC from CCS
* To determine the effect of food on ACC absorption

Phase II

* To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS will not cause an increase in hypercalciuria in patients with hypoparathyroidism
* To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the side effects related with high calcium consumption.

Amorphical has a strong basis to believe that the ACC product is better absorbed compared to the commercially available CCS products and therefore, can maintain desirable target albumin corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As results, the burden of taking high doses of calcium supplementation along with the side effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be reduced.

Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a straightforward method to test this hypothesis.

The study is designed to be conducted with extra precaution in order to avoid disturbing the fragile balance between CA levels in serum and calcium levels urine. The crossover design of phase II of the study allows a more accurate and reliable comparison of results attributable to the specific treatment within the same individual. In addition, the subjects will continue consuming all their routine medication throughout the trial. The subjects in the control arm will consume their routine calcium supplement doses thus, will be treated with a standard of care. conditions: Hypoparathyroidism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL) primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: amorphous calcium carbonate measure: Calcium (albumin-corrected) serum level - composite value based on multiple measurements measure: Urine calcium level - 24h urine collection measure: Phosphorous serum level - composite value based on multiple measurements measure: Urine calcium level - 24h urine collection measure: Urine calcium level - 24h urine collection measure: Assessment of symptoms and signs related with hypocalcemia - composite value based on multiple measurements measure: Urine creatinine level - 24h urine collection measure: Urine creatinine level - 24h urine collection measure: Urine creatinine level - 24h urine collection measure: Urine phosphorus level - 24h urine collection measure: Urine phosphorus level - 24h urine collection measure: Urine phosphorus level - 24h urine collection sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambam Health Care Campus city: Haifa zip: 31096 country: Israel lat: 32.81841 lon: 34.9885 hasResults: False

 nctId: NCT06288477 id: 2023-2 briefTitle: Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-05-01 date: 2025-02-01 date: 2024-03-01 date: 2024-03-18 name: October University for Modern Sciences and Arts class: OTHER briefSummary: Despite the benefit of formocresol, there are toxic effects allergic reactions and local soft and hard tissue necrosis have been reported when such formaldehyde compounds were used clinically, however, the adverse effect of the clinically used of this compound are not widely reported. It has been stated that it has a side effect on the permanent successor although it results as a successful technique for the treatment of the primary teeth conditions: Vital conditions: Pulpotomy conditions: Techniques studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: A cotton pellet moistened with full-strength FC name: Neo-Putty measure: Clinical success sex: ALL minimumAge: 4 Years maximumAge: 9 Years stdAges: CHILD hasResults: False

 nctId: NCT06288464 id: 315656 id: 22/WM/0222 type: OTHER domain: Health Research Authority briefTitle: Enteral Feeding of Fibre to Improve Microbiota overallStatus: RECRUITING date: 2023-01-09 date: 2025-12-01 date: 2025-12-01 date: 2024-03-01 date: 2024-03-01 name: Lancashire Teaching Hospitals NHS Foundation Trust class: OTHER name: Lancaster University briefSummary: Following surgical removal of diseased bowel, patients often require a temporary redirection of bowel contents to a stoma, to allow healing prior to re-joining of the remaining bowel at a later date. Some patients may experience complications, either during or after reversal surgery, and this may be due to changes in the 'friendly' bacteria that live in our bowels. Previous research shows that the distal section of bowel that is non-functioning undergoes tissue-wasting and the 'friendly' bacteria that help our digestion die. Data shows that patients that have a reduction in their microflora are more likely to experience side effects. This study investigates a method of replenishing the microflora prior to surgery. conditions: Bowel Dysfunction conditions: Colon Disease conditions: Ileum--Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cohort primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 15 type: ESTIMATED name: Soluble Fibre measure: Concentration of Microbiota measure: Concentration of Immune Cell Populations measure: Length of Stay measure: Rate of clinical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lancashire Teaching Hospitals NHS status: RECRUITING city: Preston state: Lancashire zip: PR2 9HT country: United Kingdom name: Kina Bennett role: CONTACT phone: (+44) 01772 522031 email: kina.bennett@lthtr.nhs.uk name: Research Access role: CONTACT email: research.access@lthtr.nhs.uk name: Arnab Bhowmick role: PRINCIPAL_INVESTIGATOR lat: 53.76282 lon: -2.70452 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-02-01 uploadDate: 2024-02-23T12:17 filename: Prot_000.pdf size: 250752 hasResults: False

 nctId: NCT06288451 id: STUDY00018021 id: 1K23DK136930-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DK136930-01 briefTitle: DePTH: De-emphasize PTH overallStatus: RECRUITING date: 2024-03-11 date: 2027-02-28 date: 2027-02-28 date: 2024-03-01 date: 2024-03-18 name: University of Washington class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The De-emphasize Parathyroid Hormone (DePTH) Study is a 12-month pragmatic, randomized, parallel-group, active comparator, open-label, blinded end-point study of 90 patients with incident or prevalent secondary hyperparathyroidism and kidney failure treated with in-center hemodialysis. It tests the hypothesis that low fixed-dose oral calcitriol (intervention) will have more favorable effects on a comprehensive panel of biomarkers that assesses mineral metabolism, bone turnover, and serum calcification propensity, compared with variably-dosed intravenous activated vitamin D titrated to PTH targets (usual care). conditions: Kidney Failure, Chronic conditions: Chronic Kidney Disease-Mineral and Bone Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Oral calcitriol with cinacalcet rescue name: IV activated vitamin D measure: Change in fibroblast growth factor-23 measure: Change in serum calcium measure: Change in serum phosphate measure: Change in serum bone-specific alkaline phosphatase measure: Change in serum parathyroid hormone measure: Change in T50 test of serum calcification propensity measure: Patient acceptability measure: Patient acceptability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98104 country: United States name: Simon Hsu, MD, MS role: CONTACT phone: 206-540-5714 email: sihsu@uw.edu name: Ian H de Boer, MD, MS role: PRINCIPAL_INVESTIGATOR name: Simon Hsu, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06288438 id: E5012-R id: 23-2306 type: OTHER domain: COMIRB briefTitle: Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions overallStatus: RECRUITING date: 2024-04-01 date: 2026-11-02 date: 2028-03-31 date: 2024-03-01 date: 2024-04-08 name: VA Office of Research and Development class: FED briefSummary: Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions. conditions: Multimorbidity conditions: Physical Deconditioning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized into 1 of 2 groups. Group 1 will receive the intervention for 24 weeks. Group 2 will receive the control condition for 24 weeks. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor will be blinded to group allocation. whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Motivational Interviewing Techniques name: Physical Therapy Interventions name: Education name: Health Status Updates name: Physical Therapy Consult measure: 2 Minute Step Test measure: Arm Curl Test measure: 30 Second Sit To Stand measure: Physical Activity measure: Exercise readiness to change measure: Self-efficacy for Exercise Scale measure: Self-efficacy of Managing Chronic Conditions measure: The Patient-Specific Functional Scale measure: Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form measure: Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey measure: Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a measure: Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a measure: Physical Activity and Social Support Scale measure: Geriatric Pain Measure measure: Pain Coping Inventory sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Mountain Regional VA Medical Center, Aurora, CO status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Jennifer E Stevens-Lapsley, PhD role: CONTACT phone: 303-949-9304 email: Jennifer.Stevens-Lapsley@va.gov name: Michelle R Rauzi, DPT role: CONTACT phone: (208) 630-4002 email: michelle.rauzi@va.gov name: Jennifer E. Stevens-Lapsley, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06288425 id: SPACE-KIT briefTitle: Spatial Transcriptomics in Kidney Transplantation acronym: SPACE-KiT overallStatus: ENROLLING_BY_INVITATION date: 2024-04-03 date: 2030-01-01 date: 2035-01-01 date: 2024-03-01 date: 2024-04-24 name: Western Sydney Local Health District class: OTHER briefSummary: The study is an investigator-led, prospective, longitudinal, observational cohort study.

The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology.

By utilising new spatial technologies, the investigators aim to:

* Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes
* Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney
* Develop refinements to histological kidney rejection diagnostic and scoring classification
* Correlate of spatial and refined biopsy scoring features to clinically important outcomes conditions: Transplant Complication conditions: Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Non interventional measure: Kidney biopsy features measure: Kidney biopsy transcriptomic signature measure: Kidney cell type composition measure: All cause graft loss measure: Death censored graft loss (DCGL) measure: Treatment resistant rejection measure: Delayed graft function (DGF) measure: Biopsy evidence of borderline rejection measure: Biopsy proven acute rejection measure: Chronic rejection measure: Interstitial fibrosis scores (IFTA) measure: BK virus associated nephropathy measure: Kidney function measure: Albuminuria measure: Surrogate end-points measure: Donor to recipient mismatches measure: Proteinomic signature sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westmead Hospital city: Westmead state: New South Wales zip: 2145 country: Australia lat: -33.80383 lon: 150.98768 hasResults: False

 nctId: NCT06288412 id: NN1436-7615 id: U1111-1285-1665 type: OTHER domain: World Health Organization (WHO) id: 2023-505012-38 type: OTHER domain: European Medical Agency (EMA) briefTitle: A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting overallStatus: RECRUITING date: 2024-02-26 date: 2024-11-04 date: 2024-11-04 date: 2024-03-01 date: 2024-04-02 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Insulin icodec name: Insulin degludec measure: Time below range, glucose less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) within 24 hours after start of exercise (TBR3.0mmol/L,exe) measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 24 hours after start of exercise (TBR3.9mmol/L,exe) measure: Time in range, glucose 3.9-10.0 mmol/L (70-180 mg/dL) within 24 hours after start of exercise (TIR3.9-10.0mmol/L,exe) measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 24 hours after start of exercise (TAR10.0mmol/L,exe) measure: Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe) measure: Amount of carbohydrate intake during exercise (CHOexe) measure: Amount of carbohydrate intake from end of standardised lunch meal until start of exercise (CHOpre-exe) measure: Amount of carbohydrate intake after stop of exercise until start of standardised dinner meal (CHOpost-exe) measure: Number of hypoglycaemic within 24 hours after start of exercise (Hypo24h,exe) measure: Number of hypoglycaemic episodes for 24 hours in reference week (43 to 67 hours after dosing) (Hypo24h,ref) measure: Time below range, glucose <3.0 mmol/L (54 mg/dL) within 18 hours after start of fasting (TBR3.0mmol/L,fast) measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 18 hours after start of fasting (TBR3.9mmol/L,fast) measure: Time in range, glucose 3.9-10 mmol/L (70-180 mg/dL) within 18 hours after start of fasting (TIR3.9-10.0mmol/L,fast) measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 18 hours after start of fasting (TAR10.0mmol/L,fast) measure: Number of clinically significant hypoglycaemic episodes during fasting (Hypofast) measure: Amount of carbohydrate administered intravenously during fasting (CHOfast) measure: Number of hypoglycaemic episodes within 18 hours after start of fasting (Hypo18h,fast) measure: Number of hypoglycaemic episodes for 18 hours in reference week (26 to 44 hours after dosing) (Hypo18h,ref) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz zip: 8010 country: Austria lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06288399 id: DAS-7688 id: U1111-1292-7248 type: OTHER domain: World Health Organization (WHO) briefTitle: Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study overallStatus: ENROLLING_BY_INVITATION date: 2023-12-21 date: 2024-06-30 date: 2024-06-30 date: 2024-03-01 date: 2024-04-09 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult people with obesity, as well as estimate the annual incidence and point prevalence of the ORCs among adult people with obesity. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1322 type: ESTIMATED name: No treatment given measure: Proportion of Obesity Related Comorbidities (ORC, existing/newly diagnosed) among adult people with obesity (BMI above or equal to 30 kg/m2) over a period of 12 months across the Gulf region in primary and secondary hospitals as well as obesity clinics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Farwaniya Hospital city: Farwaniya zip: 85000 country: Kuwait facility: Al-Adan Hospital city: Hadiya zip: 52700 country: Kuwait facility: Al-Amiri Hospital city: Kuwait City zip: 13001 country: Kuwait lat: 29.36972 lon: 47.97833 facility: Novo Nordisk Investigational Site city: Kuwait zip: 12030 country: Kuwait lat: 29.36972 lon: 47.97833 facility: National Diabetes and Endocrine Center city: Muscat zip: 113 country: Oman lat: 23.58413 lon: 58.40778 facility: Samail Polyclinic city: Samail zip: 620 country: Oman lat: 23.3 lon: 57.98333 facility: Hamad General Hospital city: Doha zip: 122104 country: Qatar lat: 25.28545 lon: 51.53096 facility: PHCC city: Doha zip: 122104 country: Qatar lat: 25.28545 lon: 51.53096 hasResults: False

 nctId: NCT06288386 id: 2024-ATTACHMENTS briefTitle: Influence of Different Nanohybrid Flowable Composite Resin on Shear Bond Strength and Dimensional Changes of Invisalign Attachments After 6 Months of Brushing overallStatus: ENROLLING_BY_INVITATION date: 2024-03-04 date: 2025-02 date: 2025-02 date: 2024-03-01 date: 2024-03-15 name: University of Pavia class: OTHER briefSummary: The present study will be a single-center, split-mouth, randomized controlled clinical trial. Patients undergoing orthodontic treatment with Invisalign aligners will be enrolled after signing the informed consent. Two different flowable composite resins will be evaluated for the performing of attachments using a split-mouth design:

* group A: Filtek Supreme Flow (3M Unitek, Monrovia, Calif)
* group B: Grandioso Heavy Flow (VOCO GmbH, Cuxhaven Germany)

Digital impressions with iTero intraoral scanner will be performed; digital impressions will be performed after 3 months (T1) and 6 months (T2) from the baseline.

Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software.

After attachments placement, the clinicians will be asked to answer, on a scale from 1 to 10, to this questionnaire's questions about the two different flowable composites; each question is repeated for each composite resin.

Type of brushing (with manual or electric toothbrush) and hand of brushing will be recorded. conditions: Malocclusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Split-mouth design primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: GrandioSO Heavy Flow name: Filtek Z350XT Flowable measure: Changes in the volume of attachments measure: Attachments failure rate measure: Type of brushing measure: Change in questionnaire's answers measure: Hand of brushing sex: ALL minimumAge: 14 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06288373 id: NACI-CERV-003 briefTitle: Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2031-03-01 date: 2031-03-01 date: 2024-03-01 date: 2024-03-01 name: Tongji Hospital class: OTHER name: Southwest Hospital, China name: Women Hospital, School of Medicine, Zhejiang University name: Anhui Provincial Cancer Hospital name: Sichuan Cancer Hospital and Research Institute name: Qilu Hospital of Shandong University name: Beijing Friendship Hospital name: Tianjin Medical University General Hospital name: West China Second University Hospital name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: Xiangya Hospital of Central South University name: Gansu Provincial Maternal and Child Health Care Hospital name: Zhejiang Cancer Hospital name: Shengjing Hospital briefSummary: It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group. conditions: Cervical Cancer conditions: Locally Advanced Cervical Cancer conditions: Concurrent Chemoradiotherapy conditions: Neoadjuvant Chemoimmunotherapy studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 440 type: ESTIMATED name: Camrelizumab name: Cisplatin name: Nab paclitaxel name: Radical surgery name: external beam radiation therapy (EBRT) + brachytherapy name: Cisplatin measure: Progression-free survival, PFS measure: Objective Response Rate, ORR measure: Overall survival, OS measure: Proportion of patients undergoing radical surgery measure: Pathologic Complete Response measure: The surgical complication rate measure: Safety and toleraty measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Kezhen Li role: CONTACT phone: 086-027-8362 email: tjkeke@126.com name: Jing Chen role: CONTACT phone: 086-027-8362 email: chenjing3223@126.com name: Kezhen Li role: PRINCIPAL_INVESTIGATOR name: Gang Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06288360 id: NACI-CERV-002 briefTitle: Neoadjuvant Immunochemotherapy in PD-L1-negative LACC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2030-12-12 date: 2024-03-01 date: 2024-03-01 name: Tongji Hospital class: OTHER name: Southwest Hospital, China name: Women Hospital, School of Medicine, Zhejiang University name: Anhui Provincial Cancer Hospital name: Sichuan Cancer Hospital and Research Institute name: Gansu Provincial Maternal and Child Health Care Hospital name: Beijing Friendship Hospital name: Tianjin Medical University General Hospital name: Xiangya Hospital of Central South University name: West China Second University Hospital name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: Zhejiang Cancer Hospital name: Shengjing Hospital name: Qilu Hospital of Shandong University briefSummary: This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer. conditions: Cervical Cancer conditions: Locally Advanced Cervical Cancer conditions: PD-L1 Negative conditions: Neoadjuvant Chemoimmunotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Camrelizumab name: Paclitaxel-albumin name: Cisplatin name: radical surgery measure: Pathologic complete response measure: Surgical Complications measure: Objective response rate measure: Positive surgical margin rate measure: event-free survival measure: overall survival measure: adverse event sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Jing Chen role: CONTACT phone: 086-027-8362 email: chenjing3223@126.com name: Kezhen Li role: PRINCIPAL_INVESTIGATOR name: Gang Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06288347 id: 216099 briefTitle: Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa. overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-06-17 date: 2024-06-17 date: 2024-03-01 date: 2024-03-15 name: University of Valencia class: OTHER briefSummary: The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) in non-clinical adult population. Specifically, a randomized controlled trial with crossover assignment design and two groups (experimental and control) will be carried out in adults aged 18-65 years to assess the changes pre and post use the app. It's expected that after the use of the GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app in experimental group, and 15 days after to finish the app in control group. conditions: Orthorexia Nervosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants were requested to complete web-based assessment, with questionnaires relating to maladaptive beliefs associated with ON, ortorexia, eating and depressive symptomatology, obsessive belifs and self-esteem at baseline (T1).

The experimental group started using the app for 15 days, and later completed the following assessment (T2). The control group also completed the T2 in the same date but started to use the app after this second assessment.15 days and one month later, both groups completed T3 and T4. primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: GGON mobile app. measure: Change in the degree of ascription to dysfunctional beliefs associated with Orthorexia Nervosa measure: Change in Orthorexia symptomatology measure: Change in eating symptomatology measure: Change in self-esteem. measure: Change in emotional symptomatology measure: Change in obsessive beliefs sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-04-18 uploadDate: 2024-03-11T04:30 filename: ICF_000.pdf size: 79708 hasResults: False

 nctId: NCT06288334 id: PUTH PD_V 1.2 briefTitle: Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children overallStatus: RECRUITING date: 2020-08-06 date: 2024-03-31 date: 2024-05-31 date: 2024-03-01 date: 2024-03-01 name: Peking University Third Hospital class: OTHER briefSummary: To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease. conditions: Allergic Disease conditions: Children studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 80 type: ESTIMATED name: 1-3 Cetirizine Pharmacokinetic samples measure: Plasma concentration sex: ALL minimumAge: 6 Months maximumAge: 16 Years stdAges: CHILD facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Yafen Li role: CONTACT phone: 18222566785 email: liyafen314159@163.com name: Wei Zhou role: PRINCIPAL_INVESTIGATOR name: Wei Liu role: PRINCIPAL_INVESTIGATOR name: Dongyang Liu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06288321 id: UW22221 briefTitle: A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity. overallStatus: COMPLETED date: 2022-08-10 date: 2023-03-22 date: 2023-03-22 date: 2024-03-01 date: 2024-03-01 name: The University of Hong Kong class: OTHER briefSummary: A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose Mydrin-P.

Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The primary outcome measured whether a successful ROP examination was conducted. Secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the mydriatics administration.

A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded. All episodes with microdrops instillation led to successful ROP exams. There was no statistically significant difference between standard eyedrops and microdrops in determining the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in the occurrence of systemic side effects when compared to standard Mydrin P drops.

Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops. conditions: Retinopathy of Prematurity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ACTUAL name: Microdrop Mydrin-P name: Standard Mydrin-P measure: Successfulness of a ROP exam measure: Pupil diameters measure: Heart rate measure: Blood pressure measure: Oxygen saturation measure: Oxygen requirement measure: Episodes of vomiting measure: Volume of gastric residuals measure: Episodes of apnoea measure: Episodes of periorbital blanching sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-07-14 uploadDate: 2024-02-18T04:50 filename: Prot_000.pdf size: 94463 hasResults: False

 nctId: NCT06288308 id: FAR in lupus nephritis (LN) briefTitle: Fibrinogen to Albumin Ratio (FAR) as a Predictive Biomarker for Lupus Nephritis (LN) overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-11 date: 2024-12 date: 2024-03-01 date: 2024-03-01 name: Assiut University class: OTHER briefSummary: Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN) conditions: Lupus Nephritis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED name: fibronigin to albumin ratio measure: Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06288295 id: Etude SCORDOM briefTitle: Retrospective Study on Data Aiming to Establish a Prediction Score for Return Home at the Time of Admission to a Multidisciplinary Medical Department (SCORDOM acronym: SCORDOM overallStatus: COMPLETED date: 2021-10-01 date: 2023-02-28 date: 2023-02-28 date: 2024-03-01 date: 2024-03-01 name: Elsan class: OTHER briefSummary: The goal of this observational study is to define clinical, biological and socio-cultural criteria, from the very first days of hospitalization on the multidisciplinary medicine department, to guide the patient's discharge from hospital (return to home when discharged from hospital).

The data collected will be those contained in the medical records of patients over 60 years of age who were admitted to the multidisciplinary medical department between October 2021 and February 2022 and between October 2022 and February 2023.

This study also aims at developing and validating a predictive score of orientation at the end of hospitalisation.

Participants are patients previously hospitalized. They will be informed about the study by post and will be able to object to the use of his or her data. conditions: Continuity of Patient Care studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ACTUAL measure: Number of patients with a return to home after hospitalization and with similar clinical parameters, similar age category, similar pathology and similar biological parameters measure: Number of patients with a return to home after hospitalization and with similar clinical parameters, similar age category, similar pathology and similar biological parameters sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Privé Nancy Lorraine city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06288282 id: STUDY-23-01287 briefTitle: Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain overallStatus: RECRUITING date: 2023-12-20 date: 2024-12-20 date: 2024-12-20 date: 2024-03-01 date: 2024-03-01 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants. conditions: Chronic Back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 130 type: ESTIMATED name: No Intervention measure: Screener and Opioid Assessment for patients with pain revised (SOAPPR) measure: Current Opioid misuse measure (COMM) surveys measure: Pain Intensity with Brief Pain inventory (BPI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Pain management centers status: RECRUITING city: New York state: New York zip: 10029 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06288269 id: PhrapokklaoHospital briefTitle: Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat overallStatus: COMPLETED date: 2023-11-01 date: 2023-12-30 date: 2024-01-15 date: 2024-03-01 date: 2024-03-07 name: Phrapokklao Hospital,Thailand class: OTHER briefSummary: The purpose of this study was to study factors for controlling hypertension or type 2 diabetes before stroke diagnosis on the severity level when a stroke occurs, NIHSS, and survival rate after having a stroke in 1 year in Trat Province The research hypothesis was patients with hypertension or type 2 diabetes who are well-controlled Will have a lower NIHSS score than the group whose disease is not well-controlled. and patients with hypertension or type 2 diabetes that is well controlled There will be a higher survival rate for patients diagnosed with cerebrovascular disease within 1 year than those whose disease cannot be controlled. conditions: Stroke conditions: Hypertension conditions: Type2diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 291 type: ACTUAL name: Severity of Stroke and 1 year survival measure: Stroke severity was assessed using the National Institute of Health Stroke Scale (Clinical Mild NIHSS = 0-4 and Clinical Moderate to severe NIHSS = 5-42) measure: 1 year survival death sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Trat Provincial Public Health Office city: Trat zip: 23000 country: Thailand lat: 12.24364 lon: 102.51514 hasResults: False

 nctId: NCT06288256 id: STUDY-22-01390 briefTitle: Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-06 date: 2024-06 date: 2024-03-01 date: 2024-03-01 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.

To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.

This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts. conditions: Lumbar Spine Pathology conditions: Elective Spine Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: No Intervention measure: Current Opioid Misuse Measure (COMM) Score measure: Numerical Rating Scale (NRS) Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Spine Center city: New York state: New York zip: 10029 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06288243 id: Samatya briefTitle: Functionality, Cognition And Swallowing Skills In Patients With AcuteSTROKE overallStatus: COMPLETED date: 2018-12-01 date: 2019-05-28 date: 2019-05-29 date: 2024-03-01 date: 2024-03-01 name: Medipol University class: OTHER briefSummary: Aim: Studies in which the results of the screening test evaluating swallowing skills in acute stroke patients are evaluated together with other components that may affect swallowing function are limited. The aim of this study is to determine which factors are associated with swallowing abilities in patients with acute stroke, including lesion location, cognitive level, clinical features, risk factors for stroke, and level of functionality.

Methods: The 97 acute stroke patients included in the study were grouped in terms of lesion type, affected side, and risk factors for stroke. Turkish MMASA (TR-MMASA) was used to evaluate the swallowing ability of the patients. Additionally, Standardized Mini Mental Test (SMMT) and Modified Rankin Scale (MRS) were applied to evaluate cognition level and functionality, respectively. conditions: Stroke, Acute conditions: Swallowing Disorder conditions: Cognitive Impairment conditions: Stroke conditions: Movement Disorders conditions: Dysphagia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 97 type: ACTUAL name: Clinician-observed assessment tests measure: The Correlation Between Swallowing Skills and Cognitive Status measure: The Correlation Between Swallowing Skills and Functionality measure: The relationship between stroke risk factors and swallowing skills measure: The relationship between demographic informations and swallowing skills sex: ALL minimumAge: 45 Years maximumAge: 92 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06288230 id: LT01-101 briefTitle: An Open Label Study of Gene Therapy Product in Spinal Muscular Atrophy Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2027-03-01 date: 2024-03-01 date: 2024-03-01 name: Lantu Biopharma class: INDUSTRY briefSummary: This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients. conditions: Spinal Muscular Atrophy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: vesemnogene lantuparvovec measure: Numbers of participants with adverse events (AEs), serious adverse events (SAEs) measure: Change from baseline in hours of daily ventilation support and motor function measure: Change from baseline in ambulatory function measure: Change from baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288217 id: NS-CIP-001 briefTitle: Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits overallStatus: RECRUITING date: 2024-03-05 date: 2024-12 date: 2024-12 date: 2024-03-01 date: 2024-03-12 name: NeuraStasis, Inc class: INDUSTRY briefSummary: This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study. conditions: Stroke, Ischemic conditions: Upper Extremity Paresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) name: Upper Limb Rehabilitation name: Sham Stimulation measure: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change measure: Action Research Arm Test (ARAT) Average Change measure: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response % measure: Proportion of subjects completing all pre-specified treatment doses measure: Subject Questionnaire on Device Usage measure: Therapist Questionnaire on Device Usage measure: Serious adverse device effects (SADE) rate at 24 hours post-therapy session measure: Stroke impact scale (SIS) Summative Score Average Change measure: Analysis of the number of stimulations per therapy session sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at Houston status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Sean Savitz, MD role: CONTACT phone: 713-500-7083 email: Sean.I.Savitz@uth.tmc.edu name: Emily Stevens, OTR role: CONTACT phone: 713-500-7914 email: emily.a.stevens@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06288204 id: Denise Mafra16 briefTitle: Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-07-31 date: 2027-07-31 date: 2024-03-01 date: 2024-03-01 name: Universidade Federal Fluminense class: OTHER name: Conselho Nacional de Desenvolvimento Científico e Tecnológico name: Rio de Janeiro State Research Supporting Foundation (FAPERJ) name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. briefSummary: This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with CKD and SAH, in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months. conditions: Chronic Kidney Diseases conditions: Hypertension conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 153 type: ESTIMATED name: Propolis + Royal Jelly name: Royal Jelly name: Placebo measure: Change in inflammation, oxidative stress measure: Change in intestinal microbiota measure: Change in senescence biomarkers measure: Change in uremic toxins measure: Change in adhesion molecules measure: Change in blood pressure sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Denise Mafra city: Rio de Janeiro state: RJ zip: 22260050 country: Brazil name: Denise Mafra, phd role: CONTACT phone: 21985683003 email: dmafra30@gmail.com lat: -22.90278 lon: -43.2075 hasResults: False

 nctId: NCT06288191 id: MIA2023/490 id: CA224-1065 type: OTHER domain: Bristol-Myers Squibb briefTitle: Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2036-04 date: 2024-03-01 date: 2024-03-04 name: Melanoma Institute Australia class: OTHER name: Bristol-Myers Squibb briefSummary: The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival. conditions: Cutaneous Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open label, single arm, single centre, clinical trial primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination measure: Pathological complete response rate measure: Pathological near pathological response (near pCR), partial response (pPR) and pathological non-response (pNR) rate measure: Toxicity and tolerability of neoadjuvant immunotherapy and surgery measure: Objective response rate to neoadjuvant therapy measure: Metabolic response rate to neoadjuvant immunotherapy measure: Recurrence-free survival measure: Disease progression rate measure: Event-free survival rate measure: Overall survival measure: Patient reported quality of life (QLQ-C30) measure: Patient reported quality of life (EQ-5L-5D) measure: Study treatment completion rate and the causes of any missed treatments measure: De-escalation of adjuvant radiotherapy. measure: Identification of tissue and blood biomarkers of response / resistance measure: Profile of the gut microbiome from faecal samples and relationship to response and toxicities. measure: The pathological response to RECIST, immune related response criteria and PERCIST response measure: Assessment of the response to neoadjuvant using the immune-related response criteria (irRC) and correlate the assessment with the RECIST 1.1 response at each timepoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288178 id: 2022/18 briefTitle: The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations acronym: Obesity overallStatus: COMPLETED date: 2022-12-19 date: 2023-01-20 date: 2023-02-20 date: 2024-03-01 date: 2024-03-01 name: Ege University class: OTHER briefSummary: The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB).

Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels. conditions: Obesity conditions: Glycemic Index conditions: Blood Glucose conditions: Bread studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 103 type: ACTUAL name: Bread consumption measure: One loaf of bread was been consumed every week. Blood glucose measurements were performed with a glucometer at 0 (fasting), 30, 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: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Avrasya University city: Trabzon zip: 61000 country: Turkey lat: 41.005 lon: 39.72694 hasResults: False

 nctId: NCT06288165 id: CopperHealthCentre2 briefTitle: Lower Silesia Sinus Reducer Registry acronym: LSSRR overallStatus: RECRUITING date: 2022-05-11 date: 2027-05-11 date: 2027-05-11 date: 2024-03-01 date: 2024-03-01 name: Regional Cardiology Center, The Copper Health Centre (MCZ), class: OTHER briefSummary: Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation . conditions: Safety Issues conditions: Efficacy, Self studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Coronary Sinus Reducer Implantation measure: The Clinical success - reduction of angina symptoms measure: Incidence of Treatment-Emergent Adverse Events measure: Change in potential aerobic capacity and endurance - The six minute walking test (6MWT) measure: Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Cardiology, The Copper Health Centre (MCZ) status: RECRUITING city: Lubin state: Lower Silesia zip: 59-300 country: Poland name: Adrian Włodarczak, M.D; Ph.D.Assoc Prof. role: CONTACT phone: +48768460300 email: wlodarczak.adrian@gmail.com name: Szymon Włodarczak, MD role: CONTACT phone: +4876 846 03 00 email: wlodarczak.szy@gmail.com lat: 51.40089 lon: 16.20149 facility: Cardiac Department of Copper Health Center status: RECRUITING city: Lubin state: Lower Silesia zip: 59301 country: Poland name: Adrian Włodarczak, Prof role: CONTACT phone: 76 846 03 00 phoneExt: 0048 email: wlodarczak.adrian@gmail.com name: Szymon Włodarczak, MD role: CONTACT phone: 76 846 03 00 phoneExt: 0048 email: wlodarczak.szy@gmail.com name: Piotr Rola, Ph D; MD role: SUB_INVESTIGATOR lat: 51.40089 lon: 16.20149 hasResults: False

 nctId: NCT06288152 id: STS-Transplant briefTitle: Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-03-01 date: 2024-03-01 name: Alp Sener class: OTHER briefSummary: End-stage renal disease (ESRD) is a significant clinical problem for which dialysis or transplantation is required. The current need for kidneys for transplantation vastly exceeds the supply available from live donors, necessitating the use of kidneys from deceased donors. However, kidneys from deceased donors are associated with reduced viability, as lack of blood supply upon cardiac death increases tissue damage. In addition, the standard protocol for cold preservation of donor kidneys between procurement and transplantation increases the risk of delayed donor kidney function by 23% for every 6-hours of storage. Moreover, compared to other organs, the kidney is particularly prone to transplantation-induced injury due to its high metabolic activities and oxygen consumption. Hence, any minor disturbances in blood supply can easily lead to kidney injury. Therefore, it is not surprising that deceased donor kidneys have a low tolerance for damage associated with lack of blood supply. The focus of the investigators research has been to pioneer the development and supplementation of existing kidney preservation solutions with novel hydrogen sulfide (H2S) donor molecules to improve kidney viability for clinical transplantation. Specifically, the investigators demonstrated that supplementation of standard kidney preservation solutions with non-clinically viable H2S donor molecules significantly increased donor kidney protection and prolonged transplant recipient survival in murine and porcine models of kidney transplantation. Having shown the same salutary effect using sodium thiosulfate (STS; a clinically viable H2S donor drug) in rat kidney transplantation, the investigators aim to repeat this work using STS in porcine and clinical kidney transplantation.

This single-blind study will enroll participants receiving a kidney transplant. Through randomization, half of the participants will receive STS through administration into the pump the kidney is placed on after procurement from the donor and before transplant to the recipient. Participants will be followed for 1-year post transplant where blood and urine will be collected to determine graft function. conditions: Renal Transplant conditions: Kidney Transplant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Sodium Thiosulfate measure: Effects of STS will be measured by: Delayed graft function sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06288139 id: open fracture tibia briefTitle: Management of Open Fracture Tibia in Teenagers overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-02-01 date: 2024-03-01 date: 2024-03-01 name: Assiut University class: OTHER briefSummary: The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes conditions: Open tíbia Fracture studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Number measure: To evaluate treatment outcomes measure: Soft tissue healing measure: Complication sex: ALL minimumAge: 10 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06288126 id: MoMM-FET briefTitle: Maternal and Fetal Metabolic Changes acronym: MoMM-FET overallStatus: COMPLETED date: 2019-08-01 date: 2020-10-09 date: 2021-01-18 date: 2024-03-01 date: 2024-03-01 name: Azienda Ospedaliero, Universitaria Pisana class: OTHER briefSummary: The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring.

Primary objectives:

* measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM
* ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits.
* Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia.

Secondary objectives:

* Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women.
* Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit).

The participants will be recruited during first trimester ultrasound after signing the informed consent. conditions: Pregnancy Related conditions: Maternal-Fetal Relations conditions: Metabolism Disorder, Glucose studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 457 type: ACTUAL measure: Blood adipokine levels measure: Abdominal Fat Thickness measure: Fetal Adipose Tissue Deposits measure: Gestational diabetes prevalence measure: Obstetric complications and mode of delivery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria Pisana city: Pisa zip: 56126 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06288113 id: 23-001509 id: NCI-2024-00310 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-001509 type: OTHER domain: UCLA / Jonsson Comprehensive Cancer Center briefTitle: Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-27 date: 2027-01-27 date: 2024-03-01 date: 2024-03-06 name: Jonsson Comprehensive Cancer Center class: OTHER name: Novartis Pharmaceuticals briefSummary: This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer. conditions: Castration-Resistant Prostate Carcinoma conditions: Stage IVB Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Gallium Ga 68 Gozetotide name: Lutetium Lu 177 Vipivotide Tetraxetan name: Positron Emission Tomography name: Questionnaire Administration name: Single Photon Emission Computed Tomography measure: 12-month overall survival measure: Incidence of adverse events (AEs) measure: Rate of prostate specific antigen (PSA) response measure: Biochemical progression-free survival (PFS) measure: Overall Survival from start of first regimen measure: Overall survival from the end of the first regimen measure: Radiographic progression-free survival (rPFS) measure: Bone Pain measure: Changes in health-related quality of life_Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT). measure: Changes in health-related quality of life_Brief Pain Inventory Short form measure: Changes in health-related quality of life_ Eastern Cooperative Oncology Group score sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA / Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90095 country: United States name: Ethan Lam role: CONTACT phone: 310-206-7372 email: clam@mednet.ucla.edu name: Stephanie Lira role: CONTACT phone: 3102060596 email: StephanieLira@mednet.ucla.edu name: Jeremie Calais role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06288100 id: OWHTOPTS briefTitle: The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2024-01-01 date: 2024-03-01 date: 2024-03-01 name: Al-Azhar University class: OTHER briefSummary: High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy . conditions: Genu Varum studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Observation measure: The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamed Abdelfattah Abbas city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06288087 id: 2023-20/672 briefTitle: Comparing Machine Guided VR Based Training With Educator Guided Training in Metaverse overallStatus: RECRUITING date: 2024-03-04 date: 2024-03-29 date: 2024-04-11 date: 2024-03-01 date: 2024-03-01 name: Acibadem University class: OTHER briefSummary: The main aim of this study is to compare the learning outcomes of machine guided VR based training for adult advanced life support with educator guided training in metaverse environment. conditions: Advanced Cardiac Life Support conditions: Virtual Reality conditions: Serious Game studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: OTHER masking: SINGLE maskingDescription: the group trained with VR Based Training with Machine Guidance will be referred as MG group and the group trained with VR Based Training with Educators Guidance in Metaverse will be referred as EG group. whoMasked: PARTICIPANT count: 62 type: ESTIMATED name: VR Based Training with Machine Guidance (MG Group) name: VR Based Training with Educator Guidance in Metaverse (EG Group) measure: Comparing Learning outcome of the Advanced Cardiac Life Support Training of the two interventions used in this study sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Acibadem University CASE (Center of Advanced Simulation and Education) status: RECRUITING city: Istanbul state: Non-US/Canada zip: 34752 country: Turkey name: Dilek Kitapcioglu, Assist.Prof role: CONTACT phone: +905323636115 email: dilek.kitapcioglu@acibadem.edu.tr name: Mehmet Emin Aksoy, Assoc.Prof role: CONTACT phone: +905052685158 email: emin.aksoy@acibadem.edu.tr name: Dilek Kitapcioglu, Assist.Prof role: PRINCIPAL_INVESTIGATOR name: Mehmet Emin Aksoy, Assoc.Prof role: PRINCIPAL_INVESTIGATOR name: Arun Ekin Ozkan, M.Sc. role: SUB_INVESTIGATOR name: Tuba Usseli, M.Sc. role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 facility: Acibadem University CASE (Center of Advanced Simulation and Education) status: NOT_YET_RECRUITING city: Istanbul state: Non-US/Canada zip: 34752 country: Turkey name: Mehmet Emin Aksoy, Assoc.Prof role: CONTACT phone: +902165004201 email: emin.aksoy@acibadem.edu.tr name: Dilek Kitapcioglu, Ph.D. role: CONTACT phone: +2165004202 phoneExt: Aksoy email: dilek.kitapcioglu@acibadem.edu.tr name: Dilek Kitapcioglu, MD, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Mehmet Emin Aksoy, MD, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Arun Ekin Ozkan, M.Sc. role: SUB_INVESTIGATOR name: Tuba Usseli, M.S role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06288074 id: SF-2022-1-1061 briefTitle: Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration overallStatus: RECRUITING date: 2024-03-10 date: 2024-12-31 date: 2024-12-31 date: 2024-03-01 date: 2024-03-01 name: Capital Medical University class: OTHER briefSummary: Severe community-acquired pneumonia still has a high incidence and mortality, but the molecular mechanism and prognostic biomarkers of severe community-acquired pneumonia caused by different pathogens are still unclear, and the best treatment strategy has not been determined. Based on this, this project intends to take patients with severe community-acquired pneumonia caused by different pathogens as the research object, explore the molecular mechanism of severe community-acquired pneumonia from multiple angles, integrate relevant research data to evaluate the rationality of initial empirical medication, and lay the foundation for precise treatment of severe pneumonia. The research results will help to develop a new rapid and accurate target for clinical diagnosis and efficacy evaluation of severe pneumonia, and build a precise treatment system for severe pneumonia. conditions: Severe Community-acquired Pneumonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Multi-omics tests measure: Hospital mortality measure: Cause of death measure: Length of stay measure: Length of ICU stay measure: Expense during hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Institute of Respiratory Medicine status: RECRUITING city: Beijing state: Beijing zip: 100027 country: China name: Zhaohui Tong, Dr role: CONTACT phone: +86 010 8523 1000 email: 13910930309@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06288061 id: Phrenic Nerve Neuromodulation briefTitle: Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain. overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-06-06 date: 2025-07-04 date: 2024-03-01 date: 2024-03-05 name: University of Seville class: OTHER briefSummary: Inflammatory bowel diseases (IBD) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. Its prevalence is increasing worldwide. These include Ulcerative Colitis (UC) and Crohn's Disease(CD).

The Phrenic nerve originates at the roots C3-C4-C5 carrying motor and sensory information. Directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, Glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. It also has fibres of the autonomic nervous system.

Studies show that there is a link between people suffering from IBD and hepatopancreato-biliary diseases. It can therefore generate referred pain to the C3-C4-C5 dermatomes.

Based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the Phrenic nerve reduces neck pain in people with IBD. Secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between IBD and cervical pain.

Hypothesis:

Non-invasive Phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility. conditions: Inflammatory Bowel Diseases conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 68 type: ESTIMATED name: Non-invasive Neuromodulation name: Cervico-dorsal Massage measure: The Visual Analogue Scale (VAS) measure: Cervical mobility measure: The Neck Disability Index (NDI) measure: The Pressure Pain Threshold (PPT) measure: The Inflammatory Bowel Disease Questionnaire (IBDQ-32) measure: The World Health Organization Quality of Life (WHOQOL-BREF) measure: The Central Sensitization Inventory (CSI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Puerto Real city: Puerto Real state: Cádiz zip: 11510 country: Spain lat: 36.52819 lon: -6.19011 hasResults: False

 nctId: NCT06288048 id: 23/107-EC X TFM 07/03/2023 briefTitle: Effect of Mirror Therapy on Post-Needling Pain Following Deep Dry Needling of Myofascial Trigger Point in Lateral Elbow Pain overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2024-03-07 date: 2024-06-30 date: 2024-03-01 date: 2024-03-01 name: Universidad Europea de Canarias class: OTHER briefSummary: The goal of this randomized, controlled pilot trial is to investigate the immediate effects of incorporating Mirror Visual Feedback Therapy (MFT) on pain sensitivity and motor performance in individuals experiencing Post-needling pain associated with lateral elbow pain. The main questions it aims to answer are:

* Does incorporating Mirror Visual Feedback Therapy reduce Post-needling pain intensity?
* Does incorporating Mirror Visual Feedback Therapy improve pressure pain threshold?
* Does incorporating Mirror Visual Feedback Therapy improve maximum grip strenght?

Participants will be asked to undergo pre- and post-treatment evaluations, which include assessments of Post-needling pain intensity, pressure pain threshold, two-point discrimination threshold, and maximum hand grip strength.

Participants in the Experimental Group will receive Deep Dry Needling in the m. Brachioradialis, Ischemic Compression, Cold Spray, Stretching, and Mirror Visual Feedback Therapy. Those in the Control Group will not receive Mirror Visual Feedback Therapy.

Researchers will compare the Experimental Group to the Control Group to see if the incorporation of Mirror Visual Feedback Therapy results in a reduction in Post-needling pain intensity and improvement in pressure pain threshold. conditions: Lateral Elbow Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Allocation and data assessor were blinded. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 49 type: ESTIMATED name: Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT name: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching measure: Pain Intensity measure: Pain pressure threshold measure: Two-point discrimination threshold measure: Maximum hand grip strength sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Europea de Canarias city: La Orotava state: Santa Cruz De Tenerife zip: 38300 country: Spain lat: 28.39076 lon: -16.52309 hasResults: False

 nctId: NCT06288035 id: R.21.02.1191 briefTitle: Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy overallStatus: RECRUITING date: 2024-03-04 date: 2025-03 date: 2025-03 date: 2024-03-01 date: 2024-03-12 name: Mansoura University class: OTHER briefSummary: Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy. conditions: Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone at night before surgery. The primary outcome will be the incidence of postoperative nausea and vomiting. 814 patients are intended to be recruited for this non-inferiority trial. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcome assessors will be blinded to the group allocation. whoMasked: OUTCOMES_ASSESSOR count: 814 type: ESTIMATED name: Dexamethasone Oral name: Dexamethasone measure: Postoperative nausea or vomiting (PONV) measure: Rescue antiemetic measure: Early PONV measure: Late PONV measure: Visual Analogue Scale (VAS) at the time of discharge from PACU measure: VAS at the time of discharge from hospital measure: Postoperative fatigue measure: Postoperative quality of recovery measure: Post-Discharge Nausea and Vomiting (PDNV) measure: Surgical Site Infection (at follow-up) measure: Itching or burning sensation on dexamethasone injections sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University Faculty of Medicine status: RECRUITING city: Mansoura state: Aldakahlia zip: 35516 country: Egypt name: Moataz M Emara, MD, EDAIC role: CONTACT phone: 01064048848 email: mm.emara@mans.edu.eg lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06288022 id: COA. MURA2023/947 briefTitle: Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-30 date: 2026-06-30 date: 2024-03-01 date: 2024-03-07 name: Mahidol University class: OTHER briefSummary: Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.

This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL. conditions: Surgery-Complications conditions: Nephrolithiasis Staghorn Calculus conditions: Safety Issues studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial in 2 group

1. total tubeless mini-PCNL
2. tubeless mini-PCNL primaryPurpose: OTHER masking: DOUBLE maskingDescription: All eligible patients will be provided with an explanation of the research and invited to participate.

Patient will participate or not depends on whether they not meet the surgical exclusion criteria. If they meet the criteria, they will not participate in the research. If they not meet the criteria, they will be randomly assigned to one of the groups.

Patients will not be informed of the treatment intervention in advance whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 130 type: ESTIMATED name: total tubeless mini-PCNL name: tubeless mini-PCNL measure: incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL measure: The secondary objective is to assess the surgical outcomes between total tubeless mini-pcnl and tubeless mini-PCNL sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ramathibodi Hospital, Mahidol University city: Bangkok state: Ratchathewi zip: 10400 country: Thailand name: Thanakorn Sirajarus role: CONTACT phone: 086-599-3259 email: Thanakorn.sjr@gmail.com name: Chinnakhet Ketsuwan role: CONTACT phone: 086-345-6901 email: chinnakhet.ket@mahidol.ac.th lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06288009 id: 2135389 briefTitle: Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-06-01 date: 2024-03-01 date: 2024-03-01 name: University of California, Davis class: OTHER briefSummary: When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. The most commonly performed closure technique uses running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches. However, alternative closure techniques exist such as the running locking suture, which can offer advantages such as improved tension and thus reduce post-operative complications with better aesthetic outcome. In this study, half the wound will be stitched with standard running sutures and the other half will be stitched with running locking sutures. This will allow us to see if the side with running locking sutures heals with less scarring. conditions: Scarring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Two blinded observers will record their scores independently using the POSAS instrument. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Running locking suture name: Standard running suture measure: Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) measure: Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) measure: Width of Scar as measured using Trace-to-Tape Method measure: Complications or Adverse Events from Treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Davis - Dermatology Department status: RECRUITING city: Sacramento state: California zip: 95816 country: United States name: John Robb, BS role: CONTACT phone: 916-551-2636 email: jmrobb@ucdavis.edu name: Daniel Eisen, MD role: CONTACT phone: 916-551-2611 email: dbeisen@ucdavis.edu name: Daniel Eisen, MD role: PRINCIPAL_INVESTIGATOR name: Keemberly Kim, MD role: SUB_INVESTIGATOR name: Samantha Daniel, MD role: SUB_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False

 nctId: NCT06287996 id: 23MMHIS503e NA briefTitle: Effects of Warm Water Footbath Intervention on Sleep Quality , Fatigue and Heart Rate Variability in Patients With Heart Failure overallStatus: ENROLLING_BY_INVITATION date: 2024-02-23 date: 2024-06-01 date: 2024-08-01 date: 2024-03-01 date: 2024-03-01 name: Mackay Memorial Hospital class: OTHER briefSummary: This study adopted an experimental research design to explore the effects of a warm water foot bath program on fatigue, sleep, and heart rate variability in patients with heart failure. The subjects of the study were heart failure patients in the cardiology outpatient department. The patients were randomly assigned to the experimental group and the control group. The control group received routine care and wore an actigraph. The experimental group received 4 additional care in addition to routine care and wearing an actigraph. Weekly warm water foot bath, data collection includes subjective sleep quality and fatigue level, physiological measurements: sleep quality-sleep time and efficiency, and heart rate variability index. conditions: Footbath conditions: Heart Failure conditions: Sleep Quality conditions: Fatigue conditions: Heart Rate Variability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: footbath and actigraphy name: actigraphy measure: sleep quality measure: fatigue measure: heart rate variability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mackay Memorial Hospital city: Taipei state: Zhongshan zip: 104 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06287983 id: KayseriCHIMT001 briefTitle: Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity overallStatus: RECRUITING date: 2023-06-01 date: 2024-03-31 date: 2024-05-15 date: 2024-03-01 date: 2024-03-07 name: Kayseri City Hospital class: OTHER_GOV briefSummary: In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life. conditions: Ankylosing Spondylitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A total of 44 patients were randomly divided into 2 groups using the sealed envelope randomization method. The exercise program will be applied to both groups 3 sessions a week for 60 minutes for 6 weeks. Inspiratory muscle training will also be added to the intervention group. Patients included in the study; At weeks 0, 6, 12 and 24, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index), ASQoL (The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, Visual Analog scale (VAS) and maximum Dyspnea measurement during exercise, 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) will be evaluated. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic) name: The Sample Spondylitis Exercise Program measure: Respiratory function test (Spirometry) measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): measure: Bath Ankylosing Spondylitis Functional Index (BASFI) measure: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) measure: Modified Borg Scale measure: Measurement of dyspnea at maximum exercise with the Visual Analog Scale (VAS) measure: 6-minute walk test (6MWT) measure: Chest expansion measurement sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital status: RECRUITING city: Kayseri zip: 38080 country: Turkey name: Havva Talay Çalış, Prof role: CONTACT phone: +90352 315 77 00 phoneExt: 61244 email: htalaycalis@yahoo.com name: Esra Yaprak Tas, MD role: CONTACT phone: +905062007571 email: yaprak8100@gmail.com lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06287970 id: 2023-250-KY briefTitle: TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-12-31 date: 2027-02-18 date: 2024-03-01 date: 2024-03-21 name: Jiani Wu class: OTHER briefSummary: This trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This study is a prospective, randomized, controlled trial. A total of 68 patients with CP/CPPS will be recruited. After baseline assessment, the patients will be randomized into taVNS group (n = 34) and sham-taVNS group (n = 34). The intervention of two group will last for 4 weeks with a 8-week follow-up period after the treatment. The National Institutes of Health chronic Prostatitis Symptom Score index (NIH-CPSI), International Prostate Symptom Score Scale (IPSS), European quality of Life-5 Dimensions Questionnaire (EQ-5D), self-rating anxiety Scale (SAS) and self-rating depression scale (SDS) will be assessed. The adverse events during the whole study will be recorded detailedly. conditions: Chronic Prostatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Transcutaneous Auricular Vagus Nerve Stimulation name: Sham Transcutaneous Auricular Vagus Nerve Stimulation measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4 measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12 measure: The changes from baseline of NIH-CPSI pain score, urinary score and quality of life score, respectively at week 4, 8 and 12 measure: Proportion of responders at week 4, 8 and 12 measure: The change from baseline in International Prostate Symptom Score (IPSS) score at week 4, 8 and 12 measure: The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at week 4, 8 and 12 measure: The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12 measure: The change from baseline in the Self-rating Depression Scale (SDS) at week 4, 8 and 12 measure: Evaluation of patient expectations measure: Blinding Evaluation measure: Incidence of Treatment-Emergent Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Guang'anmen Hospita, China Academy of Chinese Medical Sciences city: Beijing state: Beijing zip: 100053 country: China name: Jiani Wu role: CONTACT phone: +8613426116653 email: jiani_wu@aliyun.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06287957 id: IU-DHF-AG-01 briefTitle: Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment: A Randomized Clinical overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2025-02-15 date: 2024-03-01 date: 2024-03-01 name: Istanbul University class: OTHER briefSummary: Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept. conditions: Peri-implant Mucositis conditions: Peri-Implantitis conditions: Bleeding on Probing conditions: Periodontal Pocket studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are going to be 4 treatment groups. Group 1: Mini Implant Platform treated with Labrida Bioclean Group 2: Regular Implant Platform treated with Labrida Bioclean Group 3: Mini Implant Platform treated with Air-Flow Device Group 4: Regular Implant Platform treated with Air-Flow Device primaryPurpose: PREVENTION masking: NONE count: 54 type: ESTIMATED name: Labrida BioClean name: EMS Handy 3.0 Perio Premium measure: Probing Depth measure: Bleeding on Probing measure: Plaque Index sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University status: RECRUITING city: Istanbul state: Fatih zip: 34080 country: Turkey name: Alper Gultekin, Assistant Professor role: CONTACT phone: +90 5326757236 email: alperg@istanbul.edu.tr name: Kerem Bahceci, PhD Candidate role: CONTACT phone: +90 5317132633 email: kerembhc@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06287944 id: 23694 id: NCI-2024-01131 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23694 type: OTHER domain: City of Hope Medical Center id: P30CA033572 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA033572 briefTitle: 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-06-18 date: 2027-02-24 date: 2027-02-24 date: 2024-03-01 date: 2024-03-01 name: City of Hope Medical Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS. conditions: Acute Lymphoblastic Leukemia conditions: Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Actinium Ac 225-DOTA-Daratumumab name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Computed Tomography name: Daratumumab name: Echocardiography name: Fludarabine name: Hematopoietic Cell Transplantation name: Indium In 111-DOTA-Daratumumab name: Melphalan name: Multigated Acquisition Scan name: Radionuclide Imaging name: Single Photon Emission Computed Tomography name: Sirolimus name: Tacrolimus name: Total Marrow and Lymphoid Irradiation measure: Incidence of adverse events (CTCAE) measure: Incidence of adverse events (Bearman) measure: Dose limiting toxicity (DLT) measure: Maximum tolerated dose/recommended phase II dose (MTD/RP2D) measure: Overall survival (OS) measure: Event-free survival (EFS) measure: Cumulative incidence of relapse/progression (CIR) measure: Graft versus host disease and relapse free survival (GRFS) measure: Complete remission (CR) proportion measure: Non-relapse mortality (NRM) measure: Incidence of infection measure: Neutrophil recovery rate measure: Incidence of grade 2-4 and 3-4 acute graft-versus-host disease (GVHD) measure: Incidence of chronic GVHD (cGVHD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center city: Duarte state: California zip: 91010 country: United States name: Jeffrey Y. Wong role: CONTACT phone: 626-218-2247 email: jwong@coh.org name: Jeffrey Y. Wong role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 hasResults: False

 nctId: NCT06287931 id: sdllycyy001 briefTitle: Probiotics for Gallstones in Post-bariatric Surgery Patients overallStatus: RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2025-06-01 date: 2024-03-01 date: 2024-03-01 name: Shandong Linglong Yingcheng Hospital class: NETWORK briefSummary: Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery. conditions: Bariatric Surgery Candidate conditions: Gallstone conditions: Gallstone Attack conditions: Gastrointestinal Quality of Life Index conditions: Probiotics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Ursodoxycholic acid group name: Bifidobacterium group measure: The incidence of gallstones in bariatric surgery patients sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Shandong Linglong Yingcheng Hospital status: RECRUITING city: Yantai state: Shandong zip: 264000 country: China name: Xuan Qiu, MD role: CONTACT phone: 8618354280081 email: qiuxuan100@163.com name: Ni Wang, MD role: CONTACT phone: 8618705353551 email: wangni1989@163.com lat: 37.47649 lon: 121.44081 hasResults: False

 nctId: NCT06287918 id: 3HP-2827-101 briefTitle: A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-03 date: 2028-06 date: 2024-03-01 date: 2024-04-11 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. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II). conditions: Solid Tumors With FGFR2 Alterations, Adult studyType: INTERVENTIONAL phases: PHASE1 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: Plasma Concentration of 3HP-2827 and/or its major metabolites measure: Duration of Response (DOR) as assessed by RECIST v1.1 measure: Progression-free survival (PFS) as assessed by RECIST v1.1 measure: Overall survival 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 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Phoenix state: Arizona zip: 85054 country: United States lat: 33.44838 lon: -112.07404 facility: The University of Texas MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06287905 id: Soh-Med-23-02-24 briefTitle: A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin overallStatus: RECRUITING date: 2023-02-01 date: 2024-07-01 date: 2024-07-01 date: 2024-03-01 date: 2024-03-01 name: Sohag University class: OTHER briefSummary: Interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to Sohag University Hospitals in 2 randomized groups. The first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. The second group will receive a combination of prazosin plus scorpion antivenom whether by the intravenous or the intramuscular route of administration. Both groups will receive proper first aid and supportive treatment conditions: Morality studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: observational comparative primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Simple randomization whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Prazosin Oral Tablet measure: Mortality measure: Morbidity sex: ALL minimumAge: 1 Year maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Meray Medhat Shokry Zaghary status: RECRUITING city: Sohag zip: 82515 country: Egypt name: Meray M Shokry Zaghary role: CONTACT phone: +201028911003 email: drevanho2013@gmail.com name: Mai M Abd El Kader role: CONTACT phone: +201028911003 email: drevanho2013@gmail.com lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06287892 id: AI-ECG-HCM briefTitle: Diagnosis of HCM With AI-ECG overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-01 date: 2024-03-06 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram. conditions: Hypertrophic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED measure: Diagnosis of HCM with AI-ECG sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road status: RECRUITING city: Shanghai zip: 200032 country: China name: Yixiu Liang, MD role: CONTACT phone: +8664041990 phoneExt: 612844 email: liang.yixiu@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06287879 id: 20231121 briefTitle: Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia overallStatus: RECRUITING date: 2023-04-01 date: 2024-12-20 date: 2024-12-30 date: 2024-03-01 date: 2024-03-01 name: Zhongnan Hospital class: OTHER briefSummary: Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592).

Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms.

This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia conditions: Dry Eye conditions: MGD-Meibomian Gland Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Dry eye examination measure: Lacrimal river height measure: tear break-up time measure: tear-film lipid layer thickness measure: meibomian glands two-dimensional digital infrared images sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Min Ke, Doctor role: CONTACT phone: +86-18672395959 email: keminyk@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06287866 id: 2099470 briefTitle: Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-06-01 date: 2024-03-01 date: 2024-03-01 name: University of California, Davis class: OTHER briefSummary: Oftentimes, following surgery on the scalp, wounds are left to heal by themselves. This is called "second intention." Open wounds left to heal on the scalp often take 8 weeks or more to completely heal. We are investigating how second intention closure compares to another established reconstruction technique, called "pinch graft." In the pinch graft technique, we numb and then shave off a thin piece of skin (usually from the groin area) and place it in the wound bed it (also known as "grafting"), to encourage growth of new healthy skin. This study will compare time-to-healing in the second intention method versus the pinch graft method. conditions: Scarring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Two blinded observers will record their scores independently using the POSAS instrument. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Pinch Graft measure: Time to re-epithelialization measure: Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) measure: Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Davis - Dermatology Department status: RECRUITING city: Sacramento state: California zip: 95816 country: United States name: John Robb, BS role: CONTACT phone: 916-551-2636 email: jmrobb@ucdavis.edu name: Daniel Eisen, MD role: CONTACT phone: 916-551-2611 email: dbeisen@ucdavis.edu name: Daniel Eisen, MD role: PRINCIPAL_INVESTIGATOR name: Keemberly Kim, MD role: SUB_INVESTIGATOR name: Ilana Breen, MD role: SUB_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False

 nctId: NCT06287853 id: EMBODY-004 briefTitle: Tapestry Rotator Cuff Repair PMCF overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2028-06-30 date: 2029-06-30 date: 2024-03-01 date: 2024-03-01 name: Zimmer Biomet class: INDUSTRY briefSummary: The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the Sponsor. conditions: Rotator Cuff Tears conditions: Rotator Cuff Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 170 type: ESTIMATED name: Tapestry Biointegrative Implant measure: Re-tear rate after arthroscopic rotator cuff repair measure: The American Shoulder and Elbow Surgeons (ASES) Score measure: Constant-Murley Score (CMS) measure: The Single Assessment Numeric Evaluation (SANE) Score measure: EQ-5D-5L (EuroQol) measure: Return to Work/Activity measure: Patient Satisfaction measure: Adverse Event measure: MRI Sugaya Classification measure: MRI Goutallier Classification sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287840 id: 17-301 id: 488294 type: OTHER_GRANT domain: Canadian Institute for Health Research briefTitle: Canadian Bone Strength Development Study acronym: CanBSDS overallStatus: RECRUITING date: 2024-04-01 date: 2028-12-31 date: 2028-12-31 date: 2024-03-01 date: 2024-03-06 name: University of Saskatchewan class: OTHER name: University of Calgary name: The Hospital for Sick Children name: Children's Hospital of Eastern Ontario briefSummary: The goal of this project is to learn about differences in bone development between children with and without type-1 diabetes (T1D). The main questions this study aims to answer are:

1. Assess how and when sex-specific bone developmental trajectories in the leg and arm will differ between children with T1D and control cohorts relative to the critical period of rapid skeletal growth in puberty. It is hypothesized that children with T1D will have inferior bone development, particularly lower gains in bone strength.
2. Assess why bone trajectories differ between T1D and control cohorts by identifying the role of body composition, site-specific muscle force and physical activity on differences in bone properties in female and male children with and without T1D. It is hypothesized that children with T1D will have lower gains in lean mass, muscle force, number of daily bone impacts and minutes of moderate-vigorous physical activity and will be associated with inferior gains in bone development.
3. Assess why T1D may impair sex-specific bone development by exploring the role of disease-related factors (e.g., duration, glucose control, hormones and markers of bone turnover) and fracture history on bone trajectories of children with T1D. It is hypothesized that longer exposure to T1D, poorer glucose control, alterations in hormones, lower bone formation markers and higher history of fracture will be negatively associated with bone trajectories of children with T1D.

Participant's physical growth, bone growth, muscle strength, physical activity and nutrition habits will be assessed and followed up annually for up to 4 years. conditions: Type-1 Diabetes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 204 type: ESTIMATED measure: Trabecular Thickness (μm) measure: Bone Strength (Failure load) measure: Total, Cortical and Trabecular Bone Area (mm^2) measure: Total, Cortical and Trabecular Bone Density (mg HA/cm^3) measure: Cortical Thickness (μm) measure: Cortical Porosity measure: Trabecular Bone Volume Fraction (%) measure: Trabecular Bone Number (1/mm) measure: Trabecular Bone Separation (μm) measure: Total Body and Hip Bone Mineral Content (g) measure: Total Body and Hip Areal Bone Mineral Density (g/cm^2) measure: Age from Peak Height Velocity (years) measure: Pubertal Development measure: Long Jump (m) measure: Hand Grip (N) measure: Bone Impacts measure: Physical Activity (minutes/day) measure: Food Frequency Questionnaire measure: Health measure: Osteocalcin measure: Procollagen type I N-propeptide (P1NP-N) measure: C-terminal telopepide (CTx) measure: Sclerostin measure: Insulin growth factor-1 measure: Alkaline phosphatase sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD facility: University of Saskatchewan status: RECRUITING city: Saskatoon state: Saskatchewan zip: S7N5B2 country: Canada name: Saija Kontulainen, PhD role: CONTACT phone: (306)966-1077 email: saija.kontulainen@usask.ca lat: 52.13238 lon: -106.66892 hasResults: False

 nctId: NCT06287827 id: 190224 briefTitle: Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research overallStatus: RECRUITING date: 2024-02-14 date: 2024-06-01 date: 2024-06-01 date: 2024-03-01 date: 2024-03-05 name: UNICEF - Venezuela class: OTHER briefSummary: The goal of this observational study is to compare the effectiveness, safety, and efficiency of the simplified protocol, which includes the following three modifications: a) use of a single treatment product (RUTF), b) reduced dose, c) expanded cut-offs, with the standard protocol based on the 2023 World Health Organization (WHO) guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months, in outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela.

The main question it aims to answer is:

What is the effectiveness, safety, and efficiency of the simplified protocol, which includes these three modifications (use of a single treatment product (RUTF), reduced dose, expanded cut-offs) when compared to a standard protocol that is based on the 2023 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in the outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela? This prospective cohort, longitudinal study will be conducted in 4 states, treating children aged 6-59 months diagnosed with uncomplicated AM, defined as WHZ \<-2 or mid-upper-arm circumference (MUAC) \<125mm or bilateral edema. Children will be prospectively followed for 16 weeks or until their recovery.

Researchers will compare the simplified protocol cohort with the standard protocol cohort to determine which one has the best effectiveness, safety, and efficiency indicators in the Venezuela context.

The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment, and changes in anthropometry (weight, height, and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death, and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered. conditions: Acute Malnutrition in Childhood conditions: Wasting conditions: Child Malnutrition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Simplified protocol name: Standard protocol measure: Recovery rate measure: Weight gain measure: Mid-Upper Arm Circumference (MUAC) gain measure: Duration of the treatment measure: Prevalence of child morbidity measure: Number of RUTF delivered per child measure: Cost per child measure: Prevalence of child stunting sex: ALL minimumAge: 6 Months maximumAge: 59 Months stdAges: CHILD facility: Bolivar State Centers status: RECRUITING city: Puerto Ordaz state: Bolivar zip: 8050 country: Venezuela name: Mary Lares, PhD role: CONTACT phone: +584166203588 email: marylares@hotmail.com name: Mary Lares, PhD role: PRINCIPAL_INVESTIGATOR lat: 8.29829 lon: -62.72198 facility: Ditrict Capital centers status: RECRUITING city: Caracas state: Capital District zip: 1090 country: Venezuela name: Pablo Hernandez, MSc role: CONTACT phone: +584142561345 email: doctuscumliber@gmail.com name: Pablo Hernandez, MSc role: PRINCIPAL_INVESTIGATOR lat: 10.48801 lon: -66.87919 facility: Miranda State Centers status: RECRUITING city: Santa Lucia state: Miranda zip: 1214 country: Venezuela name: Pablo Hernandez, MSc role: CONTACT phone: +584142561345 email: doctuscumliber@gmail.com name: Pablo Hernandez, MSc role: PRINCIPAL_INVESTIGATOR facility: La Guaira State Centers status: RECRUITING city: La Guaira zip: 1160 country: Venezuela name: Claret Mata, MSc role: CONTACT phone: +584142052498 email: clujaym@gmail.com name: Claret Mata, MSc role: PRINCIPAL_INVESTIGATOR lat: 10.59901 lon: -66.9346 hasResults: False

 nctId: NCT06287814 id: RECHMPL23_0299 briefTitle: French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-10-31 date: 2028-10-31 date: 2024-03-01 date: 2024-03-01 name: University Hospital, Montpellier class: OTHER briefSummary: Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.

There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.

The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.

FRENCH-MRD-CRC is the French study of the european GUIDE.MRD project. conditions: Colorectal Cancer conditions: Stage III Colon Cancer conditions: Minimal Residual Disease conditions: Liquid Biopsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Blood sample/lliquid biopsy measure: 3-year disease-free survival (DFS) measure: Sensitivity (Se) of the ctDNA diagnostics measure: Specificity (Sp) of the ctDNA diagnostics measure: Positive predictive value of the ctDNA diagnostics measure: Negative predictive value of the ctDNA diagnostics measure: Area under the curve of the ctDNA diagnostics measure: Time to clinical recurrence measure: Overall survival measure: Time to molecular recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287801 id: 2024P000271 briefTitle: Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 1 acronym: SPIRE1 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-01 date: 2025-06-01 date: 2024-03-01 date: 2024-03-25 name: Massachusetts General Hospital class: OTHER name: Brandeis University name: Patient-Centered Outcomes Research Institute name: Vanderbilt University Medical Center name: Dartmouth-Hitchcock Medical Center name: Indiana University briefSummary: This study consists of three aims focused on examining the feasibility of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) to improve patient and caregiver outcomes and reduce hospitalizations in older adults with complex health needs. The objectives are to:

1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms
2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants
3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention. conditions: Healthy Aging conditions: Health Care Utilization conditions: Health-Related Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Feasibility of a clinical comparative effectiveness trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcomes assessor team will be blinded to the intervention assignments of participants. Due to the nature of the intervention, the participants, the investigator, and the care providers are unable to be blinded to the participant assignments. whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Annual Wellness Visit name: Geriatric Resources and Assessment for the Care of Elders measure: Hospitalizations measure: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS) measure: Net Promotor Score measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH) measure: Caregiver Strain measure: Patient's out-of-pocket costs for up to 180 days after enrollment measure: Caregiver's hours spent caregiving. measure: Pilot ACOs Staffing costs measure: Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes measure: Exploratory Geriatric Outcomes- number of participants that complete advanced care planning documents measure: Exploratory Geriatric Outcomes - number of participants with inappropriate medications measure: Covariate - Demographics measure: Covariate - Medicare Entitlement Status measure: Covariate - Elixhauser comorbidity index measure: Covariate - Area Deprivation Index measure: Covariate - Loneliness measure: Exploratory - Hope measure: Covariate - Activities of daily living (ADL) measure: Exploratory - ED visits measure: Exploratory - Observation visits sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287788 id: NFEC-2024-068 briefTitle: A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis overallStatus: RECRUITING date: 2024-03-01 date: 2026-10-30 date: 2026-12-31 date: 2024-03-01 date: 2024-03-01 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: The performance of the predictive models for severe oropharyngeal mucositis established using current oral mucosal contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance. The aim of this prospective, multicenter, observational study was to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC. conditions: Radiation-induced Oropharyngeal Mucositis conditions: Swallowing-induced Breakthrough Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 240 type: ESTIMATED measure: The AUC of the predictive model measure: The accuracy, sensitivity, specificity, positive predictive value, negative predictive value and F1 score of the predictive model measure: The important predictors of severe oropharyngeal mucositis in the predictive model sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Jian Guan, Ph.D. role: CONTACT phone: 86+13632102247 email: guanjian5461@163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06287775 id: NCI-2024-01398 id: NCI-2024-01398 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10629 type: OTHER domain: JHU Sidney Kimmel Comprehensive Cancer Center LAO id: 10629 type: OTHER domain: CTEP id: UM1CA186691 type: NIH link: https://reporter.nih.gov/quickSearch/UM1CA186691 briefTitle: Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-24 date: 2026-01-31 date: 2026-01-31 date: 2024-03-01 date: 2024-03-12 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer. conditions: Extensive Stage Lung Small Cell Carcinoma conditions: Stage IV Lung Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Atezolizumab name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Durvalumab name: Echocardiography name: Iadademstat name: Magnetic Resonance Imaging name: Multigated Acquisition Scan measure: Progression free survival measure: Objective response rate measure: Overall survival measure: Incidence of adverse events measure: Detection of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) minimal residual disease measure: Impact of iadademstat on the correlation of immune checkpoint inhibitors (ICIs) and the presence of cachexia measure: Exposure response relationships of iadademstat in combination with ICIs measure: Changes to small cell lung cancer subtype sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287762 id: 10001737 id: 001737-NR briefTitle: A Natural History Study of RYR1-Related Disorders overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2031-04-30 date: 2031-12-30 date: 2024-03-01 date: 2024-04-26 name: National Institute of Nursing Research (NINR) class: NIH briefSummary: Background:

Congenital myopathies (CM) are genetic disorders that can cause decreased muscle tone and muscle weakness. Most CMs in the United States are related to the ryanodine receptor 1 (RYR1) gene. Researchers need more natural history data to learn about these CMs in children and adults.

Objective:

To learn more about the signs, symptoms, and course of RYR1-related disorders.

Eligibility:

People aged 7 years and older with an RYR1-related disorder.

Design:

Ambulatory participants will come to the Clinical Center and non-ambulatory participants will visit via telehealth.

Visits will be once a year for 3 or 5 years. Clinical Center visits will take 2 to 3 days.

All participants will undergo tests including:

Photos and videos. These will be taken to document the participant s condition.

Blood and urine tests.

Activity Tracker. Participants will wear a device to record their activity.

Questionnaires. Participants will answer questions about their health, pain, fatigue, stress, quality of life, and other topics.

Participants who visit the Clinical Center will also undergo:

Tests of heart and lung function.

Motor skills and strength tests. Participants will walk, climb stairs, kneel, crawl, stand up, and perform other movements to test their strength and abilities. They will squeeze and pinch a handheld device to test their grip.

Imaging scans.

Skin biopsy. Adult participants may opt to have a sample of skin taken (one time only).

Eye exam conditions: Ryanodine Receptor 1-Related Myopathy conditions: Ryanodine Receptor 1 Related Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Adverse and disease-related events measure: Medical data review measure: Ophthalmology measure: Patient-reported outcomes measure: Pulmonary function measure: Motor function and performance measure: Characterize phenotype and disease course over an extended (2-year) period (total 5 years).Collect exploratory biomarker data. sex: ALL minimumAge: 7 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: Irene Chrismer role: CONTACT phone: 240-591-8884 email: irene.chrismer@nih.gov name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: (800) 411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06287749 id: RECHMPL23_0298 briefTitle: French Assessment of MRD by Liquid Biopsies in PDAC Patients (FRENCH.MRD.PDAC) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-10-31 date: 2028-10-31 date: 2024-03-01 date: 2024-03-01 name: University Hospital, Montpellier class: OTHER briefSummary: The overall objective of this GUIDE.MRD consortium is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.

Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.

Specifically, the investigators want to determine the association between disease-free survival (DFS) and ctDNA detection status after

1. curative-intended surgery and
2. adjuvant chemotherapy.

FRENCH.MRD.PDAC is the French study of the european GUIDE.MRD project conditions: Pancreatic Cancer Resectable conditions: Pancreatic Ductal Adenocarcinoma conditions: Minimal Residual Disease conditions: Liquid Biopsy conditions: ctDNA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 37 type: ESTIMATED name: Blood sample/Liquid Biopsy measure: 3-year Disease-free survival (DFS) measure: Sensitivity (Se) of the ctDNA diagnostics measure: Specificity (Sp) of the ctDNA diagnostics measure: Positive predictive value of the ctDNA diagnostics measure: Negative predictive value of the ctDNA diagnostics measure: Are Under the Curve of the ctDNA diagnostics measure: Time to clinical recurrence measure: Overall survival measure: Time to molecular recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287736 id: 2023H0386 briefTitle: Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-01 date: 2024-03-01 name: Ohio State University class: OTHER name: Neuright, Inc. briefSummary: This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers. conditions: Diabetic Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Spinal Cord Stimulator Implantation (SCS) measure: Change in Pain level measure: Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4) measure: Change in PROMIS quality of life in relation to pain level measure: change in neuropathic symptoms using Michigan Neuropathy Screening instrument sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University Wexner Medical Center city: Columbus state: Ohio zip: 43210 country: United States name: Uchechi Okafor role: CONTACT phone: 614-366-3439 email: Uchechi.Okafor@osumc.edu name: Brian Dalm, MD role: PRINCIPAL_INVESTIGATOR name: Kristy Townsend, PhD role: SUB_INVESTIGATOR name: Magdalena Blaszkiewicz, PhD role: SUB_INVESTIGATOR name: Miriam Freimer, MD role: SUB_INVESTIGATOR name: Bakri Elsheikh, MD role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06287723 id: RECHMPL23_0297 briefTitle: French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-10-31 date: 2028-10-31 date: 2024-03-01 date: 2024-03-01 name: University Hospital, Montpellier class: OTHER briefSummary: Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.

There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.

The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.

FRENCH.MRD.CRLM is the French study and part of the european GUIDE.MRD project. conditions: Colorectal Cancer conditions: Liver Metastases conditions: Stage IV Colorectal Cancer conditions: Minimal Residual Disease conditions: Liquid Biopsy conditions: ctDNA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Blood sample/Liquid biopsy measure: 3-year disease free survival measure: Sensitivity (Se) of the ctDNA diagnostics measure: Specificity (Sp) of the ctDNA diagnostics measure: Positive predictive value of the ctDNA diagnostics measure: Negative predictive value of the ctDNA diagnostics measure: Area under the curve of the ctDNA diagnostics measure: Time to clinical recurrence measure: Overall survival measure: Time to molecular recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287710 id: CHUBX 2023/32 briefTitle: Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA acronym: FRENCH-PREMA overallStatus: RECRUITING date: 2024-01-17 date: 2024-11-17 date: 2025-04-17 date: 2024-03-01 date: 2024-03-01 name: University Hospital, Bordeaux class: OTHER briefSummary: In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in preterm infants (term below 37 gestational week) with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion). conditions: Premature Baby 26 to 32 Weeks conditions: Premature Baby 33 to 36 Weeks studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment). measure: Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, measure: Diagnostic accuracy of the SAV mean and the ΔPeak for the diagnosis of fluid responsiveness sex: ALL minimumAge: 1 Minute maximumAge: 5 Months stdAges: CHILD facility: Bordeaux Hospital University status: RECRUITING city: Bordeaux zip: 33076 country: France name: Sophie CRAMAREGEAS, MD role: CONTACT phone: 0557821269 name: sophie.cramaregeas@chu-bordeaux.fr role: CONTACT lat: 44.84044 lon: -0.5805 hasResults: False

 nctId: NCT06287697 id: LOA/RAP/2019/20 briefTitle: Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia overallStatus: ACTIVE_NOT_RECRUITING date: 2020-01-21 date: 2024-11-30 date: 2024-11-30 date: 2024-03-01 date: 2024-03-01 name: Mahidol University class: OTHER name: International Atomic Energy Agency name: National Institute of Nutrition, Vietnam name: Faculty of Medicine, University of Ruhuna, Sri Lanka name: Pakistan Institute of Nuclear Science and Technology (PINSTECH) name: Food and Nutrition Research Institute, Philippines name: FAO briefSummary: This project is a collaboration between International Atomic Energy Agency (IAEA), FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design. conditions: Energy Expenditure conditions: Body Composition conditions: Infants and Young Children conditions: Infant and Young Child Feeding studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 391 type: ACTUAL name: No intervention measure: Total Energy Expenditure measure: Body composition measure: Weight measure: Length measure: Head circumference measure: Mid-upper arm circumference measure: Triceps skinfold thickness measure: Subscapular skinfold thickness measure: Infant and Young Child Feeding (IYCF) measure: Dietary intake sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Institute of Nutrition, Mahidol University city: Salaya state: Nakhon Pathom zip: 73170 country: Thailand lat: 13.802 lon: 100.32111 hasResults: False

 nctId: NCT06287684 id: ESICM-22 briefTitle: Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis acronym: MENDSEP overallStatus: RECRUITING date: 2023-09-13 date: 2025-12-30 date: 2025-12-30 date: 2024-03-01 date: 2024-03-01 name: Mater Dei Hospital, Malta class: OTHER name: European Society of Intensive Care Medicine name: University of Malta briefSummary: Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection. conditions: Sepsis conditions: Septic Shock conditions: Pneumonia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 132 type: ESTIMATED name: Blood transcriptomics and BAL protein profiling measure: Patient stratification as transcriptomic endotypes measure: Lung endothelial barrier integrity measure: Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mater Dei hospital, Intensive Care Unit status: RECRUITING city: Imsida zip: MSD2080 country: Malta name: Carmel Abela role: CONTACT phone: +35625450000 email: carmel.c.abela@gov.mt lat: 35.8925 lon: 14.48278 hasResults: False

 nctId: NCT06287671 id: COCO briefTitle: Colorectal Omics and ofCS Proteoglycans acronym: COCO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-12 date: 2032-12 date: 2024-03-01 date: 2024-03-01 name: Claus Anders Bertelsen, PhD, MD class: OTHER name: Viborg Regional Hospital briefSummary: This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.

The main questions to answer are:

* can these biomarkers predict anastomotic leakages
* can these biomarkers predict recurrence after colorectal cancer
* can these biomarkers be used as diagnostic tests for colorectal cancer
* can these biomarkers be identified in the tumor

Participants will undergo elective colorectal resection or stoma closure. conditions: Colorectal Cancer conditions: Diverticulitis, Colonic conditions: Inflammatory Bowel Diseases conditions: Stoma Colostomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Colorectal resection or stoma closure measure: Rate of anastomotic leakage diagnosed by CT-scan or reoperation measure: Rate of major postoperative complications measure: Short-term mortality measure: Recurrence after colorectal cancer measure: Diagnostic value of omics and other biomarkers detecting colorectal cancer measure: Correlation between biomarker in plasma and tissue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nordsjaellands Hospital city: Hillerød zip: 3400 country: Denmark name: Nanna B Hupfeld, MD role: CONTACT phone: +4548292793 email: nanna.baekvang.hupfeld.01@regionh.dk name: Claus A Bertelsen, PhD role: CONTACT phone: +4548295972 email: claus.anders.bertelsen@regionh.dk lat: 55.92791 lon: 12.30081 facility: Regionshospitalet Viborg city: Viborg zip: 8800 country: Denmark name: Uffe S Løwe, PhD role: CONTACT lat: 56.45319 lon: 9.40201 hasResults: False

 nctId: NCT06287658 id: E-57428665-050.04-240046 briefTitle: The Effect of Kegel Exercise and Ba Duan Jin Applications on Premenopausal Women With Urinary Incontinence overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2025-03-01 date: 2024-03-01 date: 2024-04-03 name: Ondokuz Mayıs University class: OTHER briefSummary: This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement. conditions: Urinary Incontinence conditions: Menopause conditions: Wolman Disease conditions: Quality of Life conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Training on Kegel exercise and Ba Duan Jin applications online name: training on Kegel exercises and Ba Duan Jin applications after the research is completed measure: Psychological Well-Being Scale measure: Incontinence Quality of Life Scale sex: FEMALE minimumAge: 45 Years maximumAge: 55 Years stdAges: ADULT facility: Tuba Yilmaz Bulut status: RECRUITING city: Kocaeli country: Turkey name: TUBA YILMAZ BULUT, Dr. role: CONTACT phone: 05343435109 email: tuba_yilmaz1991@hotmail.com lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06287645 id: Retinal Images Dataset briefTitle: Color Fundus Photograph With Experts Labelling overallStatus: RECRUITING date: 2022-05-12 date: 2025-12-31 date: 2026-06-30 date: 2024-03-01 date: 2024-03-07 name: Pakistan Council of Scientific and Industrial Research class: OTHER name: Al-Ibrahim Eye Hospital briefSummary: This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care. conditions: Retinal Disease conditions: Diabetic Retinopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 50000 type: ESTIMATED name: Color Fundus Photography/Non-Mydriatic Opthalmic Cameras measure: Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale measure: Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale measure: Finding inter-rater agreement among the graders sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Al Ibrahim Eye Hospital status: RECRUITING city: Karachi country: Pakistan name: Ghulam Mustafa role: CONTACT email: mustafabme@gmail.com lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06287632 id: 2024P000451 briefTitle: CPAP in Patients With Severe Obesity After Anesthesia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-11 date: 2026-06 date: 2024-03-01 date: 2024-03-01 name: Massachusetts General Hospital class: OTHER briefSummary: The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are:

1. Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia?
2. Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia?

Participants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes.

* Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure
* Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present). conditions: Obesity, Abdominal conditions: Anesthesia Morbidity conditions: Apnea, Obstructive Sleep conditions: Atelectases, Postoperative Pulmonary conditions: Ventilator Lung studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Recruitment/ITP-CPAP (Intervention A) name: Standard CPAP (Intervention B) name: Atmospheric Pressure measure: End expiratory lung impedance measure: Regional lung ventilation measure: Right ventricular function measure: Mean pulmonary artery pressure measure: Inspiratory effort measure: Abdominal muscle thickness measure: Respiratory rate measure: Oxygen saturation measure: Systemic blood pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287619 id: 22-5685 briefTitle: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery acronym: POAM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-03-01 date: 2024-03-07 name: University Health Network, Toronto class: OTHER name: Queen's University name: Sunnybrook Health Sciences Centre name: Heart and Stroke Foundation of Canada briefSummary: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo. conditions: Chronic Iron Deficiency Anaemia conditions: Cardiac Surgery studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: This is a blinded study, with patients randomized to receive ferric derisomaltose (Monoferric) or placebo. Given that the products have different physical appearances, an unblinded research pharmacist will prepare the IMP then blind the appearance of the IMP for both the intervention group and control group by covering the IV bag and tubing with opaque plastic. All other clinicians, research coordinators, outcome assessors, and patients will remain blinded by using a generic product label in the patient chart and/or the electronic product name (i.e., POAM study drug dose 1 and dose 2, rather than specifying type of product used). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Monoferric Injectable Product name: 0.9% sodium chloride solution measure: Feasibility Outcome 1: Percentage of major protocol deviations measure: Feasibility Outcome 2: Adequate patient enrollment measure: Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kingston Health Sciences Centre city: Kingston state: Ontario zip: K7L 3N6 country: Canada lat: 44.22976 lon: -76.48101 facility: Sunnybrook Health Sciences Centre city: Toronto state: Ontario zip: M4N 3M5 country: Canada lat: 43.70011 lon: -79.4163 facility: Toronto General Hospital - University Health Network city: Toronto state: Ontario zip: M5G 2C4 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06287606 id: CTP0302 briefTitle: A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-29 date: 2024-01-17 date: 2024-05-14 date: 2024-03-01 date: 2024-03-01 name: Taejoon Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy conditions: Bowel Preparation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 161 type: ACTUAL name: CTP0302-A name: CTP0302-B name: Conventional OST measure: Ratio of subjects With successful Bowel Cleansing measure: Each segments ratio of subject with successful Bowel Cleansing measure: Comparison of Acute gastropathy probability score sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taejoon Pharmaceutical Co., Ltd. city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06287593 id: NeoLiq briefTitle: The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-31 date: 2027-12-31 date: 2024-03-01 date: 2024-04-24 name: Zhejiang University class: OTHER briefSummary: This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients. conditions: EGF-R Positive Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: ctDNA monitoring measure: the rate of major pathological response (MPR) measure: the rate of pathological complete response (pCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287580 id: STU-2024-0140 briefTitle: Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults With Hypertension. overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-01-01 date: 2027-01-01 date: 2024-03-01 date: 2024-04-24 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: High blood pressure (BP) is a public health problem worldwide. Nearly three-quarters of older adults (age \~60 years) in the United States have high BP. High BP links to many health problems, like stroke. Drug treatments are typically used in clinics to reduce high BP and the risk of associated health problems. However, these drug treatments may not always benefit brain health. For example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high BP. Alternatively, reduced brain blood flow may cause high BP due to increased nervous system activity (the so-called "fight or flight response"). Thus, monitoring brain blood flow may help to manage high BP during drug treatment.

It is unknown if brain blood flow and its control will be altered by drug treatment in older high BP patients. Therefore, study team will recruit older adults with high BP, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment.

Results from this study will provide novel and clinically relevant information on the impact of drug treatment for high BP on brain health. Investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for BP control and brain health. conditions: Essential Hypertension conditions: Older Adults studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: chlorthalidone 25 mg name: Placebo measure: Change in Muscle sympathetic nerve activity (MSNA) from baseline at 2 weeks post intervention measure: Change in cognitive performance from baseline at 2 weeks post intervention via Stroop Color and Word Test measure: Change in cognitive performance from baseline at 2 weeks post intervention via NIH Toolbox Cognitive Battery measure: Change in Cerebral blood flow from baseline at 2 weeks post intervention sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Exercise and Environmental Medicine city: Dallas state: Texas zip: 75231 country: United States name: Takuro Washio, Ph.D. role: CONTACT phone: 214-345-4852 email: TakuroWashio@texashealth.org lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06287567 id: IIT2023078-EC-1 briefTitle: Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP) overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-30 date: 2024-11-30 date: 2024-03-01 date: 2024-03-04 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy conditions: Idiopathic Thrombocytopenic Purpura conditions: Immune Thrombocytopenia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 17 type: ESTIMATED name: Lusutrombopag Oral Tablet measure: Percentage of Participants with a Platelet Response after 4 Weeks (Day 29) measure: Percentage of Participants with a Platelet Response after 12 Weeks (Day 85) measure: Percentage of Participants Who at least once Achieved a Platelet Count of ≥100x10^9/L in the Core Study measure: Change in Platelet Count measure: Percentage of Participants Who at least once Achieved a Platelet Count of≥50x10^9 /L during the Treatment measure: Percentage of Participants Who at least once Achieved a Platelet Count of≥100x10^9 /L during the treatment measure: Time to first Achieve a Platelet Count of ≥ 50x10^9/L measure: Time to first Achieve a Platelet Count of ≥100x10^9 /L measure: Percentage of Participants Who at least once Achieved a Platelet Coun platelet count≥30×10^9/L, a≥2-fold increase from baseline within week 1-4 and week 5-12，respectively. measure: Durable Platelet Response (platelet count ≥50×10^9/L in ≥75% of weeks) Rate measure: Cumulated Number of Weeks of Response（≥50x10^9/L） measure: Percentage of Participants with a Reduction in the use of Concomitant ITP Medications from Baseline measure: The Incidence and Rating of Bleeding Events During the Study measure: Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study measure: Number of Participants With Adverse Events (AEs) measure: Change in Health-related Quality of Life Assessed by FACIT-F Scale from Baseline to Week 16 measure: Change in Health-related Quality of Life Assessed by ITP-PAG Scale from Baseline to Week 16 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology & Blood Diseases Hospital city: Tianjin state: Tianjin zip: 300020 country: China lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06287554 id: 404/2024 briefTitle: Effect of Early Implementation of Prone Positioning acronym: prone overallStatus: COMPLETED date: 2020-03-04 date: 2022-04-20 date: 2022-04-20 date: 2024-03-01 date: 2024-03-01 name: Zulekha Hospitals class: OTHER name: Al-Azhar University briefSummary: Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU. conditions: Severe Acute Respiratory Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 70 type: ACTUAL name: PRONE POSITION measure: Number of discharged patients measure: The total length of stay measure: ICU length of stay measure: Patients who underwent tracheostomy procedures sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Al-Azhar faculty of medicine city: Cairo zip: 12546 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06287541 id: 2023-SR-486 briefTitle: The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection overallStatus: RECRUITING date: 2023-07-01 date: 2025-12-01 date: 2027-07-01 date: 2024-03-01 date: 2024-03-01 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT. conditions: Non Muscle Invasive Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines.

Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes. primaryPurpose: TREATMENT masking: NONE count: 428 type: ESTIMATED name: Urine biomarker -Guided without reTURBT measure: 2-year RFS rate measure: RFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Qiang Lv, Ph.D role: CONTACT email: doctorlvqiang@sina.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06287528 id: 23-307 briefTitle: A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL) overallStatus: RECRUITING date: 2024-02-23 date: 2028-02-23 date: 2028-02-23 date: 2024-03-01 date: 2024-04-03 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z/IL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks. conditions: Philadelphia-Negative ALL conditions: Philadelphia-Positive ALL conditions: Relapsed ALL, Adult conditions: Refractory Acute Lymphoblastic Leukemia conditions: Refractory Acute Lymphoblastic Leukemia (ALL) conditions: Refractory Acute Lymphoid Leukemia in Relapse studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: 19-28z/IL-18 CAR T cells measure: Toxicity as determined by CTCAE, version 5.0 sex: ALL minimumAge: 17 Years stdAges: CHILD 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: Jae Park, MD role: CONTACT phone: 646-608-3743 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: Jae Park, MD role: CONTACT phone: 646-608-3743 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: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Jae Park, MD role: CONTACT phone: 646-608-3743 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: Jae Park, MD role: CONTACT phone: 646-608-3743 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: Jae Park, MD role: CONTACT phone: 646-608-3743 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: Jae Park, MD role: CONTACT phone: 646-608-3743 lat: 40.70038 lon: -73.59291 hasResults: False

 nctId: NCT06287515 id: 2023-0940 id: NCI-2024-01986 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2025-07-01 date: 2027-07-01 date: 2024-03-01 date: 2024-03-04 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain. conditions: Hypophysectomy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Stereotactic Radiosurgery 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: Chenyang Wang, MD role: CONTACT phone: 832-710-1570 email: cwang23@mdanderson.org name: Chenyang Wang, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06287502 id: KHRehab_LeungHC_2 briefTitle: Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-09 date: 2024-04-30 date: 2024-06-30 date: 2024-03-01 date: 2024-03-04 name: Kowloon Hospital, Hong Kong class: OTHER briefSummary: This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention. conditions: Sarcopenia conditions: Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: β-hydroxy β-methylbutyrate (HMB) name: Resistance, aerobic, flexibility and balance exercise training measure: Grip strength measure: Body weight measure: Body mass index measure: Appendicular skeletal muscle mass index measure: 6-metre walk test measure: 5-time chair stand test measure: Short Physical Performance Battery (SPPB) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kowloon Hospital city: Kowloon country: Hong Kong lat: 22.31667 lon: 114.18333 hasResults: False

 nctId: NCT06287489 id: No.:2023-08-010ACF briefTitle: Effects of Mediterranean Diet on Subjective Cognitive Decline overallStatus: RECRUITING date: 2023-10-26 date: 2025-10-31 date: 2025-12-31 date: 2024-03-01 date: 2024-03-01 name: Chih-Ping Chung class: OTHER_GOV name: National Yang Ming Chiao Tung University briefSummary: Research Questions:

1. Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals, and while the observed effects were significant, they were not particularly substantial, does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline (SCD)?
2. What is the mechanism behind the effects of the Mediterranean diet on physical or/and cognitive function? Is it through vascular protection or improvements in brain structure/brain network function?

Research Objective:

Conduct a cross-over randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline (SCD) in the community. Utilize brain MRI and circulatory biomarkers measurements to elucidate the underlying mechanisms. conditions: Subjective Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Mediterranean diet phase X regular diet phase primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Mediterranean diet name: Regular diet measure: Cognitive functional change measure: Physical function 1 - gait speed change measure: Physical function 2 - handgrip strength change measure: Physical function 3 - stand from chair speed change measure: Brain MRI structural change - total and regional voxel-based brain parenchymal features change measure: Brain MRI functional change - total and regional voxel-based brain functional features change measure: Brain MRI neurovascular lesion change - small vessel disease markers measure: Brain MRI neurovascular structural change - microvascular density measure: AD circulatory biomarkers sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei zip: 11217 country: Taiwan name: Chih-Ping Chung, MD PhD role: CONTACT phone: +886-2-918155976 email: pin324pin324@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06287476 id: H-23043870 briefTitle: Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA) overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-03-01 date: 2024-03-01 name: Rigshospitalet, Denmark class: OTHER briefSummary: It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 32 type: ESTIMATED name: Acute exercise bout on visit 2 and 3 measure: Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls measure: Pulmonary DTPA clearance at rest in COPD vs. controls measure: Pulmonary DTPA clearance after exercise in COPD vs. controls measure: Rest-to-exercise change in lung tissue mass in COPD vs. controls measure: Lung tissue mass at rest in COPD vs. controls measure: Lung tissue mass after exercise in COPD vs. controls measure: Rest-to-exercise pulmonary DTPA clearance and lung tissue mass change according to GOLD measure: Supine pulmonary capillary blood volume after exercise in COPD vs. controls measure: Supine cardiac output after exercise in COPD vs. controls measure: Supine pulmonary capillary blood volume at rest in COPD vs. controls measure: Supine cardiac output at rest in COPD vs. controls measure: Supine pulmonary diffusing capacity to nitric oxide (DLNO) after exercise in COPD vs. controls measure: Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) after exercise in COPD vs. controls measure: Supine alveolar-capillary membrane diffusing capacity (DM) after exercise in COPD vs. controls measure: Supine pulmonary diffusing capacity to nitric oxide (DLNO) at rest in COPD vs. controls measure: Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) at rest in COPD vs. controls measure: Supine alveolar-capillary membrane diffusing capacity (DM) at rest in COPD vs. controls sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center For Physical Activity Research, Rigshospitalet city: Copenhagen country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06287463 id: DCC-3084-01-001 briefTitle: Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2027-08 date: 2024-03-01 date: 2024-04-29 name: Deciphera Pharmaceuticals LLC class: INDUSTRY briefSummary: This is a multicenter, Phase 1/2 clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). conditions: Advanced Solid Tumor conditions: RAF Mutation conditions: RAS Mutation conditions: NF1 Mutation conditions: Non-Small Cell Lung Cancer conditions: Pancreatic Ductal Adenocarcinoma conditions: Melanoma conditions: BRAF Gene Mutation conditions: CRAF Gene Mutation studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: DCC-3084 measure: Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1) measure: Objective Response Rate (ORR) (ModA Part 2) measure: ORR (ModA Part 1) measure: Progression-Free Survival (PFS) (ModA Part 1 and 2) measure: Overall Survival (OS) (ModA Part 1 and 2) measure: Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology city: San Antonio state: Texas zip: 78229 country: United States name: Ildefonso Ismael Rodriguez Rivera, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: NEXT Oncology Virginia city: Fairfax state: Virginia zip: 22031 country: United States name: Alexander Spira, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 hasResults: False

 nctId: NCT06287450 id: IN006001 briefTitle: A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-04 date: 2026-10 date: 2024-03-01 date: 2024-03-01 name: Shenzhen Shenxin Biotechnology Co., Ltd class: INDUSTRY briefSummary: The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Bivalent RSV Vaccine (IN006) name: Placebo measure: Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination measure: Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination measure: Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation Through 12 Months After Initial Vaccination measure: Percentage of Participants With Any Medically Attended AEs (MAAEs) Through 6 Months After Initial Vaccination measure: Geometric Mean Titer (GMT) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) measure: Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) measure: Vaccine Response Rate for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) measure: GMC for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) measure: GMFR for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) measure: Vaccine Response Rate for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) measure: Frequency of Pre-F Specific IFN-γ/IL-4 Secreting T cells (Via Enzyme-Linked Immunospot [ELISpot] Assay) measure: Frequency of Pre-F Specific CD4 and CD8 T Cells Expressing Activation Markers (Via Intracellular Cytokine Staining [ICS] Assay) measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Solicited Local and Systemic Adverse Reactions Through 14 Days After Revaccination measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Unsolicited AEs Through 28 Days After Revaccination measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any MAAEs Through 6 Months After Revaccination measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any SAEs, AESIs, and AEs Leading to Study Discontinuation Through 6 Months After Revaccination sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287437 id: B2023-335R briefTitle: HRS9531 Controls Weight Regain in Obese Subjects overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-06-30 date: 2025-12-31 date: 2024-03-01 date: 2024-03-01 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: HRS9531 name: HRS9531 placebo measure: Percent Change in Body Weight from 24 weeks measure: Energy intake change from 24 weeks measure: Energy expenditure change from 24 weeks measure: Metabolic adaptation from 24 weeks measure: Systolic blood pressure and diastolic blood pressure change from 24 weeks measure: Body fat rate change from 24 weeks measure: Serum total cholesterol change from 24 weeks measure: Triglyceride change from 24 weeks measure: Nonestesterified fatty acid change from 24 weeks measure: Energy intake at baseline measure: Energy expenditure at baseline measure: Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale) measure: Percent Change in Body Weight at 24 weeks measure: Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale) measure: Energy expenditure at 24 weeks measure: Energy intake at 24 weeks measure: Change of body weight at 24 weeksl from baseline sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Xiaoying Li city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06287424 id: HMO-2O-0536 briefTitle: The Efficacy Of AGE On Periodontitis overallStatus: COMPLETED date: 2021-04-04 date: 2022-09-30 date: 2023-01-01 date: 2024-03-01 date: 2024-03-01 name: Hadassah Medical Organization class: OTHER name: Wakunaga Pharmaceutical Co., Ltd. briefSummary: The objective of this study is to assess the long-term efficacy of "AGE among on deep periodontal pockets by different doses of "AGE" for a period of 18 months. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 4 Regimen parralel groups primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Eligible subjects will be stratified based on Screening mean PPD (above or below 2mm), mean GBI (above or below 0.44), mean age (above or below 45 years old), gender (male or female) and tobacco use (yes or no). Within strata, subjects will be randomly assigned to one of the treatment groups using an encoded program. This assignment process and the distribution of test products will be conducted in a protected area that will ensure blinding of the examiner to the identity of the test products. whoMasked: PARTICIPANT count: 300 type: ACTUAL name: Aged Garlic Extract name: Placebo measure: Gingival Bleeding Index (GBI) measure: Probing Pocket Depth (PPD) sex: ALL minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Hebrew University city: Jerusalem zip: 9112102 country: Israel lat: 31.76904 lon: 35.21633 hasResults: False

 nctId: NCT06287411 id: 202436 briefTitle: Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies overallStatus: RECRUITING date: 2023-12-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-01 date: 2024-03-05 name: Xiao Chen class: OTHER briefSummary: This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards. conditions: Hepatic Malignancies studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: FAPI PET/MR combined with gadoxetate disodium measure: Diagnostic performance measure: Quantitative parameters of PET/MR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Xiao Chen, Ph.D role: CONTACT phone: 15922970174 email: xiaochen229@foxmail.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06287398 id: NHL38 briefTitle: Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2031-11 date: 2024-03-01 date: 2024-03-01 name: Australasian Leukaemia and Lymphoma Group class: OTHER briefSummary: The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:

* Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant?
* Is consolidation epcoritamab after ASCT deliverable and safe?
* Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?
* Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.

Participants will undergo three phases in this trial:

1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab
2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.
3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT. conditions: DLBCL - Diffuse Large B Cell Lymphoma conditions: High-grade B-cell Lymphoma conditions: High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements conditions: DLBCL, Nos Genetic Subtypes conditions: High Grade B-Cell Lymphoma, Not Otherwise Specified conditions: Follicular Large Cell Lymphoma, Relapsed conditions: Follicular Large Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Epcoritamab measure: Event-free survival (EFS) measure: Evaluate safety and tolerability of combination Epcoritamab with salvage-ASCT measure: Overall response rate (ORR) measure: Complete response rate (CRR) measure: Overall Survival (OS) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287385 id: NELN202212A briefTitle: An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-12-15 date: 2024-03-01 date: 2024-03-01 name: Danone Nutricia class: INDUSTRY briefSummary: This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives. conditions: Healthy Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 120 type: ESTIMATED name: Goat-milk Based Formula measure: Stool characteristics measure: Gastrointestinal symptoms measure: Quality of life of subjects measure: Lifestyle-related immune indicators measure: Safety parameters sex: ALL minimumAge: 1 Year maximumAge: 2 Years stdAges: CHILD facility: Peking University Third Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06287372 id: 3261 briefTitle: Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia overallStatus: COMPLETED date: 2022-07-04 date: 2023-07-04 date: 2023-07-04 date: 2024-03-01 date: 2024-03-07 name: Damascus University class: OTHER briefSummary: The aim of the present study was to investigate intra-operative changes in markers of myocardial injury and myocardial intracellular amino acids during ischemia and reperfusion, comparing two methods of myocardial protection; Calafiore intermittent antegrade warm blood cardioplegia or modified del Nido intermittent antegrade cold blood cardioplegia in routine coronary artery bypass grafting procedures. conditions: Myocardial Injury conditions: Cardiac Surgery conditions: Myocardial Protection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 20 type: ACTUAL name: Cardioplegic solution measure: Changes in markers of myocardial injury measure: Changes in myocardial amino acid concentrations sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus University Cardiac Surgery Hospital city: Damascus country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False

 nctId: NCT06287359 id: Local/2024/MP-01 briefTitle: Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain? acronym: Vé-Quo-Pa-H-R overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-03-01 date: 2024-04-05 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering.

For patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management.

The investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities.

To achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain.

With this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents. conditions: Low Back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: individual interviews measure: Individual interviews sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287346 id: 240101 briefTitle: 5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece. acronym: 240101 overallStatus: RECRUITING date: 2024-01-01 date: 2029-01-01 date: 2030-01-01 date: 2024-03-01 date: 2024-03-01 name: CeraRoot SL class: INDUSTRY briefSummary: The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question\[s\] it aims to answer are:

* Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?
* What are the complications associated to the procedure and differences between the two groups. conditions: Edentulism conditions: Tooth Loss studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 652 type: ESTIMATED name: dental implant measure: Survival rate measure: Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Family Holistic Dentistry status: RECRUITING city: Boulder state: Colorado zip: 80303 country: United States name: CARMEN BURKE, DDS role: CONTACT phone: 303-219-0499 email: carmen@carmenburke.com name: CARMEN BURKE, DDS role: PRINCIPAL_INVESTIGATOR lat: 40.01499 lon: -105.27055 facility: CeraRoot CLINIC status: RECRUITING city: Les Franqueses del Vallès state: Barcelona zip: 08520 country: Spain name: JOSEP OLIVA-OCHOA, DDS MSC role: CONTACT phone: 800-485-1613 email: josep.oliva@cerarootclinic.com name: Ekaterina Treatment coordinator role: CONTACT phone: +34 935 950 247 email: ekaterina@ceraroot.com name: JOSEP OLIVA-OCHOA, DDS MSC role: PRINCIPAL_INVESTIGATOR name: XAVIER OLIVA-OCHOA, DDS MSC role: SUB_INVESTIGATOR name: CARLA OLIVA-PORTA, STUDENT role: SUB_INVESTIGATOR name: ARNAU OLIVA-PORTA, STUDENT role: SUB_INVESTIGATOR lat: 41.61929 lon: 2.29829 hasResults: False

 nctId: NCT06287333 id: 2023PI221 briefTitle: Video-respiratory Polygraphy in Children overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-02-22 date: 2024-02-28 date: 2024-03-01 date: 2024-03-01 name: Central Hospital, Nancy, France class: OTHER briefSummary: The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse. But PSG is a cumbersome exam, sometimes difficult to perform in children. Simplified exams as respiratory polygraphy (RP) which uses only respiratory signals can be used for the diagnosis of OSAS but studies show that it underestimates the obstructive apnea-hypopnea index (OAHI) because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not. conditions: Sleep Apnea, Obstructive studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 66 type: ESTIMATED name: Polysomnography in routine care measure: OAHI in video-RP significantly correlated with OAHI in PSG measure: Diagnostic ability of video-RP to identify OSAS in children measure: Diagnostic ability of video-RP to identify moderate-severe OSAS in children sex: ALL minimumAge: 2 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06287320 id: Bioplc briefTitle: The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-02-28 date: 2024-03-01 date: 2024-03-01 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs). conditions: Locally Advanced Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: concurrent or sequential chemoradiotherapy name: Immunotherapy measure: Adverse Event measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective Response Rate (ORR) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese Academy of Medical Science and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Nan Bi, MD, PhD role: CONTACT email: binan_email@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06287307 id: NOK000024 briefTitle: Semaglutide 2.4mg for Low Responders After Bariatric Surgery acronym: SEABAR overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-02 date: 2026-09 date: 2024-03-01 date: 2024-03-01 name: Zuyderland Medisch Centrum class: OTHER name: Nederlandse Obestias Kliniek (NOK) briefSummary: In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight. conditions: Obesity conditions: Obesity, Morbid conditions: Weight Gain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 152 type: ESTIMATED name: Placebo name: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] measure: Weight change from start study at 3 months post operative until 15 months later measure: Difference between placebo group and treatment group in weight change measure: Weight loss 3 months after surgery measure: Weight loss 6 months after surgery measure: Weight loss 12 months after surgery measure: Weight loss 18 months after surgery measure: Metabolic health before surgery (bloodpressure) measure: Metabolic health before surgery (HbA1c) measure: Metabolic health before surgery (glucose) measure: Metabolic health before surgery (triglyceride) measure: Metabolic health before surgery (LDL) measure: Metabolic health before surgery (HDL) measure: Metabolic health before surgery (total cholesterol) measure: Metabolic health 3 months after surgery (Bloodpressure) measure: Metabolic health 3 months after surgery (HbA1c) measure: Metabolic health 3 months after surgery (glucose) measure: Metabolic health 3 months after surgery (triglyceride) measure: Metabolic health 3 months after surgery (LDL) measure: Metabolic health 3 months after surgery (HDL) measure: Metabolic health 3 months after surgery (total cholesterol) measure: Metabolic health at 6 months after surgery (bloodpressure) measure: Metabolic health at 6 months after surgery (HbA1c) measure: Metabolic health at 6 months after surgery (glucose) measure: Metabolic health at 6 months after surgery (triglyceride) measure: Metabolic health at 6 months after surgery (LDL) measure: Metabolic health at 6 months after surgery (HDL) measure: Metabolic health at 6 months after surgery (total cholesterol) measure: Metabolic health at 12 months after surgery (bloodpressure) measure: Metabolic health at 12 months after surgery (HbA1c) measure: Metabolic health at 12 months after surgery (glucose) measure: Metabolic health at 12 months after surgery (triglyceride) measure: Metabolic health at 12 months after surgery (LDL) measure: Metabolic health at 12 months after surgery (HDL) measure: Metabolic health at 12 months after surgery (total cholesterol) measure: Metabolic health at 18 months after surgery (bloodpressure) measure: Metabolic health at 18 months after surgery (HbA1c) measure: Metabolic health at 18 months after surgery (glucose) measure: Metabolic health at 18 months after surgery (triglyceride) measure: Metabolic health at 18 months after surgery (LDL) measure: Metabolic health at 18 months after surgery (HDL) measure: Metabolic health at 18 months after surgery (total cholesterol) measure: Health-related quality of life also related to gastro intestinal symptoms before surgery measure: Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery measure: Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery measure: Health-related quality of life also related to gastro intestinal symptoms measure: Health-related quality of life also related to gastro intestinal symptoms measure: Cardiorespiratory fitness level before surgery measure: Cardiorespiratory fitness level 3 months after surgery measure: Cardiorespiratory fitness level 6 months after surgery measure: Cardiorespiratory fitness level 12 months after surgery measure: Cardiorespiratory fitness level 18 months after surgery measure: Change in liver fat and liver stiffness at start of treatment measure: Change in liver fat and liver stiffness 15 months after semaglutide start measure: To describe the persistence of therapy measure: To describe the average weekly dose sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287294 id: RS23-042 briefTitle: An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer overallStatus: RECRUITING date: 2023-08-30 date: 2024-12-31 date: 2024-12-31 date: 2024-03-01 date: 2024-03-01 name: Our Lady's Hospice and Care Services class: OTHER briefSummary: Taste problems and xerostomia (dry mouth) are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. This study will explore the relationship between dry mouth and taste problems in patients with advanced cancer. conditions: Taste, Altered conditions: Xerostomia conditions: Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: To measure the prevalence of taste problems in patients with advanced cancer with a dry mouth using the Oral Symptom Assessment Scale (questionnaire) measure: To identify an association of any other oral symptoms present in patients with taste problems and dry mouth who have advanced cancer using the Oral Symptom Assessment Scale (questionnaire) measure: To characterise the taste disturbances i.e. to identify reduced taste, heightened taste, altered taste or no taste using the Taste Questionnaire in Palliative Care (questionnaire) and Waterless Empirical Taste Test (objective taste test) measure: To identify what impact taste problems are having on patients dietary intake using the Taste Questionnaire in Palliative Care (questionnaire). measure: To identify what impact taste problems are having on patients quality of life using the Taste Questionnaire in Palliative Care (questionnaire). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Our Lady's Hospice and Care Services status: RECRUITING city: Dublin zip: D6WRY72 country: Ireland name: Andrew Davies, FRCP role: CONTACT phone: 0035314986235 email: andavies@tcd.ie name: Marie Hannon, BSc role: CONTACT phone: 0035314912558 email: marie.hannon@ucdconnect.ie lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06287281 id: Heel01 briefTitle: High-heeled Shoes in a Sample of Young Women overallStatus: RECRUITING date: 2023-12-15 date: 2024-02-15 date: 2024-02-28 date: 2024-03-01 date: 2024-03-01 name: Manusapiens class: OTHER briefSummary: At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association.

Furthermore, in most of the websites consulted, even by non-experts, the reason for the onset of spinal pain is attributed to hyperlordosis and pelvic anteversion. However, this thought is not entirely in agreement with other scientific publications. Therefore it is necessary to pay attention to online searches which often answer these questions without taking EBM into account.

None of the studies reported above take into consideration the time factor. In fact, all the studies have evaluated the immediate changes brought about by heel raising. Women who complain of lower back pain when wearing high-heeled shoes rarely experience pain as soon as they start wearing them.

The objective of the research arises from these considerations. The aim of this study (primary outcome) is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the spinopelvic parameters compared to the barefoot condition and as soon as the shoes are worn.

The secondary outcome will be to verify in the sample analyzed whether there are different behaviors between the subgroups of those who have complained in their anamnesis and those who have never complained of lower back pain when using high-heeled shoes for a few hours. conditions: Low Back Pain conditions: Healthy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 34 type: ESTIMATED name: heel hight shoes measure: effect of high-heeled shoes on trunk inclination measure: effect of high-heeled shoes on pelvic inclination measure: effect of high-heeled shoes on lordotic angle measure: effect of high-heeled shoes on kyphotic angle measure: effect of high-heeled shoes on lumbar arrow measure: effect of high-heeled shoes on cervical arrow measure: different response on trunk inclination between the subgroups (suffering from back pain and asymptomatic) measure: different response on pelvic inclination between the subgroups (suffering from back pain and asymptomatic) measure: different response on lordotic angle between the subgroups (suffering from back pain and asymptomatic) measure: different response on kyphotic angle between the subgroups (suffering from back pain and asymptomatic) measure: different response on lumbar arrow between the subgroups (suffering from back pain and asymptomatic) measure: different response on cervical arrow between the subgroups (suffering from back pain and asymptomatic) sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Spine Center status: RECRUITING city: Bologna zip: 40128 country: Italy name: Saverio Colonna, MD role: CONTACT phone: +39 051 095 2375 email: direzione@spine-center.it lat: 44.49381 lon: 11.33875 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-10 uploadDate: 2024-02-10T21:29 filename: Prot_SAP_000.pdf size: 222277 hasResults: False

 nctId: NCT06287268 id: CETB115G1401 briefTitle: Revolade Tablets Specified Drug-use Survey overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2028-10-31 date: 2028-10-31 date: 2024-03-01 date: 2024-03-01 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA). conditions: Aplastic Anemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 10 type: ESTIMATED name: eltrombopag measure: Occurrence of serious adverse events measure: Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation measure: Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies) measure: Occurrence of clonal evolution measure: Hematologic response status measure: Change over time from baseline in platelet count measure: Change over time from baseline in hemoglobin measure: Change over time from baseline in neutrophil count measure: Change over time from baseline in reticulocyte count measure: Change over time from baseline in transfusion dependence measure: Change over time from baseline in transfusion volume sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06287255 id: 2023H0314 briefTitle: Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals acronym: EIM+ overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-09-30 date: 2025-09-30 date: 2024-03-01 date: 2024-03-01 name: Ohio State University class: OTHER briefSummary: The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.

The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.

The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels. conditions: Physical Inactivity conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A single-arm trial primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: EIM+ measure: Feasibility of EIM+ measure: Acceptability of EIM+ measure: Change in physical activity measure: Change in weight measure: Change in BMI measure: Change in hip circumference measure: Change in waist circumference measure: Change in blood pressure measure: Change in heart rate variability measure: Change in hemoglobin A1c measure: Change in perceived stress measure: Change in depressive symptoms measure: Change in diet measure: Change in activity minutes per week measure: Change in daily steps total measure: Change in measured steps per minute measure: Change in sleep quality measure: Change in sleep duration measure: Change in estimated energy expenditure measure: Change in heart rate measure: Change in distance moved measure: Change in minutes of vigorous activity measure: Change in minutes of moderate activity measure: Change in minutes of light activity measure: Change in minutes of sedentary time measure: Change in number of manually entered and automatically detected physical activities (walking, running, etc.) measure: Change in quality of life measures sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43202 country: United States name: Toluwa C Nafiu, B.S. role: CONTACT phone: 614-293-2404 email: toluwaniose.nafiu@osumc.edu name: Joshua Joseph, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06287242 id: 24-01-282 briefTitle: Validation of the Cervicothoracic Differentiation Test acronym: EMU overallStatus: RECRUITING date: 2024-02-20 date: 2025-02 date: 2025-02 date: 2024-03-01 date: 2024-03-01 name: University of Hartford class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of two spinal manipulations in adults between the ages of 18-65 based on the results of a non-invasive clinical test. The main question it aims to answer is: • Does matched or unmatched region of manipulation based on the CTDT result in greater reduction of pain levels and improvement in range of motion in adults with neck pain compared to unmatched manipulations? Participants will be asked to:

* rate their pain with neck movement, complete brief questionnaires about their pain,
* have their neck range of motion measured,
* perform a test known as the cervico-thoracic differentiation test (CTDT),
* receive either a cervical or thoracic manipulation,
* repeat the range of motion measurements.
* A second session will occur 7-10 days later where questionnaires and range of motion measures will be repeated.

Researchers will compare the effects of manipulation matched to CTDT test result to individuals in the unmatched CTDT manipulation group to see if the CTDT may indicate which region will provide a greater treatment effect for individuals with neck pain. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Blinded research assistants will perform all baseline and follow-up measures. Investigator providing manipulation is blinded to group allocation (matched/unmatched) Participants will not be told if the CTDT indicates that they would benefit from cervical or thoracic manipulation, and the investigator performing the CTDT will only indicate which region is to be manipulated. All investigators are blinded to the work of the others and submit their results to an additional research assistant who will enter the data in a spreadsheet not accessible to the remainder of the research team until the conclusion of the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: spinal manipulation measure: pain with motion measure: pain at rest measure: range of motion measure: neck disability index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Hartford status: RECRUITING city: West Hartford state: Connecticut zip: 06117 country: United States name: Brian Swanson, PT, DSc role: CONTACT phone: 860-768-5314 email: bswanson@hartford.edu lat: 41.76204 lon: -72.74204 hasResults: False

 nctId: NCT06287229 id: 2023-0627 id: NCI-2024-01756 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2028-12-31 date: 2030-12-31 date: 2024-03-01 date: 2024-04-12 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease. conditions: Relapsed/Refractory conditions: B-cell Acute Lymphocytic Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Blinatumomab name: Inotuzumab Ozogamicin name: Hyper-CVAD name: Mini-hyper-CVD 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: Elias Jabbour, MD role: CONTACT phone: 713-792-4764 email: ejabbour@mdanderson.org name: Elias Jabbour, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06287216 id: 2024001 briefTitle: Preliminary Evaluation of a Mental Health Program: a Comparison Study overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-04-30 date: 2024-04-30 date: 2024-03-01 date: 2024-03-01 name: The Royal Ottawa Mental Health Centre class: OTHER briefSummary: The mental hygiene challenge is a Royal Ottawa Health Care Group led initiative to engage the staff, clients and community members to attend to their mental well-being by way of practicing mental hygiene activities for 10 min on a daily basis, throughout the month of March. Participants are encouraged to choose one or many of the practices recommended and do them for about 10 minutes a day. Participants are encouraged to make it their own, in that they can combine the practice or tailor them in a way that suits them best. When signing up for the challenge, participants receive free access to a toolkit with brief outlines and instructional videos on various mental hygiene practices.

We also encourage participants to divide the 10 minutes in whatever way best works for them, such as 10 minutes all at once, 5 minutes twice, or even 2 minutes five times. This study aims to expand on the work that was done in 2022 and 2023, when the World Health Organization - 5 Wellbeing Index (WHO-5) and the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) were collected from participants to ascertain the impact of mental hygiene, by way of including a control group. conditions: Mental Wellbeing studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Mental Hygiene name: Self-Care measure: Change in level of mental wellbeing as measured by the WHO-5 index. measure: Change in level of mental wellbeing as measured by the WEMWBS. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287203 id: Pro2023001498 id: 3R01DA050721-04S1 type: NIH link: https://reporter.nih.gov/quickSearch/3R01DA050721-04S1 briefTitle: Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults acronym: ARFP overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-11-20 date: 2024-11-20 date: 2024-03-01 date: 2024-03-01 name: Rutgers, The State University of New Jersey class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this research study is to test whether completion of a new personalized feedback program is associated with reductions in risky substance use among emerging adults (18-25 years of age). conditions: Substance Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE maskingDescription: Participants will not be made aware of their condition at baseline; however, they will know their condition once they receives their estimates (or not, in the case of the control condition) and are taken to their follow-up resources. count: 450 type: ESTIMATED name: Addiction Risk Feedback Program measure: Alcohol Consumption measure: Alcohol Problems measure: Drug Use Problems measure: Readiness to change measure: Future substance use intentions measure: Worry About Substance Use Disorders measure: Perceived Susceptibility measure: Well-Being measure: Anxiety and Depressive Symptoms measure: Addiction Risk Program Satisfaction measure: Feelings About Results measure: Satisfaction with the Assigned Conditions sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Rutgers Robert Wood Johnson Medical School city: Piscataway state: New Jersey zip: 08854 country: United States name: Emily Balcke role: CONTACT email: dnadiscoverystudy@rutgers.edu name: Danielle Dick, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.49927 lon: -74.39904 hasResults: False

 nctId: NCT06287190 id: Self-confidence assessment briefTitle: Assessment of Self-Confidence of Dental Interns Regarding Provision of Different Pediatric Dentistry Procedures overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-11-30 date: 2024-03-01 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: This study mainly about dental interns testing their knowledge before and after entering the pediatric rotation conditions: Self Confidence studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 383 type: ESTIMATED name: Dental interns measure: Self-confidence regarding treatment measure: difficulties in dental practice through this period sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University city: Cairo country: Egypt name: Sherine E Eldin, Prof role: CONTACT phone: +20 1009073142 lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06287177 id: Protocol 28/2023 briefTitle: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy acronym: CHOLINET overallStatus: RECRUITING date: 2022-11-01 date: 2024-02-29 date: 2024-11-01 date: 2024-02-29 date: 2024-03-19 name: Federico II University class: OTHER briefSummary: Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population conditions: Hypercholesterolemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Inclisiran measure: Description of adherence to treatment with Inclisiran in a real-life Italian population measure: Description of persistence to treatment with Inclisiran in a real-life Italian population measure: Description of efficacy of treatment with Inclisiran in a real-life Italian population sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federico II University of Naples, Department of Advanced Biomedical Sciences status: RECRUITING city: Napoli zip: 80131 country: Italy name: Pasquale Perrone Filardi, MD role: CONTACT phone: 0817462224 email: fpperron@unina.it lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06287164 id: 101 briefTitle: Management of Heart Failure in Italian Outpatients Clinics: Observational Study acronym: OPTIMA-HF overallStatus: RECRUITING date: 2023-03-01 date: 2024-02-01 date: 2025-02-01 date: 2024-02-29 date: 2024-02-29 name: Federico II University class: OTHER briefSummary: OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.

Aim of the Optimization of Therapy in the Italian Management of Heart Failure \[OpTIMa-HF\] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4000 type: ESTIMATED name: Data collection measure: HF treatment adherence according to the most recent European Guidelines sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federico II University of Naples, Department of Advanced Biomedical Sciences status: RECRUITING city: Napoli zip: 80131 country: Italy name: Pasquale Perrone Filardi, MD role: CONTACT phone: 0817462224 email: fpperron@unina.it lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06287151 id: STUDY00002844 briefTitle: Regional Anesthesia EMG Study overallStatus: RECRUITING date: 2023-08-09 date: 2024-12 date: 2024-12 date: 2024-02-29 date: 2024-02-29 name: Nationwide Children's Hospital class: OTHER briefSummary: This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Choice of group will be made by attending anesthesiologist based on clinical judgement. primaryPurpose: OTHER masking: SINGLE maskingDescription: Only the individuals performing data analysis will be blinded to type of anesthetic technique performed. whoMasked: OUTCOMES_ASSESSOR count: 124 type: ESTIMATED name: BlockSynop surface electromyography device name: Clonidine name: Sevoflurane measure: Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. . measure: Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the onset of SA or CA and measured by the power of signal amplitude. measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the duration of SA or CA and measured by the power of signal amplitude. measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the density of SA or CA and measured by the power of signal amplitude. measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the dermatomal level of SA or CA and measured by the power of signal amplitude. measure: Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. sex: ALL minimumAge: 0 Years maximumAge: 5 Years stdAges: CHILD facility: Nationwide Children's Hospital status: RECRUITING city: Columbus state: Ohio zip: 43205 country: United States name: Catherine Roth role: CONTACT phone: 614-722-2997 email: catherine.roth@nationwidechildrens.org name: Grant Heydinger, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06287138 id: KY2023-182-03 briefTitle: The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients overallStatus: RECRUITING date: 2023-05-10 date: 2024-12-31 date: 2025-03-31 date: 2024-02-29 date: 2024-02-29 name: Capital Medical University class: OTHER briefSummary: Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. The sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the Richmond Agitation Sedation Scale (RASS). However, studies have found that sedation depth based on RASS is not a reliable marker of respiratory drive during critical illness. In recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as P0.1, Pocc, Pmus, WOB, and PTP. However, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. Ciprofol is an analog of propofol, with increased stereoselective effects adding to its anesthetic properties, is increasingly used in the intensive care unit, but its effects on respiration are not well understood. Therefore, this study aims to investigate the effects of ciprofol on respiratory patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients. conditions: Mechanical Ventilation conditions: Sedation and Analgesia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: ciprofol measure: Explore the effect of ciprofol on tidal volume measure: Explore the effect of ciprofol on respiratory rate measure: Explore the effect of ciprofol on minute ventilation measure: Explore the effect of ciprofol on P0.1 measure: Explore the effect of ciprofol on PMI measure: Explore the effect of ciprofol on ΔPocc measure: Explore the effect of ciprofol on tidal volume measure: Explore the effect of ciprofol on respiratory rate measure: Explore the effect of ciprofol on minute ventilation measure: Explore the effect of ciprofol on P0.1 measure: Explore the effect of ciprofol on PMI measure: Explore the effect of ciprofol on ΔPocc measure: Explore the effect of ciprofol on systolic blood pressure measure: Explore the effect of ciprofol on diastolic blood pressure measure: Explore the effect of ciprofol on mean arterial pressure measure: Explore the effect of ciprofol on heart rate measure: Explore the effect of ciprofol on saturation of pulse oxygen measure: Explore the effect of ciprofol on end-tidal carbon dioxide pressure measure: Explore the effect of ciprofol on RASS score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100071 country: China name: Jian-Xin Zhou, MD role: CONTACT phone: 8610 59978019 email: zhoujx.cn@icloud.com name: Rui Su role: CONTACT phone: +8618611993866 email: surui1969@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06287125 id: Renal assess in SSc and SLE briefTitle: Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-29 date: 2024-02-29 name: Assiut University class: OTHER briefSummary: * Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment.
* Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment.
* Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment.
* Correlation between detected markers and other assessment tools. conditions: Systemic Sclerosis and Systemic Lupus Erythematous studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 95 type: ESTIMATED name: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147 measure: Evaluate serum levels of CD147 in SSc and SLE patients measure: Evaluate renal resistive index in SSC and SLE patients measure: Evaluate Multiparametric MRI in SSC and SLE measure: Utility of CD 147 in ssc and SLE patients measure: Utility of renal resistive index in SSC and SLE patients measure: Utility of Multiparametric MRI in SSC and SLE sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287112 id: PAC-ETGBD briefTitle: Prevention of Acute Cholecystitis With ETGBD overallStatus: NOT_YET_RECRUITING date: 2024-03-02 date: 2025-02-20 date: 2025-03-30 date: 2024-02-29 date: 2024-02-29 name: Seoul National University Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.

In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility. conditions: Biliary Obstruction conditions: Acute Cholecystitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 35 type: ESTIMATED name: Endoscopic transpapillary gallbladder drainage (ETGBD) measure: Incidence rate of acute cholecystitis sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287099 id: 2023-BRL-101-SCD briefTitle: Clinical Study of BRL-101 in the Treatment of Sickle Cell Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-10-20 date: 2026-05-10 date: 2024-02-29 date: 2024-03-19 name: Bioray Laboratories class: INDUSTRY name: Nanfang Hospital, Southern Medical University briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101). conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: BRL-101 measure: Proportion of stem cell engrafted subjects measure: Time to neutrophil engraftment measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion. sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06287086 id: 2024-BRL-101-SCD briefTitle: Clinical Study on the Safety and Efficacy of BRL-101 in the Treatment of Sickle Cell Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-14 date: 2025-08-20 date: 2026-06-10 date: 2024-02-29 date: 2024-03-12 name: Bioray Laboratories class: INDUSTRY name: Chinese Academy of Medical Sciences briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101) conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ESTIMATED name: BRL-101 autologous hematopoietic stem and progenitor cells injection measure: Proportion of stem cell engrafted subjects measure: Time to neutrophil engraftment measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion.. sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06287073 id: 1245-0323 id: EUPAS107293 type: REGISTRY domain: EU PAS Register briefTitle: JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD) overallStatus: RECRUITING date: 2024-03-29 date: 2025-08-18 date: 2025-11-22 date: 2024-02-29 date: 2024-04-23 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.

The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment. conditions: Kidney Disease, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: JARDIANCE® measure: Number of subjects with adverse events measure: Number of subjects with serious adverse event measure: Number of subjects with non-serious adverse events measure: Number of subjects with adverse drug reaction measure: Number of subjects with serious adverse drug reactions measure: Number of subjects with unexpected adverse events measure: Number of subjects with adverse events of special interest measure: Number of subjects with specific adverse events measure: Number of subjects with adverse events leading to temporary or permanent discontinuation measure: Number of subjects with adverse events by intensity measure: Number of subjects with adverse events by outcome of the events measure: Number of subjects with adverse events by causality measure: Number of subjects with adverse events leading to death measure: Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 03181 country: Korea, Republic of name: Boehringer Ingelheim role: CONTACT phone: 0808802084 email: namhan@bitrialsupport.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06287060 id: Strawberry extract briefTitle: Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2024-12 date: 2024-02-29 date: 2024-02-29 name: Cairo University class: OTHER briefSummary: with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity. conditions: Bleaching Effect and Postoperative Sensitivity of Strawberry Extract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: strawberry extract. measure: Bleaching effect of strawberry extract versus Hydrogen peroxide. measure: post operative sensitivity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06287047 id: spinal needle sizes and DPE briefTitle: The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block overallStatus: ACTIVE_NOT_RECRUITING date: 2021-01-01 date: 2022-01-31 date: 2024-04-15 date: 2024-02-29 date: 2024-03-19 name: Cairo University class: OTHER briefSummary: The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications. conditions: Dural Puncture Epidural Technique studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 81 patients meeting the inclusion criteria will be randomly divided into three equal groups: Group A (n=27): Conventional epidural. Group B (n=27): Dural puncture epidural with 25-gauge spinal needle. Group C (n=27): Dural puncture epidural with 27-gauge spinal needle. primaryPurpose: OTHER masking: DOUBLE maskingDescription: The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelope will be opened by the nurse, the card inside will determine the patient group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 81 type: ACTUAL name: Epidural analgesia measure: Onset of analgesia measure: Degree of analgesia sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medidcne, Cairo Univerisity city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06287034 id: RS1833/23 briefTitle: The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF) overallStatus: RECRUITING date: 2023-03-21 date: 2025-03-21 date: 2025-09-21 date: 2024-02-29 date: 2024-02-29 name: Regina Elena Cancer Institute class: OTHER briefSummary: Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT) conditions: Larynx Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 102 type: ESTIMATED name: Primary suture measure: questionnaires for evaluation of the quality of life measure: Identification of risk factors measure: Evaluation of swallowing function measure: Evaluation of vocal rehabilitation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: "Regina Elena" National Cancer Institute status: RECRUITING city: Rome zip: 00144 country: Italy name: Pellini Raul, Doctor role: CONTACT phone: 06-52664484 email: raul.pellini@ifo.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06287021 id: TRASERBMD2022 briefTitle: Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-02 date: 2027-02 date: 2024-02-29 date: 2024-04-03 name: Permedica spa class: INDUSTRY briefSummary: The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up. conditions: Total Hip Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Controlled, randomized, unblinded, multicenter primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Jump System Traser® cup name: Jump System HAX-Pore® cup measure: BMD - ROI 1 measure: BMD - ROI 2,3,4 measure: Harris hip score measure: Moore's osseointegration signs sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Clinico San Siro city: Milan zip: 20148 country: Italy name: Matteo Del Re, MD role: CONTACT email: matteodelre91@gmail.com lat: 45.46427 lon: 9.18951 facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio city: Milan zip: 20161 country: Italy name: Ricardo Ciliberto, MD role: CONTACT email: rciliberto@gmail.com name: Laura role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06287008 id: 2023-0085 briefTitle: ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery overallStatus: COMPLETED date: 2020-10-01 date: 2023-09-30 date: 2024-01-31 date: 2024-02-29 date: 2024-03-01 name: Asan Medical Center class: OTHER briefSummary: While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.

The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure. conditions: Kidney Transplantation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 239 type: ACTUAL name: robot-assisted kidney transplantation measure: Graft survival measure: renal function measure: . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06286995 id: 6280 briefTitle: Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems overallStatus: COMPLETED date: 2023-10-14 date: 2024-01-29 date: 2024-02-14 date: 2024-02-29 date: 2024-02-29 name: Ain Shams University class: OTHER briefSummary: The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS) conditions: Post Operative Pain conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was designed to be randomized,single- blinded, single-center clinical trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A) Sequence generation: was done using random sequence number generated by computer software B) Allocation concealment Mechanism:folded,numbered papers were placed in tightly sealed envelopes containing patients' coding whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Chemomechanical preparation for root canals measure: Level of post operative pain using 10-cm visual analogue scale ( VAS) measure: Level of inflammatory mediators substance P in apical fluid samples sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Ain Shams university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06286982 id: OASIS III briefTitle: The Oral Symptom Assessment Scale in Older Patients With Frailty overallStatus: RECRUITING date: 2023-06-06 date: 2024-07-06 date: 2024-07-06 date: 2024-02-29 date: 2024-03-07 name: Our Lady's Hospice and Care Services class: OTHER briefSummary: Oral (or mouth) symptoms are common in older patients who live with frailty. It is known that frailty describes someone's overall resilience and how this relates to the chances of recovery following a health problem. A questionnaire called the Oral Symptom Assessment Scale (or OSAS) was designed to look at mouth symptoms in patients who had an advanced cancer. These symptoms may overlap with patients who have frailty.

This research study is taking place to find out if the OSAS will be a suitable questionnaire that can be used in older patients with frailty.

This study will take place in Our Lady's Hospice \& Care Services, Harold's Cross and St James' Hospital over six months. conditions: Frailty conditions: Older Adults studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Oral Symptom Assessment Scale measure: To determine the prevalence of oral symptoms in older patients with frailty measure: To determine the clinical features of these oral symptoms in this group (i.e. frequency, severity and level of distress) measure: To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications measure: To provide initial validation of OSAS in older patients with frailty sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: St James's Hospital status: RECRUITING city: Dublin zip: D8 country: Ireland name: Niamh Cleary, MB MICGP role: CONTACT phone: +353876603466 (Ireland) email: clearynm@tcd.ie name: Amanda Lavan, PhD MRCPI role: SUB_INVESTIGATOR name: Roman Romero Ortuno, MSc PhD MRCP role: SUB_INVESTIGATOR lat: 53.33306 lon: -6.24889 facility: Our Lady's Hospice and Care Services status: RECRUITING city: Dublin zip: Dublin 6W country: Ireland name: Niamh M Cleary, MB MICGP role: CONTACT phone: +353876603466 (Ireland) email: clearynm@tcd.ie name: Norah Fagan, RGN MSc role: SUB_INVESTIGATOR lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06286969 id: ZSLL-ZN-2024-007-01 briefTitle: Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-03-01 date: 2024-02-29 date: 2024-02-29 name: Xu Xinnan class: OTHER briefSummary: Acupuncture is widely used as a routine treatment for lumbar muscle strain. The aim of this randomized controlled trial is to evaluate the effectiveness of the intensive multi-acupuncture method. This trial will include 108 patients with lumbar muscle strain injury from two outpatient clinics. All participants will be randomized in a 1:1 ratio to the intensive multi-acupuncture method group and the normal needling group. Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment. The primary outcome indicator will be the clinical efficacy evaluation criteria, and the secondary outcome indicators will be the pain visual analog scale (VAS) score, the Japanese Orthopaedic Association Assessment Treatment Score (JOA) score, the lumbar joint mobility measurement scale, and the Modified Ashworth Grading Scale. This study will provide evidence as to whether the intensive multi-acupuncture method is safe and effective. conditions: Lumbar Muscle Strain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: acupuncture measure: clinical efficacy evaluation criteria measure: Pain visual analog scale (VAS) score measure: Japanese Orthopaedic Association Scores measure: Lumbar Joint Mobility Measurement Scale measure: Improvement of the Ashworth Rating Scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286956 id: vec-pr-1901 briefTitle: Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device acronym: UNI-VEC overallStatus: RECRUITING date: 2021-04-19 date: 2024-05-07 date: 2024-09-07 date: 2024-02-29 date: 2024-02-29 name: Vecmedical Spain, S.L. class: INDUSTRY briefSummary: The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial). conditions: Rectal Polyp conditions: Rectal Polyps conditions: Rectal Lesion conditions: Sessile Colonic Polyp conditions: Pedunculated Colorectal Polyps studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Treatment of rectal lesions with UNI-VEC measure: Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps measure: Rate of anorectal hemorrhagic events measure: Rate of injuries to the anorectal canal and perianal region measure: Assessment of anorectal continence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de Cabueñes status: RECRUITING city: Gijón state: Asturias zip: 33394 country: Spain name: Carlos Álvarez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 43.53573 lon: -5.66152 facility: Hospital Universitari Mútua de Terrassa status: RECRUITING city: Terrassa state: Bercelona zip: 08221 country: Spain name: Salvadora Delgado, Medicine role: PRINCIPAL_INVESTIGATOR lat: 41.56667 lon: 2.01667 facility: Complexo Hospitalario Universitario de A Coruña status: RECRUITING city: A Coruña state: Galicia zip: 15006 country: Spain name: José F Noguera, Medicin role: CONTACT phone: +34 981178049 email: jose.francisco.noguera.aguilar@sergas.es name: José F Noguera, Medicine role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: Hospital Quirón-Salud A Coruña status: RECRUITING city: A Coruña state: Galicia zip: 15006 country: Spain name: Alba Gómez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: Hospital Universitario Lucus Augusti status: RECRUITING city: Lugo state: Galicia zip: 27003 country: Spain name: Olga Maseda, Medicine role: PRINCIPAL_INVESTIGATOR lat: 43.00992 lon: -7.55602 facility: Complejo Hospitalario Universitario de Vigo status: RECRUITING city: Vigo state: Galicia zip: 36204 country: Spain name: Raquel Sánchez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 42.23282 lon: -8.72264 facility: Hospital del Mar status: RECRUITING city: Barcelona zip: 08003 country: Spain name: Marta Jiménez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital La Paz status: RECRUITING city: Madrid zip: 28046 country: Spain name: Mario Álvarez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Reina Sofía de Murcia status: RECRUITING city: Murcia zip: 30003 country: Spain name: Pedro Parra, Medicine role: PRINCIPAL_INVESTIGATOR lat: 37.98704 lon: -1.13004 facility: Hospital Universitario Río Hortega status: RECRUITING city: Valladolid zip: 47012 country: Spain name: Javier Sánchez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 41.65518 lon: -4.72372 facility: Hospital Universitario La Fe status: RECRUITING city: València zip: 46026 country: Spain name: Blas Flor, Medicine role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06286943 id: S68124 briefTitle: The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions acronym: GUTSIE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-05 date: 2024-02-29 date: 2024-02-29 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: United States Department of Defense briefSummary: The aim of the present trial is to examine core executive functions (EFs) as a functional outcome of attenuating the cortisol response to acute laboratory stress through colonic delivery of an Short Chain Fatty Acids (SCFAs) mix (acetate, propionate, butyrate).

A triple-blind randomized placebo-controlled parallel group trial will be conducted to compare the effects of SCFAs vs. placebo on core EFs (working memory \[WM\], cognitive flexibility \[CF\], response inhibition \[RI\]) under stress vs. no-stress conditions, after one week of SCFA vs. placebo treatment.

First, the effects of SCFAs on stress-induced changes in core executive functions, with WM as the primary outcome, and CF and RI as secondary outcomes will be tested. Second, interindividual differences in microbiota composition (particularly abundance of SCFA-producers), saliva cortisol and serum SCFA levels will be explored to assess whether they are associated with interindividual differences in core EFs at baseline or following acute stress.

Each participant will undergo 2 study visits: one will involve a stress condition and the other will involve a no-stress condition. Each study visit is preceded by a 1-week intervention or placebo period and separated by a 3-4 week washout period. To induce stress, participants will perform the Maastricht Acute Stress Task (MAST) or sham MAST as the control condition. To assess EF performance, three cognitive tasks will be performed 15 minutes after task offset: n-back task for WM; Stop Signal Task for RI; and Wisconsin Card Sorting Test for CF. Saliva samples will be collected before, during and after the (sham) MAST to assess the cortisol response. Blood samples will be collected throughout all study visits to quantify serum SCFAs, inflammatory markers and ACTH. Additionally, cardiovascular variables will be measured, and self-report questionnaires will be completed to evaluate autonomic response to the condition and subjective stress responses, respectively conditions: Executive Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Short Chain Fatty Acids (SCFAs). name: Placebo name: Maastricht Acute Stress Task name: No-stress control task measure: Working memory measure: Cognitive Flexibility measure: Response Inhibition sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06286930 id: STU-2023-0470 briefTitle: Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-02 date: 2026-01-02 date: 2024-02-29 date: 2024-02-29 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: Hypothesis: Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors, social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies?

Primary Outcomes:

1. To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game.
2. To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest (ROI) of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks.

Secondary Outcomes:

1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation. conditions: Anorexia Nervosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: anodal trans cranial direct current stimulation (tDCS) name: cathodal trans cranial direct current stimulation (tDCS) measure: tDCS impact on social behaviors using Cyberball measure: tDCS impact on social behaviors using the Trust Game measure: neurological impacts of tDCS as measured by fMRI imaging measure: measure the differences of social stimuli and eating disorder/depressive symptomology measure: measure the differences of social stimuli and eating disorder/depressive symptomology measure: measuring the differences of social stimuli and eating disorder/depressive symptomology measuring using the Food Rating Task. measure: measure the differences of social stimuli and mental flexibility with Trail Making Task measure: measure the differences of social stimuli and eating disorder/depressive symptomology utilizing Patient Health Questionnaire-9. sex: FEMALE minimumAge: 15 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06286917 id: R24001 briefTitle: Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency acronym: InNIVALS overallStatus: RECRUITING date: 2024-03-05 date: 2028-12 date: 2029-12 date: 2024-02-29 date: 2024-03-22 name: Tampere University class: OTHER briefSummary: This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are. conditions: Ventilation Therapy conditions: ALS conditions: Chronic Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: NIV initiation in patients with ALS measure: NIV usage hours according to different initiation locations in patients with ALS measure: Compliance with NIV according to NIV initiation setting in patients with ALS measure: Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation. measure: Costs of initiation of NIV in outpatient setting compared with inpatient setting in patients with ALS sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tampere University Hospital status: RECRUITING city: Tampere zip: 33520 country: Finland name: Heidi A Rantala, MD, PhD role: CONTACT phone: +3583311611 email: heidi.rantala@tuni.fi name: Lauri Lehtimäki, MD, PhD role: CONTACT phone: +3583311611 email: lauri.lehtimaki@tuni.fi name: Hanna Korkeamäki, MD, MSc role: PRINCIPAL_INVESTIGATOR name: Hannele Hasala, MD, PhD role: SUB_INVESTIGATOR name: Sirpa Leivo-Korpela, MD, PhD role: SUB_INVESTIGATOR lat: 61.49911 lon: 23.78712 hasResults: False

 nctId: NCT06286904 id: McMaster-Myant 16633 briefTitle: Sleep Position Pattern Recording overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-03-30 date: 2024-02-29 date: 2024-03-01 name: Myant Medical Corp. class: INDUSTRY name: McMaster University briefSummary: The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth. conditions: Pregnant Women studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 52 type: ESTIMATED name: Skiin Garment system measure: Accuracy of Skiin Garment system for detecting sleep position of pregnant women measure: Questionnaire on wearable device invasiveness and satisfaction measure: Participant recruitment rate measure: Participant retention rate sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: McMaster University city: Hamilton state: Ontario zip: L8S 4K1 country: Canada name: Kyle McGowan role: CONTACT phone: 905.521.2100 phoneExt: 21334 email: mcgowank@mcmaster.ca name: Eran Ashwal role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 hasResults: False

 nctId: NCT06286891 id: CAAE: 73520523.7.0000.0068 briefTitle: Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients overallStatus: RECRUITING date: 2024-02-29 date: 2024-11-01 date: 2025-09-30 date: 2024-02-29 date: 2024-03-19 name: University of Sao Paulo General Hospital class: OTHER briefSummary: The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET). conditions: Chronic Thromboembolic Pulmonary Hypertension conditions: Physical Disability conditions: Fragility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: To investigate changes in physical performance measured by Six-Minute Walk Test. measure: To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB). measure: To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST). measure: To investigate changes in peripheral muscle strength. measure: To investigate changes in respiratory muscle strength: measure: To investigate changes in lung function test measure by spirometry: measure: To investigate frailty by Clinical Frailty Scale (CFS) measure: To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss. measure: To investigate changes in hemodynamic and respiratory variables during the funcional tests. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo status: RECRUITING city: São Paulo state: SP zip: 05403-000 country: Brazil name: Orival Freitas Filho, MD role: SUB_INVESTIGATOR name: Fabio B Jatene, MD,PhD role: SUB_INVESTIGATOR name: Kelly CO Abud, PT, PhD role: SUB_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06286878 id: SDC 4620/17/120 briefTitle: Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes overallStatus: RECRUITING date: 2021-12-08 date: 2024-12-30 date: 2025-07-30 date: 2024-02-29 date: 2024-02-29 name: University of Sao Paulo class: OTHER briefSummary: Type 2 diabetes mellitus (T2DM) is one of the most important risk factors for atherosclerotic heart disease. Strategies focused solely on glycemic control have failed to demonstrate vascular events reduction in this population. On the other hand, new antidiabetic drugs recently have demonstrated significant decrease of cardiovascular mortality, raising the hypothesis that possible effects beyond glycemia control could explain this benefit. Aim: This study is intended to evaluate possible pleiothropic effects of dapaglifozin, a SGLT-2 (sodium glucose cotransporter 2) inhibitor, in individuals admitted with a diagnosis of Acute Myocardial Infarction (AMI). Methods: This is a prospective, randomized, double-blind, placebo controlled trial. Individuals presenting with AMI whithin the first seven days of evolution will be randomized to dapaglifozin or placebo. The investigators's goal is to analyze platelet aggregability 48 hours after randomization (primary endpoint), as well as glycemic control, cardiac biomarkers, corrected QT interval electrocardiographic analysis, autonomic modulation through spectral analysis of the RR interval and inflammatory biomarkers at inclusion and 30 days after starting study drug (secondary endpoints). Sample size calculation resulted in 80 individuals (40 per group). Expected results: This study will seek to aggregate new insights to the current knowledge about this new antidiabetic drug class. Previous randomized clinical trials have demonstrated that SGLT-2 inhibitors significantly reduced the composite endpoint of cardiovascular death, AMI or stroke, as well as Heart Failure (HF) hospitalization. Therefore, this study is supposed to clarify possible mechanisms that could explain these results aforementioned. conditions: Myocardial Infarction conditions: Acute Coronary Syndrome conditions: Diabetes conditions: Ventricular Dysfunction studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-center, prospective, randomized, double-blind, placebo-controlled clinical study. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Placebo name: Dapagliflozin measure: Platelet aggregation using ADP measure: Platelet aggregation using ADP at 30 (± 5) days after study therapy measure: Platelet aggregation using ASPI at 30 (± 5) days after study therapy measure: Analyze the primary objective of the study in the following pre-specified subgroups: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo status: RECRUITING city: Sao Paulo zip: 05403-900 country: Brazil name: José Carlos Nicolau role: CONTACT phone: 551126615058 email: josecarlosnicolau@gmail.com lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06286865 id: 260972(REK) briefTitle: Improving Quality of ICD-10 Coding Using AI: Protocol for a Crossover Randomized Controlled Trial acronym: ClinCode overallStatus: RECRUITING date: 2023-10-20 date: 2024-04 date: 2024-04 date: 2024-02-29 date: 2024-02-29 name: University Hospital of North Norway class: OTHER name: The Research Council of Norway briefSummary: The goal of this randomised trial is to learn about the role of AI in clinical coding practice. The main question it aims to answer is:

Can the AI-based CAC system reduce the burden of clinical coding and also improve the quality of such coding? Participants will be asked to code clinical texts both while they use our CAC system and while they do not. conditions: Gastrointestinal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Easy-ICD measure: Time measure: Accuracy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Norwegian Centre for E-health Research status: RECRUITING city: Tromso state: Troms zip: 9019 country: Norway name: Taridzo F Chomutare, PhD role: CONTACT phone: +4747680032 email: taridzo.chomutare@ehealthresearch.no name: Hercules Dalianis, PhD role: CONTACT phone: +46705681359 email: hercules@dsv.su.se lat: 69.6489 lon: 18.95508 hasResults: False

 nctId: NCT06286852 id: EDE BA briefTitle: Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-01 date: 2023-12-30 date: 2024-06-30 date: 2024-02-29 date: 2024-02-29 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Although eating disorders often occur during or after puberty, it is likely that critical antecedent conditions can be established before adolescence. The Eating Disorder Examination has been adapted for children and is described by Bryant - Waugh, Cooper, Taylor and Lask (1996). The EDE is considered the gold standard of measures of eating disorder psychopathology (Wilson, 1993), and this adaptation, which allows its use with a younger age group, is a potentially important addition to the assessment of eating disorders in children. The latest version of EDE, the l7th edition, has now surpassed its predecessors.

The aim of the study is to evaluate the psychometric properties of the Child vers ion EDE (chEDE) translated into Italian, in a sample of patients with eating disorder conditions: Feeding and Eating Disorders of Childhood studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002) name: Administration of ChEDE- Child Version of the EatingDisorder Examination measure: K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire measure: ChEDE (Child Version of the EatingDisorder Examination) sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Meyer Children's Hospital IRCCS city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: USL Toscana Centro city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Ospedale Villa Garda city: Garda country: Italy lat: 45.57889 lon: 10.71763 hasResults: False

 nctId: NCT06286839 id: AFCRO-150 briefTitle: Study of Cannabidiol (CBD) in Healthy Volunteers overallStatus: COMPLETED date: 2022-05-12 date: 2022-10-28 date: 2022-12-14 date: 2024-02-29 date: 2024-02-29 name: NextEvo Inc. class: INDUSTRY name: Atlantia Food Clinical Trials briefSummary: This was a prospective, single-centre, open label, randomized, two-arm, parallel design study to evaluate the effect of four-weeks consumption of active study product on primary endpoint in healthy adults conditions: Immune System and Related Disorders conditions: Immune System Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 26 type: ACTUAL name: Cannabidiol (CBD) measure: Plasma CBD pharmacokinetics of twice daily intake of 2 different doses of CBD over three days measure: Evaluate the safety of twice daily intake of 2 different doses of CBD over three 3 days measure: Plasma CBD maximal concentration (Cmax, ng/ml) measure: Plasma CBD time to peak (Tmax, minutes) measure: Percentage Change between groups on whole blood LPS stimulated cytokines (% change) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Altantia Clinical Trials city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06286826 id: ATRESO briefTitle: A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia overallStatus: RECRUITING date: 2023-10-12 date: 2024-10-12 date: 2026-01-12 date: 2024-02-29 date: 2024-03-04 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).

Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.

This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.

The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation conditions: Atresia Esophagus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Postero-lateral thoracotomy name: Minithoracotomy measure: incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically measure: incidence of musculoskeletal abnormalities in the short term measure: incidence of musculoskeletal abnormalities in the medium term measure: Evaluation of severity of outcomes in the medium, short and long term measure: Predective Facotrs evaluation sex: ALL minimumAge: 1 Day maximumAge: 13 Years stdAges: CHILD facility: Spedali Civili di Brescia status: RECRUITING city: Brescia zip: 25123 country: Italy name: Daniele Alberti role: CONTACT email: daniele.alberti@unibs.it lat: 45.53558 lon: 10.21472 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence zip: 50139 country: Italy name: Elisa Severi role: CONTACT phone: 0555662900 email: elisa.severi@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedale Bambino Gesù di Roma status: RECRUITING city: Roma zip: 00165 country: Italy name: Andrea Conforti, MD role: CONTACT email: andrea.conforti@opbg.net lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06286813 id: Akarakoc briefTitle: The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates overallStatus: RECRUITING date: 2024-03-02 date: 2024-05-03 date: 2024-05-30 date: 2024-02-29 date: 2024-02-29 name: Marmara University class: OTHER briefSummary: This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.

Interventional research with two parallel groups and no control group conditions: Skin Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Interventional research with two parallel groups (almond olive group and virgin olive oil group) and no control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Plant (natural) oils measure: Neonatal skin condition score measure: Skin moisture meter(DMM): sex: ALL minimumAge: 1 Hour maximumAge: 72 Hours stdAges: CHILD facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital status: RECRUITING city: Istanbul zip: 34854 country: Turkey name: AYŞE KARAKOÇ role: CONTACT phone: +905335695138 email: akarakoc@marmara.edu.tr name: Irem Zulal Topçuoglu Arslan role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06286800 id: PRO00036824 briefTitle: Personalized Transcranial Direct Current Stimulation in Stroke Recovery overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2026-03-14 date: 2026-09-14 date: 2024-02-29 date: 2024-02-29 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Transcranial direct current stimulation (tDCS) with OT name: Sham tDCS with OT measure: fMRI functional connectivity biomarker measure: Wolf Motor Function Test measure: Fugl-Meyer assessment sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286787 id: HSEARS20221110002 briefTitle: Efficacy of Mountain Craft Training at Enhancing the Resilience and Physio-psychological Well-being of Children From Low-income Families overallStatus: RECRUITING date: 2023-11-16 date: 2024-11-01 date: 2024-11-01 date: 2024-02-29 date: 2024-02-29 name: The Hong Kong Polytechnic University class: OTHER briefSummary: It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families. conditions: Resilience conditions: Well-being conditions: Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Intervention name: Placebo measure: Resilience Scale-14 (RS-14) measure: Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC) measure: Chinese version of Rosenberg's Self-Esteem Scale (RSES) measure: The children's peak expiratory flow rate sex: ALL minimumAge: 12 Years maximumAge: 14 Years stdAges: CHILD facility: The Asbury Methodist Social Service status: RECRUITING city: Hong Kong country: China name: Chung role: CONTACT email: okjoyce.chung@polyu.edu.hk lat: 22.39407 lon: 114.13737 hasResults: False

 nctId: NCT06286774 id: 2096884 briefTitle: Sleep as a Mechanism of Change in Alcohol Use acronym: ReTRAIN overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-04-01 date: 2028-04-01 date: 2024-02-29 date: 2024-02-29 name: University of Missouri-Columbia class: OTHER briefSummary: This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes. conditions: Insomnia conditions: Alcohol; Harmful Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) or waitlist control. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 256 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia measure: Insomnia Symptoms measure: Drinking quantity measure: Alcohol-related consequences measure: Treatment willingness (alcohol) measure: Alcohol craving measure: Negative emotionality measure: Response inhibition measure: Working memory measure: Delay discounting measure: Alcohol to help with sleep measure: Heartrate variability measure: Dysfunctional Beliefs and Attitudes about Sleep Scale sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: University of Missouri-Columbia city: Columbia state: Missouri zip: 65212 country: United States lat: 38.95171 lon: -92.33407 hasResults: False

 nctId: NCT06286761 id: 2100332 briefTitle: Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL) acronym: VAL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-03 date: 2028-03 date: 2024-02-29 date: 2024-02-29 name: Bettina Mittendorfer class: OTHER briefSummary: The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: endothelial cell collection measure: Validation and reproducibility testing for blood assays measure: Validation and reproducibility testing for endothelial cell collection measure: Validation and reproducibility testing for mixed meal ingestion measure: Validation and reproducibility testing for glucose tolerance testing measure: Validation and reproducibility testing for DEXA measure: Validation and reproducibility testing for MRI measure: Validation and reproducibility testing for MRS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286748 id: DeniseMafra19 briefTitle: Beetroot Extract Supplementation Associated With an Exercise Protocol for Chronic Kidney Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-12-10 date: 2024-12-10 date: 2024-02-29 date: 2024-02-29 name: Universidade Federal Fluminense class: OTHER briefSummary: Chronic kidney disease (CKD) patients often present systemic inflammation and oxidative stress, resulting in metabolic disorders and high rates of disease-associated cardiovascular death. The literature has indicated that dietary control, the use of bioactive compounds, and the practice of regular physical exercise are essential for the prevention and management of CKD and its complications. In this context, beetroot (Beta vulgaris rubra) deserves attention as it is a source of several bioactive compounds, such as nitrate, betaine, and betalain, with beneficial effects for CKD patients, including anti-inflammatory, antioxidant effects, reduction of blood pressure, and vasodilatory action. The antioxidant and anti-inflammatory properties, in addition to their vasodilatory and antihypertensive capacity, can make supplementation of beetroot an excellent nutritional strategy to help in the treatment of CKD patients. So, this research project will bring contributions to the scientific world, providing strategies for application in clinical practice and the care of patients with CKD, on the use of beetroot associated with an exercise protocol as a non-pharmacological strategy in modulating inflammation, oxidative stress, and improved functional capacity. Furthermore, when supplemented hours before physical training, has been identified as an important factor in improving performance in these activities. Therefore, this study aims to evaluate the effects of supplementation (acute and chronic) of beetroot extract associated with an exercise protocol on complications associated with CKD. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 25 type: ESTIMATED name: Beetroot juice name: Placebo measure: Change individual quality of life measure: Change physical activity level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286735 id: DeniseMafra18 briefTitle: Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-22 date: 2024-11-22 date: 2024-12-22 date: 2024-02-29 date: 2024-03-25 name: Universidade Federal Fluminense class: OTHER briefSummary: Patients with chronic kidney disease (CKD) experience many complications related to inflammation and oxidative stress that are closely related to the progression of kidney failure and increased mortality. Furthermore, these patients may have intestinal dysbiosis associated with persistent uremia, generating greater production of uremic toxins arising from the metabolism of intestinal bacteria and also helping to maintain the inflammatory process and oxidative stress. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation and improve the antioxidant response of patients with CKD, and even more so to modulate the intestinal microbiota. Based on the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation, oxidative stress, and also the modulation of the intestinal microbiota, cinnamon, a member of the Lauraceae family, has been widely used as a spice and traditional herbal medicine for centuries and has indicated beneficial benefits in cardiovascular diseases, obesity, diabetes. The bioactive compounds in cinnamomum, such as cinnamaldehyde, cinnamic acid, and cinnamate, can attenuate oxidative stress, inflammation, hyperglycemia, intestinal dysbiosis, and dyslipidemia, which are common complications in CKD patients. Therefore, the present project proposes a longitudinal clinical trial study that aims to evaluate the effects of cinnamomum on transcription factors and inflammatory markers, oxidative stress and modulation of intestinal health in patients with CKD on hemodialysis. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: cinnamomum name: Placebo measure: Concentration of Nuclear factor kappa B (NF-KB) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286722 id: LollandCD briefTitle: Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study acronym: ENHANCE overallStatus: RECRUITING date: 2024-02-08 date: 2025-06-30 date: 2025-06-30 date: 2024-02-29 date: 2024-02-29 name: Lolland Community, Denmark class: OTHER name: Vordingborg Municipality name: Stevns Municipality name: Guldborgsund Municipality briefSummary: Older adults suffering from a hip fracture are a significant concern, with higher incidence rates among women. Mortality rates post-hip fracture are alarming, with up to 8-fold increased risk within 3 months and significant percentages within 30 days and 12 months. Older adults with hip fracture face challenges in regaining pre-fracture level of function, especially those with cognitive impairment, which affects 25% to 40% of cases and increases mortality risk. While interventions exist, such as progressive strength training and structured exercise programs, patients with hip fracture don't consistently restore pre-fracture function, particularly in cognitively impaired patients, who are often excluded from studies. Limited evidence exists on effective management for this subgroup, with a lack of clarity on community-based rehabilitation. Although guidelines suggest exercise interventions for patients with mild to moderate cognitive impairment, the specifics remain uncertain due to insufficient research focused solely on this population.

This feasibility study aims to assess the practicality and safety of implementing a 12-week individualized, progressive exercise program for older adults with hip fracture and cognitive impairment in an outpatient setting. Additionally, the investigators seek to gather qualitative insights through observations and interviews regarding participants' experiences and the perceived value of rehabilitation post-hip fracture, particularly focusing on the exercise intervention provided. conditions: Hip Fractures conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Progressive, individualized and structured exercise program measure: The New Mobility Score measure: Mini Mental State Examination measure: Height measure: Weight measure: Tandem balance test measure: The Barthel-20 measure: 30 sec chair raise test measure: Brief Assessment of Impaired Cognition Questionaire measure: Handgrip strength measurement measure: The Cumulated Ambulation Score measure: Four meter walk test measure: Euroqol 5 dimensions measure: Clinical Frailty Scale measure: The Verbal Rating Scale measure: Activity accelerometers sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Stevns Healthcare Center, Stevns Municipality status: NOT_YET_RECRUITING city: Hårlev zip: 4652 country: Denmark name: Lotte Bylov role: CONTACT email: jover@lolland.dk lat: 55.34936 lon: 12.23382 facility: Maribo Health Center, Lolland Municipality status: RECRUITING city: Maribo zip: 4930 country: Denmark name: Jan Arnholtz Overgaard, MSc. role: CONTACT phone: +4554677700 email: jover@lolland.dk name: Gwen Tremmel role: CONTACT phone: +4554677700 email: gptr@lolland.dk name: Jan A Overgaard, MSc. role: PRINCIPAL_INVESTIGATOR lat: 54.77662 lon: 11.50017 facility: Guldborgsund Healthcare Center, Guldborgsund Municipality status: RECRUITING city: Nykøbing Falster zip: 4800 country: Denmark name: Cecilie Kristensen role: CONTACT email: jover@lolland.dk lat: 54.76906 lon: 11.87425 facility: Vordingborg Healthcare Center, Vordingborg Municipality status: RECRUITING city: Vordingborg zip: 4760 country: Denmark name: Line Flemmer, Bachelor role: CONTACT email: jover@lolland.dk lat: 55.00801 lon: 11.91057 hasResults: False

 nctId: NCT06286709 id: RG_22-063 briefTitle: FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis acronym: FARGO overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2026-04-30 date: 2026-07-29 date: 2024-02-29 date: 2024-02-29 name: University of Birmingham class: OTHER name: PSC Support name: Life Arc briefSummary: FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease. conditions: Primary Sclerosing Cholangitis conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IIa, multi-centre, randomised, placebo-controlled, single-blinded, parallel group, clinical trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 58 type: ESTIMATED name: Faecal Microbiota Transplant name: FMT Placebo measure: Serum Alkaline Phosphatase (ALP) measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Surrogate biomarkers of liver fibrosis measure: Surrogate biomarkers of liver fibrosis measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: PSC specific prognostic scores measure: PSC specific prognostic scores measure: Quantitative assessment of Inflammatory Bowel Disease (IBD) activity measure: Quantitative assessment of IBD activity measure: Quantitative assessment of IBD activity measure: The incidence of clinical non-trial endpoint events measure: The incidence of trial endpoint events measure: Occurrence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust city: Birmingham zip: B15 2TH country: United Kingdom name: Palak Trivedi role: PRINCIPAL_INVESTIGATOR lat: 52.48142 lon: -1.89983 facility: St Mark's Hospital, London North West University Healthcare NHS Trust city: London zip: NW10 7NS country: United Kingdom name: Ailsa Hart role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Royal Free Hospital, Royal Free London NHS Foundation Trust city: London zip: NW3 2QG country: United Kingdom name: Douglas Thorburn role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: King's College Hospital, King's College Hospital NHS Foundation Trust city: London zip: SE5 9RS country: United Kingdom name: Deepak Joshi role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust city: Norwich zip: NR4 7UY country: United Kingdom name: Simon Rushbrook role: PRINCIPAL_INVESTIGATOR lat: 52.62783 lon: 1.29834 facility: John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust city: Oxford zip: OX3 9DU country: United Kingdom name: Emma Culver role: PRINCIPAL_INVESTIGATOR lat: 51.75222 lon: -1.25596 hasResults: False

 nctId: NCT06286696 id: NL84914.058.23 briefTitle: Optic Nerve Sheath Diameter in Hypertensive Emergency acronym: OpticUS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-07-01 date: 2024-02-29 date: 2024-02-29 name: Leiden University Medical Center class: OTHER briefSummary: This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor. conditions: Hypertensive Emergency conditions: Papilledema conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 375 type: ESTIMATED name: Optic Nerve Sheath Diameter measure: Papilledema measure: Hypertensive retinopathy grade 3 & 4 combined measure: Hypertensive encephalopathy measure: Rapid acting medications administered intravenously to lower the elevated blood pressure measure: Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286683 id: APHP231706 briefTitle: Impact of Early Mobilization on SAH Patients Physiological Parameters acronym: MOBALPAH overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-02 date: 2027-02 date: 2024-02-29 date: 2024-03-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The aim of the study is to evaluate the physiological response to out-of-bed mobilization in patients admitted to the intensive care unit for subarachnoid hemorrhage. More specifically, the aim is to measure the impact on cerebral perfusion, lung aeration, cardiovascular and respiratory parameters. conditions: Subarachnoid Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: lung ultrasound name: Transcranial Doppler name: near-infrared spectroscopy (NIRS) name: clinical examination measure: Impact on lung aeration measure: Impact on cerebral blood flow measure: Impact on cerebral tissue oxygenation measure: Impact on heart rate measure: Impact on arterial pressure measure: Impact on Saturation measure: Impact on neurological examination measure: Impact on patient comfort sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Adéla FOUDHAÏLI city: Paris zip: 75010 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06286670 id: IRB00108312 id: HT94252311075 type: OTHER domain: Department of Defense briefTitle: Single Versus Dual Implant Fixation of Distal Femur Fractures acronym: PRORP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-12 date: 2024-02-29 date: 2024-04-16 name: Wake Forest University Health Sciences class: OTHER name: United States Department of Defense briefSummary: The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities. conditions: Articular Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: Single Implant Fixation name: Dual Implant Fixation measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores measure: Number of Unions measure: Number of Resource Utilizations measure: Number of Reoperations measure: Number of Complications measure: Time to Walking Without an Assistive Device measure: Prescribed Weight Bearing Status measure: Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores measure: Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores measure: Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores measure: Change in the Work Productivity and Activity Impairment Questionnaire Scores measure: Change in Numeric Pain Rating measure: Change in Pain Inventory (BPI) measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference measure: Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) classification measure: Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS measure: Isokinetic Knee Flexion/Extension Strength Testing measure: Counter-Movement Jump measurement measure: Single Leg Static and Dynamic Postural Stability Index measure: Triple Hop Performance Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atrium Health Musculoskeletal Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Erica Grochowski role: CONTACT email: Erica.Grochowski@atriumhealth.org name: Laurence Kempton, MD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 hasResults: False

 nctId: NCT06286657 id: UVienna23a briefTitle: Xanthohumol and Viral Infections (XL) overallStatus: RECRUITING date: 2023-08-01 date: 2024-04-30 date: 2024-12-30 date: 2024-02-29 date: 2024-02-29 name: University of Vienna class: OTHER briefSummary: The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections. conditions: Infection Viral studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Xanthohumol name: Placebo measure: Changes in severity and duration of viral infections measure: Changes in blood lipid levels measure: Changes in cognitive skills sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Ina Bergheim, Prof. Dr. role: CONTACT phone: +43-1-4277-54981 email: ina.bergheim@univie.ac.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06286644 id: UVienna23 briefTitle: Hop Compounds on the Immune System (VH) overallStatus: RECRUITING date: 2022-05-30 date: 2024-05-30 date: 2024-12-30 date: 2024-02-29 date: 2024-02-29 name: University of Vienna class: OTHER briefSummary: The aim of the present study is to determine the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 14 type: ESTIMATED name: Xanthohumol name: Iso-alpha-Acids name: Xanthohumol + Iso-alpha-Acids measure: Changes in parameters of immune response measure: Changes in parameters of immune response sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Ina Bergheim, Prof. Dr. role: CONTACT phone: +431427754981 email: ina.bergheim@univie.ac.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06286631 id: Rating scale-202402 briefTitle: Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale overallStatus: RECRUITING date: 2023-05-01 date: 2025-10-01 date: 2026-10-01 date: 2024-02-29 date: 2024-02-29 name: Second Affiliated Hospital of Xi'an Jiaotong University class: OTHER briefSummary: The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients. conditions: Papillary Thyroid Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 800 type: ESTIMATED measure: Height measure: Weight measure: Age measure: Genders measure: BMI measure: Whether lymph node dissection was performed during previous surgery measure: Tumor Diameter Size measure: Tumor limitation of the primary focus measure: Extratumoral invasion measure: Pathologic lymph node metastasis measure: Tumor cystic solidity on preoperative ultrasound measure: Preoperative ultrasound tumor echo intensity measure: Preoperative ultrasound tumor boundaries measure: Preoperative ultrasound tumor for the presence of calcifications measure: Preoperative ultrasound tumor aspect ratios measure: Preoperative ultrasound for enlarged cervical lymph nodes measure: TSH measure: TPOAb measure: TgAb measure: Calcium measure: B-raf gene mutation sex: ALL minimumAge: 16 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Xi'an Jiaotong University status: RECRUITING city: Xi'an state: Shaanxi zip: 710000 country: China name: Yang Liu, doctor role: CONTACT phone: 0086+029-13384986500 email: individualliu@163.com lat: 34.25833 lon: 108.92861 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-29 uploadDate: 2024-02-22T03:07 filename: Prot_000.pdf size: 79490 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-29 uploadDate: 2024-02-22T03:08 filename: ICF_001.pdf size: 132491 hasResults: False

 nctId: NCT06286618 id: HHSN268201800015I briefTitle: Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-01 date: 2024-08-31 date: 2024-08-31 date: 2024-02-29 date: 2024-02-29 name: University of Southern Mississippi class: OTHER name: My Brother's Keeper briefSummary: The objective for the study is to implement a pilot study to establish essential components to address diet quality in healthcare settings and examine what value an integrated service model delivery has for the primary prevention of cardiometabolic diseases with an initial focus on dietary behaviors. This objective will be met by 1: Utilizing a multiphase optimization study design to select and optimize essential components to address diet behaviors and 2: Comparing an integrated and referral-based delivery model for healthcare-based strategies that address structural and psychosocial barriers to a healthy diet for racial/ethnic minority, marginalized and disadvantaged background young to middle aged adult populations in Mississippi. conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: Psychosocial Intervention name: Structural Intervention name: Traditional Psychosocial+Structural name: Integrated Psychosocial+Structural measure: Participant Burden measure: Diet Quality measure: cost effectiveness sex: ALL minimumAge: 25 Years maximumAge: 50 Years stdAges: ADULT facility: The University of Southern Mississippi city: Hattiesburg state: Mississippi zip: 39406-0001 country: United States lat: 31.32712 lon: -89.29034 hasResults: False

 nctId: NCT06286605 id: UNISS_PHD_Osstem_4 briefTitle: RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-30 date: 2028-12-30 date: 2024-02-29 date: 2024-02-29 name: Università degli Studi di Sassari class: OTHER name: Dr. Dario Melodia name: Dr. Milena Pisano name: Dr. Aurea Lumbau name: Prof. Silvio Mario Meloni name: Prof. Edoardo Baldoni briefSummary: The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group). conditions: Guided Bone Regeneration conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter, randomized controlled trial of parallel-group design. primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: A-oss and autogenous bone name: A-oss an LCR-A measure: Rate of Implants survival measure: Number of Participants with prosthesis failure measure: Number of complications measure: Horizontal and volumetric dimensional changes measure: Rate of peri-implant marginal bone level measure: Plaque Index and bleeping on probing measure: Valuation of patient satisfaction measure: Valuation of soft tissue thickness and amount of keratinized tissue measure: Rate of pes score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marco Tallarico city: Sassari zip: 07100 country: Italy name: Dario Melodia, Dr role: CONTACT phone: 3331226618 email: dariomld1@gmail.com name: Marco Tallarico, Prof role: CONTACT phone: 3280758769 email: me@studiomarcotallarico.it lat: 40.72586 lon: 8.55552 hasResults: False

 nctId: NCT06286592 id: Pro2023002053 briefTitle: LUNGevity: Lung Cancer Stigma Community Based Participatory Research overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-11 date: 2024-02-29 date: 2024-03-29 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: Lung cancer survival rates are low for intersectional underserved groups. Lung cancer stigma and intersectional stigma related to minoritized group status leads to increased morbidity and mortality and health disparities. Mindfulness interventions have been shown to decrease stigma and the negative impacts of stigma, however, these interventions have never been tested to decrease lung cancer stigma specifically. In this study, the investigators will use Community Based Participatory Research framework and MOST methodology to build and optimize a brief virtual mindfulness intervention to decrease lung cancer stigma, through first building a diverse coalition of lung cancer patients on a participatory action council. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Details of the specific interventions will be selected in collaboration with the Community Advisory Board.

Then, in a Phase IB trial, we will use a MOST design to assign patients to promising intervention components, combining them and altering exposure time, measuring preliminary effects of possible components of interventions. Details of the specific interventions will be selected in collaboration with the Community Advisory Board. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Ultra-brief mindfulness intervention video name: Forgiveness video name: ACT values video measure: Lung Cancer Stigma Inventory (LCSI) measure: Tobacco use quit likelihood sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286579 id: UNISS_PHD_Osstem_3 briefTitle: SOI Immediately vs Delayed overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2028-01-31 date: 2024-02-29 date: 2024-02-29 name: Università degli Studi di Sassari class: OTHER name: Dr. Dario Melodia name: Dr. Milena Pisano name: Dr. Aurea M. I. Lumbau name: Prof. Silvio Mario Meloni name: Prof. Edoardo Baldoni briefSummary: The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface conditions: Dental Implant conditions: Dental Implant-Abutment Design studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled trial of parallel group design. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: One "blinded (when possible)" independent assessor whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Immediately implant placement name: Delayed measure: Number of prosthesis failure measure: Number of implant failure measure: Number of complications measure: Rate of peri-implant marginal bone level changes measure: Valuation of patient satisfaction measure: Rate of implant stability quotient (ISQ) measure: Valuation of soft tissue thickness and amount of keratinized tissue measure: Number of PES score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marco Tallarico city: Sassari zip: 07100 country: Italy lat: 40.72586 lon: 8.55552 hasResults: False

 nctId: NCT06286566 id: UNISS_PHD_Osstem_2 briefTitle: Soi TS3 Surface in Patients With and Without Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2028-01-31 date: 2024-02-29 date: 2024-02-29 name: Università degli Studi di Sassari class: OTHER name: Dr. Dario Melodia name: Dr. Milena Pisano name: Dr. Aurea M. I. Lumbau name: Prof. Silvio Mario Meloni name: Prof. Edoardo Baldoni briefSummary: The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes. conditions: Dental Implant conditions: Dental Implant-Abutment Design studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter prospective cohort study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: centralized radiographic assessor, outcome assessors(when possible), and the statistical advisors will be blind to the used implants whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Implant placement with soi surface in diabetic subjects name: Implant placement with soi surface in healthy subjects measure: Number of prosthesis failure: measure: Number of implant failure measure: Number of complication measure: Rate of peri-implant marginal bone level changes measure: Valuation of patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marco Tallarico city: Rome state: Sassari zip: 07100 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06286553 id: DRA Rehab TEG & IMT briefTitle: Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training acronym: DR-TIME overallStatus: RECRUITING date: 2024-03-11 date: 2025-05-30 date: 2025-08-30 date: 2024-02-29 date: 2024-03-13 name: University of Patras class: OTHER briefSummary: Diastasis Recti Abdominis (DRA) is the separation of the rectus muscles caused by stretching and thinning of the linea alba during pregnancy and childbirth. It's a common condition, affecting 66-100% of women post-birth and can persist for many years, leading to abdominal protrusion, discomfort, and aesthetic concerns. It might also contribute to back pain, urinary issues, and reduced abdominal strength, impacting quality of life. Recent guidelines propose that conservative management, such as rehabilitation interventions, should be prioritized for DRA. However, there is a lack of consensus among researchers regarding the most effective exercise regimen, resulting in diverse rehabilitation programs. Recent evidence advocates not only for closing the gap but also for achieving optimal function. Current studies often neglect to address functional rehabilitation, underscoring the necessity for robust clinical trials, which is the primary focus of this study.

Additionally, although breathing exercises are commonly prescribed for DRA, the precise role of the diaphragm, the primary respiratory muscle, in rehabilitation hasn't been fully examined. The diaphragm forms the upper boundary of the abdominal cavity and plays a key role in the stability of the trunk, working together with the abdominal and pelvic floor muscles. A recent study found reduced diaphragm excursion in postpartum women with lumbopelvic pain during a low postural demanding task, while previous studies suggest that diaphragm training could alleviate such symptoms influencing factors such as diaphragm thickness and excursion, which may be linked to improved trunk stability. Hence, training the diaphragm and accessory inspiratory muscles through Inspiratory Muscle Training (IMT) could potentially play a crucial role in managing DRA.

In summary, the goal of this study is to develop and assess a comprehensive rehabilitation program aimed at effectively reducing DRA and addressing associated dysfunctions. The program will integrate evidence-based rehabilitation interventions, such as trunk stabilization exercises and IMT, targeting all related dysfunctions caused by DRA, and introducing a novel therapeutic protocol not previously implemented. The study will take the form of a prospective, randomized controlled trial (RCT). conditions: Diastasis Recti And Weakness Of The Linea Alba conditions: Diastasis, Muscle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this interventional study, three distinct groups are included. The Trunk Exercise Group (TEG) will partake in a comprehensive 12-week therapeutic exercise program that involves progressive strengthening exercises specifically targeting the trunk and pelvic floor muscles, alongside functional retraining exercises. The Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG) will adhere to the same 12-week therapeutic exercise program as TEG, with additional exercises focusing on strengthening the inspiratory muscles using inspiratory resistance (IMT). The control group (CG) will not participate in the 12-week exercise program but will receive a single exercise session and general management information (oral and written) for DRA. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Trunk exercise name: Inspiratory Muscle Training (IMT) name: Control Group measure: Inter-recti distance (IRD) measure: Diaphragmatic Thickness measure: Diaphragmatic Excursion measure: Maximum Inspiratory Pressure (MIP) measure: Strength Index (S-Index) measure: Peak Inspiratory Flow (PIF) measure: Trunk flexion test measure: Plank test measure: Side plank test measure: McGill's trunk flexor endurance test measure: Body Image States Scale (BISS) measure: Activities Assessment Scale (AAS) measure: Hernia-Related Quality-of-Life Survey (HerQLes) sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras status: RECRUITING city: Patras state: Achaia, Greece zip: 26504 country: Greece name: Evdokia Billis, PhD role: CONTACT phone: 00306973047170 email: billis@upatras.gr name: Anastasia Skoura, MSc role: CONTACT phone: 00306947784948 email: a.skoura@upatras.gr lat: 38.24444 lon: 21.73444 hasResults: False

 nctId: NCT06286540 id: 26031993 briefTitle: Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair. overallStatus: RECRUITING date: 2023-02-22 date: 2026-02 date: 2026-05 date: 2024-02-29 date: 2024-03-15 name: Petrovsky National Research Centre of Surgery class: OTHER briefSummary: Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data. conditions: Aorta Abdominalis; Aneurysm conditions: Aorta Thoracic; Aneurysm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 138 type: ESTIMATED name: Lymphoblock name: Placebo measure: Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea) measure: Number of Participants with Lymphocele measure: The amount of drainage discharge 1 measure: The amount of drainage discharge 2 measure: The amount of drainage discharge 3 measure: Concentration of triglycerides in the drainage discharge measure: Concentration of triglycerides in blood plasma measure: Concentration of cholesterol in the drainage discharge measure: Concentration of cholesterol in the blood plasma measure: Concentration of protein in the drainage discharge measure: Concentration of protein in the blood plasma measure: Concentration of albumin in the drainage discharge measure: Concentration of albumin in the blood plasma measure: Concentration of lactate dehydrogenase in the drainage discharge measure: Concentration of lactate dehydrogenase in the blood plasma measure: Concentration of glucose in the drainage discharge measure: Concentration of glucose in the blood plasma measure: Number of Participants with Pleural effusion within 10 days measure: Number of Participants with Lymphocele 3 months after the surgery measure: Number of Participants with Pleural effusion 3 months after the surgery sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Petrovsky NRCS status: RECRUITING city: Moscow zip: 119991 country: Russian Federation name: Denis Breshenkov, Phd role: CONTACT phone: +79773439041 email: denisbreshenkov@gmail.com name: Boris Tivelev role: CONTACT phone: +79044244886 email: boristivelev@gmail.com name: Omar Mutaev role: SUB_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06286527 id: EssaiClinique_PREP-QUAL-VS briefTitle: Quality of Sexual Life of PrEP Users acronym: PREP-QUAL-VS overallStatus: NOT_YET_RECRUITING date: 2024-03-06 date: 2024-09-06 date: 2024-09-06 date: 2024-02-29 date: 2024-03-01 name: University Hospital, Grenoble class: OTHER briefSummary: The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France.

PrEP users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that PrEP has an impact on the quality of sexual life. conditions: HIV Pre-exposure Prophylaxis Use conditions: Adult studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1000 type: ESTIMATED name: anonymous self-administered online questionnaire measure: quality of sexual life as assessed by a set of questions measure: perceived influence of PrEP use on the quality of sexual life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Olivier EPAULARD city: Grenoble state: Is zip: 38043 country: France name: Olivier EPAULARD, MD, PhD role: CONTACT phone: +33476765291 email: oepaulard@chu-grenoble.fr lat: 45.16667 lon: 5.71667 hasResults: False

 nctId: NCT06286514 id: STUDY00019996 briefTitle: Food at Home Study overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-30 date: 2026-03-30 date: 2024-02-29 date: 2024-04-16 name: University of Minnesota class: OTHER briefSummary: The study objective is to develop an accessible home food environment assessment toolkit that includes valid and reliable paper and electronic tools targeting foods known to impact diet-related health that can be user-administered across literacy levels in English and Spanish. conditions: Obesity conditions: Diet, Healthy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 350 type: ESTIMATED name: No intervention measure: Usability of HFI core measure: Acceptability of HFI core measure: Concurrent criterion validity of HFI core measure: Concurrent criterion validity of HFI core measure: Convergent construct validity of HFI core measure: Convergent construct validity of HFI core measure: Test-retest reliability of HFI core measure: Usability of eHFI measure: Acceptability of eHFI measure: Concurrent criterion validity of eHFI measure: Concurrent criterion validity of eHFI measure: Convergent construct validity of eHFI measure: Convergent construct validity of eHFI sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Sarah Friend role: CONTACT lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06286501 id: R23060L briefTitle: Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases acronym: LumoPrevent overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-09-30 date: 2025-12-31 date: 2024-02-29 date: 2024-04-17 name: Wellbeing Services County of Pirkanmaa class: OTHER name: Tampere University name: University of Helsinki name: Metropolia University of Applied Sciences briefSummary: The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging. conditions: Dental Caries in Children conditions: Dental Plaque conditions: Tooth Decay conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical study on a CE-approved medical device primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Lumoral Treatment name: Standard, personalized oral health care measure: Bleeding on probing (BOP) measure: Bleeding on probing (BOP) measure: Active matrix metalloproteinase 8 (aMMP-8) measure: Probing Pocket Depth (PPD) measure: Probing Pocket Depth (PPD) measure: Visible plaque index (VPI) measure: Visible plaque index (VPI) measure: Decayed tooth assessment (DT) measure: Clinical attachment level (CAL) measure: Clinical attachment level (CAL) measure: Microbiological evaluation/16S rRNA analysis measure: Microbiological evaluation/16S rRNA analysis measure: Oral-related quality of life measurement (OHIP-14) measure: Absence of adverse effects sex: ALL minimumAge: 14 Years maximumAge: 16 Years stdAges: CHILD facility: Wellbeing Services of County Pirkanmaa city: Tampere state: Pirkanmaa zip: 33520 country: Finland name: Milla Sarja, dentist role: CONTACT phone: +358405337979 email: milla.sarja@pirha.fi name: Mikko Kylmänen role: CONTACT email: mikko.kylmanen@metropolia.fi name: Anna Maria Heikkinen, Professor role: PRINCIPAL_INVESTIGATOR lat: 61.49911 lon: 23.78712 hasResults: False

 nctId: NCT06286488 id: KB/96/2020 briefTitle: Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza overallStatus: ACTIVE_NOT_RECRUITING date: 2020-09-15 date: 2023-08-23 date: 2026-05-01 date: 2024-02-29 date: 2024-03-01 name: Medical University of Warsaw class: OTHER briefSummary: The aim of the study is to evaluate simultaneously the immunological and clinical efficacy and tolerability of an influenza vaccine, inactivated, quadrivalent, with cleaved virus, in patients at risk for severe and complicated influenza routinely vaccinated against influenza in family medicine clinics or specialty clinics (pediatric, internal medicine, cardiology, gynecological diabetes, pregnant women, transplant). conditions: Influenza conditions: Obesity conditions: Pregnancy; Infection conditions: Elderly Infection conditions: Vaccine Reaction conditions: Vaccine Adverse Reaction conditions: Tolerance studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1500 type: ACTUAL name: Vaxigrip measure: influenza vaccine immunogenicity, seroconversion and seroprotection measure: assessment of vaccination tolerance sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Social Medicine and Public Health, Medical University of Warsaw city: Warsaw zip: 02-077 country: Poland lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06286475 id: VGCS-50635-003 briefTitle: A Study of VRG50635 in Healthy Volunteers overallStatus: RECRUITING date: 2024-02-29 date: 2024-05 date: 2024-05 date: 2024-02-29 date: 2024-03-27 name: Verge Genomics class: INDUSTRY briefSummary: The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a 2-part study that includes both an open-label (Part 1) and a double-blind, placebo-controlled (Part 2) design. In Part 1, participants will be randomly assigned to receive open-label VRG50635 in 1 of 2 treatment sequences. In Part 2, participants will receive VRG50635 or placebo in a double-blind manner. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: VRG50635 name: Placebo measure: Number of Participants with Adverse Events measure: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf) measure: Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast) measure: Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24) measure: Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau) measure: Maximum Observed Concentration (Cmax) measure: Half-life (t1/2) measure: Time of Maximal Plasma Concentration (tmax) sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Site 001 status: RECRUITING city: Lincoln state: Nebraska zip: 68502 country: United States lat: 40.8 lon: -96.66696 hasResults: False

 nctId: NCT06286462 id: R01CA278617 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA278617 briefTitle: Evaluation of the Cancer Tracking System (CATSystem) acronym: CATSystem overallStatus: RECRUITING date: 2024-02-05 date: 2026-08-31 date: 2028-01-31 date: 2024-02-29 date: 2024-03-05 name: University of Kansas Medical Center class: OTHER name: Global Health Innovations name: DARTNet Institute name: San Diego State University name: University of Michigan briefSummary: Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care). conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Matched, cluster randomized controlled design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 6600 type: ESTIMATED name: Cancer Tracking System (CATSystem) measure: Guideline adherent treatment for a positive screen measure: Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes measure: Cervical cancer screening sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Akala Health Center status: RECRUITING city: Akala country: Kenya name: May H Maloba, MCH role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng, BA role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: -0.06003 lon: 34.42693 facility: Bondo Referral Hospital status: RECRUITING city: Bondo country: Kenya name: May H Maloba, MCH role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng, BA role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.23861 lon: 34.26944 facility: Alupe Sub-County Hospital status: RECRUITING city: Busia country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Busia County Referral Hospital status: RECRUITING city: Busia country: Kenya name: May H Maloba, MCH role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng, BA role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Khunyangu Sub-County Hospital status: RECRUITING city: Busia country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Matayos Health Center status: RECRUITING city: Busia country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Port Victoria Sub-County Hospital status: RECRUITING city: Busia country: Kenya name: May H Maloba, MCH role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng, BA role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Nambale Sub-County Hospital status: RECRUITING city: Siaya country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.06116 lon: 34.28823 facility: Yala Sub-County Hospital status: RECRUITING city: Siaya country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.06116 lon: 34.28823 facility: Ukwala Sub-County Hospital status: RECRUITING city: Ukwala country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.19039 lon: 34.18908 hasResults: False

 nctId: NCT06286449 id: CSV_AUD briefTitle: Identification of Cellular and Molecular Mechanisms Involved in the Pathophysiology of Alcohol Use Disorder by Examination of Cerebrospinal Fluid overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-29 date: 2024-02-29 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: BACKGROUND

The brain and spinal cord are enveloped by cerebrospinal fluid (CSF), which extends down to the base of the spine, a few centimeters below the termination of the spinal cord. Here, it can be collected through a minor needle puncture. This procedure enables the gathering of information about otherwise concealed molecular and cellular processes in the brain. Analyzing various specific molecules in the CSF has yielded crucial insights into the underlying mechanisms of many neurological and psychiatric disorders, such as multiple sclerosis (MS) and dementia, significantly enhancing the prospects for its treatment. However, for several brain disorders, including Alcohol Use Disorder (AUD) and substance use disorders, CSF studies are absent. AUD, a brain disease affecting the reward system, is characterized by an inability to limit alcohol consumption. High levels of alcohol intake, as seen in AUD, are a leading cause of morbidity and premature mortality. Yet, there is a lack of effective medications for its treatment. Analyzing molecules in CSF, believed to be significant for the development and maintenance of AUD, could enhance the development of effective pharmacological treatments. At present, there are no CSF studies on individuals with AUD, that explore the underlying mechanisms of the disease. Additionally, several CSF studies lack a representative control group of truly healthy controls (i.e. have not presented any neurological or psychiatric symptoms), which is crucial for drawing accurate conclusions.

OBJECTIVE

Sub-study 1 aims to collect CSF from individuals with AUD across various ages to analyze brain molecules that contribute to the development and maintenance of the disease.

Sub-study 2 aims to gather CSF from healthy controls across various ages to study molecules involved in neurological and psychiatric conditions, including AUD, substance dependency, brain inflammation, and narcolepsy. The goal is to create a reference group of CSF from healthy controls for comparison with CSF collected from individuals with the aforementioned conditions.

We hypothesize that levels of certain molecules, such as dopamine, differ between healthy controls and those with e.g. AUD. This study may provide insights into cellular and molecular mechanisms underlying brain disorders, which is in turn crucial for developing new, effective treatments.

Sub-study 3 will examine how the incubation of nerve cells in CSF collected in sub-study 1 and 2 affects their excitability and ability to form new synapses, essential for communication in the brain.

We hypothesize that the excitability and synaptogenesis of nerve cells will vary depending on whether they are incubated in CSF from neurologically and psychiatrically healthy individuals versus those with AUD, substance use disorders, brain inflammation, and narcolepsy. Understanding how CSF composition influences brain function in these conditions could be instrumental in creating new therapeutic drugs.

METHODS

Individuals with AUD, as well as psychiatrically and neurologically healthy volunteers, will be successively recruited for CSF collection and analyses. Recruitment will be performed through media advertisements and posters within healthcare facilities (The Sahlgrenska University Hospital) and the University of Gothenburg. Additional participants will be recruited from parallel research projects performed within the group (IV-ASA BO10 dnr: 2019-04120, COMB BO8 dnr 431-18, GlycinA BO5 dnr 806-14, PI Bo Söderpalm and NordAlc BO9 dnr: 430-18, PI Andrea de Bejczy) CSF will be obtained through lumbar puncture (spinal tap), a procedure where a thin needle is inserted below the end of the spinal cord. Local anesthesia will be administered in order to mitigate potential discomfort. The lumbar puncture will be performed by an experienced physician, minimizing the risk of injury. Blood samples will also be collected to correlate molecule levels in CSF with those in the blood. Participants will be interviewed about their medical history including their alcohol consumption, and a comprehensive medical examination will be performed.

SIGNIFICANCE

CSF studies offers unique insights into the cellular and molecular processes within the brain. This approach has been utilized for exploring the mechanisms behind several psychiatric and neurological disorders, but not for certain brain diseases like AUD. AUD inflicts significant suffering for affected individuals, contributes to high mortality rates, and imposes considerable burdens on the society. Moreover, a deeper understanding of the cellular and molecular underpinnings of brain diseases such as AUD, can facilitate the development of novel, more effective medications for its treatment. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The intervention in this study consists of a spinal tap that all study participants undergo. We are comparing biomarkers in cerebrospinal fluid collected from either participants with Alcohol Use Disorder or from healthy controls. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Spinal tap measure: CSF-DA levels sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286436 id: IR.SBMU.RETECH.REC.1401.842 briefTitle: Effect of Dual-task Training on the Number of EEG Band in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2024-04-29 date: 2024-05-29 date: 2024-02-29 date: 2024-03-01 name: Universidad de Zaragoza class: OTHER briefSummary: Stroke is a prevalent global health concern, causing widespread disability as it disrupts blood supply to the brain, leading to functional impairments. Upper limb dysfunction affects over 80% of stroke survivors acutely and becomes permanent in approximately 60%, hindering daily activities and autonomy. Dual-task training (DTT), involving simultaneous cognitive and motor tasks resembling daily activities, is proposed as an effective intervention.

The study suggests using electroencephalogram (EEG) analysis, particularly the Fast Fourier Transform (FFT), to assess changes in brain signals pre- and post-DTT intervention. EEG provides real-time insights into brain function, and FFT analyzes signal frequencies. The intervention involves three tasks performed concurrently with mental calculations, such as sorting blocks and manipulating objects. This 12-session, four-week intervention aims to improve upper limb function. The study explores EEG's role in evaluating DTT effects on stroke patients, particularly using FFT to analyze brain signal frequencies. conditions: Stroke conditions: Electroencephalography studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Dual-task training measure: EEG Data measure: Upper limb function measure: Elbow flexor muscle tone measure: Wrist extension range of motion measure: ADLs sex: FEMALE minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shahid Beheshti University of Medical Sciences city: Tehran state: Velenjak country: Iran, Islamic Republic of name: Borhan Asadi, Eng role: CONTACT lat: 35.69439 lon: 51.42151 hasResults: False

 nctId: NCT06286423 id: HSR220446 briefTitle: Colchicine in Acutely Decompensated HFREF overallStatus: RECRUITING date: 2024-03 date: 2026-02 date: 2028-02 date: 2024-02-29 date: 2024-03-20 name: University of Virginia class: OTHER briefSummary: This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo.

Upon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76±14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Disease Improving Global Outcomes (KDIGO) Stage I, as specified in the protocol.

These patients will continue with their standard of care for the management of heart failure which consists of a combination of medications that relieve congestion, normalize blood pressure and heart rate, and block the effects of hormones on the heart. The proposed treatment will be in addition to standard of care. No standard of care medications will be withheld. While inflammation is a known risk factor in heart failure, there are no standard anti-inflammatory drugs used in patients with heart failure, as the benefit is not established. The study team will study colchicine, an anti-inflammatory drug, as compares with placebo.

Blood will be obtained from the patients in order to measure hsCRP and IL-6. Blood samples will be collected at baseline, 24±6h, 48±6h and 72±6h after treatment initiation, and subsequently at 14±7 days and at study closure. The first four blood samples will be obtained while the subject is still admitted to the hospital. The blood sample at 14±7 days will be obtained during an outpatient encounter. A study closure visit with clinical assessment and experimental drug collection for capsule counting to assess compliance will be conducted at 90±14; the final blood sample will be collected at that time. conditions: Heart Failure conditions: Decompensated Heart Failure conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study team is planning to use controls in the present study. Controls will be patients from the target population, i.e. acutely decompensated heart failure with reduced ejection fraction. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Colchicine 0.6 mg name: Control/Placebo group measure: Difference in the change in high sensitivity C-reactive protein (hsCRP) between colchicine arm and placebo arm in the first 72 hours of treatment measure: Difference in hsCRP area under curve between colchicine and placebo arm at 14 days measure: Difference in change in plasma IL-6 concentration between colchicine arm and placebo arm in the first 72 hours of treatment measure: Difference in the incidence of a composite of all-cause mortality or hospitalizations for heart failure at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UVA Health status: RECRUITING city: Charlottesville state: Virginia zip: 22908 country: United States name: Austin Hogwood role: CONTACT email: ach2jb@virginia.edu name: Francesco Moroni, MD role: CONTACT email: nmf7mm@uvahealth.org name: Antonio Abbate, MD role: PRINCIPAL_INVESTIGATOR lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06286410 id: 184950 briefTitle: Accommodation Response in Hypermetropic Anisometropia (ARIHA Study) acronym: ARIHA overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-29 date: 2024-03-01 name: University of Sheffield class: OTHER name: Sheffield Children's NHS Foundation Trust briefSummary: Anisometropic amblyopia is when one eye has a much stronger glasses prescription than the other, causing poor vision in one eye, even with glasses, because the brain favours the better-seeing eye.

With standard care treatment (glasses plus either patching or atropine drops given to the better seeing eye), 35% of children with anisometropic amblyopia do not have any significant visual improvements, and will have reduced vision in one eye for life. There is no consensus for the reasons why some children do not respond as well as others.

Recent research using the Plusoptix PowerRefractor (PR3), which quickly measures eye focusing (accommodation), suggested that in children with anisometropic amblyopia, the focusing of the amblyopic eye might influence treatment success. However, such measurements weren't previously common due to equipment limitations in clinics.

The investigators aim to use the non-invasive PR3 to assess accommodation in hypermetropic anisometropic amblyopia, at the University of Sheffield. This will be a two-phase study of children aged 4-10 years who have hypermetropic anisometropia. The investigators will recruit participants attending the Ophthalmology Department at Sheffield Children's NHS Foundation Trust (SCH). The investigators will take repeated measurements of accommodation at points during standard care treatment (phase 1) and conduct a pilot intervention study (phase 2) to determine whether adjusting glasses prescriptions based on accommodation responses with amblyopia treatment can improve vision in the weaker eye. The goal is to gather evidence to inform a future larger multicentre RCT to improve the visual outcomes for anisometropic amblyopic children in the future. conditions: Anisometropic Amblyopia conditions: Accommodation Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: During Phase 2 of the study:

The participants found to have residual amblyopia following standard care treatment (completed treatment but still have unequal vision) and asymmetrical accommodation (following their PR3 measurements and data interpretation), will be offered an intervention dependent upon their type of asymmetrical accommodation. There will not be any cross over in the treatment arms, and no randomisation during this pilot study, as the interventions differ and are bespoke to each patient.

Asymmetrical accommodation can be one of two things: Aniso-A and Anti-A. primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Bespoke glasses prescription worn during amblyopia treatment. measure: Change in visual acuity measure: Change in PR3 accommodation measurements sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield city: Sheffield state: South Yorkshire zip: S10 2RX country: United Kingdom name: Holly Geraghty role: CONTACT phone: 0114 215 9005 email: hgeraghty@sheffield.ac.uk name: Gemma Arblaster role: CONTACT phone: 0114 215 9005 email: g.arblaster@sheffield.ac.uk name: Holly Geraghty role: PRINCIPAL_INVESTIGATOR lat: 53.38297 lon: -1.4659 hasResults: False

 nctId: NCT06286397 id: 855173 briefTitle: Topical Anti-Androgens in Pilonidal Sinus Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-12-01 date: 2024-02-29 date: 2024-03-04 name: University of Pennsylvania class: OTHER briefSummary: The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are:

* Does clascoterone improve the severity of pilonidal disease as scored by a physician?
* Does clascoterone improve patient symptoms due to pilonidal disease?
* Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey.

Researchers will compare participants who received clascoterone treatment to those who received placebo. conditions: Pilonidal Disease conditions: Pilonidal Disease of Natal Cleft conditions: Pilonidal Sinus conditions: Pilonidal Cyst studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-Blinded, Placebo-Controlled Trial primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: 1% Clascoterone name: Vehicle Cream measure: Physician-Assessed Disease Severity Assessment measure: Dermatology Life Quality Index measure: Subcutaneous Inflammation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19103 country: United States name: Lillias Maguire, MD role: CONTACT phone: 215-662-2078 email: lillias.maguire@pennmedicine.upenn.edu name: Lillias Maguire, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06286384 id: LEMU47 briefTitle: Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments overallStatus: RECRUITING date: 2023-07-03 date: 2024-09-15 date: 2025-03-15 date: 2024-02-29 date: 2024-02-29 name: First Affiliated Hospital of Jinan University class: OTHER briefSummary: By utilizing standardized photographs in conjunction with quantification detection instruments, data analysis before and after treatment is conducted, along with long-term efficacy observations. This approach aims to provide more comprehensive scientific evidence for the clinical application of ultrasound treatment in anti-aging therapy. conditions: Facial Aging studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 32 type: ESTIMATED measure: Total Volume Change of Nasolabial Folds measure: Change in Maximum Depth of Nasolabial Folds measure: Vertical Elevation Value of Nasolabial Fold Curve Projection Curve measure: Elevation Value of Nasolabial Fold Curve Projection Curve (Along the Nasal Wing Method measure: Change in Mid-Facial Volume measure: Brow Lift Height sex: FEMALE minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: First Affiliated Hospital of Jinan University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Xuangu LI role: CONTACT phone: +8613825136477 email: 443747565@qq.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06286371 id: 2023-13/37 briefTitle: Pelvic Neuro-Angiogenesis in Deep Endometriosis overallStatus: RECRUITING date: 2023-12-01 date: 2024-09 date: 2025-04 date: 2024-02-29 date: 2024-03-04 name: Uludag University class: OTHER briefSummary: Endometriosis is observed in one out of every ten women in society, causing endometrial cells to be found outside their normal location in the body and proliferate in other locations, leading to fibrosis in the tissue due to the secretion of various factors from the cells. Additionally, the substances secreted by the cells can cause various other changes in the tissue besides fibrosis. Increased neurogenesis and neovascularization are among the primary changes, which occur as a result of the secretion of substances from the cells. Increased neovascularization, neurogenesis, and fibrosis in the tissue lead to the formation of nodular structures in the pelvic region, resulting in pain development in women.

Nodular formations in the pelvic region due to endometriosis are especially observed in the rectovaginal space. Despite being small in size, they can induce increased neovascularization and neurogenesis even in healthy peritoneal tissue due to the microenvironment they create, leading to different clinical symptoms clinically. However, it is not known how far these changes occur around the endometriotic nodule in the presence of endometriosis.

In this project, in patients operated on due to endometriosis, the density of nerve and vascular structures in the surgical margins of the peritoneal tissue excised along with the nodule, and the synthesis and release of chemical mediators causing pain (e.g., Bradykinin, Substance-P) are evaluated. The aim is to determine the minimum surgical margin where excision should be applied in surgery and to demonstrate any endometriotic changes that may exist in the tissues, even though they may appear macroscopically healthy. conditions: Endometriosis-related Pain conditions: Endometriosis conditions: Deep Endometriosis conditions: Endometriosis; Peritoneum studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Laparoscopic Endometriosis Surgery measure: Density of Neuro-Angiogenesis measure: Density of Pain Mediators in Pelvic Peritoneum measure: Relationship between Neuro-Angiogenesis Density and Pelvic Pain Scores sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Uludag University Faculty Hospital status: RECRUITING city: Bursa state: Gorukle zip: 16285 country: Turkey name: Kiper Aslan, Assoc. Prof. role: CONTACT phone: +905548127272 email: kiperaslan@uludag.edu.tr name: Erberk Cimer, M.D. role: CONTACT phone: +905316770596 name: Kiper Aslan, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR name: Erberk Cimer, M.D. role: PRINCIPAL_INVESTIGATOR name: Isil Kasapoglu, Assoc. Prof. role: SUB_INVESTIGATOR name: Cihan Cakir, M.D. role: SUB_INVESTIGATOR name: Berrin Avci, Prof. role: SUB_INVESTIGATOR name: Gurkan Uncu, Prof. role: SUB_INVESTIGATOR lat: 40.19559 lon: 29.06013 hasResults: False

 nctId: NCT06286358 id: P2023/346 / CCB : B40620230001 briefTitle: Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK) acronym: ARTIK overallStatus: RECRUITING date: 2024-03-07 date: 2025-03-30 date: 2025-09-30 date: 2024-02-29 date: 2024-03-12 name: Université Libre de Bruxelles class: OTHER name: Erasme University Hospital briefSummary: Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.

The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable us to diagnose aortic valve disease and aortic aneurysm.

In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging and KCG recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG. conditions: Aortic Valve Disease conditions: Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Kinocardiography measure: Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA measure: Comparing KCG to clinical assessment measure: Asses the clinical application of KCG to diagnose AVD and TAA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasme hospital status: RECRUITING city: Brussels zip: 1070 country: Belgium name: Philippe van de Borne, MD, PhD role: CONTACT phone: 2 555 39 60 phoneExt: +32 email: philippe.vandeborne@hubruxelles.be name: Philippe van de Borne, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Elza Abdessater, MD role: SUB_INVESTIGATOR lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06286345 id: 17644 briefTitle: Lifestyle InterVEntion Study in General Practice: LIVES - GP acronym: LIVES-GP overallStatus: RECRUITING date: 2023-08-01 date: 2025-03-01 date: 2025-07-01 date: 2024-02-29 date: 2024-03-04 name: University Medical Center Groningen class: OTHER name: GGZ Drenthe Mental Health Institution briefSummary: Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease. This may be attributed primarily to an unhealthy lifestyle related to their disorder. Interestingly, the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms, thus creating a hazardous vicious circle. Consequently, there is a great potential for 'Lifestyle Medicine' for depression. Yet, it is known that patients with depression often have motivational and self-management problems. Therefore an 18 session multimodal lifestyle intervention (MLI) specifically tailored to the needs of depressed patients was developed and piloted in mental health care, with promising results. This research aims to investigate using a process evaluation the feasibility of this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply. conditions: Depression, Unipolar conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Uncontrolled cohort study primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: GLI-LEEF measure: Reach of GLI-LEEF measure: General practice adoption of GLI-LEEF measure: General practitioner adoption of GLI-LEEF measure: Lifestyle coach adoption of GLI-LEEF measure: Adherence to GLI-LEEF measure: Drop-out from GLI-LEEF measure: Barriers and facilitators of the GLI-LEEF implementation measure: Body weight of the participant as assessed by a medical weight scale measure: Body height of the participant as assessed by a stadiometer measure: Waist circumference of the participant as assessed using a tape meter line measure: Diastolic and systolic blood pressure as assessed using a sphygmomanometer measure: Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45) measure: Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC) measure: Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF) measure: Self esteem according to the Rosenberg Self-Esteem Scale (RSES) measure: Insomnia according to the Insomnia Severity Index (ISI) measure: Quality of life according to the Recovering Quality of Life (ReQol) measure: Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen status: RECRUITING city: Groningen zip: 9700 AD country: Netherlands name: Huibert Burger, MD PhD role: CONTACT phone: +31(0)50 361 6722 phoneExt: 6722 email: h.burger@umcg.nl name: Patrick Brink role: CONTACT phone: +31(0)50 361 6724 phoneExt: 6724 email: p.brink@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06286332 id: Interventional briefTitle: Music Therapy in Acute Leukemia Patients With Fatigue overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-02-29 date: 2024-03-06 name: Chang Gung University class: OTHER briefSummary: The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia. conditions: Acute Myeloid Leukemia conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Music Therapy measure: Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21. measure: Change from baseline in neutrophil, hemoglobin, abumin at day 21. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286319 id: 23-00726 briefTitle: Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler" overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-29 date: 2024-02-29 name: NYU Langone Health class: OTHER briefSummary: The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period. conditions: Lung Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Angel Cooler measure: Proportion of Devices Deemed "Functional" sex: ALL minimumAge: 18 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: NCT06286306 id: 2022_0232 id: 2022-A02813-40 type: OTHER domain: ID-RCB number, ANSM briefTitle: Pronostic Value of Fluid Responsiveness Evaluated by Inferior Vena Cava Collapsibility Index in Patients Admitted in ICU With Acute Respiratory Failure acronym: PRIVACY overallStatus: RECRUITING date: 2023-02-24 date: 2025-05-25 date: 2025-05-25 date: 2024-02-29 date: 2024-02-29 name: University Hospital, Lille class: OTHER briefSummary: Acute respiratory failure represents a frequent cause of admission to intensive care units (ICUs). In the absence of tailored interventions, it poses an imminent threat to patients' lives. Most patients admitted in ICU undergo fluid expansion to enhance oxygen delivery and preserve cellular function.

This practice is grounded in the concept of " preload responsiveness ". However, the accrual of positive fluid balance resulting from fluid administration is now acknowledged as an autonomous risk factor for mortality.

Consequently, preload unresponsiveness assumes a pathological character, potentially indicative of fluid overload or right ventricular dysfunction, both deleterious conditions linked to unfavorable outcomes.

Maintaining patients in a preload-responsive state may be interesting to limit fluid expansion and the need of invasive mechanical ventilation.

The objective of this prospective observational study is to evaluate the prognostic significance of preload responsiveness in patients admitted to the ICU with hypoxemic, non-hypercapnic respiratory failure.

* Main objective: To evaluate the association between fluid responsiveness, assessed by the inferior vena cava collapsibility index (cIVC) with trans-thoracic echocardiography within the initial 48 hours post-ICU admission, and mortality or the need for invasive mechanical ventilation by day 28 in patients admitted to the ICU for hypoxemic, non-hypercapnic acute respiratory failure.
* Secondary objectives: To evaluate the association between fluid responsiveness and mortality at day 28 and day 90, the need of invasive mechanical ventilation, and the number of days free from organ support (vasopressors, mechanical ventilation and renal replacement therapy) by day 28.

Upon receipt of both oral and written information, patients will provide non-objection to participate in the study. This prospective single-center study has obtained approval from the Regional Ethics Committee of Ile de France III approval (No. 2022-A02813-40). conditions: Hypoxemic Without Hypercapnia Acute Respiratory Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Association between fluid responsiveness and death or the need of invasive mechanical ventilation measure: All cause mortality measure: Need of invasive mechanical ventilation measure: Days alive without vasopressor agents measure: Days alive without mechanical ventilation or oxygen support measure: Days alive without renal replacement therapy measure: Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Roger Salengro status: RECRUITING city: Lille zip: 59037 country: France name: PREAU Sebastien, Md PHd role: CONTACT phone: 03 20 44 64 45 email: sebastien.preau@chu-lille.fr name: Delforge Quentin, Md role: CONTACT phone: 0320446445 email: quentin.delforge@chu-lille.fr lat: 50.63297 lon: 3.05858 hasResults: False

 nctId: NCT06286293 id: 18171 briefTitle: YOD-RiSoCo: Social Cognition and Risky Decision-making in Patients With Young-onset Dementia acronym: YOD-RiSoCo overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-30 date: 2027-03-31 date: 2024-02-29 date: 2024-03-04 name: University Medical Center Groningen class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: The goal of this observational study is to learn about social cognition and risky behaviour in patients with young-onset dementia (YOD). The investigators want to

* Examine differences in performance on social cognition test and measures of risky behaviour between behavioural variant YOD patients, patients with frontal brain injury, non-behavioural YOD patients and healthy controls.
* Examine if there is a relation between social cognition tests and measures of risky behaviour.

Participants will be administered a neuropsychological assessment including social cognition measures and patients will complete a driving simulator task in which risky behaviour will be elicited. conditions: Young-onset Dementia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 140 type: ESTIMATED name: Neuropsychological assessment, driving simulator task measure: Social cognitive performance measure: Association between social cognition and risky decision-making sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286280 id: AZ221/21 id: F/23/22 type: OTHER_GRANT domain: German Foundation of Heart Research briefTitle: Removal Of CytoKines With cytoSorbenTs After Inflammatory Response Reaction During Cardiac Surgery acronym: ROCKSTAR overallStatus: RECRUITING date: 2023-05-01 date: 2024-12-01 date: 2025-05-01 date: 2024-02-29 date: 2024-03-18 name: University of Giessen class: OTHER name: Deutsche Stiftung für Herzforschung briefSummary: Detailed knowledge about the association between systemic inflammation and endothelial progenitor cell (EPCs) activation during extracorporeal circulation (ECC) is lacking.

This pilot study aims to clarify the relationship between CD34-positive EPCs and cytokine release during ECC using the cytokine adsorber to make a predictive statement regarding the clinical expression of inflammation. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: single-center, two-arm randomized-controlled prospective study primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participant will not be informed about group allocation whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: cytokine adsorber (CytoSorb®) measure: correlation of endothelial progenitor cells with cytokine levels with and without adsorber use measure: Overall mortality rate measure: Days on ventilator, vasopressor and renal replacement therapy measure: incidence of stroke measure: length of ICU and in-hospital stay measure: Echocardiographic changes measure: Influence of Cytokine on endothelial progenitor cells sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universityhospital Giessen, Department of Cardiovascular Surgery status: RECRUITING city: Giessen zip: 35392 country: Germany name: Zulfugar T Taghiyev, MD, MBA role: CONTACT phone: 80064198556743 email: gk5019@uni-giessen.de name: Zulfugar T Taghiyev, MD, MBA role: PRINCIPAL_INVESTIGATOR lat: 50.58727 lon: 8.67554 hasResults: False

 nctId: NCT06286267 id: SYSKY-2023-351-02 briefTitle: AI-Assisted System for Accurate Diagnosis and Prognosis of Breast Phyllodes Tumors overallStatus: RECRUITING date: 2023-03-01 date: 2027-12-31 date: 2027-12-31 date: 2024-02-29 date: 2024-02-29 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER name: Sun Yat-sen University name: Peking University Shenzhen Hospital name: Guangdong Provincial Maternal and Child Health Hospital name: The Third Affiliated Hospital of Guangzhou Medical University briefSummary: Breast phyllodes tumor (PT) is a rare fibroepithelial tumor, accounting for 1% to 3% of all breast tumors, categorized by the WHO into benign, borderline, and malignant, based on histopathology features such as tumor border, stromal cellularity, stromal atypia, mitotic activity and stromal overgrowth. Malignant PTs account for 18%-25%, with high local recurrence (up to 65%) and distant metastasis rates (16%-25%). Benign PT could progress to malignancy after multiple recurrences. Therefore, Early, accurate diagnosis and identification of therapeutic targets are crucial for improving outcomes and survival rates.

In recent years, there has been growing interest in the application of artificial intelligence (AI) in medical diagnostics. AI can integrate clinical information, histopathological images, and multi-omics data to assist in pathological and clinical diagnosis, prognosis prediction, and molecular profiling.AI has shown promising results in various areas, including the diagnosis of different cancers such as colorectal cancer, breast cancer, and prostate cancer. However, PT differs from breast cancer in diagnosis and treatment approach. Therefore, establishing an AI-based system for the precise diagnosis and prognosis assessment of PT is crucial for personalized medicine.

The research team, led by Dr. Nie Yan, is one of the few in Guangdong Province and even nationally, specializing in PT research. Their team has been conducting research on the malignant progression, metastasis mechanisms, and molecular markers for PT. The team has identified key mechanisms, such as fibroblast-to-myofibroblast differentiation, and the role of tumor-associated macrophages in promoting this differentiation. They have also identified molecular markers, including miR-21, α-SMA, CCL18, and CCL5, which are more accurate in predicting tumor recurrence risk compared to traditional histopathological grading.

The project has collected high-quality data from nearly a thousand breast PT patients, including imaging, histopathology, and survival data, and has performed transcriptome gene sequencing on tissue samples. They aim to build a comprehensive multi-omics database for breast PT and create an AI-based model for early diagnosis and prognosis prediction. This research has the potential to improve the diagnosis and treatment of breast PT, address the disparities in breast PT care across different regions in China, and contribute to the development of new therapeutic targets. conditions: Phyllodes Breast Tumor conditions: Artificial Intelligence conditions: Multiomics conditions: Prognostic Cancer Model conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 4000 type: ESTIMATED name: imaging measure: Sensitivity measure: False-negative Rate measure: Specificity measure: False-positive Rate measure: Receiver Operating Characteristic Curve measure: Area under roc Curve sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510050 country: China name: Feng Ye, Prof.Dr. role: CONTACT phone: 15914388994 lat: 23.11667 lon: 113.25 facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Yan Nie, Prof.Dr. role: CONTACT phone: +86 020-81332587 email: nieyan7@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510145 country: China name: Hui Mai, Prof.Dr. role: CONTACT phone: 13925129112 lat: 23.11667 lon: 113.25 facility: Guangdong Maternal and Child Health Hospital status: RECRUITING city: Guangzhou state: Guangdong zip: 511400 country: China name: Yu Tan, Prof.Dr. role: CONTACT phone: 13632356526 lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06286254 id: CYCL-NTTF-2023 briefTitle: Study of Safety and Efficacy of the Drug Cycloferone in Patients With Acute Respiratory Viral Infection overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-20 date: 2024-02-20 date: 2024-07-30 date: 2024-02-29 date: 2024-02-29 name: POLYSAN Scientific & Technological Pharmaceutical Company class: INDUSTRY briefSummary: The study will collect the information on clinical effects and safety of the basic therapy of acute respiratory viral infection (ARVI) + Cycloferone® and basic therapy of ARVI1 + Arbidol® in real-life clinical settings. conditions: Acute Respiratory Viral Infection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 742 type: ACTUAL name: Cycloferone measure: Average fever duration according to the data of the Patient's Diary measure: Dynamics of symptom severity parameter according to WURSS-21* questionnaire by visit 2, 3 and 4 (AUC value of change in symptom severity according to WURSS-21 questionnaire)** measure: Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4 measure: Time (days) till disappearance of disease symptoms according to WURSS-21 scale. measure: Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale. measure: Number of patients with symptoms of disease of different severity degree according to CCQ scale. measure: Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy. measure: Frequency of the need to administer the systemic antibacterial therapy measure: Percentage of patients who needed hospitalization measure: Average duration of the temporary incapacity period. measure: Frequency of revealing ARVI pathogen before beginning of the therapy (at visit 1) for each pathogen among those patients who underwent the qualitative investigation for ARVI pathogen. measure: Percentage of patients with negative result of the qualitative investigation for ARVI pathogen by visits 3 and 4 among those patients in whom the pathogen was revealed at visit 1. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic Zvezdnaya city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical center Astarta city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Energiya Zdoroviy city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Meily city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Oris city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center PiterClinica city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Reavita Med city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center SOGAZ city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Research Center Eco-Safety city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No. 117 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No. 44 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No.109 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity hospital No. 40 city: Sestroretsk country: Russian Federation lat: 60.09801 lon: 29.96378 hasResults: False

 nctId: NCT06286241 id: 877/2564(IRB2) briefTitle: Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room acronym: Step down ward overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-30 date: 2024-07-30 date: 2024-02-29 date: 2024-03-15 name: Siriraj Hospital class: OTHER name: Faculty of Medicine Siriraj Hospital briefSummary: The goal of this observational study is to comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in HEPA-filtered room and non-HEPA-filtered room. The main questions it aims to answer are:

* The incidence of febrile neutropenia, infection, and duration of hospital stay
* 2-year progression free survival Participants will be collected the data of baseline diagnosis, treatment, treatment results and complications during admission and follow-up visits from hospital medical record. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 344 type: ESTIMATED measure: febrile neutropenia measure: Infection measure: duration of admission measure: progression free survival sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286228 id: 751/2563(IRB4) briefTitle: Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease acronym: Haplo overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-04-01 date: 2030-04-01 date: 2024-02-29 date: 2024-03-01 name: Siriraj Hospital class: OTHER name: Faculty of Medicine Siriraj Hospital briefSummary: The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:

* 1-year progression free survival rate
* 1-year overall survival rate
* Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year
* Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year
* Rate of Neutrophil and platelet engraftment
* Efficacy of donor specific antibody desensitization
* Relapsed rate
* Primary and late graft failure
* Safety and complication of haploHSCT
* Complication of viral, bacterial, and fungal infection
* Viral reactivation
* Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
* Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 43 type: ESTIMATED measure: register hematologic patients with haploidentical hematopoietic stem cell transplantation measure: progression free survival rate measure: overall survival rate measure: Chronic Graft-versus-host free relapsed free survival measure: Relapsed rate measure: Primary and late graft failure measure: Rate of Neutrophil and platelet engraftment measure: Efficacy of donor specific antibody desensitization measure: Safety and complication of haploHSCT measure: Complication of viral, bacterial, and fungal infection measure: Viral reactivation measure: outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT measure: cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286215 id: 586/2564(IRB2) briefTitle: Registry of Patients With Plasma Cell Disorders acronym: Registry PCD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2034-04-01 date: 2035-04-01 date: 2024-02-29 date: 2024-02-29 name: Siriraj Hospital class: OTHER name: Faculty of Medicine Siriraj Hospital briefSummary: The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:

* The incidence of plasma cell disorders both before and after malignancy
* Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
* Progression free survival (PFS)
* overall survival
* factors influencing overall survival, progression-free survival, and time to progression
* Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.
* genetic characteristics of plasma cell disorder
* cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record. conditions: Plasma Cell Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 750 type: ESTIMATED measure: register the plasma cell disorder patients measure: incidence of plasma cell disorders measure: Time to progression measure: Progression free survival measure: overall survival measure: influencing factors measure: Symptoms and signs measure: genetic characteristics measure: cost-effectiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286202 id: RECAS-0306 briefTitle: Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-07 date: 2024-02-29 date: 2024-03-04 name: Singapore Institute of Technology class: OTHER name: Singapore Anglican Community Services briefSummary: Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied.

Therefore, the aims of the study are:

* To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings.
* To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability.

Participants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers.

This research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later. conditions: Schizophrenia conditions: Schizoaffective Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention study model is a parallel randomized controlled trial. There will be two arms. The experimental arm is 'cognitive remediation' and the control arm is 'standard psychiatric rehabilitation'. Participants will be assigned to one of the treatment arms at the beginning of the trial and will continue in that arm throughout the length of the trial. Assignment to the group is done using a computer randomization generator. All eligible participants will be randomly assigned to one of the treatment arms (experimental or control arm) based on a 1:1 treatment allocation. Hence, those who are randomly allocated to the experimental arm will receive cognitive remediation throughout the trial, while those randomly allocated to the control arm will receive standard psychiatric rehabilitation throughout the trial. Both treatment arms will run in parallel. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Upon randomization, the co-investigators will indicate the allocated group in a separate spreadsheet from the outcome measurements. The co-investigator who is collecting baseline, post-intervention and 8-week outcome measurements will be blinded to the treatment allocation of each participant. whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) name: Standard Psychiatric Rehabilitation at Anglican Care Centers measure: Brief Assessment of Cognition in Schizophrenia (BACS) measure: Penn Emotion Recognition Task (ER40) measure: The Awareness of Social Inference Test (TASIT)- Part 3 measure: Goal Attainment Scale measure: Social and Occupational Functioning Assessment Scale (SOFAS) measure: Recovery Assessment Scale-Domain and Stages (RAS-DS) measure: Positive and Negative Syndrome Scale (PANSS) measure: Brief Negative Symptom Scale (BNSS) measure: Brief Regulation of Motivation Scale (BRoMS) measure: The Global Assessment of Functioning Scale (GAF) sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: Anglican Care Center-Bukit Batok city: Singapore country: Singapore name: Jonathan Poh, MA role: CONTACT phone: +6592333020 email: Jonathan_poh@sacs.org.sg lat: 1.28967 lon: 103.85007 facility: Anglican Care Center-Hougang city: Singapore country: Singapore name: Mingxiu Cai, BSc (Hons) role: CONTACT phone: +6563869338 phoneExt: 101 email: mingxiu_cai@sacs.org.sg lat: 1.28967 lon: 103.85007 facility: Anglican Care Center-Simei city: Singapore country: Singapore name: Noel Tan, MA role: CONTACT phone: +6591853094 email: noel_tan@sacs.org.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06286189 id: 2020P002760-t briefTitle: Trazodone on OSA Endotypes overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2025-06-01 date: 2024-02-29 date: 2024-02-29 name: Brigham and Women's Hospital class: OTHER briefSummary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Placebo oral tablet name: Trazodone Hydrochloride measure: Effect of trazodone on arousal threshold (%eupnea) measure: Effect of trazodone on apnea hypopnea index (events/h) sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Nicole Calianese, BS role: CONTACT phone: 617-732-8976 email: ncalianese@mgb.org lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06286176 id: LIUIRB-200311-NR1 briefTitle: Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention overallStatus: COMPLETED date: 2022-11-17 date: 2023-06-30 date: 2023-06-30 date: 2024-02-29 date: 2024-02-29 name: Nabiha Ramadan class: OTHER name: Universitat de Girona briefSummary: The study is a randomized control trial to assess the effect of a salutogenic intervention on breastfeeding initiation and duration of exclusive breastfeeding in Lebanon. In this Salutogenic intervention, infant feeding helpers will provide subjects of the intervention group breastfeeding related information , and will support these subjects by counseling and guiding them to find general resistance resources. This aims to increase sense of coherence and its parameters: comprehensibility, manageability and meaningfulness, which are the base of salutogenesis. conditions: Breast Feeding conditions: Exclusive Breastfeeding conditions: Salutogenesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 101 type: ACTUAL name: Videos with breastfeeding education material and encouraging messages name: Whatsapp group measure: breastfeeding initiation measure: Duration of Exclusive breastfeeding measure: Mean change in Self- esteem in participants from baseline to 6 months postpartum measure: The Change in Sense of Coherence (SOC) scores from baseline to 6 months postpartum sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Lebanese International University city: Beirut zip: 146404 country: Lebanon lat: 33.88894 lon: 35.49442 hasResults: False

 nctId: NCT06286163 id: PA4099 briefTitle: Neuroinflammatory Interactions of ATP and P2X3 Receptor in the Airways of Chronic Cough Patients overallStatus: RECRUITING date: 2023-10-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-29 date: 2024-02-29 name: Imperial College London class: OTHER name: Merck Sharp & Dohme LLC briefSummary: This study is being done in order to understand what causes people to have a chronic cough, which is defined as a cough lasting for more than 8 weeks. The research team wish to find out whether there is any inflammation in the lungs of patients with chronic cough. The research team will also determine whether a suspected chemical produced in the body, called adenosine triphosphate (ATP) can be responsible for causing the chronic cough. In order to be able to find out what is abnormal in those who have a chronic cough, The research team will need to compare their results with those that do not have a chronic cough.

In this study, the research team will examine 10 participants who suffer from chronic cough and 8 individuals who do not have a chronic cough and are healthy. conditions: Chronic Cough studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 18 type: ESTIMATED measure: Presence of ATP in airways of idiopathic chronic cough patients and the localisation of P2X2/3 receptors in the airways measure: Cough sensitivity and laryngeal sensitivity to exogenous ATP measure: Examine the effects of exogenous ATP on the inflammatory response in the upper and lower airways. sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Brompton & Harefield NHS Trust, status: RECRUITING city: London zip: SW3 6HP country: United Kingdom name: Sally Meah, SRN role: CONTACT phone: 0207 3518051 email: Sally.Meah@imperial.ac.uk name: Pankaj K Bhavsar role: CONTACT phone: 02075947961 email: p.bhavsar@imperial.ac.uk lat: 51.50853 lon: -0.12574 facility: Royal Brompton Hospital status: RECRUITING city: London zip: SW3 6HP country: United Kingdom name: Kian Fan Chung, MD role: CONTACT phone: 44205947959 email: f.chung@imperial.ac.uk name: Sally Meah, SRN role: CONTACT phone: 02073518051 email: Sally.Meah@imperial.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06286150 id: EC-2023-087(QX)-03 briefTitle: Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery overallStatus: RECRUITING date: 2023-09-15 date: 2025-07-15 date: 2027-07-15 date: 2024-02-29 date: 2024-02-29 name: The First Affiliated Hospital of Guangzhou Medical University class: OTHER briefSummary: Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Surgical robot system measure: Intraoperative conversion rate measure: Surgical complications rate measure: Intraoperating bleeding volume measure: Surgical time measure: Length of hospital admissions measure: Postoperative wound pain score measure: Surgeon satisfaction measure: Adverse events measure: Rate of re-admission to hospital measure: Rate of reoperation measure: Postoperative mortality 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: 510000 country: China name: Jianxing He, M.D. role: CONTACT phone: +86-20-83337792 email: hejx@vip.163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06286137 id: NL82922.078.22 briefTitle: Duration of Music Interventions and Pain Tolerance (DOMINANT) acronym: DOMINANT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date: 2025-06 date: 2024-02-29 date: 2024-03-06 name: Erasmus Medical Center class: OTHER briefSummary: This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance. conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The randomized controlled trial will have four study arms. Subjects will be assigned to one of the four arms: control without music and music groups with 1 minute, 5 minutes and 20 minutes. All subjects will receive electric stimuli in three phases. In each phase, subject will be exposed to three consecutive stimuli. First a detection threshold will be measured. Secondly a baseline test will be performed in order to assess basic levels of pain endurance. Hereafter, the intervention phase starts. Subjects in the music groups will listen to 1, 5 and 20 minutes of their own preferred music through headphones. Directly after, all subjects will again receive three electric stimuli. primaryPurpose: TREATMENT masking: NONE maskingDescription: Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators. However, participants will not be informed of the study arm to which they are randomized in advance. count: 80 type: ESTIMATED name: Listening to music for 1 minute name: Listening to music for 5 minutes name: Listening to music for 20 minutes name: Not listening to music measure: Pain tolerance measure: Heart rate variability (HRV) measure: Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire measure: Valence and arousal, Self-Assessment manikin (SAM) questionnaire measure: Music listening Questionnaire measure: Pain intensity measure: Pain unpleasantness sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Erasmus Medical Center city: Rotterdam zip: 3015 GD country: Netherlands name: Emy S van der Valk Bouman, MD role: CONTACT phone: +31646461901 email: e.vandervalkbouman@erasmusmc.nl name: Antonia S Becker, MD role: CONTACT phone: +31641188966 email: a.becker@erasmusmc.nl name: Markus Klimek, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06286124 id: 8612 briefTitle: Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA) acronym: HYDRA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-02-29 date: 2024-02-29 name: Erasmus Medical Center class: OTHER name: Medtronic name: Alrijne Hospital briefSummary: The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid (open- and laparoscopic) incisional hernia repair. The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine. conditions: Incisional Hernia of Midline of Abdomen studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 52 type: ESTIMATED name: Hybrid Surgery measure: Mean peak torque 1 year measure: Mean peak torque 2 years measure: Recurrent Incisional Hernia measure: Severity of surgical complications measure: Surgical complications measure: General Quality of Life measure: Mesh specific Quality of Life measure: Scar satisfaction measure: Pain in the abdominal region sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alrijne Hospital city: Leiden country: Netherlands name: Willem Hueting, MSc role: CONTACT lat: 52.15833 lon: 4.49306 hasResults: False

 nctId: NCT06286111 id: ASU MD briefTitle: Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-06-01 date: 2024-08-01 date: 2024-02-29 date: 2024-04-23 name: Ain Shams University class: OTHER briefSummary: In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF conditions: Atrial Fibrillation conditions: Inflammatory Marker conditions: Heart; Surgery, Heart, Functional Disturbance as Result studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 76 type: ESTIMATED measure: Red cell distribution width as a predictor for Post-operative Atrial fibrillation after Open Heart Surgeries sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286098 id: ALA in Pediatrics on HD briefTitle: Alpha Lipoic Acid in Pediatrics on Hemodialysis overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-20 date: 2024-10-20 date: 2024-02-29 date: 2024-03-12 name: Ain Shams University class: OTHER name: Eva Pharma briefSummary: The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:

* Will the use of alpha lipoic acid lower cardiovascular events in that population?
* Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population?
* Will the drug cause side effects?

Participants will:

* take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug.
* be monitored for the occurrence of cardiovascular events (stroke, angina, etc.)
* be monitored for the occurrence of side effects
* give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme
* undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet. conditions: Hemodialysis Complication conditions: Pediatric Kidney Disease conditions: Cardiovascular Complication studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Alpha lipoic acid name: Placebo measure: Serum level of E-Selectin measure: Serum levels of superoxide dismutase (SOD) measure: Number of cardiovascular events measure: Number of Adverse effects sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: New Pediatrics Hospital, Faculty of Medicine, Ain Shams University city: Cairo state: El Weili zip: 11381 country: Egypt name: Mahmoud Mohsen, Pharmacist role: CONTACT phone: +201275811494 email: mahmoudfast41@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06286085 id: 337788 briefTitle: A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma acronym: MODELS overallStatus: RECRUITING date: 2024-02-27 date: 2024-04-24 date: 2024-07-24 date: 2024-02-29 date: 2024-04-04 name: Portsmouth Hospitals NHS Trust class: OTHER_GOV briefSummary: This study aims to assess the concordance of international asthma guidelines in the diagnosis of asthma and explore the presence of airways disease using additional non-guideline physiologic criteria, such as IOS (impulse osciollometry), not included in the guidelines, but available in the Portsmouth lung function service. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 750 type: ESTIMATED name: Lung function tests measure: International asthma guidelines scores measure: non-guideline physiologic criteria measure: non-guideline physiologic criteria for asthma. measure: Comparison of the diagnostic outcomes of each guideline with a "reference standard". sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Portsmouth Hospitals University NHS Trust status: RECRUITING city: Portsmouth country: United Kingdom name: Laura Marshall role: CONTACT phone: 02392286000 email: research.office@porthosp.nhs.uk lat: 50.79899 lon: -1.09125 hasResults: False

 nctId: NCT06286072 id: YCEYHANS briefTitle: The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD overallStatus: RECRUITING date: 2023-11-01 date: 2024-01-30 date: 2024-03-30 date: 2024-02-29 date: 2024-02-29 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: COPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD.

The main questions it aims to answer are:

1. Does the training given in COPD affect the level of fatigue?
2. Do the education given and text messages sent regarding COPD affect the level of fatigue?

In this study, patients were given informative education about COPD and ways to cope with fatigue were explained. Then, in order to increase the permanence of the training, motivational messages and short briefings were continued for 8 weeks.2 messages were sent per week. Three groups were created to reveal the effectiveness of the trainings and messages.

Group 1 was trained and messages were sent for 8 weeks. Group 2 was trained and no message was sent. Group 3 is the control group. No training has been provided other than routine maintenance.

The initial information of all groups was taken again at the end of the 8th week.

Main outcomes:

* Dyspnea severity,
* COPD general conditions and
* Fatigue level. The results obtained will be interpreted by comparing between 3 groups. conditions: Copd conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled Trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Education and message measure: Fatigue Level measure: Dyspnea Severity measure: COPD general condition sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin CEYHAN status: RECRUITING city: Kırşehir state: Center zip: 40100 country: Turkey name: Yasemin CEYHAN, PhD role: CONTACT phone: +9054645898065 email: yasemin-ceyhan@hotmail.com role: CONTACT phoneExt: CEYHAN email: yasemin-ceyhan@hotmail.com name: Yasemin CEYHAN, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06286059 id: Phentolamine for CA-AKI briefTitle: Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI overallStatus: RECRUITING date: 2024-03-07 date: 2024-12-31 date: 2025-01-31 date: 2024-02-29 date: 2024-03-18 name: Helwan University class: OTHER briefSummary: To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI. conditions: CA-AKI - Contrast-Associated Acute Kidney Injury conditions: Coronary Artery Disease conditions: Acute Coronary Syndrome conditions: Adrenergic Receptor Antagonist Adverse Reaction studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled clinical trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Single Blinded whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Phentolamine measure: Rate of CA-AKI measure: Peak of serum creatinine elevation measure: Duration of CA-AKI measure: Change in HR measure: Change in SBP measure: Change in DBP measure: Urine output measure: Rate of RRT measure: Rate of MACE measure: Rate of rehospitalization measure: Duration of hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Badr university hospital status: RECRUITING city: Badr state: Cairo country: Egypt name: Mohammed Soliman, MBBCH role: CONTACT phone: +201032137563 email: Mohammed_Mostafa@med.helwan.edu.eg hasResults: False

 nctId: NCT06286046 id: AG348-C-026 id: 2023-510289-28-00 type: OTHER domain: EU Clinical Trial Number briefTitle: A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-05 date: 2027-09 date: 2024-02-29 date: 2024-04-12 name: Agios Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the effect of mitapivat on albumin creatinine ratio (ACR) response in participants with sickle cell disease (SCD) and nephropathy. conditions: Sickle Cell Disease conditions: Nephropathy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Mitapivat measure: Percentage of Participants With Albumin Creatinine Ratio (ACR) Response measure: Change From Baseline in Cystatin C and Creatinine-based Estimated Glomerular Filtration Rate (eGFRcr-cys) measure: Change From Baseline in Albumin Creatinine Ratio (ACR) measure: Percentage of Participants With Stable ACR measure: Annualized Rate of Emergency Room (ER) Visits measure: Annualized Rate of Days of Hospitalizations measure: Type, Frequency, Severity, and Relationship to Study Drug of Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06286033 id: AG181-C-001 briefTitle: A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants overallStatus: RECRUITING date: 2024-02-20 date: 2025-06-01 date: 2025-06-01 date: 2024-02-29 date: 2024-04-16 name: Agios Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: AG-181 name: Placebo measure: SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug measure: MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug measure: Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: Food Effect: Area Under the Concentration-time Curves (AUCs) of AG-181 measure: Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181 measure: Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181 measure: Food Effect: Apparent Oral Clearance (CL/F) of AG-181 measure: Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: SAD: Terminal Elimination Rate Constant (Kel) of AG-181 measure: SAD: Terminal Elimination Half-Life (t1/2) of AG-181 measure: SAD: Area Under the Concentration-time Curves (AUCs) of AG-181 measure: SAD: Apparent Oral Clearance (CL/F) of AG-181 measure: SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: SAD: Renal Clearance (CLR) of AG-181 measure: SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%) measure: SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%) measure: SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t) measure: SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2) measure: MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: MAD: Terminal Elimination Rate Constant (Kel) of AG-181 measure: MAD: Terminal Elimination Half-Life (t1/2) of AG-181 measure: MAD: Area Under the Concentration-time Curve (AUC) of AG-181 measure: MAD: Apparent Oral Clearance (CL/F) of AG-181 measure: MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181 measure: MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181 measure: MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181 measure: Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON 1255 East 3900 South status: RECRUITING city: Salt Lake City state: Utah zip: 84124 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06286020 id: VR-Zhenqiu briefTitle: Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome overallStatus: RECRUITING date: 2024-02-28 date: 2024-07 date: 2024-07 date: 2024-02-29 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy. conditions: Wallenberg Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Virtual Reality Therapy name: Conventional dysphagia treatment measure: standardized swallowing assessment measure: Murray secretion scale measure: Rosenbek penetration-aspiration scale measure: swallowing-quality of life sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinzhu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False

 nctId: NCT06286007 id: PRIPASCO-2023 briefTitle: Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control acronym: PRIPASCO overallStatus: RECRUITING date: 2023-12-21 date: 2024-07-31 date: 2026-07-01 date: 2024-02-29 date: 2024-03-01 name: Hospital Clinico Universitario de Santiago class: OTHER name: Translational Research In Airway Diseases Group (TRIAD) name: CIBER of Respiratory Diseases CIBERES name: Complexo Hospitalario Universitario de A Coruña name: Hospital de Galdakao name: Hospital Universitario Doctor Peset name: Hospital San Pedro de Alcantara name: Hospital Universitario Marqués de Valdecilla name: Hospital Universitario Vall d´Hebron name: Universitat Autonoma de Barcelona name: Universidade de Santiago de Compostela name: Consortium for Biomedical Research in Epidemiology and Public Health name: Hospital Universitario Virgen del Rocio name: Hospital de La Princesa name: University Hospital Virgen de las Nieves name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau name: Germans Trias i Pujol Hospital name: Hospital Universitario de Navarra name: Hospital Universitario de Jerez de la Frontera name: Hospital El Bierzo name: Hospital Clinico Universitario San Cecilio name: Hospital Universitario Donostia name: Hospital Universitario Central de Asturias name: Hospital Universitario de la Ribera name: Hospital Costa del Sol name: Hospital General Universitario Dr. Balmis name: Hospital de Sagunto name: Hospital Lluis Alcanyís de Xàtiva name: Hospital Universitario Lucus Augusti name: Hospital del Mar name: Hospital Clínico Universitario Virgen de la Arrixaca name: Hospital Clinic of Barcelona briefSummary: The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).

A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.

Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up conditions: Asthma conditions: Pertussis conditions: RSV Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 784 type: ESTIMATED name: PCR measure: Incidence of Bordetella pertussis and RSV infections in adult patients with asthma, measure: To describe the seroprevalence of Bordetella pertussis in adult patients with asthma measure: To describe the seroprevalence of RSV in adult patients with asthma measure: To evaluate the severity and control of the asthma caused by either BP or RSV infection sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Santiago de Compostela status: RECRUITING city: Santiago De Compostela state: A Coruña zip: 15706 country: Spain name: Francisco Javier González Barcala, Ph.D. role: CONTACT email: francisco.javier.gonzalez.barcala@sergas.es lat: 42.88052 lon: -8.54569 hasResults: False

 nctId: NCT06285994 id: SRB2024016 briefTitle: Complications of High Frequency Jet Ventilation overallStatus: RECRUITING date: 2024-04-20 date: 2024-08-31 date: 2024-10-31 date: 2024-02-29 date: 2024-04-24 name: Erasme University Hospital class: OTHER briefSummary: High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:

* Hypoxia: SpO2 \< 90% for 1 min
* Severe hypoxia: SpO2 \< 85% for 1 min
* Hemodynamic instability, defined as Arterial pressure \< 90/60
* Cardiac arrhythmia
* Laryngospasm or bronchospasm
* Barotrauma or volutrauma
* Need for ICU admission

A model predicting the risk for developing any complication will be developped using 2 mathematical methods:

* a multivariate analysis
* a data mining approach

For both approaches, the following variables will be included in the model:

* Age
* Gender
* Weight
* Height
* BMI
* Smoking
* Alcohol consumption
* Consumption of Other drugs
* ASA class
* Obstructive pulmonary disease
* Restrictive lung disease
* COPD status (1, 2, 3, 4)
* Interstitial lung disease
* Lung tumor

  * Trachea location
  * Carina location
  * Bronchial location
* Pulmonary or tracheal stenosis
* Presence of stridor
* Severe stenosis (\< 6 mm)
* Baseline SpO2 (pre-intervention)
* Pre-intervention oxygen requirement Procedure
* Duration (min)
* Stent placement
* Dilation
* Laser treatment
* Length of hospital stay Lung function tests
* FEV1 (forced expiratory volume)
* VC (Vital Capacity)
* FEV1/VC (Tiffeneau ratio)
* CPT (total lung capacity)
* DLCO (carbon monoxide diffusion) conditions: High-Frequency Jet Ventilation conditions: Bronchoscopy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ESTIMATED name: High frequency jet ventilation measure: Occurence of complications measure: Prediction model of complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Universitaire de Bruxelles - Hôpital erasme status: RECRUITING city: Brussels zip: 1070 country: Belgium name: Denis Schmartz, MD role: CONTACT phone: +3225553919 email: denis.schmartz@hubruxelles.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06285981 id: OCI_2206 briefTitle: Retrospective Study Chimaera Long Nail in Adult Patient overallStatus: RECRUITING date: 2023-11-27 date: 2024-06-30 date: 2024-06-30 date: 2024-02-29 date: 2024-04-12 name: Orthofix s.r.l. class: INDUSTRY briefSummary: The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice. conditions: Pertrochanteric Fracture of Femur conditions: Intertrochanteric Fracture of Femur conditions: Subtrochanteric Fracture of Femur studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 44 type: ESTIMATED name: Chimaera Long Nail measure: percent of patients in wich bone union has been achieved measure: percent of patients that required a reoperation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AORN Sant'Anna e San Sebastiano status: NOT_YET_RECRUITING city: Caserta state: CE zip: 81100 country: Italy name: Gaetano Bruno role: CONTACT phone: 0823 232111 lat: 41.07262 lon: 14.33231 facility: Craeggi Hospital status: RECRUITING city: Florence state: FI zip: 50134 country: Italy name: Roberto Civinini role: CONTACT phone: 055 794 111 lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06285968 id: AAAU8937 id: P50MD017341 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017341 briefTitle: The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities overallStatus: RECRUITING date: 2024-03-12 date: 2026-03-31 date: 2027-03-31 date: 2024-02-29 date: 2024-03-28 name: Columbia University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The purpose of this randomized controlled trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in Hispanic/Latina/o/x adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention. conditions: Blood Pressure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 250 type: ESTIMATED name: Multidimensional Sleep Health Promotion Intervention measure: Change in office systolic blood pressure measure: Change in office systolic blood pressure (sustained effect at 24 weeks) measure: Change in office diastolic blood pressure measure: Change in out-of-office blood pressure measure: Change in fasting glucose measure: Change in body weight measure: Change in waist circumference measure: Change in diet quality measure: Change in sleep health measure: Acceptability of Implementation measure: Feasibility of Implementation measure: Appropriateness of Implementation sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Columbia University Irving Medical Center, Mailman School of Public Health status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Nour Makarem, PhD role: CONTACT email: nm2968@cumc.columbia.edu lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06285955 id: 307-reinforced teeth briefTitle: Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips overallStatus: RECRUITING date: 2024-01-15 date: 2024-07-31 date: 2024-08-31 date: 2024-02-29 date: 2024-02-29 name: Beijing 302 Hospital class: OTHER briefSummary: Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate. conditions: Pilot Study conditions: Clips studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: Clinical success rate measure: Technical success rate measure: Delayed bleeding rate measure: Delayed perforation rate sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The fifth Medical Center of Chinese PLA General Hospital status: RECRUITING city: Beijing state: Beijing zip: 100071 country: China name: Jindong Chu, MD role: CONTACT phone: +8615811201126 email: chu465292278@163.com name: Shuqian Hu role: CONTACT phone: +8618526504112 email: 1811045@mail.nankai.edu.cn name: Yan Liu, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06285942 id: 277.535 id: CE366/2023 type: REGISTRY domain: CET AOU Maggiore della Carità di Novara briefTitle: EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation acronym: ORIGAMI II overallStatus: RECRUITING date: 2024-02-01 date: 2025-01-31 date: 2025-01-31 date: 2024-02-29 date: 2024-02-29 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH.

Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation.

The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months. conditions: Atrial Fibrillation conditions: Fragility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: An interim-analysis will be performed on the primary endpoint when at least 50% of patients will have been randomized and completed the 6 months follow-up. The interim-analysis will be performed by an independent statistician, blinded for the treatment allocation. The statistician will report to the independent data and safety monitoring board whoMasked: OUTCOMES_ASSESSOR count: 168 type: ESTIMATED name: Edoxaban name: No Edoxaban measure: Difference in Anti-Clot treatment scale (ACTS) questionnaire results among the two groups assessed at 6 and 12 months. measure: Number of cardio-embolic events at 6 and12 months measure: Number of bleeding events measure: Assessment of drugs efficacy by measuring the anti-factor Xa activity measure: Assessment of drugs efficacy by measuring the thrombin generation measure: Assess the quality of life measure: Cost-effectiveness analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Policlinico San Martino status: RECRUITING city: Genova zip: 16132 country: Italy name: Pietro Ameri, Prof role: CONTACT phone: +39 010 3538975 email: pietro.ameri@unige.it lat: 44.40478 lon: 8.94438 facility: AOU Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Domenico D'Amario, Prof role: CONTACT phone: 0039 0321 3733141 email: domenico.damario@uniupo.it lat: 45.44694 lon: 8.62118 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Cristiano Spada, Prof role: CONTACT phone: 06 30151 email: cristiano.spada@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06285929 id: 2013209-1 briefTitle: ACS Community Access to Resources Education and Support acronym: ACS CARES overallStatus: ENROLLING_BY_INVITATION date: 2023-09-01 date: 2025-08-31 date: 2025-12-31 date: 2024-02-29 date: 2024-02-29 name: American Cancer Society, Inc. class: OTHER name: University of Alabama at Birmingham briefSummary: The goal of this study is to evaluate the pilot phase of ACS Cares to identify key implementation outcomes and assess effectiveness of the program to improve distress, enhance communication, and reduce missed appointments and healthcare utilization. conditions: Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: ACS CARES Student Navigation measure: Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers measure: Measure the impact of ACS CARES on patient-reported outcomes: Information Needs measure: Measure the impact of ACS CARES on patient-reported outcomes: Distress needs measure: Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program measure: Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs measure: Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication measure: Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge measure: Measure the impact of ACS CARES on patient-reported outcomes: Patient activation measure: Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity measure: Measure the impact of ACS CARES on patient-reported outcomes: Quality of life measure: Context, Training, and Process Measures: Service Penetrance and Process Measures: Service Penetrance measure: Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients measure: Impact of ACS CARES on treatment adherence and healthcare measure: Context, Training, and Process Measures: Volunteer Satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Health city: Los Angeles state: California zip: 90024 country: United States lat: 34.05223 lon: -118.24368 facility: American Cancer Society city: Kennesaw state: Georgia zip: 30144 country: United States lat: 34.02343 lon: -84.61549 facility: University of Iowa Health Care city: Iowa City state: Iowa zip: 52242 country: United States lat: 41.66113 lon: -91.53017 facility: Medical University Hospital Authority, Hollings Cancer Center city: Charleston state: South Carolina zip: 29492 country: United States lat: 32.77657 lon: -79.93092 hasResults: False

 nctId: NCT06285916 id: NORA520-PT-US-1a briefTitle: A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression acronym: NuMom overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-02 date: 2026-03 date: 2024-02-29 date: 2024-02-29 name: Gerbera Therapeutics, Inc. class: INDUSTRY briefSummary: The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:

* How well NORA520 is tolerated and what side effects it may cause
* If NORA520 reduces depressive symptoms in subjects with severe PPD
* The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken
* In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days. conditions: Depression, Postpartum conditions: Postpartum Depression conditions: Post-partum Depression conditions: Postnatal Depression conditions: Post-Natal Depression 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: NORA520 Dose 1 name: NORA520 Dose 2 name: Placebo measure: Incidence, severity, and causality of AEs, SAEs, and AESIs measure: Change from baseline in HAM-D17 total score compared to placebo measure: Change from baseline in HAM-D17 total score measure: HAM-D17 response measure: HAM-D17 remission measure: Change from baseline in HAM-D17 subscale and individual item scores measure: Change from baseline in Clinical Global Impression - Severity (CGI-S) score measure: Clinical Global Impression - Improvement (CGI-I) scale positive response measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score measure: Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score measure: Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score measure: Number of patients who start any new antidepressant or anti-anxiety medication sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Gerbera site city: Canoga Park state: California zip: 91304 country: United States lat: 34.20112 lon: -118.59814 facility: Gerbera sites city: Miami Gardens state: Florida zip: 33014 country: United States lat: 25.94298 lon: -80.24452 facility: Gerbera site city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Gerbera site city: Saint Petersburg state: Florida zip: 33607 country: United States lat: 27.77086 lon: -82.67927 facility: Gerbera site city: League City state: Texas zip: 77573 country: United States lat: 29.50745 lon: -95.09493 facility: Gerbera site city: Richardson state: Texas zip: 75080 country: United States lat: 32.94818 lon: -96.72972 hasResults: False

 nctId: NCT06285903 id: AUAREC20220002-11 briefTitle: Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing acronym: RCT overallStatus: COMPLETED date: 2022-09-02 date: 2022-12-01 date: 2023-12-30 date: 2024-02-29 date: 2024-03-28 name: Al-Azhar University class: OTHER briefSummary: Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain conditions: Bone Density, Low studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to de-termine implant stability by recording the values of implant stability quotient (ISQ) im-mediately after implant placement and after 3 months. CBCT was performed before, af-ter 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 months and after 12 months via CBCT. primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: internal sinus lift surgery measure: Implant stability using the Osstell device by percentage measure: Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm measure: Bone Densityby mm sex: ALL minimumAge: 35 Years maximumAge: 39 Years stdAges: ADULT facility: Alazhar university ,Assuit branch ,Egypt city: Assiut state: Assuit zip: 0000 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06285890 id: 2023-1016 id: NCI-2024-01733 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2027-12-31 date: 2029-12-31 date: 2024-02-29 date: 2024-04-12 name: M.D. Anderson Cancer Center class: OTHER name: HiberCell, Inc. briefSummary: To find a recommended dose of HC-7366 that can be given in combination with azacitidine and venetoclax to patients with AML. The safety and effects of this drug combination will also be studied. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: HC-7366 name: Azacitidine name: Venetoclax 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: Abhishek Maiti, MD role: CONTACT phone: 346-725-0901 email: amaiti@mdanderson.org name: Abhishek Maiti, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06285877 id: 291120234382023 briefTitle: Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury overallStatus: RECRUITING date: 2024-02 date: 2024-02 date: 2025-01 date: 2024-02-29 date: 2024-02-29 name: Universidad Rey Juan Carlos class: OTHER briefSummary: Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.

Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.

Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8. conditions: Occupational Therapy conditions: Acquired Brain Injury conditions: Adults studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control Group (CG), which received their usual sessions of conventional therapy sessions, and an Experimental Group (EG), which received therapy with Nintendo Switch plus their conventional therapy sessions. primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Conventional therapy sessions name: Conventional therapy sessions plus Nintendo Switch measure: Abilhand measure: MEC-Lobo measure: Function in Sitting Test (FIST) measure: Fugl-Meyer measure: Berg Balance Scale (BBS) measure: Client Satisfaction Questionnaire (CSQ-8) sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Rey Juan Carlos status: RECRUITING city: Móstoles state: Madrid zip: 28933 country: Spain name: Isabel Quirosa Galan, MsC role: CONTACT phone: +34655551210 email: i.quirosa.2016@alumnos.urjc.es lat: 40.32234 lon: -3.86496 hasResults: False

 nctId: NCT06285864 id: 122/2023 briefTitle: Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-12 date: 2024-02-29 date: 2024-03-01 name: Iscte-University Institute of Lisbon class: OTHER name: Foundation for Science and Technology (FCT) name: University of Évora briefSummary: The ability to be connected and act according to bodily information is fundamental in chronic pain adjustment. This study aims to test the feasibility of an intervention designed to improve interoceptive sensibility, i.e., the ability to sense, interpret, and regulate bodily sensations in chronic musculoskeletal pain patients. conditions: Musculoskeletal Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be unaware of their assigned treatment. whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Interoception-based intervention measure: Feasibility - Sessions' acceptability measure: Feasibility - Program acceptability, appropriateness, and feasibility measure: Feasibility - Recruitment, retention, and attendance rates measure: Feasibility - safety/unexpected events measure: Feasibility - Treatment Fidelity Check measure: Interoceptive sensibility measure: Psychological flexibility measure: Emotion regulation measure: Pain-related self-efficacy measure: Pain catastrophizing measure: Activity patterns measure: Affective distress (depression and anxiety) measure: Pain severity measure: Physical function and Vitality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Iscte - University Institute of Lisbon status: RECRUITING city: Lisbon zip: 1649-026 country: Portugal name: Inês Oliveira, MSc role: CONTACT phone: +351217903000 email: iamoa@iscte-iul.pt name: Sónia Bernardes, PhD role: CONTACT phone: +351217903000 email: sonia.bernardes@iscte-iul.pt name: Inês Oliveira, MSc role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: University of Évora status: RECRUITING city: Évora zip: 7004-516 country: Portugal name: Inês Oliveira, MSc role: CONTACT phone: +351266740800 email: iamoa@iscte-iul.pt name: Sónia Bernardes, PhD role: CONTACT phone: +351217903000 email: sonia.bernardes@iscte-iul.pt name: Inês Oliveira, MSc role: PRINCIPAL_INVESTIGATOR lat: 38.56667 lon: -7.9 hasResults: False

 nctId: NCT06285851 id: 23-0825 briefTitle: A Novel Iron Supplement for Athletes: Phase I overallStatus: COMPLETED date: 2023-11-23 date: 2023-12-12 date: 2023-12-12 date: 2024-02-29 date: 2024-03-28 name: University of Calgary class: OTHER name: Lallemand Bio-Ingredients briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance. conditions: Constipation conditions: Diarrhea conditions: Cramp, Abdominal conditions: Bleeding Gastric studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 14 type: ACTUAL name: FeSC measure: GI Symptoms measure: Gastrointestinal symptoms measure: Supplement Tolerability and Preferences Questionnaire measure: Recovery sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: University of Calgary city: Calgary state: Alberta country: Canada lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06285838 id: 2020/2706 briefTitle: Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes overallStatus: COMPLETED date: 2020-07-17 date: 2023-11-30 date: 2024-01-20 date: 2024-02-29 date: 2024-02-29 name: Singapore Health Services class: OTHER briefSummary: Swift and decisive actions on the part of healthcare and hospital authorities are required to effectively contain the current COVID-19 pandemic. These measures firstly allow personnel and facilities leeway to provide surge capabilities to meet anticipated increased demands on the healthcare service. In addition, by deferring none urgent hospital visits, admissions and investigations, such measures support social distancing and aid attempts to control disease transmission. Deferring perceived non-urgent patient services may however lead to unintended delayed diagnoses and exacerbation of current patient conditions and lead to increased emergency admissions and surgeries.

A policy decision was made that essential surgical services pertaining to cancer and urgent cardiovascular surgery were allowed but that surgeons had the option to postpone what is assessed to be less urgent cases. Increasingly patients also postpone their surgeries or visits because of anxieties over the developing situation. Elective surgical services at the Outram Campus were thus significantly reduced from January 2020 as part of the measures to contain the COVID-19 outbreak.

The surgical philosophy during this period was that a judicious policy that allowed surgeons to proceed with surgery deemed critical but to postpone those deemed less so will at the system level, avoid poor outcomes for patients who required surgery and yet successfully re-allocate resources required to address the unfolding pandemic. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 11000 type: ACTUAL measure: Impact of measures taken to contain COVID-19 on hospital surgical care services and clinical outcomes sex: ALL minimumAge: 21 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Singapore Health Services Pte ltd city: Singapore zip: 169856 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06285825 id: 2023-0864 id: NCI-2024-01736 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-08-22 date: 2028-08-22 date: 2024-02-29 date: 2024-03-13 name: M.D. Anderson Cancer Center class: OTHER name: Sobi, Inc. briefSummary: To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART. conditions: Cytopenia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Emapalumab 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: Paolo Strati, MD role: CONTACT phone: 713-745-1776 email: pstrati@mdanderson.org name: Paolo Strati, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06285812 id: 000003 briefTitle: Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children acronym: OTO-MATIC overallStatus: RECRUITING date: 2023-01-10 date: 2024-05-30 date: 2024-05-30 date: 2024-02-29 date: 2024-02-29 name: PhotoniCare, Inc. class: INDUSTRY name: TTi Health Research & Economics briefSummary: A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs. conditions: Otitis Media Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 700 type: ESTIMATED name: OtoSight Middle Ear Scope measure: Change the clinician rate of antibiotic prescriptions measure: Change the number of antibiotic rounds per patient measure: Change costs associated with management of pediatric patients presenting with ear-related pain measure: Change in unnecessary antibiotic prescriptions measure: Change in prescription adherence measure: Change in antibiotic prescription rate when fluid not present measure: Improve patient outcomes measure: Change medical resource utilization measure: Change unnecessary medical intervention measure: Impact clinician confidence measure: Impact caregiver satisfaction measure: Change in Health-related Quality of Life (HQoL) sex: ALL minimumAge: 6 Months maximumAge: 17 Years stdAges: CHILD facility: Children's National Hospital status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 20010 country: United States name: Bobbe Thomas role: CONTACT lat: 38.89511 lon: -77.03637 facility: Trillim Health status: RECRUITING city: Rochester state: New York zip: 14620 country: United States name: Shealynn Hilliard role: CONTACT lat: 43.15478 lon: -77.61556 facility: Cyn3rgy Research status: RECRUITING city: Gresham state: Oregon zip: 97030 country: United States name: Allie Calaman role: CONTACT lat: 45.49818 lon: -122.43148 facility: Carolina ENT status: RECRUITING city: Orangeburg state: South Carolina zip: 29118 country: United States name: Simone Ansley role: CONTACT lat: 33.49182 lon: -80.85565 hasResults: False

 nctId: NCT06285799 id: IHAT_ID_2024 briefTitle: Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women overallStatus: RECRUITING date: 2024-03-05 date: 2025-12-01 date: 2025-12-31 date: 2024-02-29 date: 2024-04-19 name: Nemysis Ltd class: INDUSTRY name: RDC Clinical Pty Ltd briefSummary: This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks. conditions: Iron-deficiency studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: Low Dose IHAT name: High Dose IHAT name: Carob Flour measure: Percentage of women recovering from iron deficiency at week 12 measure: Time to reach normalisation of ferritin levels measure: Change in iron status measure: Change in fatigue measure: Incidence and prevalence of gastrointestinal side effects measure: Iron deficiency symptoms sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical Pty Ltd status: RECRUITING city: Brisbane state: Queensland zip: 4006 country: Australia name: Amanda Rao, PhD role: CONTACT phone: +61 414 488 559 email: amanda@rdcglobal.com.au name: David Briskey, PhD role: CONTACT phone: +61 421 784 077 email: david@rdcglobal.com.au name: Amanda Rao, PhD role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False

 nctId: NCT06285786 id: REB 2023-109 briefTitle: Patient Handling Techniques and New Technology for Health Care Workers overallStatus: RECRUITING date: 2023-09-20 date: 2024-03-15 date: 2024-04-20 date: 2024-02-29 date: 2024-02-29 name: University of New Brunswick class: OTHER briefSummary: Patient handling is a major risk-factor for the development of musculoskeletal injuries in healthcare providers. To have a significant impact on injury reduction related to patient handling will require the incorporation of technology. This project is to investigate a piece of technology that has been designed to facilitate in-bed patient handling: The Vendlet.

The purpose of this research project is to assess the ability of the Vendlet system outfitted on a Span-America Medical Systems (SAMS) bed to reduce the physical load on healthcare providers performing patient handling tasks. This evidence-based outcomes will be used to support the mitigation of the Vendlet from the European market into the Canadian market. The SAMS bed is currently available in North America and has several adjustable features to support patient transfer activities.

The project will provide a biomechanical comparison of commonly used patient handling techniques performed using a SAMS bed outfitted with and without a Vendlet patient transfer device. This Vendlet technology has the potential to significantly reduce the musculoskeletal and joint strain of healthcare providers while handling patients. conditions: Work-related Injury studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One single group of participants will be performing the same patient handling tasks:

1. During session 1 (Pre-Intervention) participants will not receive any instruction on how to perform the patient handling techniques on both beds.
2. During session 2 (Post-Intervention) participants will be asked to perform the patient handling techniques as seen during the intervention on both beds. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Participants will be masked of the proper technique/training during the pre-intervention session (with and without the use of technology). Specifically, on how to manually move the patient in both beds. count: 30 type: ESTIMATED name: Ergonomic Training on Patient Handling Techniques measure: Neuromuscular Activity - Average muscle activation measure: Neuromuscular Activity - Peak muscle activation measure: Motion Capture: To assess postural changes in patient handling technique. measure: Motion Capture: To assess cumulative load forces measure: Motion Capture: To assess joint angles measure: Foot Pressure Distribution: Peak pressure will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique. measure: Foot Pressure Distribution: Contact area will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique. measure: Bed Pressure Distribution: Average pressure distribution will be outcome measures to assess the safe placement of the patient. measure: Bed Pressure Distribution: Peak pressure distribution will be outcome measures to assess the safe placement of the patient. measure: Self Reported Questionnaires measure: Exit Survey measure: Rating of Perceived Exertion (RPE) sex: ALL minimumAge: 17 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Universite de Moncton status: RECRUITING city: Moncton state: New Brunswick zip: E1A 3E9 country: Canada name: Dre. Michelle Cardoso, PhD, Doctorate role: CONTACT phone: 506-470-3979 email: michelle.cardoso@umoncton.ca lat: 46.09454 lon: -64.7965 hasResults: False

 nctId: NCT06285773 id: Medipol Hospital 36 briefTitle: Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery overallStatus: RECRUITING date: 2024-02-25 date: 2024-10-20 date: 2024-11-10 date: 2024-02-29 date: 2024-02-29 name: Medipol University class: OTHER briefSummary: In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy. conditions: Cardiac Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for open heart surgery (coronary artery bypass) with median sternotomy will be included in the study. Patients will be randomly divided into two groups (Group PR = PIFPB + RIFPB group, Group C = Control group) including 30 patients each, before entering the operating room. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Outcomes Assessor and participant were blinded to the study whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: RIFPB block name: Postoperative analgesia management name: PIFPB block measure: Global recovery scoring system / Quality of Recovery 15 questionairre measure: Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") measure: The use of rescue analgesia measure: The use of rescue analgesia sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University Hospital status: RECRUITING city: Istanbul state: Bagcilar zip: 34070 country: Turkey name: Bahadir Ciftci, MD role: CONTACT phone: +905325034428 email: bciftci@medipol.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06285760 id: 135/23 briefTitle: Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY) acronym: SANDI overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date: 2025-02 date: 2024-02-29 date: 2024-03-04 name: Puerta de Hierro University Hospital class: OTHER name: Hospital Clinic of Barcelona name: Hospital Central de la Defensa Gómez Ulla name: Hospital Vall d'Hebron name: Hospital Universitario Ramon y Cajal name: University Hospital of Girona Dr.Josep Trueta name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa briefSummary: The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors.

The main question it aims to answer is whether there is a difference in natriuresis 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2). conditions: Heart Failure conditions: Persistent Congestion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: Standarized diuretic therapy measure: Change in natriuresis 48 hours after acetazolamide measure: Increase in diuresis 48 hours after acetazolamide administration measure: Weight difference 48 hours after acetazolamide administration measure: Difference in congestion score 48 hours after acetazolamide administration. measure: Difference in ultrasound measurements 48 hours after acetazolamide administration. measure: Changes in renal function 48 hours after acetazolamide administration. measure: Ionic (potassium (mmol/L) changes measure: chloride (mmol/L) changes 48 hours after acetazolamide administration measure: bicarbonate (mmol/L) changes 48 hours after acetazolamide administration measure: Changes in blood pressure 48 hours after administration of acetazolamide sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Julia González González city: Madrid zip: 28222 country: Spain name: Julia González González role: CONTACT phone: 0034617453693 email: juliagfk@gmail.com lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06285747 id: 23-004117 id: NCI-2024-01191 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-004117 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function overallStatus: RECRUITING date: 2023-07-28 date: 2025-08-01 date: 2025-08-01 date: 2024-02-29 date: 2024-02-29 name: Mayo Clinic class: OTHER briefSummary: This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function. conditions: Breast Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 85 type: ESTIMATED name: Non-Interventional Study measure: Chest wall lymphedema measure: Quality of life - Limb Lymphoedema Quality of Life (LymQOL) measure: Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Kayla A. Van Der Weerd, PT, DPT role: CONTACT phone: 507-266-8721 email: VanDerWeerd.Kayla@mayo.edu name: Kayla A. Van Der Weerd, PT, DPT role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06285734 id: KYLL-202312-049 briefTitle: Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Distention overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-07 date: 2025-01-07 date: 2024-02-29 date: 2024-02-29 name: Shandong University class: OTHER name: Qilu Hospital of Shandong University (Qingdao) name: Jinan Central Hospital name: Zaozhuang Municipal Hospital name: Binzhou Medical University name: Weihai Municipal Hospital name: Central Hospital of Zibo name: Weifang People's Hospital name: Qilu hospital of Shandong University Dezhou hospital name: Qihe Xian Renmin Hospital briefSummary: Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention. conditions: Abdominal Distention studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 402 type: ESTIMATED name: Breath test measure: Positive rate of SIBO in patients with abdominal distension measure: Positive rate of abnormal OCTT in patients with abdominal distension measure: Correlation between clinical features of patients with abdominal distension and SIBO measure: Correlation between clinical features of patients with abdominal distension and OCTT sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06285721 id: DELTES briefTitle: Delirium Treatment With Transcranial Electrical Stimulation acronym: DELTES overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2027-01-31 date: 2027-03-31 date: 2024-02-29 date: 2024-02-29 name: A.J.C. Slooter class: OTHER name: Radboud University Medical Center name: HagaZiekenhuis briefSummary: The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with postoperative delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.

To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.

Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months postoperative. conditions: Delirium studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 159 type: ESTIMATED name: transcranial alternating current stimulation (tACS) name: Sham transcranial alternating current stimulation (tACS) measure: Relative delta power measure: Duration of delirium measure: Severity of delirium measure: Length of hospital stay measure: Cognitive status three months post delirium measure: Subjective sensations during treatment measure: Average peak frequency measure: Phase Lag Index measure: Corrected Amplitude Envelope Correlation (AECc) measure: Relative power sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboudumc city: Nijmegen state: Gelderland zip: 6525 GA country: Netherlands name: Indira Tendolkar, MD, PhD role: CONTACT lat: 51.8425 lon: 5.85278 facility: HagaZiekenhuis city: Den Haag state: Zuid-Holland zip: 2545 AA country: Netherlands name: Thomas H Ottens, MD, PhD role: CONTACT lat: 52.07667 lon: 4.29861 hasResults: False

 nctId: NCT06285708 id: 2023B0193 briefTitle: Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD overallStatus: RECRUITING date: 2024-02 date: 2025-07 date: 2026-01 date: 2024-02-29 date: 2024-02-29 name: Ohio State University class: OTHER briefSummary: The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD. conditions: PTSD conditions: Suicidal Ideation conditions: Suicide, Attempted conditions: Trauma, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Prolonged exposure measure: Beck Scale for Suicidal Ideation (SSI) measure: Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) measure: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure measure: Interpersonal Needs Questionnaire (INQ) - Abbreviated measure: Beck Hopelessness Scale (BHS) - Abbreviated measure: Brief Suicide Cognitions Scale (SCS) measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) measure: Monetary Choice Questionnaire (MCQ) measure: Behavioral Inhibition Scale (BIS) measure: Behavioral Activation Scale (BAS) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Jaryd Hiser role: CONTACT phone: 614-814-0163 email: jaryd.hiser@osumc.edu name: Justin Baker, Ph.D. role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06285695 id: ILS241-I001 briefTitle: Clareon Toric Study (T2-T9) overallStatus: RECRUITING date: 2024-04-04 date: 2028-04 date: 2028-04 date: 2024-02-29 date: 2024-04-24 name: Alcon Research class: INDUSTRY briefSummary: The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs). conditions: Aphakia conditions: Corneal Astigmatism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Clareon Toric IOL name: Cataract surgery measure: Mean monocular best corrected distance visual acuity (BCDVA) measure: Mean monocular absolute residual refractive cylinder measure: Mean absolute IOL rotation from previous visit measure: Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gimbel Eye Centre status: RECRUITING city: Calgary state: Alberta zip: T3B 0M3 country: Canada lat: 51.05011 lon: -114.08529 facility: Uptown Eye Specialists status: RECRUITING city: Concord state: Ontario zip: L4K 2Z5 country: Canada lat: 43.80011 lon: -79.48291 facility: Prism Eye Institute status: RECRUITING city: Oakville state: Ontario zip: L6H 0J8 country: Canada lat: 43.45011 lon: -79.68292 facility: Laurentians Eye Institute status: RECRUITING city: Boisbriand state: Quebec zip: J7H 0E8 country: Canada lat: 45.61678 lon: -73.83249 facility: Bellevue status: RECRUITING city: Montréal state: Quebec zip: H1V 1G5 country: Canada lat: 45.50884 lon: -73.58781 facility: McGill University status: RECRUITING city: Montréal state: Quebec zip: R7A 3N2 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06285682 id: ETH2324-2826 briefTitle: Bioavailability of Hydroxytyrosol in Healthy Adult Humans overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-03 date: 2024-03-30 date: 2024-05-01 date: 2024-02-29 date: 2024-02-29 name: Anglia Ruskin University class: OTHER name: Fattoria La Vialla name: Instituto Kurz briefSummary: Brief summary: There is current scientific interest in hydroxytyrosol due to its anti-inflammatory and antioxidant properties, efficient protection of vascular tissue and ability to neutralise free radicals via hydrogen donation. Recognised as the potent polyphenol within a commercially available olive-fruit water (OliPhenolia®), data from this research will determine the dose of OliPhenolia® required for the optimum absorption and metabolism of hydroxytyrosol. The primary aim of this research is to identify the dose of hydroxytyrosol (0.5, 1.0 or 1.5 mg∙kg-1) within OliPhenolia® that demonstrates the greatest area under the plasma concentration curve for hydroxytyrosol over a four-hour period. A secondary aim is to assess maximum concentration (CMAX) and time to maximum concentration (TMAX) of total hydroxytyrosol and secondary metabolites (Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein) following consumption of 3 randomised doses of OliPhenolia® on separate occasions with healthy adult volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants are randomly assigned a dose of olive-derived hydroxytyrosol in a double-blind manner. Following a ≥3 day wash out participants then cross-over to an alternate dose. This process is then repeated for the third and final dose. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Volume of nutritional supplement is provided in a double-blinded manner. Both participants and research testers will be masked from knowing the specifics of the volume allocation. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 8 type: ACTUAL name: OliPhenolia®) measure: Hydroxytyrosol bioavailability measure: Bioavailability of hydroxytyrosol metabolites. measure: Hydroxytyrosol CMax measure: Hydroxytyrosol TMAX measure: CMAX of hydroxytyrosol secondary metabolites measure: TMAX of hydroxytyrosol secondary metabolites sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University city: Cambridge zip: CB5 8DZ country: United Kingdom lat: 52.2 lon: 0.11667 hasResults: False

 nctId: NCT06285669 id: KA18/35 briefTitle: Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants overallStatus: COMPLETED date: 2018-01-01 date: 2020-06-30 date: 2020-06-30 date: 2024-02-29 date: 2024-02-29 name: Ondokuz Mayıs University class: OTHER briefSummary: This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion. conditions: Preterm conditions: Premature conditions: Infant, Newborn, Diseases conditions: Respiratory Distress Syndrome conditions: Neonatal Respiratory Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Kinesio-Taping Application primaryPurpose: TREATMENT masking: NONE count: 26 type: ACTUAL name: kinesiotaping application measure: Level of pH sex: ALL minimumAge: 1 Month maximumAge: 4 Months stdAges: CHILD facility: Nilay Çömük Balci city: Samsun state: Atakum zip: 55139 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06285656 id: ASH-KG briefTitle: Femoral Blood Gas and Prediction of Postoperative Bleeding overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2024-10-03 date: 2024-02-29 date: 2024-02-29 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Postoperative bleeding is still an important concern after major abdominal surgery. Postoperative bleeding is the most important determinant of morbidity and death. It results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. Early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.Simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.Lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. The purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible. conditions: Postoperative Hemorrhage conditions: Blood Transfusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Eritrocyte replacement measure: Postoperative Hemmorhagea sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06285643 id: ASK-PD5-CS201 briefTitle: A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD) acronym: REGENERATE-PD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-11-30 date: 2027-11-30 date: 2024-02-29 date: 2024-02-29 name: Asklepios Biopharmaceutical, Inc. class: INDUSTRY name: Bayer briefSummary: The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 87 type: ESTIMATED name: AAV2-GDNF Gene therapy name: Control Surgery measure: Motor symptoms-MDS-UPDRS parts 2 and 3 measure: PD Motor Diary Non-Motor symptoms-MDS-UPDRS part1 measure: PDQ39 Levodopa Equivalent Daily Dose measure: Change from baseline in the MDS-UPDRS parts 2 and 3, and the PD Motor Diary measure: Change from baseline in the MDS-UPDRS part 1 and PDQ-39 measure: Change in Levodopa equivalent daily dose sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06285630 id: Alba101 id: 2023-05299-01 type: OTHER domain: Ethix briefTitle: The Development and Health of the Intestinal Flora During the First Year of Life acronym: PREVENT overallStatus: ENROLLING_BY_INVITATION date: 2024-02-26 date: 2024-10-30 date: 2024-12-20 date: 2024-02-29 date: 2024-02-29 name: Alba Health AB class: INDUSTRY name: Universiteit Antwerpen name: Uppsala University name: Copenhagen Studies on Asthma in Childhood briefSummary: In this research study (PREVENT 1), Alba Health, in collaboration with academic institutions (Uppsala University, COPSAC and University of Antwerp) is investigating the association between the developing gut microbiota (collection of microbes present in the human gut) in the first year of life and lifestyle, wellbeing and health in a Swedish population. The study is the first of its kind in a Swedish population to collect and associate microbiome composition to an extensive family history and health questionnaire, stool colour and crying type, building on learnings from previous studies performed in other countries, such as the HELMI and COPSAC studies (HELMI - Finnish Health and Early Life Microbiota cohort from the University of Helsinki in Finland; COPSAC - Copenhagen Prospective Studies on Asthma in Childhood in Denmark).

The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the study's start. After providing informed consent, the participating families will be asked to provide three stool samples from their child (the sample collection is not invasive and does not cause discomfort) and will be asked to answer questionnaires on lifestyle, well-being and family health. The participating families will not be asked to change their lifestyle beyond sample and data collection.

From the collected stool samples, we will extract microbial DNA and subject this to deep metagenomic sequence analysis. The study will only analyze microbial DNA, any human related material will be discarded. The stool samples will be destroyed within one month of sequencing (maximum 3 months from collection). The data will be stored according to GDPR and Swedish law, with informed consent in Sweden and with appropriate security measures. All research will be carried out in Sweden. conditions: Healthy conditions: Microbial Colonization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Observational, no intervation will be made measure: Microbiome composition of infants in variable age ranges measure: Is the composition associated with and gastrointestinal issues sex: ALL minimumAge: 3 Months maximumAge: 12 Months stdAges: CHILD facility: Alba Health AB city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06285617 id: 2022GDRC016 briefTitle: Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis acronym: SAT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-31 date: 2025-04-30 date: 2024-02-29 date: 2024-02-29 name: Xinqiao Hospital of Chongqing class: OTHER briefSummary: The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis. The main questions it aims to answer are: Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group? Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/day prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy in the control group. conditions: Subacute Thyroiditis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prednisone primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: 1-week predisone+1-week celecoxib name: 6-weeks predisone measure: The difference in efficacy between the two groups at the completion. measure: Thyroid function measure: Total cholesterol (TC) measure: Triglycerides (TG) measure: Systolic blood pressure (SBP) measure: Diastolic blood pressure (DBP) measure: Parathyroid hormone (PTH) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06285604 id: IRB-20230398-R briefTitle: Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-09-30 date: 2025-12-31 date: 2024-02-29 date: 2024-02-29 name: Women's Hospital School Of Medicine Zhejiang University class: OTHER briefSummary: The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:

* Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.
* To provide objective basis for clinical rational use of blood in the selection of blood products.

Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators. conditions: Neonatal Anemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Blood transfusion measure: Clinical efficacy of different red blood cell products transfusion in anemic neonates measure: The changes of inflammatory response before and after transfusion in anemic neonates sex: ALL minimumAge: 1 Day maximumAge: 1 Year stdAges: CHILD facility: Women's Hospital School of Medicine Zhejiang University city: Hangzhou state: Zhejiang zip: 310006 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06285591 id: 2023-1801 briefTitle: Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors overallStatus: RECRUITING date: 2023-11-10 date: 2025-03-31 date: 2025-03-31 date: 2024-02-29 date: 2024-02-29 name: West China Hospital class: OTHER briefSummary: Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus Reuteri is a natural flora of the human body that can be found in the gastrointestinal tract, skin, etc. Among them, Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry, and are common Lactobacillus strains marketed for the production of oral probiotics, which are commonly used in infant formulas, among others. In oral inflammatory diseases, it has been reported in the literature that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce gingival and periodontal inflammation, mainly through the mechanisms of modulating the host inflammatory response and displacing pathogenic bacteria. In terms of safety, oral Lactobacillus Reuteri has good stability, very low pathogenic potential, and is not toxic to humans. Therefore, this study is a placebo-controlled, multi-center, open, randomized controlled clinical study to evaluate the efficacy of Lactobacillus Reuteri for the prevention of radioactive oral mucosal reactions in intensity-modulated radiotherapy for head and neck tumors, including nasopharyngeal carcinoma. conditions: Oral Mucositis (Ulcerative) Due to Radiation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: Lactobacillus Reuteri Tablets name: Placebo-containing tablets name: Radiotherapy measure: The incidence of Severe Oral mucositis (WHO grade ≥3) measure: The time to onset of Severe Oral mucositis (WHO grade ≥3) measure: The duration of Severe Oral mucositis (WHO grade ≥3) measure: Taste function measure: Xerostomia summated xerostomia inventory (SXI) measure: Functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire measure: Adverse events measure: Oral activities scores measure: Mouth and throat soreness (MTS) scores sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Xingchen Peng, PhD role: CONTACT phone: +86 18980606753 email: pxx2014@163.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06285578 id: MOST 107-2410-H-277-003 briefTitle: Effects of Probiotic and HIIT in Obese Women overallStatus: COMPLETED date: 2018-10-01 date: 2019-01-31 date: 2019-03-01 date: 2024-02-29 date: 2024-02-29 name: University of Taipei class: OTHER briefSummary: The aim of this study is to investigate whether there are the additive effects when implementing both high-intensity interval training (HIIT) and probiotics simultaneously on improving cardiorespiratory endurance and metabolism in middle-aged women. conditions: Cardiorespiratory Fitness conditions: Metabolism conditions: Anthropometry studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 47 type: ACTUAL name: Probiotics supplementation name: HIIT training name: Placebo supplementation measure: Height measure: Body weight measure: Body mass index (BMI) measure: Body fat percentage measure: Waist circumference measure: Hip circumference measure: Maximum oxygen uptake (VO2max) measure: Time to exhaustion (TTE) measure: Running economy (RE) measure: Fasting blood glucose (FBG) measure: Total cholesterol (TC) measure: Triglyceride (TG) measure: High-density lipoprotein cholesterol (HDL-C) measure: Low-density lipoprotein cholesterol (LDL-C) measure: Muscle mass measure: Fat mass measure: Bone mineral density (BMD) measure: Caloric intake sex: FEMALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: University of Taipei city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06285565 id: CE390/2023 briefTitle: A Nurse-led Coaching Programme With Telemonitoring in Heart Failure acronym: INTERCOACH overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-01 date: 2025-05-01 date: 2024-02-29 date: 2024-02-29 name: Alberto Dal Molin class: OTHER name: Azienda Ospedaliero Universitaria Maggiore della Carita briefSummary: The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are:

* Are implementation strategies effective in facilitating participant fidelity?
* What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence?
* Are the methods and tools established the most appropriate to ensure the completeness of the data collection?

Participants will follow a combined intervention consisting of:

1. pre-discharge educational meeting;
2. telephone nurse-led coaching sessions;
3. home telemonitoring of vital signs.

In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities conditions: Heart Failure conditions: Telemonitoring conditions: Hospitalizations conditions: Feasibility conditions: Mentoring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel, open-label randomized controlled feasibility study primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The assessors will collect clinical outcomes by telephone and will be blinded to the group assignment whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Nurse-led telephone coaching intervention with home telemonitoring of vital signs measure: Recruitment rate measure: Retention rate measure: Adherence to the coaching intervention measure: Adherence to telemonitoring program measure: Completeness of data collection measure: 90- and 180-day all-cause hospital readmissions measure: 90- and 180-day heart failure-related hospital readmissions measure: 90- and 180-day Emergency Departments visits measure: 90- and 180-day General Practioner visits measure: 90- and 180-day oupatient visits measure: Self-care capacity (Self-Care of Heart Failure Index ) measure: Self Care - Self-Efficacy Scale measure: Quality of life (SF-12 scale) measure: Anxiety (Hamilton Anxiety Scale ) measure: Depression (Geriatric Depression Scale) measure: Heart Failure Somatic Perception Scale v.3 (HFSPS) measure: Mortality sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Università del Piemonte Orientale Amedeo Avogadro city: Novara zip: 28100 country: Italy name: Alberto Dal Molin, Prof role: CONTACT phone: +390321660607 email: alberto.dalmolin@med.uniupo.it name: INES BASSO role: CONTACT phone: +393927599727 email: ines.basso@uniupo.it lat: 45.44694 lon: 8.62118 hasResults: False

 nctId: NCT06285552 id: 4792/0842 briefTitle: Evaluation of the Comprehensive Family Support Program (PAIF) overallStatus: RECRUITING date: 2024-02-20 date: 2026-07 date: 2026-07 date: 2024-02-29 date: 2024-04-12 name: University of Seville class: OTHER name: Gobierno de Cantabria name: Loyola University name: University of Jaen briefSummary: The goal of this study is to evaluate the effectiveness of positive parenting programs targeted to parents of toddlers, children and adolescents carried out in Cantabria (Spain).

We will collect information from the participants before the intervention, in the last session of the program and some months after, to verify if there have been some changes in the family dynamics of these parents, and if these changes continue after some time. Besides, we will compare these results with information from other families that are not taking part in the program. The main caregivers of the participating families and the practitioners in charge of the intervention will provide the information for the study.

We expect that families participating in the programs will improve their parenting competencies and their family dynamics, and that these change will stay after the program. conditions: Parenting studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants will be assigned to the manualized program according to the inclusion criteria. The comparison group will be composed of families in areas where the intervention is not available but with similar sociodemographic characteristics. primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Positive parenting PAIF program measure: Perception of the parental role measure: Parenting practices (Authoritative parenting style: Warmth and Support, Reasoning/Induction, Democratic Participation) measure: Parenting practices (Overreactivity and Laxness) measure: Satisfaction with the intervention measure: Children adjustment measure: Social support measure: Satisfaction with Family Life sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Consejería de Inclusión Social, Juventud, Familias E Igualdad status: RECRUITING city: Santander state: Cantabria zip: 39004 country: Spain name: JOSÉ ANGEL RODRÍGUEZ role: CONTACT phone: 942 207 756 email: rodriguez_ja@cantabria.es lat: 43.46472 lon: -3.80444 hasResults: False

 nctId: NCT06285539 id: 2022-502968-20 briefTitle: Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases acronym: DRIMID overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-02-29 date: 2024-02-29 name: UMC Utrecht class: OTHER name: Alfasigma S.p.A. name: ReumaNederland name: Autoimmune Research and Collaboration Hub briefSummary: Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations. Patients with Behçet's disease (BD), idiopathic inflammatory myopathy (IIM, also known as myositis) and IgG4-related disease (IgG4-RD) are treated with high-dosed glucocorticoids, methotrexate, azathioprine and mycophenolate mofetil, mostly for long periods of time with attendant risks of long-term toxicity, including infections. Therefore, there is an urgent need for new, more specific anti-inflammatory therapies such as targeted synthetic and biological disease-modifying antirheumatic drugs. Due to the role of type 1 interferon in both BD, IIM and IgG4-RD, JAK-STAT inhibition may be a promising treatment strategy in these conditions, because JAK1 is critical for the signal transduction of pro-inflammatory cytokine receptors. Previous research showed that JAK1 inhibition reduces activation of type 1 interferon-regulated proteins and key chemokines that control tissue inflammation. conditions: Behcet's Disease conditions: Idiopathic Inflammatory Myopathies conditions: IgG4-related Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A 26-week multicenter, open-label, uncontrolled, non-randomized, non-blinded proof-of-concept, two-stage phase 2 study primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Filgotinib measure: EQ-5D-5L measure: Disease activity in Behcet's patients measure: Disease activity in myositis patients measure: Disease activity in IgG4-RD patients measure: Corticosteroid toxicity measure: Corticosteroid dosage measure: VAS score of pain measure: Fatigue measure: Treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC city: Amsterdam country: Netherlands name: Joost Raaphorst, Dr. role: CONTACT email: j.raaphorst@amsterdamumc.nl name: Joost Raaphorst, Dr. role: PRINCIPAL_INVESTIGATOR name: Sander W Tas, Prof. dr. role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Hagaziekenhuis city: Den Haag country: Netherlands name: Robbert J Goekoop, MD role: CONTACT email: r.goekoop@hagaziekenhuis.nl name: Robbert J Goekoop, MD role: PRINCIPAL_INVESTIGATOR lat: 52.07667 lon: 4.29861 facility: Zuyderland Medical Center city: Heerlen country: Netherlands name: Cesar Magro Checa, Dr role: CONTACT email: c.magrocheca@zuyderland.nl name: Cesar Magro Checa, Dr role: PRINCIPAL_INVESTIGATOR lat: 50.88365 lon: 5.98154 facility: Radboud university medical center city: Nijmegen country: Netherlands name: Rogier Thurlings, Dr role: CONTACT email: rogier.thurlings@radboudumc.nl name: Rogier Thurlings, Dr role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 facility: Erasmus MC city: Rotterdam country: Netherlands name: Jan van Laar, Dr. role: CONTACT email: j.vanlaar@erasmusmc.nl name: Jan van Laar, Dr. role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: University Medical Center city: Utrecht country: Netherlands name: Anne Karien Marijnissen, Dr. role: CONTACT email: a.c.a.marijnissen@umcutrecht.nl name: Jaap M. van Laar, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Bettina C. Geertsema-Hoeve, MD role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06285526 id: 2023/0046/OB id: 2023-A00350-45 type: REGISTRY domain: French Minister briefTitle: Glycocalyx Monitoring in Major Abdominal Surgery acronym: GLYCOCHIP overallStatus: RECRUITING date: 2022-07-05 date: 2024-07-05 date: 2025-01-05 date: 2024-02-29 date: 2024-02-29 name: University Hospital, Rouen class: OTHER briefSummary: The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters. conditions: Major Abdominal Surgery studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy name: Cephalic DuodenoPancreatectomy measure: Glycocalyx thickness measure: Glycocalyx thickness and a biological marker of tissue hypoperfusion measure: Glycocalyx thickness and a biological marker of tissue hypoxia measure: Blood cell velocity and macrocirculatory function measure: Perfused capillary density and macrocirculatory function measure: Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rouen University Hospital status: RECRUITING city: Rouen zip: 76000 country: France name: DEMAILLY Zoé, MD role: CONTACT phone: 02 32 88 24 40 phoneExt: +33 email: Zoe.Demailly@chu-rouen.fr name: Thomas CLAVIER, MD role: CONTACT phone: 02 32 88 82 92 phoneExt: +33 email: Thomas.Clavier@chu-rouen.fr lat: 49.44313 lon: 1.09932 hasResults: False

 nctId: NCT06285513 id: 2021/387/OB id: 2023-A00503-42 type: REGISTRY domain: Frecnh Ministry briefTitle: Cardiovascular Metabolic Remodeling in Shock acronym: METASHOCK overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-02 date: 2024-02-29 date: 2024-02-29 name: University Hospital, Rouen class: OTHER briefSummary: The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved. conditions: Shock studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Cardiac ultrasound measure: Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Rouen city: Rouen country: France name: Grégoire JOLLY, MD role: CONTACT lat: 49.44313 lon: 1.09932 hasResults: False

 nctId: NCT06285500 id: UNIQUE id: 23-5095 type: OTHER domain: University Health Network briefTitle: Umbrella Study for Single Patient Treatments in Oncology acronym: UNIQUE overallStatus: RECRUITING date: 2024-02-01 date: 2027-02-01 date: 2029-02-01 date: 2024-02-29 date: 2024-02-29 name: University Health Network, Toronto class: OTHER briefSummary: The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments. conditions: Advanced Cancer conditions: Rare Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 400 type: ESTIMATED name: Patient-specific treatments measure: Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy measure: Overall survival rate measure: Progression-free survival rate measure: Number of participants with adverse events as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network, Princess Margaret Cancer Centre status: RECRUITING city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Amit Oza, Dr. role: CONTACT phone: 416 946 4450 email: amit.oza@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06285487 id: 23-1600 briefTitle: Depression in Youth Onset Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-06 date: 2026-06 date: 2024-02-29 date: 2024-02-29 name: University of Colorado, Denver class: OTHER briefSummary: The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes. conditions: Type 2 Diabetes conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Group Program measure: Acceptability of IPT-T2D measure: Depression Changes measure: Changes in Glycemic Control sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Children's Hospital Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06285474 id: 22-001323 briefTitle: Investigating LIFUP in Anhedonic Depression acronym: ILIAD overallStatus: ENROLLING_BY_INVITATION date: 2022-10-27 date: 2024-04-30 date: 2024-04-30 date: 2024-02-29 date: 2024-02-29 name: University of California, Los Angeles class: OTHER name: Wellcome Trust briefSummary: This study will observe changes in brain imaging, behavior, and symptom measures following intervention with low intensity focused ultrasound pulsation (LIFUP) targeting reward circuitry in individuals who are depressed and anhedonic. conditions: Depression conditions: Anhedonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Low Intensity Focused Ultrasound Pulsation (LIFUP) measure: Change in Patient health questionnaire-14 self report measure (PHQ-14) from baseline measure: Change in Positive valence systems scale-21 self report measure (PVSS-21) from baseline measure: Changes in MRI images from Pre-scan to week 5 measure: Change in Ecological momentary assessment (EMA) from W0/Baseline measure: Changes in digital behavioral phenotype sleep measurement measure: Changes in digital behavioral phenotype physical activity measurement measure: Changes in heart rate measure: Changes in heart rate variability measure: Changes in respiratory rate measure: changes in World Health Organization (WHO) -5 Wellbeing index score from W0/Baseline to end of study measure: changes in Pittsburgh Sleep Quality Index (PSQI) score from W0/Baseline to end of study measure: changes in Quick Inventory of Depressive Symptoms (QIDS-SR15) score from W0/Baseline to end of study measure: changes in Patient Health Questionnaire (PHQ-9) score from day 2 to week 2 measure: changes in Brief Irritability Test (BITe) score from W0/Baseline to end of study measure: changes in Generalized Anxiety Disorder (GAD-7) score from W0/Baseline to end of study measure: Changes in Snaith Hamilton Pleasure Scale (SHAPS) score from W0/Baseline to end of study measure: Changes in Suicidal Ideation measure from Pre-scan to end of study measure: changes in Apathy Motivation Index (AMI) score from W0/Baseline to end of study measure: changes in Eudaimonic Well-Being Questionnaire (EWBQ) score from W0/Baseline to end of study measure: Changes in Work and Social Adjustment Scale (WSAS) score from W0/Baseline to end of study measure: Changes in Ruminative Response Scale (RRS) - brooding subscale score from W0/Baseline to end of study measure: changes in Trauma History Questionnaire (THQ) score from W0/Baseline to end of study measure: changes in Routines Survey from W0/Baseline to end of study measure: changes in USDA Housing and Food Insecurity score from W0/Baseline to end of study measure: changes in Holmes-Rahe Life Stress Survey score from W0/Baseline to end of study measure: Changes in emotion recognition accuracy scores from Pre-scan to end of study measure: Changes in emotion recognition response times from Pre-scan to end of study measure: Changes in continuous concentration accuracy scores from Pre-scan to end of study measure: Changes in continuous concentration response times from Pre-scan to end of study measure: Changes in continuous concentration error scores from Pre-scan to end of study measure: Changes in Apple Gathering task behavior from Pre-scan to end of study sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California Los Angeles city: Los Angeles state: California zip: 90095-1563 country: United States lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06285461 id: T2566/2023 briefTitle: Food Intake, Endocrine Factors and Brown Fat acronym: FoodBAT overallStatus: RECRUITING date: 2024-02-20 date: 2025-06-30 date: 2026-06-30 date: 2024-02-29 date: 2024-04-10 name: Turku University Hospital class: OTHER_GOV name: University of Turku briefSummary: This study will investigate how the acute intake of foods with high and low hedonic reward differentially affects brown adipose tissue and the interplay between gut peptides, brown fat, and the brain (gut-BAT-brain axis). conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This will be a crossover study in which participants undergo two postprandial test days with meals with high- or low-hedonic reward and two weeks of washout between interventions. primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Non-palatable meal name: Palatable meal measure: Brown adipose tissue metabolism measure: Changes in gut peptides measure: Differences in μ-opioid receptors in the human brain measure: Energy expenditure/Meal-induced thermogenesis measure: Visual Analogue scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Turku PET Centre status: RECRUITING city: Turku zip: 20520 country: Finland name: Kirsi A Virtanen role: CONTACT phone: +358407626564 email: kianvi@utu.fi lat: 60.45148 lon: 22.26869 hasResults: False

 nctId: NCT06285448 id: A24-028 briefTitle: Feasibility of Lecanemab Registry and Clinical Outcome Measures overallStatus: ENROLLING_BY_INVITATION date: 2024-01-02 date: 2025-12-31 date: 2026-06-30 date: 2024-02-29 date: 2024-03-01 name: HealthPartners Institute class: OTHER briefSummary: Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners. conditions: Alzheimer Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Lecanemab measure: Feasibility of enrollment measure: Feasibility of completing visits measure: Qualitative experience at 3 months measure: Qualitative experience at 12 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HealthPartners Neuroscience Center city: Saint Paul state: Minnesota zip: 55130 country: United States lat: 44.94441 lon: -93.09327 hasResults: False

 nctId: NCT06285435 id: coagulation activation in PV briefTitle: Coagulation Activation in Patients With Pemphigus overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-10 date: 2026-02 date: 2024-02-29 date: 2024-02-29 name: Assiut University class: OTHER briefSummary: Aim of work:

1. To evaluate the plasma markers of coagulation activation: prothrombin F1+2 and d-dimer levels in pemphigus patients with active disease and compare them with age and sex-matched controls.
2. To evaluate the correlation of these markers with disease severity score by using Pemphigus Disease Area Index (PDAI) and with disease activity by measurement of anti-desmoglein 1 and 3 antibody titers. conditions: Pemphigus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: prothrombin fragment 1+2 measure: Comparison of coagulation activation markers in pemphigus patients with controls measure: Correlation of markers with disease severity sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06285422 id: SC262-101 briefTitle: Study Evaluating SC262 in Subjects With r/r B-cell Malignancies (VIVID) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-03 date: 2029-03 date: 2024-02-29 date: 2024-04-04 name: Sana Biotechnology class: INDUSTRY briefSummary: SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers. conditions: Non Hodgkin's Lymphoma conditions: Large B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: SC262 measure: Evaluate safety and tolerability of SC262 measure: Evaluate preliminary anti-tumor activity of SC262 measure: Evaluate cellular kinetics and persistence of SC262 measure: Evaluate cellular kinetics and persistence of SC262 measure: Evaluate cellular kinetics and persistence of SC262 measure: Evaluate host immunogenicity to SC262 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06285409 id: 24-02 briefTitle: Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium overallStatus: RECRUITING date: 2024-04-04 date: 2024-10 date: 2024-10 date: 2024-02-29 date: 2024-04-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called "uterine atony", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered.

This study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further. conditions: Postpartum Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Carbetocin name: Oxytocin name: Carbetocin name: Oxytocin name: Ergonovine name: Carboprost measure: Motility index measure: Amplitude of contraction measure: Frequency of contraction measure: Integrated area under response curve (AUC) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Mrinalini Balki, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: mrinalini.balki@uhn.ca name: Wafa Bellan, MD role: SUB_INVESTIGATOR name: Ronald George, MD role: SUB_INVESTIGATOR name: Joseph Park, BSc role: SUB_INVESTIGATOR name: Anuradha Baishnob, BSc role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06285396 id: 24-01 briefTitle: Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study overallStatus: RECRUITING date: 2024-03-18 date: 2024-07 date: 2024-07 date: 2024-02-29 date: 2024-04-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes.

Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH.

It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory. conditions: Postpartum Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Ephedrine name: Phenylephrine name: Norepinephrine name: Oxytocin measure: Motility index measure: Amplitude of contraction measure: Frequency of contraction measure: Integrated area under response curve (AUC) sex: FEMALE minimumAge: 19 Years maximumAge: 40 Years stdAges: ADULT facility: Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Mrinalini Balki, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: mrinalini.balki@uhn.ca name: Caroline Carruthers role: SUB_INVESTIGATOR name: Joseph Park, BSc role: SUB_INVESTIGATOR name: Cynthia Maxwell, MD role: SUB_INVESTIGATOR name: Anuradha Baishnob, BSc role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06285383 id: Kar.neck briefTitle: The Effects of Music on Neck Pain overallStatus: RECRUITING date: 2024-02-15 date: 2024-03-15 date: 2024-04-15 date: 2024-02-29 date: 2024-02-29 name: KTO Karatay University class: OTHER briefSummary: The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined. conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Music listening name: classic physical therapy measure: Beck anxiety inventory measure: Visual Analogue Scale measure: Short form-36 sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Mustafa Savaş Torlak status: RECRUITING city: Karatay state: Eyalet/Yerleşke zip: 42000 country: Turkey name: Mustafa S Torlak role: CONTACT phone: +905373660138 email: mustafa.savas.torlak@karatay.edu.tr lat: 37.86726 lon: 32.52863 hasResults: False

 nctId: NCT06285370 id: 0761-CN001 id: CTR20230672 type: OTHER domain: National Medical Products Administration briefTitle: A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy overallStatus: RECRUITING date: 2023-05-29 date: 2025-10-31 date: 2026-01-31 date: 2024-02-29 date: 2024-04-29 name: Kyowa Kirin China Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of the study is to evaluate the efficacy and safety of mogamulizumab (KW-0761) in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy conditions: Cutaneous T-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open-label, multicenter, single arm study. primaryPurpose: TREATMENT masking: NONE maskingDescription: No Masking count: 20 type: ESTIMATED name: Mogamulizumab measure: Overall Response Rate measure: Skin disease response rate; measure: Lymth nodes response rate measure: Visceral metastases response rate; measure: Blood disease response rate; measure: Progression Free Survival measure: Duration of response (DOR) measure: Time to response (TTR) measure: Response rate of lymph node evaluated by Lugano 2014. measure: Response rate of viscera evaluated by Lugano 2014 criteria. measure: To evaluate pharmacokinetics (plasma mogamulizumab concentration) of mogamulizumab. measure: To evaluate immunogenicity (anti-mogamulizumab antibody) of mogamulizumab. measure: To evaluate the effects of skin disease on health-related Quality of Life (HRQoL) -Skindex 29. measure: The incidence and frequency of treatment-related adverse events (TEAEs) and drug-related TEAEs as assessed by CTCAE v5.0. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Yuankai Shi role: CONTACT phone: 13701251865 email: syuankai@cicams.an.cn name: Yuankai Shi role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University First Hospital, Department of Dermatology and Venereology status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Ping Tu role: CONTACT phone: 13021262219 email: tup0207@sina.com name: Ping Tu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Sun Yat-sen University Cancer Center, Department of Medical Oncology status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Huiqiang Huang role: CONTACT phone: 13808885154 email: huang_sysu@163.com name: Huiqiang Huang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The 2nd Affiliated Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150001 country: China name: Yuzhen Li role: CONTACT phone: 13936367628 email: liyuzhenchina@126.com name: Yuzhen Li role: PRINCIPAL_INVESTIGATOR lat: 45.75 lon: 126.65 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei country: China name: Liling Zhang role: CONTACT phone: 15871725926 email: lily1228@sina.com name: Liling Zhang role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410031 country: China name: Hui Zhou role: CONTACT phone: 13975879796 email: zhouhui9403@126.com name: Hui Zhou role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: The Affiliated Hospital of Inner Mongolia Medical University status: NOT_YET_RECRUITING city: Hohhot state: Inner Mongolia zip: 010000 country: China name: Da Gao role: CONTACT phone: 13947130473 email: gaoda72@163.com name: Da Gao role: PRINCIPAL_INVESTIGATOR lat: 40.81056 lon: 111.65222 facility: The First Hospital of China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110002 country: China name: Xinghua Gao role: CONTACT phone: 13940152467 email: gaobarry@hotmail.com name: Xinghua Gao role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 facility: Zhongshan Hospital Fudan University status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Peng Liu role: CONTACT phone: 1581725926 email: liu.peng@zshospital.sh.cn name: Peng Liu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: West China Hospital, Sichuan University status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610044 country: China name: Lin Wang role: CONTACT phone: 18980601701 email: LKZWL@126.com name: Lin Wang role: PRINCIPAL_INVESTIGATOR name: Liqun Zou role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: ZheJiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310005 country: China name: Haiyan Yang role: CONTACT phone: 18960860662 email: yanghaiyantb@126.com name: Haiyan Yang role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Henan state: Zhengzhou zip: 450052 country: China name: Xinhua Wang role: CONTACT phone: 15036115299 email: xinwang512@163.com name: Xinhua Wang role: PRINCIPAL_INVESTIGATOR hasResults: False

 nctId: NCT06285357 id: EPISTOP_22 briefTitle: The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection. overallStatus: RECRUITING date: 2024-02-19 date: 2025-02 date: 2025-12 date: 2024-02-29 date: 2024-03-18 name: Lo.Li.Pharma s.r.l class: INDUSTRY briefSummary: The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix. conditions: HPV Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: EGCG + folic acid + B12 measure: HPV DNA test negativity sex: FEMALE minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria di Modena status: RECRUITING city: Modena zip: 41124 country: Italy name: Giovanni Grandi role: CONTACT lat: 44.64783 lon: 10.92539 hasResults: False

 nctId: NCT06285344 id: kilis_3 briefTitle: Impact of Workload and Fatigue on Sleep in OR Nurses overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-29 date: 2024-02-29 name: Kilis 7 Aralik University class: OTHER name: Hasan Kalyoncu University briefSummary: This study aims to explore the impact of individual workload and fatigue levels on the sleep quality of operating room (OR) nurses, highlighting a critical aspect of healthcare professionals' well-being that directly affects patient safety and care quality. Operating room nurses face unique challenges due to the high-stress, fast-paced environment of surgical settings, which can lead to increased stress levels, emotional challenges, and a higher incidence of fatigue compared to other nursing specialties. Factors contributing to this fatigue include the demanding nature of surgical procedures, the need for constant vigilance, and the irregular hours associated with shift work, all of which can impair sleep quality.

The literature review suggests that while the relationship between workload, fatigue, and sleep quality has been extensively studied in general nursing populations, there is a lack of specific focus on operating room nurses. These professionals work under distinct conditions that may exacerbate the effects of workload and fatigue on sleep quality, yet comprehensive studies targeting this group are limited. Understanding the nuances of how workload and fatigue specifically impact the sleep quality of OR nurses is crucial for developing targeted interventions aimed at improving their health and job performance, thereby enhancing patient care and safety.

This cross-sectional and correlational study seeks to fill the gap in the literature by examining the specific effects of workload and fatigue on sleep perception among OR nurses. By identifying these relationships, the study aims to contribute valuable insights into strategies for mitigating fatigue and improving sleep among this critical group of healthcare workers, with the ultimate goal of ensuring both nurse well-being and patient safety. conditions: Shift Work conditions: Sleep Perception studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: Demographic Information Form measure: Individual Workload Perception Scale (IWPS) measure: Chalder Fatigue Scale (CFS) measure: Richard-Campbell Sleep Questionnaire (RCSQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Islam Elagöz city: Kilis zip: 79100 country: Turkey lat: 36.71611 lon: 37.115 hasResults: False

 nctId: NCT06285331 id: 2023ZDSYLL483-P01 briefTitle: the Impact of Manual or Mechanical Ways to Perform PLR on the Accuracy of Evaluation of Fluid Responsiveness acronym: PLR overallStatus: RECRUITING date: 2023-11-06 date: 2025-12-31 date: 2025-12-31 date: 2024-02-29 date: 2024-03-04 name: Southeast University, China class: OTHER briefSummary: Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness. conditions: Circulatory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Automatic Bed name: Manual measure: Accuracy of fluid responsiveness evaluation measure: Mortality sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongda Hospital Southeast University status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Jingyuan Xu, M.D. role: CONTACT lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06285318 id: 64007957MMY4004 briefTitle: A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials acronym: REALiTEC overallStatus: RECRUITING date: 2023-12-18 date: 2024-07-30 date: 2026-01-28 date: 2024-02-29 date: 2024-04-25 name: Janssen-Cilag Ltd. class: INDUSTRY briefSummary: The purpose of this study is to describe the use of teclistamab in the treatment of patients with RRMM outside of clinical trials. conditions: Relapsed/Refractory Multiple Myeloma (RRMM) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 180 type: ESTIMATED name: teclistamab measure: Describe Baseline Characteristics of Patients with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab Outside of Clinical Trials measure: Describe the Use of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials measure: Describe the Safety Management of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials measure: Describe the Clinical Outcomes of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 facility: Odense University Hospital status: RECRUITING city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: Sygehus Lillebælt, Vejle status: RECRUITING city: Vejle zip: 7100 country: Denmark lat: 55.70927 lon: 9.5357 facility: Hopital Albert Calmette - CHU Lille status: RECRUITING city: Lille cedex zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: Institut Paoli Calmettes status: RECRUITING city: Marseille zip: 13009 country: France lat: 43.29551 lon: 5.38958 facility: Hopital Saint Louis status: RECRUITING city: Paris zip: 75475 country: France lat: 48.85341 lon: 2.3488 facility: Institut Universitaire du Cancer Toulouse Oncopole status: RECRUITING city: Toulouse Cedex 9 zip: 31100 country: France lat: 43.60426 lon: 1.44367 facility: Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii status: RECRUITING city: Wurzburg zip: 97080 country: Germany lat: 49.79391 lon: 9.95121 facility: Sheba Medical Center status: RECRUITING city: Ramat Gan zip: 52621 country: Israel lat: 32.08227 lon: 34.81065 facility: Tel Aviv Sourasky Medical Center status: RECRUITING city: Tel Aviv Yafo zip: 6423906 country: Israel lat: 32.08088 lon: 34.78057 facility: Policlinico Sant'Orsola Malpighi status: RECRUITING city: Bologna zip: 40138 country: Italy lat: 44.49381 lon: 11.33875 facility: Policlinico di Milano status: RECRUITING city: Milano zip: 20121 country: Italy lat: 45.46427 lon: 9.18951 facility: Presidio Ospedaliero Santo Spirito in Sassia status: RECRUITING city: Roma zip: 65124 country: Italy lat: 41.89193 lon: 12.51133 facility: Hosp. Univ. de La Paz status: RECRUITING city: Madrid zip: 28046 country: Spain lat: 40.4165 lon: -3.70256 facility: Hosp. Costa Del Sol status: RECRUITING city: Malaga zip: 29603 country: Spain lat: 36.72016 lon: -4.42034 facility: Länssjukhuset Ryhov status: RECRUITING city: Jonkoping zip: 551 85 country: Sweden lat: 57.78145 lon: 14.15618 hasResults: False

 nctId: NCT06285305 id: kilis_2 briefTitle: Surgical ICU Nurses' Attitudes on End-of-Life Care overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-29 date: 2024-02-29 name: Kilis 7 Aralik University class: OTHER name: Hasan Kalyoncu University briefSummary: This study aims to explore the attitudes and behaviors of nurses working in surgical intensive care units (ICUs) towards end-of-life care, alongside identifying the barriers they face in providing such care. Despite the universal need for end-of-life care, with an estimated 56.8 million people requiring it annually, only a fraction receive adequate services. The concept of a "good death" has evolved, now emphasizing patient and family wishes, and aligning with clinical, cultural, and ethical standards. In the U.S., a significant portion of deaths occur in hospitals, often involving surgical interventions in the final stages of life. Nurses in ICUs play a crucial role in delivering end-of-life care, making their attitudes and behaviors pivotal to the quality of care provided. Previous studies have indicated a positive correlation between nurses' attitudes towards end-of-life care and their ethical conduct in care delivery. However, research specifically focusing on surgical ICU nurses and the challenges they encounter in end-of-life care is limited. This study seeks to fill that gap, enhancing understanding of the factors that influence end-of-life care in surgical ICUs and potentially guiding improvements in care practices and policy. conditions: PATİENT CARE conditions: Intensive Care Unit studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 250 type: ESTIMATED measure: Descriptive Information Form measure: Attitudes and Behaviors Towards End-of-Life Care Scale for Intensive Care Nurses measure: Barriers to End-of-Life Care in Surgical Intensive Care Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Islam city: Kilis zip: 79100 country: Turkey lat: 36.71611 lon: 37.115 hasResults: False

 nctId: NCT06285292 id: RC24_0097 briefTitle: Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence. acronym: PRIME overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-06 date: 2026-06 date: 2024-02-29 date: 2024-02-29 name: Nantes University Hospital class: OTHER name: FIZIMED Company briefSummary: Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation. conditions: Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 138 type: ESTIMATED name: EMY measure: Urinary symptoms using the ICIQ-UI SF questionnaire measure: Quality of life using the I-QoL questionnaire measure: Urinary symptoms using the ICIQ-UI SF questionnaire measure: Cost-utility ratio using the EQ-5D questionnaire measure: Qualitative component sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06285279 id: NJCT-2401 briefTitle: FKC288 in Participants With Autoimmune Kidney Diseases overallStatus: RECRUITING date: 2024-03-04 date: 2026-12-31 date: 2028-12-31 date: 2024-02-29 date: 2024-04-02 name: Nanjing University School of Medicine class: OTHER briefSummary: This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\^6 cells/kg, 1.0×10\^6 cells/kg, 3.0×10\^6 cells/kg, and an alternative dose of 0.1×10\^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases). conditions: Lupus Nephritis conditions: ANCA-associated Vasculitis conditions: Membranous Nephropathy - PLA2R Induced conditions: IgG4-Related Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: FKC288 measure: The proportion of subjects with dose-limiting toxicity measure: The proportion of subjects with adverse events measure: Proportion of subjects achieving renal response measure: Duration of response (DoR) of all subjects measure: Progression-free survival (PFS) of all subjects measure: Overall survival (OS) of all subjects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinling Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210016 country: China name: Xianghua Huang, MD role: CONTACT phone: 13770648824 email: hxhszb@163.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06285266 id: kilis_1 briefTitle: Nursing Students' Perceptions and Participation in Surgical Clinical Learning acronym: NSPSCP_CL overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-04-30 date: 2024-06-01 date: 2024-02-29 date: 2024-02-29 name: Kilis 7 Aralik University class: OTHER name: Hasan Kalyoncu University briefSummary: This cross-sectional study investigates the perceptions of nursing students regarding the clinical learning environment (CLE) in surgical services and their participation in clinical practices. Surgical services present a complex, dynamic, and intense learning environment crucial for the development of nursing students' professional competencies. The study explores the challenges nursing students face in these settings, including limited opportunities for participation in intraoperative processes and intensive care units, and the impact of these challenges on their learning outcomes and professional development.

Previous research has highlighted various factors that can either facilitate or hinder nursing students' ability to engage effectively in clinical practices, such as the learning atmosphere, support from nurse educators, peer support, and effective communication. However, there is a noted gap in understanding the specific difficulties encountered in surgical services, the adequacy of students' clinical skills and knowledge, and their ability to apply theoretical knowledge in practice.

By examining nursing students' experiences, this study aims to shed light on the suitability and quality of CLEs in surgical services, contributing valuable insights for optimizing clinical learning and enhancing nursing education programs. The hypotheses tested whether nursing students' perceptions of CLEs in surgical services and their participation in clinical practices are influenced by their descriptive characteristics.

Keywords: Nursing Student, Surgical Services, Clinical Practice, Clinical Learning Environment conditions: Clinical Practice studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: Descriptive Characteristics Form measure: Clinical Learning Environment Scale (CLES): measure: Clinical Practice Participation Determination Form: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06285253 id: MIRO-01-001 briefTitle: miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-31 date: 2025-02-28 date: 2024-02-29 date: 2024-03-29 name: Miromatrix Medical Inc. class: INDUSTRY briefSummary: The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver. conditions: Acute Liver Failure conditions: Acute Liver Injury, Drug Induced studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm, open label, safety study primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: miroliverELAP treatment measure: Survival measure: Adverse Events measure: 21-day survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California San Francisco Medical Center city: San Francisco state: California zip: 94143 country: United States name: Bilal Hameed, MD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Emory University School of Medicine city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Northwestern Memorial Hospital city: Chicago state: Illinois zip: 60611 country: United States name: Justin Boike, MD role: CONTACT lat: 41.85003 lon: -87.65005 facility: University of Michigan Medical School city: Ann Arbor state: Michigan zip: 48109 country: United States name: Lena Napolitano, MD role: CONTACT lat: 42.27756 lon: -83.74088 facility: University of Minnesota Medical School city: Minneapolis state: Minnesota zip: 55455 country: United States name: Thomas Leventhal, MD role: CONTACT lat: 44.97997 lon: -93.26384 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55902 country: United States lat: 44.02163 lon: -92.4699 facility: Mount Sinai Recanati/Miller Transplantation Institute city: New York state: New York zip: 10029 country: United States lat: 40.71427 lon: -74.00597 facility: Cleveland Clinic Foundation city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Intermountain Healthcare city: Salt Lake City state: Utah zip: 84103 country: United States name: Richard Gilroy, MD role: CONTACT lat: 40.76078 lon: -111.89105 facility: Virginia Commonwealth University Medical Center city: Richmond state: Virginia zip: 23970 country: United States lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06285240 id: 1167-007 briefTitle: Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007) overallStatus: RECRUITING date: 2024-03-28 date: 2024-07-25 date: 2024-07-25 date: 2024-02-29 date: 2024-04-03 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The main purpose of this study is to assess the safety and efficacy of MK-1167 administered to participants with Alzheimer's Disease (AD) receiving stable Donepezil treatment. conditions: Alzheimer's Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: MK-1167 name: Donepezil name: Placebo measure: Number of participants experiencing an Adverse Event (AE) measure: Number of participants discontinuing study treatment due to an AE measure: Area Under the Plasma Concentration-Time Curve from Dosing to 24 Hours Postdose (AUC0-24) of MK-1167 measure: Maximum Plasma Concentration (Cmax) of MK-1167 measure: Plasma Concentration at 24 hours postdose (C24) measure: Time to Reach Maximum Plasma Concentration (Tmax) of MK-1167 measure: Apparent Terminal Half-Life (t½) of MK-1167 measure: Oral Clearance (CL/F) of MK-1167 from Plasma measure: Apparent Volume of Distribution (Vz/F) of MK-1167 sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research, Hallandale Beach ( Site 0001) status: RECRUITING city: Hallandale Beach state: Florida zip: 33009 country: United States name: Study Coordinator role: CONTACT phone: 954-455-5757 lat: 25.9812 lon: -80.14838 facility: CenExel iResearch, LLC ( Site 0003) status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States name: Study Coordinator role: CONTACT phone: 404-537-1281 lat: 33.77483 lon: -84.29631 facility: CenExel iResearch, LLC ( Site 0004) status: RECRUITING city: Savannah state: Georgia zip: 31405 country: United States name: Study Coordinator role: CONTACT phone: 912-744-0800 lat: 32.08354 lon: -81.09983 hasResults: False

 nctId: NCT06285227 id: CM313-100001 briefTitle: Study of CM313 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-04-30 date: 2024-02-29 date: 2024-02-29 name: Keymed Biosciences Co.Ltd class: INDUSTRY briefSummary: This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ESTIMATED name: CM313 injection measure: Adverse event sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06285214 id: OAG1050 briefTitle: Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome overallStatus: RECRUITING date: 2022-05-26 date: 2026-06 date: 2026-06 date: 2024-02-29 date: 2024-04-18 name: Imbrium Therapeutics class: INDUSTRY name: Purdue Pharma LP briefSummary: The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo. conditions: Interstitial Cystitis/Bladder Pain Syndrome studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: V117957 name: Placebo measure: Change from baseline for bladder pain/discomfort scores over last 12 hours (morning and evening). measure: Change from baseline in mean number of micturitions per 12 hours (morning and evening) measure: Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS) measure: Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS) measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) measure: Change from baseline in Subject Global Response Assessment (SGRA) measure: Change from baseline in Symptom Impact Sleep Questionnaire (SISQ) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Urology Centers of Alabama, PC status: RECRUITING city: Homewood state: Alabama zip: 35209 country: United States name: Central Contact role: CONTACT lat: 33.47177 lon: -86.80082 facility: Urological Associates of Southern Arizona status: RECRUITING city: Tucson state: Arizona zip: 85715 country: United States name: Central Contact role: CONTACT lat: 32.22174 lon: -110.92648 facility: Applied Research Center of Arkansas status: RECRUITING city: Little Rock state: Arkansas zip: 72212 country: United States name: Central Contact role: CONTACT lat: 34.74648 lon: -92.28959 facility: Investigational Site status: RECRUITING city: Escondido state: California zip: 92025 country: United States name: Central Contact role: CONTACT lat: 33.11921 lon: -117.08642 facility: Urology Group of Southern California status: RECRUITING city: Los Angeles state: California zip: 90017 country: United States name: Central Contact role: CONTACT lat: 34.05223 lon: -118.24368 facility: Hope Clinical Research, LLC status: RECRUITING city: Los Angeles state: California zip: 91303 country: United States name: Central Contact role: CONTACT lat: 34.05223 lon: -118.24368 facility: Tri Valley Urology Medical Group status: RECRUITING city: Murrieta state: California zip: 92562 country: United States name: Central Contact role: CONTACT lat: 33.55391 lon: -117.21392 facility: Accel Research Sites status: RECRUITING city: DeLand state: Florida zip: 32720 country: United States name: Central Contact role: CONTACT lat: 29.02832 lon: -81.30312 facility: Accel Research Site - Neurostudies status: RECRUITING city: Decatur state: Georgia zip: 30033 country: United States name: Central Contact role: CONTACT lat: 33.77483 lon: -84.29631 facility: Providea Health Partners LLC status: RECRUITING city: Evergreen Park state: Illinois zip: 60805 country: United States name: Central Contact role: CONTACT lat: 41.72059 lon: -87.70172 facility: Otrimed Clinical Research status: TERMINATED city: Edgewood state: Kentucky zip: 41017 country: United States lat: 39.01867 lon: -84.58189 facility: Southern Clinical Research Associates status: RECRUITING city: Metairie state: Louisiana zip: 70001 country: United States name: Central Contact role: CONTACT lat: 29.98409 lon: -90.15285 facility: Boston Clinical Trials status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States name: Central Contact role: CONTACT lat: 42.35843 lon: -71.05977 facility: Bay State Clinical Trials, Inc. status: RECRUITING city: Watertown state: Massachusetts zip: 02472 country: United States name: Central Contact role: CONTACT lat: 42.37093 lon: -71.18283 facility: Revive Research Institute, Inc status: RECRUITING city: Dearborn Heights state: Michigan zip: 48127 country: United States name: Central Contact role: CONTACT lat: 42.33698 lon: -83.27326 facility: CentraCare - Urology Clinic status: TERMINATED city: Sartell state: Minnesota zip: 56377 country: United States lat: 45.62163 lon: -94.20694 facility: Adult & Pediatric Urology P.C. status: RECRUITING city: Omaha state: Nebraska zip: 68114 country: United States name: Central Contact role: CONTACT lat: 41.25626 lon: -95.94043 facility: Great Lakes Physician, PC status: WITHDRAWN city: Cheektowaga state: New York zip: 14225 country: United States lat: 42.90339 lon: -78.75475 facility: AccuMed Research Associates status: RECRUITING city: Garden City state: New York zip: 11530 country: United States name: Central Contact role: CONTACT lat: 40.72677 lon: -73.6343 facility: Manhattan Medical Research Practice status: TERMINATED city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Unified Women's Clinical Research-Lyndhurst Clinical Research status: RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States name: Central Contact role: CONTACT lat: 36.09986 lon: -80.24422 facility: The Lindner Research Center at The Christ Hospital status: WITHDRAWN city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: MidLantic Urology status: TERMINATED city: Bala-Cynwyd state: Pennsylvania zip: 19004 country: United States lat: 40.00761 lon: -75.23407 facility: Antria, Inc. status: WITHDRAWN city: Indiana state: Pennsylvania zip: 15701 country: United States lat: 40.62146 lon: -79.15253 facility: Epic Clinical Research status: RECRUITING city: Lewisville state: Texas zip: 75057 country: United States name: Central Contact role: CONTACT lat: 33.04623 lon: -96.99417 facility: Urology of Virginia, PLLC status: WITHDRAWN city: Virginia Beach state: Virginia zip: 23462 country: United States lat: 36.85293 lon: -75.97799 hasResults: False

 nctId: NCT06285201 id: TJ202001BE104 briefTitle: Study of Felzartamab in Healthy Adult Subjects overallStatus: RECRUITING date: 2024-03-27 date: 2024-12-31 date: 2024-12-31 date: 2024-02-29 date: 2024-04-15 name: TJ Biopharma Co., Ltd. class: INDUSTRY briefSummary: A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design) conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: T name: R measure: Primary PK Endpoint sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Hospital of Jilin University status: RECRUITING city: Jilin state: Changchun country: China name: Xiaojiao Li, Doctor role: CONTACT phone: +8613514314089 email: xingxingsuo123456@126.com lat: 43.85083 lon: 126.56028 hasResults: False

 nctId: NCT06285188 id: APHP221174 id: 2023-A01398-37 type: REGISTRY domain: ID-RCB briefTitle: Immunomonitoring of Mold Invasive Infections acronym: IMMUNOFIL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-03 date: 2024-02-29 date: 2024-02-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Mold invasive infections are associated with an important mortality despite optimization of the antifungal treatment. In a few case reports, immune checkpoints inhibitors, initially developed for neoplastic diseases, have shown a potential beneficial effect in such devastating infections by restoring an efficient immune response. The investigators propose a longitudinal monitoring of the adaptative immune response, notably immune checkpoint expression on T cells, during mold invasive infections to help identify the patients who could benefit from the adjunction of immunotherapy and the optimal timing of such strategy. conditions: Invasive Fungal Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Immune checkpoint expression on T cells measure: Aspergillus/Mucorales FLUOROSPOT measure: T cell proliferation measure: Immune checkpoint expression on monocytes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Alexandra SERRIS, MD role: CONTACT phone: +33 6 68 80 24 92 email: alexandra.serris@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06285175 id: APP-22-04497 briefTitle: REINVENT: A Brain and Muscle Computer Interface for Stroke acronym: REINVENT overallStatus: COMPLETED date: 2021-06-01 date: 2023-12-15 date: 2024-02-15 date: 2024-02-29 date: 2024-02-29 name: University of Southern California class: OTHER briefSummary: Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (\>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: Tele-REINVENT measure: Fugl Meyer Assessment - Upper Extremity measure: Maximum EMG activity measure: Corticomuscular coherence sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southern California city: Los Angeles state: California zip: 90033 country: United States lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06285162 id: 69HCL23_1372 id: 2024-A00294-43 type: OTHER domain: ID-RCB briefTitle: Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy acronym: UFANI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-02-29 date: 2024-02-29 name: Hospices Civils de Lyon class: OTHER briefSummary: The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed. conditions: Critically Ill conditions: Renal Replacement Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Percentage of changes in ANI. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel city: Bron zip: 69500 country: France name: Martin RUSTE, MD role: CONTACT phone: +33472118956 phoneExt: +33 email: martin.ruste@chu-lyon.fr name: Martin RUSTE, MD role: PRINCIPAL_INVESTIGATOR name: Matthias JACQUET-LAGREZE, MD role: SUB_INVESTIGATOR lat: 45.73333 lon: 4.91667 hasResults: False

 nctId: NCT06285149 id: AKLD-22 briefTitle: Tace With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-06-01 date: 2024-02-29 date: 2024-02-29 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus, TACE+Icaritin may potentially optimize treatment strategies for patients with poor liver function reserve. conditions: HCC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Icaritin measure: ORR measure: PFS measure: Overall survival，OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06285136 id: SHEN-PJ-KE-2024-15 briefTitle: Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-02-29 date: 2024-02-29 name: The Second Affiliated Hospital of Kunming Medical University class: OTHER name: Institute of hematology hospital,Chinese Academy of Medical Sciences name: Handan Central Hospital name: Taian City Central Hospital name: Tianjin People's Hospital name: Guizhou Provincial People's Hospital name: Central South University name: Western Theater General Hospital name: First Affiliated Hospital of Guangxi Medical University name: Chengdu Jingdongfang Hospital briefSummary: This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country. conditions: Acute Myeloid Leukemia, Adult studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: DEC3-VEN measure: ORR measure: Overall survival (OS) sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Kunming Medical University. city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 hasResults: False

 nctId: NCT06285123 id: HUM00248235 and HUM00248331 id: 1U01FD007803-01 type: FDA link: https://reporter.nih.gov/quickSearch/1U01FD007803-01 briefTitle: Implementing the COMFORT Guidelines for Postpartum Pain Management overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-26 date: 2025-07 date: 2026-04 date: 2024-02-29 date: 2024-02-29 name: University of Michigan class: OTHER name: Food and Drug Administration (FDA) briefSummary: A new national clinical practice guideline (CPG) for pain management after childbirth aims to mitigate peripartum opioid-related risks without compromising or exacerbating existing inequities in pain management in the United States. Standard dissemination approaches are often insufficient to change clinical practice-more active implementation efforts are generally required. Replicating Effective Programs (REP) is a theory-driven implementation intervention that is publicly available and highly scalable, but REP alone may be insufficient for effectively embedding the CPG across all maternity sites. For sites needing more support, REP can be augmented with facilitation (e.g., individualized consultation with site champions to overcome local barriers to CPG adoption, "Enhanced-REP" \[E-REP\]). Because E-REP is more expensive and difficult to scale than REP, it is essential to identify those settings where REP alone is effective versus those where REP may need augmentation, but this has not been evaluated in maternity contexts. Our objective is to determine the effect of a new postpartum pain management CPG, as implemented by REP and E-REP, on postpartum opioid prescribing (primary outcome: rate and amount of opioid prescribed within three days of childbirth), overall, by hospital, and among key subgroups.

This is a non-responder randomized trial within the Obstetrics Initiative (OBI), a perinatal collaborative quality initiative funded by Blue Cross Blue Shield of Michigan that includes 68 member hospitals serving more than 120,000 postpartum people over an approximately 15-month study time period. Hospitals not initially responding to REP (defined by performance below the top 15th percentile of all OBI hospitals for a) inpatient order for opioid-sparing postpartum pain management, \[e.g., scheduled acetaminophen and ibuprofen\], or b) amount of opioid prescribed at discharge, or c) provision of non-medication pain management interventions) will be allocated, via block randomization, to either continue REP vs. augment REP with facilitation (E-REP).

The primary analysis will evaluate the rate of postpartum opioid-sparing prescribing metrics at the time of discharge (primary outcome) and opioid prescription refills and high-risk prescribing (secondary outcomes) before and after CPG implementation with REP, using interrupted time series analyses. Inequities in outcomes by patient, procedure, prescriber, and hospital factors will be evaluated. Exploratory analyses will examine temporal trends in patient-reported outcomes. The effects of continued REP vs. E-REP among non-responder sites will also be examined. Finally, implementation outcomes will be characterized using clinician and patient surveys and qualitative methods. conditions: Postpartum Pain conditions: Opioid Stewardship conditions: Maternity Care conditions: Obstetric Care studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: REP name: Facillitation measure: Postpartum opioid prescribing - Rate measure: Postpartum opioid prescribing - Amount measure: Refill opioid prescribing measure: High-risk opioid prescribing measure: Patient-reported outcomes measure: Implementation outcomes - reach measure: Implementation outcomes - adoption measure: Implementation outcomes - feasibility measure: Implementation outcomes - acceptability measure: Implementation outcomes - appropriateness measure: Implementation outcomes - fidelity measure: Implementation outcomes - potential mechanisms of implementation measure: Implementation outcomes - costs of delivering implementation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06285110 id: DTG Resist briefTitle: HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen acronym: DTG-Resist overallStatus: RECRUITING date: 2022-06-13 date: 2025-08-31 date: 2025-08-31 date: 2024-02-29 date: 2024-02-29 name: University of Bern class: OTHER name: University of Zurich name: ETH Zurich name: University of KwaZulu name: University of Bristol briefSummary: This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of \>1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure.

To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS). conditions: Hiv studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2600 type: ESTIMATED measure: Type of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen. measure: Prevalence of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen. measure: Time to virologic failure measure: Number of INSTI DRMs per patient measure: DTG drug resistance measure: Phenotypic resistance levels of novel DRMs sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Medico Huesped status: RECRUITING city: Buenos Aires country: Argentina lat: -34.61315 lon: -58.37723 facility: Instituto Nacional de Infectiologia Evandro Chagas - Fiocruz status: RECRUITING city: Rio De Janeiro country: Brazil lat: -22.90278 lon: -43.2075 facility: Hopital de Jour du Centre Hospitalier Universitaire (CHU Souro Sanou) status: RECRUITING city: Bobo-Dioulasso country: Burkina Faso lat: 11.17715 lon: -4.2979 facility: National Centre for HIV/AIDS, Dermatology and STDs (NCHADS) status: RECRUITING city: Phnom Penh country: Cambodia lat: 11.56245 lon: 104.91601 facility: Regional Hospital Limbe status: RECRUITING city: Limbe country: Cameroon lat: 4.02356 lon: 9.20608 facility: Hospital Jamot status: RECRUITING city: Yaounde country: Cameroon lat: 3.86667 lon: 11.51667 facility: Centre de Traitement Ambulatoire status: RECRUITING city: Brazzaville country: Congo lat: -4.26613 lon: 15.28318 facility: Centre de Traitement Ambulatoire status: RECRUITING city: Pointe Noire country: Congo lat: -4.77609 lon: 11.86352 facility: ACONDA Centre de Prise en Charge et de Formation (CePReF) status: RECRUITING city: Abidjan country: Côte D'Ivoire lat: 5.30966 lon: -4.01266 facility: Centre médical de suivi des donneurs de sang, CNTS status: RECRUITING city: Abidjan country: Côte D'Ivoire lat: 5.30966 lon: -4.01266 facility: Moi University, AMPATH status: RECRUITING city: Eldoret country: Kenya lat: 0.52036 lon: 35.26993 facility: Lighthouse clinic status: RECRUITING city: Lilongwe country: Malawi lat: -13.96692 lon: 33.78725 facility: Martin Preuss Centre status: RECRUITING city: Lilongwe country: Malawi lat: -13.96692 lon: 33.78725 facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán status: RECRUITING city: Mexico City country: Mexico lat: 19.42847 lon: -99.12766 facility: Research for Development, Einstein-Rwanda Research and Capacity Building Program status: RECRUITING city: Kigali country: Rwanda lat: -1.94995 lon: 30.05885 facility: National Institute for Medical Research (NIMR) status: RECRUITING city: Kisesa country: Tanzania lat: -3.08333 lon: 34.15 facility: HIV-NAT/Thai Red Cross AIDS Research Center (TRCARC) status: RECRUITING city: Bangkok country: Thailand lat: 13.75398 lon: 100.50144 facility: Ramathibodi Hospital, Mahidol University status: RECRUITING city: Bangkok country: Thailand lat: 13.75398 lon: 100.50144 facility: Masaka Regional Referral Hospital / AHF Uganda Cares status: RECRUITING city: Masaka country: Uganda lat: -0.33379 lon: 31.73409 facility: Mbarara University of Science and Technology / Mbarara ISS Clinic (MUST) status: RECRUITING city: Mbarara country: Uganda lat: -0.60467 lon: 30.64851 facility: Centre for Infectious Disease Research Zambia (CIDRZ) status: RECRUITING city: Lusaka country: Zambia lat: -15.40669 lon: 28.28713 facility: Newlands Clinic status: RECRUITING city: Harare country: Zimbabwe lat: -17.82772 lon: 31.05337 hasResults: False

 nctId: NCT06285097 id: C5391001 briefTitle: A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-02-08 date: 2027-01-31 date: 2028-01-31 date: 2024-02-29 date: 2024-04-04 name: Pfizer class: INDUSTRY briefSummary: This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors. conditions: Neoplasms conditions: Non-small-cell Lung Cancer conditions: Melanoma conditions: Squamous Cell Carcinoma of the Head and Neck conditions: Renal Cell Carcinoma conditions: Urothelial Carcinoma conditions: Colorectal Carcinoma conditions: Ovarian Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: PF-07820435 name: Sasanlimab measure: Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B) measure: Number of patients with adverse events (AEs) measure: Number of patients with clinically significant lab abnormalities measure: Objective response rate (ORR) in Part 2 Expansion measure: Objective response rate (ORR) in dose escalation (Part 1A and Part 1B) measure: Duration of tumor response measure: Progression free survival (PFS) measure: Cmax (maximum concentration) of PF-07820435 and its active metabolite measure: Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite measure: AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite measure: Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only measure: Change from baseline of immune markers within biopsied tumor tissue measure: Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2) measure: Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2) measure: Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 measure: Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 measure: AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Corewell Health (reference non-engagement letter) status: NOT_YET_RECRUITING city: Grand Rapids state: Michigan zip: 49503 country: United States lat: 42.96336 lon: -85.66809 facility: START Midwest status: NOT_YET_RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: National Cancer Center Hospital East status: NOT_YET_RECRUITING city: Kashiwa state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 facility: The Cancer Institute Hospital of JFCR status: NOT_YET_RECRUITING city: Koto state: Tokyo zip: 135-8550 country: Japan lat: 35.66667 lon: 139.81718 facility: Hospital Oncologico Dr. Isaac Gonzalez-Martinez status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 facility: Pan American Center for Oncology Trials, LLC status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 hasResults: False

 nctId: NCT06285084 id: VALETUDO Trial (L4195) briefTitle: Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility acronym: VALETUDO overallStatus: RECRUITING date: 2024-02-02 date: 2025-11-02 date: 2027-02-02 date: 2024-02-29 date: 2024-02-29 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The goal of this observationl study is to evaluate the possibility of building a Deep Learning (DL) model capable of analyzing electrocardiographic traces of athletes and providing information in the form of a probability stratification of cardiovascular disease.

Researchers will enroll a training cohort of 455 participants, evaluated following standard clinical practice for eligibility in competitive sports. The response of the clinical evaluation and ECG traces will be recorded to build a DL model.

Researchers will subsequently enroll a validation cohort of 76 participants. ECG traces will be analyzed to evaluate the accuracy of the model to discriminate participants cleared for sports eligibility versus participants who need further medical tests conditions: Sports Cardiology conditions: Preventive Cardiology conditions: Electrocardiogram conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 531 type: ESTIMATED measure: DL model accuracy sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ospedale Galeazzi-Sant'Ambrogio status: RECRUITING city: Milano state: Lombardy zip: 20157 country: Italy name: davide marchetti, MD role: CONTACT phone: +390283506734 email: davide.marchetti@grupposandonato.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06285071 id: NN7415-7557 id: U1111-1274-4740 type: OTHER domain: World Health Organization (WHO) briefTitle: Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors overallStatus: ENROLLING_BY_INVITATION date: 2024-04-30 date: 2030-04-30 date: 2030-04-30 date: 2024-02-29 date: 2024-04-01 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years. conditions: Haemophilia A conditions: Haemophilia B studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 23 type: ESTIMATED name: Concizumab measure: Number of adverse reaction (AR) measure: Number of serious adverse reaction (SAR) measure: Number of serious adverse event (SAE) measure: Number of thromboembolic adverse event (AE) measure: Number of shock/anaphylaxis AE measure: Number of treated spontaneous and traumatic bleeding episodes measure: Number of treated spontaneous and traumatic target joint bleeding episodes measure: Number of all treatment requiring bleeding episode sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novo Nordisk Investigational Site city: Toshima state: Tokyo country: Japan hasResults: False

 nctId: NCT06285058 id: LUNAI briefTitle: Deep Learning Model Predicts Pathological Complete Response of Lung Cancer Following Neoadjuvant Immunochemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-03 date: 2024-02-29 date: 2024-03-13 name: Wuhan Union Hospital, China class: OTHER briefSummary: This study presents the development and validation of an artificial intelligence (AI) prediction system that utilizes pre-neoadjuvant immunotherapy plain scans and enhanced multimodal CT scans to extract deep learning features. The aim is to predict the occurrence of pathological complete response in non-small cell lung cancer patients undergoing neoadjuvant immunochemotherapyy. conditions: Deep Learning Model conditions: Pathological Complete Response conditions: Non-small Cell Lung Cancer conditions: Neoadjuvant Chemoimmunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: No interventions measure: the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of predicting model sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06285045 id: 2060302-1703-05 briefTitle: Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression overallStatus: COMPLETED date: 2018-10-01 date: 2019-08-31 date: 2019-08-31 date: 2024-02-29 date: 2024-03-05 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: To evaluate the efficacy and safety of Roujin Formula in the treatment of fibromyalgia syndrome(FMS)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with Roujin Formula. 48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data. conditions: Fibromyalgia Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ACTUAL name: Roujin Formula measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline measure: The change of the Visual Analogue Scale (VAS) for pain from baseline measure: The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline measure: The change of the Beck depression inventory(BDI) from baseline measure: The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Juan Jiao city: Beijing state: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06285032 id: STUDY00017244 id: R34DA058325 type: NIH link: https://reporter.nih.gov/quickSearch/R34DA058325 briefTitle: Decreasing Loneliness to Optimize Pain Care acronym: DLoop overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-05 date: 2024-02-29 date: 2024-03-01 name: University of Washington class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse. conditions: Loneliness conditions: Opioid Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 102 type: ESTIMATED name: Cognitive Behavior Therapy (CBT) name: Social Navigation Group name: Controlled Group measure: Opioid Misuse measure: Determine Functional Outcome measure: Loneliness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington city: Seattle state: Washington zip: 98105 country: United States lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06285019 id: GWK-2023-004 briefTitle: Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-31 date: 2025-12-31 date: 2024-02-29 date: 2024-02-29 name: Fudan University class: OTHER briefSummary: This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: TOMOX-HAIC name: Sintilimab name: Bevacizumab measure: objective response rate (ORR) measure: disease control rate (DCR) measure: Progression-Free Survival (PFS) measure: Time to progression (TTP) measure: Duration of response (DOR) measure: overall survival (OS) measure: adverse event (AE) 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: 200062 country: China name: Lu Wang, M.D. role: CONTACT phone: +86-18121299357 email: w.lr@hotmail.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06285006 id: MScAZASTPED025/23/202/12/2021 briefTitle: Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis overallStatus: RECRUITING date: 2024-02-23 date: 2024-05-01 date: 2024-05-12 date: 2024-02-29 date: 2024-04-23 name: Al-Azhar University class: OTHER briefSummary: Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.

NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis. conditions: Nocturnal Enuresis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Desmopressin measure: The number of episodes per week after desmopressin treatment sex: ALL minimumAge: 7 Years maximumAge: 14 Years stdAges: CHILD facility: Alazhar university status: RECRUITING city: Assiut zip: 11884 country: Egypt name: Omnia Nassar, Dr role: CONTACT phone: 01010112054 email: omnianassar835@gmail.com name: Hosny Elmasry, Prof role: CONTACT phone: 01010112054 email: omnianassar835@gmail.com lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06284993 id: 2023-214-KY briefTitle: Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis overallStatus: RECRUITING date: 2024-02-20 date: 2026-09-30 date: 2026-12-30 date: 2024-02-29 date: 2024-02-29 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: Plantar fasciitis (PF) is one of the most common causes of heel pain, typically characterized by a sharp pain in the plantar aponeurosis, specifically near the insertion site close to the medial process of the calcaneal tuberosity. It has been reported that 1 in 10 people are expected to be affected by PF in their lifetime. A comprehensive internet-panel survey conducted among the adult United States population revealed the population-based prevalence of self-reported PF with pain in the last month was 0.85 percent. Approximately 1 million patients are diagnosed with this disease each year in the United States. PF was believed to be an acute inflammatory disease, but patient samples show it is actually a chronic degenerative process caused by various factors such as repetitive stresses, vascular and metabolic disorders, excess free radicals, high temperatures, genetic factors, and conditions like rheumatoid arthritis and spondyloarthropathies. PF may be associated with impaired health-related quality of life, including reduced life functioning, poor perceived health status and social isolation. Additionally, a recent study indicates that the annual cost associated with PF is $284 million.

The first-line treatments recommended by guidelines for PF encompass physical therapy (including manual therapy, stretching, and others), pharmacological therapy (involving corticosteroids or platelet-rich plasma), and surgical treatment. However, the definite effects of physical therapy still require confirmation. Pharmacological treatments, such as local corticosteroid injections, exhibit a short maintenance period. Some studies indicate that the relief provided by corticosteroid injections lasts up to one month, yet its efficacy diminishes after 6 months. Surgical treatment is generally advised 6 to 12 months after unsuccessful conservative treatment, albeit with the drawback of higher costs, post-surgery recovery time, and patient apprehension.

Acupuncture is one of the most common complementary alternative therapy for the treatment of pain-related diseases such as musculoskeletal muscle, and recent guidelines recommend dry needling as a treatment for relief of plantar fasciitis, with a level of evidence of B. Dry acupuncture is different from acupuncture in terms of theoretical basis, therapeutic apparatus, technical operation and scope of indications, however, the American Alliance for Professional Acupuncture Safety also believes that dry needling falls under the umbrella of acupuncture, but under a different name. In addition, there are systematic evaluations that suggest acupuncture can be a safe and effective treatment for PF, and most of the trials in the systematic evaluations used 4-week treatment courses. Our prior study demonstrated that a 4-week intervention of both electroacupuncture and manual acupuncture resulted in improved pain outcomes among patients with PF.

The frequency of acupuncture stands as a crucial factor influencing its efficacy. A study revealed that needling trials with negative results had a significantly lower frequency compared to those yielding positive results. Furthermore, several studies indicate that acupuncture once a week can be help in conditions such as simple obesity, functional dyspepsia, and overactive bladder in women. There is no universally accepted standard of frequency of treatment for many conditions, including PF. In China, patients with chronic diseases usually receive 3-5 acupuncture treatments per week. However, in most previous trials, individuals with chronic diseases received 1-2 needling sessions per week. An increase in the frequency of acupuncture means an increase in the pain, time, and financial investment associated with the acupuncture process. Therefore, it is critical to optimize the frequency of acupuncture to ensure the effectiveness and feasibility of the treatment while avoiding increasing the burden on the patient. Accordingly, we designed the current trial to compare the effects of different acupuncture sessions (1 session per week versus 3 sessions per week) in a randomized controlled trial (RCT) of chronic PF. The hypothesis is that 1 session per week compared with 3 sessions per week of electroacupuncture treatment over a total of 4 weeks of treatment will provide a similar effect on pain relief in chronic PF. conditions: Plantar Fasciitis, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: electroacupuncture(more frequent) name: electroacupuncture(less frequent) measure: The response rate measure: The response rate measure: Change from baseline in the VAS score for worst pain intensity during the first steps in the morning measure: Change from baseline in the VAS score for mean pain intensity during the day measure: Change from baseline in the duration of heel pain during the day measure: Change from baseline in heel pressure pain threshold (PPT) measure: Change from baseline in ankle range of motion (AROM) measure: Change from baseline in Foot and Ankle Ability Measure (FAAM) total score and subscale scores measure: Participant global assessment of improvement measure: Participants' expectation towards acupuncture measure: Safety assessment measure: Adherence assessment measure: Number of cases and number of times painkillers and other treatments sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital status: RECRUITING city: Beijing country: China name: Jiaxiang Shi role: CONTACT phone: +8618396129770 email: 476605704@qq.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06284980 id: 2369 briefTitle: Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study acronym: TITANIUM overallStatus: RECRUITING date: 2019-01-24 date: 2024-12-30 date: 2025-12-31 date: 2024-02-29 date: 2024-02-29 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Gestational trophoblast diseases are characterized by abnormal proliferation of trophoblastic tissue, which can occur consequent to any pregnancy event. Pre-malignant forms (partial hydatiform mola and complete mola) and malignant forms are distinguished, the latter also known as gestational trophoblast neoplasms (invasive hydatiform mola, choriocarcinoma, placental site trophoblastic tumor, and epithelioid trophoblastic tumor).

These are neoplasms associated with good prognosis, amenable to conservative treatment and highly sensitive to chemotherapy.

The identification of ultrasonographic and echofluximetric features typical of malignant forms as well as the identification of ultrasonographic parameters predictive of chemoresistance to single-drug treatments could help improve their management. conditions: Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination conditions: To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients conditions: To Identify Ultrasound Predictors of Resistance to First-line Single Drug Chemotherapy in Low-risk GTN Patients conditions: To Investigate if Machine Learning (ML) Algorithms (Radiomics, Deep Neural Networks (DNN), and Other Machine Learning Algorithms studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: typical features of Gestational Trophoblastic Neoplasia measure: differences at the baseline US scan between low-risk and high-risk patients measure: changes characteristics of Gestational Trophoblastic Neoplasia during treatment sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS status: RECRUITING city: Rome zip: 00168 country: Italy name: Floriana Mascilini role: CONTACT phone: 0630156399 email: floriana.mascilini@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06284967 id: Vitamin D In Spondylolysis briefTitle: Association Of Serum Vitamin D Level With Isthmic Spondylolysis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-08-01 date: 2025-09-01 date: 2024-02-29 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: The aim of this study is to compare vitamin D level between young adults with isthmic spondylolysis and a matched healthy control group. conditions: Spondylolysis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 184 type: ESTIMATED measure: Mean serum vitamin D in both groups. measure: Mean serum calcium level sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06284954 id: ARGX-117-2301 id: 2023-508337-14 type: OTHER domain: CTIS number briefTitle: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis acronym: empacific overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-07-18 date: 2028-01-20 date: 2024-02-29 date: 2024-03-15 name: argenx class: INDUSTRY briefSummary: This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). conditions: Dermatomyositis conditions: Myositis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Empasiprubart IV name: Placebo IV measure: Incidence and severity of adverse events (AEs) measure: Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE) measure: Mean TIS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06284941 id: KY 2023-001-001 briefTitle: A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty overallStatus: ENROLLING_BY_INVITATION date: 2023-06-20 date: 2024-06-20 date: 2024-06-20 date: 2024-02-29 date: 2024-02-29 name: Wang wanxia class: OTHER briefSummary: Total hip arthroplasty is currently the most effective method for treating hip joint lesions and improving quality of life, but postoperative severe pain is not conducive to rapid recovery of patients. In recent years, the widespread application of ultrasound has achieved good clinical results in iliac fascia block for postoperative analgesia in THA. However, the use of high-dose local anesthetics can increase the risk of local anesthetic poisoning, and the single block analgesia time is generally less than 24 hours. Methylene blue, as a long-acting analgesic drug, can block the pain transmission of nerve fibers for a long time, achieving analgesic effects without damaging neurons. This study used ultrasound-guided ropivacaine combined with methylene blue to perform iliac fascia block on patients undergoing total hip replacement, with the aim of prolonging pain relief time, reducing complications, and promoting postoperative recovery on the basis of traditional methods. conditions: Femoral Neck Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Ropivacaine combined with methylene blue for iliac fascia block measure: Neutrophil lymphocyte ratio measure: visual analogue scale（VAS） measure: Procalcitonin measure: Hypersensitive C-reactive protein measure: Mean arterial pressure measure: Heart rate measure: Duration of surgery measure: Number of postoperative salvage analgesia measure: Walking distance for the first time getting out of bed measure: The number of activities of getting out of bed 48 hours after surgery sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine city: Taizhou state: Jiang Su zip: 225500 country: China lat: 32.49069 lon: 119.90812 hasResults: False

 nctId: NCT06284928 id: 20240104-01 briefTitle: Gut Microbiota and New Hypertension acronym: MIPHYP-CROSS overallStatus: COMPLETED date: 2019-12-01 date: 2020-06-01 date: 2020-12-01 date: 2024-02-29 date: 2024-02-29 name: Xinjiang Medical University class: OTHER briefSummary: This study aims to explore the gut microbiota patterns in patients newly diagnosed with hypertension, comparing them to those in non-hypertensive individuals. Utilizing cross-sectional analysis, it seeks to identify specific microbial profiles associated with hypertension, which could provide insights into the disease's pathogenesis and potential new avenues for treatment. The research focuses on analyzing fecal samples collected from both groups, using advanced genomic techniques to assess the diversity and abundance of gut bacteria. This investigation could contribute significantly to our understanding of the role gut microbiota plays in cardiovascular health and disease. conditions: Hypertension conditions: Gut Microbiota studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 100 type: ACTUAL name: Gut Microbiota Analysis measure: Change in Gut Microbiota Composition sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xinjiang Medical University city: Ürümqi state: Xinjiang zip: 630000 country: China lat: 43.80096 lon: 87.60046 hasResults: False

 nctId: NCT06284915 id: MEQ00089 id: MEQ00089 type: OTHER domain: Sanofi Identifier id: 2023-508177-85 type: REGISTRY domain: CTIS id: U1111-1280-6981 type: REGISTRY domain: ICTRP briefTitle: Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers overallStatus: RECRUITING date: 2024-03-19 date: 2025-03-10 date: 2025-03-11 date: 2024-02-29 date: 2024-04-17 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY briefSummary: This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants. conditions: Meningococcal Immunisation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The study will be performed in a modified double-blind fashion:

* Investigators and study staff who conduct the safety assessment, and the participants parent/ legally acceptable representative will not know which study intervention is administered
* Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 840 type: ESTIMATED name: MenACYW conjugate vaccine name: MenACYW conjugate vaccine measure: Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, Y and W measure: hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W measure: hSBA antibody titers against meningococcal serogroups A, C, W, and Y measure: hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA measure: hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse measure: Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y measure: rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA measure: rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse measure: Number of participants with immediate adverse events (AEs) measure: Number of participants with solicited injection site reactions or systemic reactions measure: Number of participants with unsolicited AEs measure: Number of participants with serious adverse events (SAEs) sex: ALL minimumAge: 6 Months maximumAge: 14 Months stdAges: CHILD facility: Investigational Site Number: 2030001 status: RECRUITING city: Ceske Budejovice country: Czechia lat: 48.97447 lon: 14.47434 facility: Investigational Site Number: 2030005 status: RECRUITING city: Prague country: Czechia lat: 50.08804 lon: 14.42076 facility: Investigational Site Number: 2080004 status: RECRUITING city: Aarhus country: Denmark lat: 56.15674 lon: 10.21076 facility: Investigational Site Number: 2460006 status: RECRUITING city: Jaarvenpa country: Finland facility: Investigational Site Number: 2460007 status: RECRUITING city: Oulu country: Finland lat: 65.01236 lon: 25.46816 facility: Investigational Site Number: 2460004 status: RECRUITING city: Tampere country: Finland lat: 61.49911 lon: 23.78712 facility: Investigational Site Number: 2460012 status: RECRUITING city: Turku country: Finland lat: 60.45148 lon: 22.26869 facility: Investigational Site Number: 2760007 status: RECRUITING city: Erfurt country: Germany lat: 50.9787 lon: 11.03283 facility: Investigational Site Number: 2760001 status: RECRUITING city: Moenchengladbach country: Germany lat: 51.18539 lon: 6.44172 facility: Investigational Site Number: 2760005 status: RECRUITING city: Schoenau Am Koenigssee country: Germany facility: Investigational Site Number: 6160017 status: RECRUITING city: Bydgoszcz country: Poland lat: 53.1235 lon: 18.00762 facility: Investigational Site Number: 6160015 status: RECRUITING city: Krakow country: Poland lat: 50.06143 lon: 19.93658 facility: Investigational Site Number: 6160021 status: RECRUITING city: Krakow country: Poland lat: 50.06143 lon: 19.93658 facility: Investigational Site Number: 6160016 status: RECRUITING city: Leczna country: Poland lat: 51.30121 lon: 22.88135 facility: Investigational Site Number: 6160012 status: RECRUITING city: Lubon country: Poland lat: 52.34705 lon: 16.89267 facility: Investigational Site Number: 6160007 status: RECRUITING city: Torun country: Poland lat: 53.01375 lon: 18.59814 facility: Investigational Site Number: 6160014 status: RECRUITING city: Trzebnica country: Poland lat: 51.31076 lon: 17.06331 facility: Investigational Site Number: 6160010 status: RECRUITING city: Wroclav country: Poland facility: Investigational Site Number: 6420005 status: RECRUITING city: Calarasi country: Romania lat: 44.2051 lon: 27.31356 hasResults: False

 nctId: NCT06284902 id: BDR17987 briefTitle: Bioavailability Study of Fexofenadine HCl New Formulation Tablet overallStatus: RECRUITING date: 2024-02-23 date: 2024-05-08 date: 2024-05-23 date: 2024-02-29 date: 2024-03-21 name: Opella Healthcare Group SAS, a Sanofi Company class: INDUSTRY briefSummary: The purpose of the study is to assess the relative bioavailability of a new galenic form of fexofenadine HCl new formulation tablet (test drug) taken with or without water compared to fexofenadine HCl film-coated tablets (reference form) taken with water under fasting conditions. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Fexofenadine HCl Coated tablet name: Fexofenadine HCl New Formulation Tablet measure: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine measure: Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine measure: Maximal Observed Concentration (Cmax) of Fexofenadine measure: Time When the Maximal Concentration is Observed (Tmax) of Fexofenadine measure: Time of Observation Prior to the First Observation with a Measurable (non-zero) Concentration (Tlag) of Fexofenadine measure: Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine measure: Terminal Elimination Rate Constant (Kel) of Fexofenadine measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Syneos Health Clinic inc. status: RECRUITING city: Quebec zip: G1P 0A2 country: Canada lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06284889 id: DepActive briefTitle: Behavioral Activation for the Treatment of Depression in Older Adults acronym: DepActive overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2027-12-31 date: 2028-12-31 date: 2024-02-29 date: 2024-02-29 name: Uppsala University class: OTHER name: Västmanland County Council, Sweden name: Sormland County Council, Sweden name: Uppsala County Council, Sweden briefSummary: Depression affects between 5-15% of adults ≥ 65 years in Sweden. Depression in older adults reduces functional ability and quality of life, and increases the risk for morbidity, loneliness, and suicide. Psychological treatment is recommended as a first-line treatment for depression, which about 3% of older adults with depression in Sweden report receiving. One effective psychological treatment is behavioral activation, which reduces depressive symptoms by increasing enjoyable, meaningful and important activities, for example exercise and social activities. The research group conducted a pilot study of telephone based behavioral activation for isolated older adults with depression during the COVID-19 pandemic. The intervention consisted of four telephone calls, and the results showed a significant decrease in depressive symptoms, with maintained effects for six months.

250 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center. Participants will be asked to fill in questionnaires before, after treatment. Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results. Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline, post-intervention and after 3-months. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled multi-center trial primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Behavioural activation name: Treatment as usual (TAU) measure: Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S measure: Change from baseline in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI measure: Change from baseline in Physical Activity level measure: Change from baseline in anxiety symptoms using the Geriatric Anxiety Scale - 10 item (GAS-10) is a self-rating scale designed to capture anxiety specifically in older adults, with items reflecting affective-, cognitive- and somatic anxiety symptoms. measure: Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS measure: Change from baseline in self rated quality of life using the EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L measure: Changes from baseline in Self Efficacy measured with the New General Self-Efficacy Scale, S-GSE. measure: Changes from baseline in loneliness measured with the UCLA Loneliness Scale version 3, UCLA-LS-3. measure: Diagnostic accuracy sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Uppsala university city: Uppsala state: Uppland zip: 753 10 country: Sweden name: Mattias Damberg, MD role: CONTACT phone: +46739480910 email: mattias.damberg@pubcare.uu.se lat: 59.85882 lon: 17.63889 hasResults: False

 nctId: NCT06284876 id: IY-NTNS03 briefTitle: Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer overallStatus: NOT_YET_RECRUITING date: 2024-08-30 date: 2026-08-30 date: 2027-02-28 date: 2024-02-29 date: 2024-02-29 name: Il-Yang Pharm. Co., Ltd. class: INDUSTRY briefSummary: To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24 conditions: Peptic Ulcer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 416 type: ESTIMATED name: Ilaprazole name: Lansoprazole name: Ilaprazole Placebo name: Lansoprazole Placebo measure: Ilaprazole, Lansoprazole peptic ulcer measure: Ilaprazole, Lansoprazole peptic ulcer measure: Ilaprazole, Lansoprazole GI bleeding sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung Ang University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06284863 id: 04-2023-200315 briefTitle: Impact Of Nutritional Education Program In Hemodialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-04 date: 2024-02-29 date: 2024-02-29 name: Assiut University class: OTHER briefSummary: The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program conditions: Hemodialysis Complication studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Natritional Education Program In Hemodialysis Patients measure: The percentage patients responded to nutritional education program on hemodialysis patients. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06284850 id: Christina Trakatelli briefTitle: Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels overallStatus: RECRUITING date: 2023-11-30 date: 2025-11 date: 2025-11 date: 2024-02-29 date: 2024-02-29 name: Aristotle University Of Thessaloniki class: OTHER briefSummary: The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors. conditions: Hematocrit Change conditions: Cardiovascular Prevention conditions: Empagliflozin conditions: SGLT2-Inhibitors conditions: Tissue Oxygenation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Empagliflozin10Mg Tab measure: Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml) measure: Mean change in Hct (%) measure: Hb (mg/dl) measure: RBC (x1000000/μl) measure: MCV (fl), measure: HbA1c (%, mmol/mol), measure: erythropoietin (mU/ml) measure: eGFR (ml/min/1.73m2), measure: Urine Albumin to Creatinine Ratio (mg/g) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Papageorgiou General Hospital status: RECRUITING city: Thessaloniki state: Central Macedonia zip: 56403 country: Greece name: KONSTANTINOS KITSIOS, MD,MSc,PhD role: CONTACT phone: +306977295744 email: kitsios_k@yahoo.gr lat: 40.64361 lon: 22.93086 hasResults: False

 nctId: NCT06284837 id: HREC/99382/Alfred-2023 briefTitle: Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation? acronym: SAFER-TAVI overallStatus: RECRUITING date: 2023-12-04 date: 2025-07 date: 2025-08 date: 2024-02-29 date: 2024-03-04 name: The Alfred class: OTHER name: Epworth Healthcare name: Cabrini Health briefSummary: Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site. conditions: Valve Stenoses, Aortic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 560 type: ESTIMATED name: Access site measure: All bleeding and vascular complications measure: All bleeding measure: All vascular complications measure: All-cause death measure: Stroke measure: Myocardial infarction measure: Major adverse cardiovascular events measure: Length of stay post-procedure measure: Overall procedure duration measure: Radiation dose measure: Conversion rate to alternative vascular access site measure: Tertiary site utilised to treat vascular complication measure: Failure to perform angiogram of primary access site at completion of TAVI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alfred Health status: RECRUITING city: Melbourne state: Victoria zip: 3004 country: Australia name: Jennifer Zhou, MBBS, BMedSc role: CONTACT email: je.zhou@alfred.org.au name: Antony Walton, MBBS role: PRINCIPAL_INVESTIGATOR name: Dion Stub, MBBS, PhD role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 facility: Epworth Healthcare status: NOT_YET_RECRUITING city: Melbourne state: Victoria zip: 3121 country: Australia name: Jennifer Zhou, MBBS, BMedSc role: CONTACT email: je.zhou@alfred.org.au name: Antony Walton, MBBS role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 facility: Cabrini Health status: NOT_YET_RECRUITING city: Melbourne state: Victoria zip: 3144 country: Australia name: Jennifer Zhou, MBBS, BMedSc role: CONTACT email: je.zhou@alfred.org.au name: Dion Stub, MBBS, PhD role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06284824 id: DPS-JMP-2022-040 briefTitle: Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2027-05 date: 2024-02-29 date: 2024-04-17 name: Southeast Orthopedic Specialists class: NETWORK name: DePuy Orthopaedics name: Stryker Orthopaedics briefSummary: The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:

* Will the patient reported outcomes differ between the two groups?
* Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken. conditions: Knee Osteoarthritis conditions: Knee Arthritis conditions: Knee Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Stryker Triathlon with MAKO Robotic-Arm name: DePuy Attune with VELYS Robotic-Assistance measure: KSS measure: KSS measure: KSS measure: KSS measure: KOOS JR measure: KOOS JR measure: KOOS JR measure: KOOS JR measure: FJS-12 Knee measure: FJS-12 Knee measure: FJS-12 Knee measure: Operative step time measure: Bone resected measure: Costs for surgery sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06284811 id: 050.06.04/155 briefTitle: Massage and Percussion Therapy on Muscle and Performance Parameters overallStatus: RECRUITING date: 2023-12-31 date: 2024-04-15 date: 2024-04-20 date: 2024-02-29 date: 2024-02-29 name: Acibadem University class: OTHER name: Istanbul Aydın University name: Biruni University briefSummary: DOMS, muscle viscoelastic properties, quadriceps strength and vertical jump performance will be evaluated in physically active individuals before the exercise and after the exercise and intervention which is either Swedish massage or Percussion therapy conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Exercise program focusing on quadriceps measure: Muscle tone/tension(Hz) measure: Muscle dynamic stiffness (N/m) measure: Muscle elasticity (log) measure: DOMS measure: Vertical Jump Performance measure: Quadriceps isometric strength sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Acibadem University status: RECRUITING city: Istanbul state: Ataşehir zip: 34752 country: Turkey name: Özge Haklı, Research Assisstant role: CONTACT phone: +902165004221 email: ozge.kocaer@acibadem.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06284798 id: NN9650-5027 id: 2023-506134-79 type: OTHER domain: European Medical Agency (EMA) id: U1111-1291-7535 type: OTHER domain: World Health Organization (WHO) briefTitle: A Research Study of a New Medicine (NNC0650-0013) in Healthy Men overallStatus: RECRUITING date: 2024-01-30 date: 2025-03-22 date: 2025-03-22 date: 2024-02-29 date: 2024-02-29 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: NNC0650-0013 A name: Placebo measure: S.C. Cohort: Number of treatment emergent adverse events (TEAEs) measure: S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose measure: S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose measure: S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose measure: S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose measure: S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose measure: S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose measure: I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose measure: I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose measure: I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose measure: S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Profil Institut für Stoffwechselforschung GmbH status: RECRUITING city: Neuss zip: 41460 country: Germany lat: 51.19807 lon: 6.68504 hasResults: False

 nctId: NCT06284785 id: 2023.0121 briefTitle: The Effects of Bariatric Surgery on Kidney Oxygenation in Obese Adults With Type 2 Diabetes and Hyperfiltration acronym: ECSTASY overallStatus: RECRUITING date: 2023-08-01 date: 2026-01-01 date: 2026-03-01 date: 2024-02-29 date: 2024-02-29 name: Amsterdam UMC, location VUmc class: OTHER name: Dutch Kidney Foundation name: Dutch Diabetes Research Foundation briefSummary: In this study the investigators will examine the effects of VAT reduction by bariatric surgery on kidney hypoxia and compare kidney oxygenation before- and after surgery in both sexes using BOLD-MRI and measures of kidney hemodynamic function. Furthermore, the investigators will assess whether kidney oxygenation is reduced in obese T2D men and women versus various controls as described below. This will determine whether kidney hypoxia can be appointed as a modifiable pathogenic factor in early DKD and non-surgical interventions targeting kidney hypoxia can be designed to slow DKD progression. conditions: Kidney Hypoxia conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Bariatric surgery measure: Difference in kidney oxygenation before and after bariatric surgery measure: Difference in kidney oxygenation between men and women measure: Difference in kidney oxygenation between obese, hyperfiltering men and women with T2D versus non-diabetic lean controls sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: VU University Medical Center status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1081HV country: Netherlands name: Daniel H van Raalte, MD role: CONTACT phone: +31 204442974 email: d.vanraalte@vumc.nl name: Daniel H van Raalte, MD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06284772 id: 4457/2023 briefTitle: FINRISK 2002 Re-examination overallStatus: ENROLLING_BY_INVITATION date: 2023-11-13 date: 2024-06-25 date: 2024-06-25 date: 2024-02-29 date: 2024-02-29 name: University of Turku class: OTHER name: Finnish Institute for Health and Welfare briefSummary: The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of \~2300 Finnish individuals who gave stool samples in the year 2002. In addition, \~300 individuals will undergo a in-depth health examination in 2024. conditions: Cardiometabolic Syndrome conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2300 type: ESTIMATED name: Questionnaire and fecal sampling name: Health examination measure: Gut microbiome change between 2002-2024 measure: Correlates of gut microbiome change between 2002-2024 sex: ALL minimumAge: 47 Years maximumAge: 96 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Turku city: Turku zip: 20100 country: Finland lat: 60.45148 lon: 22.26869 hasResults: False

 nctId: NCT06284759 id: E-77082166-302.08.01-380534 briefTitle: The Effect of Tele-Nursing Application on Self-Care Ability and Daily Living Activities in Fracture Surgery Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-15 date: 2024-03-28 date: 2024-03-28 date: 2024-02-29 date: 2024-02-29 name: Gazi University class: OTHER name: Lokman Hekim Üniversitesi name: Ankara City Hospital Bilkent briefSummary: This study aims to determine the effect of tele-nursing application based on Orem's Self-care Theory on self-care agency and daily living activities in trauma-related lower extremity fracture surgery patients. conditions: Lower Extremity Fracture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: In the study, the statistician was blinded using the blind technique. whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: post-discharge telenursing intervention measure: Self Care, Assessed using the Self-Care Agency scale. measure: Activities of daily living, Assessed using the Katz index of independence in activities of daily living (ADL) scale. measure: Instrumental activities of daily living, Assessed using the The Lawton instrumental activities of daily living scale. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lokman Hekim University city: Ankara zip: 06510 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06284746 id: 301Qiaoz briefTitle: Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer overallStatus: RECRUITING date: 2023-10-01 date: 2025-04-30 date: 2025-07-30 date: 2024-02-29 date: 2024-02-29 name: Lin Chen class: OTHER briefSummary: This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research. conditions: Locally Advanced Gastric Carcinoma conditions: HER2 Negative conditions: Efficacy conditions: Safety studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Tirolizumab+SOX/XELOX name: SOX/XELOX measure: Pathological complete response (pCR) measure: Objective Response Rate（ORR） measure: Disease-free survival（DFS） measure: Overall survival（OS） measure: Major Pathologic Response（MPR） measure: The incidence of adverse events during treatment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Surgery Institute, China PLA General Hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Yunhe Gao, Ph.D. role: CONTACT phone: 86-010-66937164 email: gaoyunhe@301hospital.org lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06284733 id: P.T.REC/012/004874 briefTitle: Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees overallStatus: COMPLETED date: 2023-11-05 date: 2024-04-08 date: 2024-04-20 date: 2024-02-29 date: 2024-04-23 name: MTI University class: OTHER briefSummary: This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel Amal hospital.

All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data. conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: They will be assigned into three equal groups: primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blinded whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 115 type: ACTUAL name: Whole-body vibration plus conservative care name: conservative care measure: Prosthetic leg stability test measure: Sway Index measure: Limits of Stability Test sex: ALL minimumAge: 40 Years maximumAge: 55 Years stdAges: ADULT facility: Ahmed Mohamed Ahmed Abdelhady city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06284720 id: Project number 144 briefTitle: Transcranial Alternating Current Stimulation for the Improvement of Episodic Memory in Healthy Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-31 date: 2024-10-31 date: 2024-02-29 date: 2024-03-12 name: Universidade Católica Portuguesa class: OTHER name: Clínica NeuroVida (Portugal) briefSummary: Memory complaints are a common symptom among Subjective Cognitive Decline, Mild Cognitive Impairment and Alzheimer disease. Indeed, episodic memory and Alzheimer disease are highly sensitive to aging. Many brain areas become active when we remember an event from the past. The precuneus, part of the posterior system of default mode network, has been identified as a central node of episodic memory retrieval and a central node in various psychiatric and neurological disorders, such as Alzheimer disease. Age-related changes have been consistently found in the default mode network connectivity, occurring within its posterior areas and with the reduction of connectivity between anterior and posterior subnetwork. It has also been found that aging is associated with decreased functional connectivity in the precuneus and posterior cingulate of the default mode network. Furthermore, γ-Aminobutyric acid (GABA), which plays an essential role in regulating brain activity and modulating the default mode network, shows a decrease throughout the normal course of aging, in Mild Cognitive Impairment and Alzheimer disease. It was also verified a link between cognitive decline and the dysfunction of the inhibitory activity of GABAergic interneurons, particularly parvalbumin-positive interneurons, that play a role in control local circuitry, brain networks and memory processing. Parvalbumin interneurons are the fast-spiking interneurons that generate and maintain gamma frequency. Gamma band has been associated with the encoding and retrieval of episodic memory. Impairments of gamma oscillations have been observed in healthy aging, Mild Cognitive Impairment and Alzheimer disease.

By identifying these functional connectivity changes, non-invasive neuromodulation techniques may offer a new strategy for improving cognitive functions. Transcranial Alternating Current Stimulation (tACS) is a form of non-invasive brain stimulation that modulates cortical activity by applying weak, oscillating electrical currents to the cortex via two or more scalp electrodes. By using alternating currents, it is possible to simulate the rhythmic pattern of electrophysiological activity of the brain. tACS can interact with neural firing at behaviorally relevant frequencies linked to memory.

In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate whether stimulation with gamma tACS on the precuneus can improve episodic memory in healthy older adults. conditions: Healthy Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Gamma tACS (40 Hz) over the precuneus name: Sham tACS over the precuneus measure: Changes in immediate and delayed free recall Auditory Verbal Learning Test scores measure: Changes in immediate free recall and delayed recognition Face-Name Memory Test scores measure: Change in functional connectivity sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Filipa Ribeiro city: Lisbon country: Portugal name: Filipa Ribeiro, PhD role: CONTACT phone: +351 217214147 email: filipa.nc.ribeiro@ucp.pt name: Joana Macedo, MSc role: PRINCIPAL_INVESTIGATOR name: Filipa Ribeiro, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 hasResults: False

 nctId: NCT06284707 id: Rhythmic_PAU_2024 briefTitle: Effect of Rhythmic Gymnastics Training in Children With Down Syndrome overallStatus: RECRUITING date: 2024-03-01 date: 2024-03-08 date: 2024-05-05 date: 2024-02-29 date: 2024-03-08 name: University of Castilla-La Mancha class: OTHER briefSummary: Some of the clinical characteristics of people with Down syndrome (DS) are orthopedic, cardiovascular, neuromuscular, visual, cognitive and perceptual disorders, which directly affect the quality of their movements. Children with DS often have a sedentary lifestyle or low levels of physical activity which exacerbates problems related to obesity and overall physical health. Therefore, the practice of physical exercise in this type of population is essential to improve their health-related physical fitness. The aim of this study was to analyze the influence of an adapted rhythmic gymnastics training program on body composition, tendon architecture and stiffness, and physical capacity in children with DS. conditions: Physical Conditioning, Human studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: TRIPLE maskingDescription: The care provider will be responsible for administering the training program. Two different people will develop swimming training and rhythmic gymnastics training. Each participant will be assigned a code. The researcher will process the data with the code of each participant. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: swimming training name: rhythmic gymnastics training measure: Body composition measure: Tendon thickness measure: Stiffness tendon measure: Hamstrings flexibility measure: body mass index measure: visceral fat area measure: metabolism measure: tendon elastography measure: balance measure: functional capacity sex: ALL minimumAge: 6 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Universidad de Castilla La Mancha status: RECRUITING city: Toledo zip: 45071 country: Spain name: Paula Esteban-García, PhD role: CONTACT phone: 925 26 88 00 email: paula.esteban@uclm.es lat: 39.8581 lon: -4.02263 hasResults: False

 nctId: NCT06284694 id: REB23-0120 briefTitle: Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-30 date: 2025-06-30 date: 2024-02-29 date: 2024-02-29 name: University of Calgary class: OTHER briefSummary: This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI). conditions: Neuropathic Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will receive active rTMS treatment. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Repetitive Transcranial Magnetic Stimulation (rTMS) measure: International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) v3.0 measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a measure: Quality of Life Index Spinal Cord Injury version (QLI-SCI) measure: Pain Catastrophizing Scale (PCS) measure: World Health Organization Disability Assessment Schedule (WHODAS) 2.0 measure: Generalized Anxiety Disorder scale-7 (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foothills Medical Centre city: Calgary state: Alberta zip: T2N 2T9 country: Canada lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06284681 id: IRB-300012557 id: 3P50MD017338-03S1 type: NIH link: https://reporter.nih.gov/quickSearch/3P50MD017338-03S1 briefTitle: Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults acronym: WISE Health overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-29 date: 2024-03-21 name: University of Alabama at Birmingham class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit). conditions: Obesity conditions: Prehypertension conditions: Hypertension conditions: PreDiabetes conditions: Type 2 Diabetes conditions: Dyslipidemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Weight-focused health coaching name: Weight-neutral health coaching name: Intensify lifestyle approach name: Augment with enhanced medical management measure: Recruitment rate measure: Retention rate measure: Response/Non-response rate to initial interventions measure: Attendance to health coaching sessions measure: Treatment Credibility and Expectancy Questionnaire (CEQ) measure: Treatment Credibility and Expectancy Questionnaire (CEQ) measure: Treatment Preference measure: Treatment Preference measure: Family medicine clinic capacity for research measure: Study visit duration measure: Time required for surveys completion measure: Response to weight-focused health coaching measure: Response to weight-neutral health coaching measurement measure: Change in blood pressure measure: Change in glucose measure: Change in insulin measure: Change in insulin sensitivity measure: Change in HbA1c measure: Change in total cholesterol measure: Change in LDL-cholesterol measure: Change in HDL-cholesterol measure: Change in triglycerides measure: Change in Metabolic Syndrome Severity Score measure: Change in blood pressure measure: Change in glucose measure: Change in insulin measure: Change in HbA1c measure: Change in total cholesterol measure: Change in LDL-cholesterol measure: Change in HDL-cholesterol measure: Change in triglycerides measure: Change in body weight measure: Change in physical activity measure: Change in fat mass measure: Change in fat mass measure: Change in lean mass measure: Change in lean mass measure: Change in waist circumference measure: Change in waist circumference measure: Dietary intake measurement measure: Dietary intake measurement measure: Change in insulin sensitivity measure: Change in Metabolic Syndrome Severity Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06284668 id: GWang027 briefTitle: Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety overallStatus: RECRUITING date: 2024-03-04 date: 2024-06-20 date: 2024-07-10 date: 2024-02-29 date: 2024-03-05 name: Tianjin Medical University General Hospital class: OTHER briefSummary: To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: normal Saline name: Esketamine name: Remimazolam measure: The incidence of postoperative sleep disturbance on the first night after surgery measure: The incidence of sleep disturbance one day before surgery measure: The incidence of postoperative sleep disturbance on the second and third postoperative nights measure: Postoperative anxiety measure: Postoperative depression measure: Pain Score (NRS) measure: Mean intraoperative blood pressure measure: Oxygen saturation measure: Somatokinetic reaction measure: Operation time measure: Duration of anesthesia measure: Time to walking down measure: Adverse event sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Tianjin Medical University General Hospital status: RECRUITING city: Tianjin zip: 300052 country: China name: Guolin Wang role: CONTACT phone: +8618604755166 email: wangguolinghad@hotmail.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06284655 id: 635362 a briefTitle: The Effect of a Brief Educational Intervention for Adults With ADHD overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-01 date: 2030-12 date: 2024-02-29 date: 2024-02-29 name: St. Olavs Hospital class: OTHER name: Norwegian University of Science and Technology briefSummary: This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel two-arms randomized control trial primaryPurpose: OTHER masking: SINGLE maskingDescription: Blinded statistician whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: group-based combined with innovative technology education name: Standard treatment measure: Change in client satisfaction using CSQ measure: Change in general self-efficacy using GSE-6 measure: Change in satisfaction with the information measure: Knowledge and treatment preferences measure: Change in patient activation using PAM measure: Change in ADHD-related symptoms using ASRS measure: Change in ADHD-related symptoms using SCL-9 measure: Change in depression and anxiety symptoms using PHQ-4 measure: Change in patient enablement using PEN-13 measure: Change in stress level using PSS-4 measure: Change in level of functioning using WSAS measure: Change in ADHD Quality of life using AAQoL measure: Change in Health-related Quality of life using EQ-5D-5L measure: Cost measure: Health care usage sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Olav's Hospital city: Trondheim country: Norway name: Mariela Loreto Lara-Cabrera, PhD role: CONTACT email: mariela.lara@ntnu.no lat: 63.43049 lon: 10.39506 hasResults: False

 nctId: NCT06284642 id: LD-ITUK-2024-001 briefTitle: Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK) overallStatus: RECRUITING date: 2024-03-28 date: 2026-01-30 date: 2026-06-30 date: 2024-02-29 date: 2024-04-15 name: Second Affiliated Hospital of Nanchang University class: OTHER name: Changhai Hospital briefSummary: The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group. Patients in the treatment group will receive standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection started within 24 hours after aneurysm treatment with 30000 IU urokinase, once a day for 3 consecutive days. Patients in the control group will receive standard treatment with the addition of lumbar drainage combined with intrathecal placebo (0.9%NaCl) injection. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 2 on the modified Rankin Scale (mRS), at 6 months after aneurysmal SAH. Primary outcome will be determined by a member of the Independent Committee on Terminal events. conditions: Aneurysmal Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 424 type: ESTIMATED name: Urokinase name: Placebo measure: Modified Rankin Scale (mRS) measure: Modified Rankin Scale (mRS) measure: Relative Modified Rankin Scale (mRS) measure: Modified Rankin Scale (mRS) distribution measure: Glasgow Outcome Scale (GOS） measure: Questionnaire EuroQol Five Dimensions Questionnaire (EQ-5D) measure: Barthel Index for Activities of Daily Living (BI) measure: Total hospitalized time measure: Total hospitalized costs measure: Cerebral vasospasm (CV) measure: Delayed cerebral ischemia (DCI) measure: Death measure: Hydrocephalus measure: Rebleeding measure: Subarachnoid hemorrhage volume clearance measure: Correlationship between cerebralspinal fluid pressure with subarachnoid hemorrhage volume measure: Correlationship between clinical grades and subarachnoid hemorrhage volume sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China name: Xingen Zhu, MS role: CONTACT email: zxg2008vip@163.com lat: 28.68396 lon: 115.85306 hasResults: False

 nctId: NCT06284629 id: PD-DigiCare briefTitle: Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes. acronym: PD-DigiCare overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-09-01 date: 2026-09-01 date: 2024-02-29 date: 2024-04-22 name: Rigshospitalet, Denmark class: OTHER name: Odense University Hospital name: Zealand University Hospital briefSummary: The overall aim of the trial is to compare the efficacy of using wearables and patient-reported outcome measures versus standard care in enhancing the timeliness of referrals to advanced monitoring of treatments for people with Parkinson's Disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Participants and physicians will be blinded to device and app data in the control group. Blinding of the group allocation is not possible due to the investigated device. count: 90 type: ESTIMATED name: Neptune name: Standard clinical care measure: Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale) measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet Glostrup city: Glostrup zip: 2600 country: Denmark name: Nikolaj la Cour Karottki, MD role: CONTACT phone: 40432773 email: nikolaj.folke.la.cour.karottki.01@regionh.dk lat: 55.6666 lon: 12.40377 facility: Odense University Hospital city: Odense country: Denmark name: Morten Blaabjerg, MD role: CONTACT lat: 55.39594 lon: 10.38831 facility: Zealand University Hospital, Roskilde city: Roskilde country: Denmark name: Helle Thagesen, MD role: CONTACT lat: 55.64152 lon: 12.08035 hasResults: False

 nctId: NCT06284616 id: K2019-0392 briefTitle: JASP-1 for Children Recently Diagnosed and Their Parents acronym: JASP-1 overallStatus: COMPLETED date: 2019-08-15 date: 2023-04-15 date: 2023-12-31 date: 2024-02-29 date: 2024-03-06 name: Region Stockholm class: OTHER_GOV briefSummary: To implement and evaluate a patient-and family-centered Juvenile Arthritis Support Program during one year (JASP-1) for children recently diagnosed with JIA and their parents and after 12 months compare satistaction with care and health outcomes with a control group receiving standard care. conditions: JIA conditions: Support Program conditions: Patient Satisfaction conditions: Patient Outcome Assessment studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a non-randomized intervention study with 2 groups receiving either a Support program (JASP-1) or standard care primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: All patient receiving a JIA diagnose was offered to participate in JASP-1. The controls had received diagnose before the start of the study. count: 82 type: ACTUAL name: JASP-1 measure: Rate of Patient Reported Experienced Measures (PREM) measure: Rate of Overall perceived health measure: Rate of Child Health Activity Questionnaire (CHAQ) measure: Number of active joints sex: ALL minimumAge: 1 Year maximumAge: 16 Years stdAges: CHILD facility: Astrid Lindgren Children´s Hospital city: Stockholm state: Region Stockholm zip: 17176 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06284603 id: AWF_LA_HBOT briefTitle: Effectiveness of Hyperbaric Oxygen Therapy in Adults overallStatus: COMPLETED date: 2022-03-01 date: 2023-12-20 date: 2023-12-20 date: 2024-02-29 date: 2024-02-29 name: Poznan University of Physical Education class: OTHER briefSummary: The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.

The main questions it aims to answer are:

1. Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?
2. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?
3. Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?

Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two study groups (dependent on frequency of HBOT treatments) and control group primaryPurpose: TREATMENT masking: NONE count: 80 type: ACTUAL name: Hyperbaric Oxygen Therapy - HBOT measure: Volume of oxygen and carbon dioxide measure: Heart rate measure: Vascular circulation measures measure: Body composition (body mass, fat mass, lean body mass, muscle mass) measure: Inflammatory cytokine profile measure: Oxidative stress indicators measure: F2-Isoprostanes (F2-IsoP) measure: Brain-derived neurotrophic factor concentration (BDNF) measure: Nicotinamide (NAD) metabolites measure: Gut microbiome and metabolome measure: Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA) measure: endothelial nitric oxide synthase (eNOS) measure: Vascular endothelial growth factor (VEGF) measure: Hypoxia inducible factor-1 (HIF-1alfa) sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Poznan University of Physical Education city: Poznan state: Wielkopolska zip: 61-871 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06284590 id: PH-ICKPD1-02/21 id: MK-3475-F20 type: OTHER domain: Merck Sharp & Dohme LLC id: KEYNOTE-F20 type: OTHER domain: missing briefTitle: Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients acronym: INTACT/MeRCI overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-19 date: 2028-07 date: 2028-07 date: 2024-02-29 date: 2024-04-08 name: Philogen S.p.A. class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma. conditions: Melanoma Stage III conditions: Melanoma Stage IV studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 162 patients. Patients enrolled will be randomized in a 1:1:1 ratio. i) systemic pembrolizumab in combination with intralesional L19IL2 (Arm 1): 54 patients.

ii) systemic pembrolizumab in combination with intralesional L19TNF (Arm 2): 54 patients iii) systemic pembrolizumab in combination with intralesional L19IL2/L19TNF (Arm 3): 54 patients primaryPurpose: TREATMENT masking: NONE count: 162 type: ESTIMATED name: L19IL2 name: L19TNF name: L19IL2/L19TNF name: KEYTRUDA® measure: Confirmed Objective Response Rate (ORR) measure: Best overall response (BOR) measure: Duration of Response (DoR) measure: Pathological response measure: Confirmed ORR measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Serious Adverse Event (SAEs) measure: Drug-Induced Liver Injury (DILI) measure: Number of patients with Adverse Events of Special Interest (AESI) measure: Number of patients with Immune-Related Adverse Events (IRAEs) measure: Number of participants with abnormal hematology laboratory tests results measure: Number of participants with abnormal hematology laboratory tests results measure: Number of participants with abnormal hematology laboratory tests results measure: Number of participants with abnormal hematology laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal serum chemistry laboratory tests results measure: Number of participants with abnormal coagulation laboratory tests results measure: Number of participants with abnormal body temperature measure: Number of participants with abnormal blood pressure measure: Number of participants with abnormal Electrocardiogram (ECG) readings measure: Number of participants with abnormal Echocardiogram (ECHO) readings measure: Number of participants with abnormal physical examination results measure: Concomitant medication usage measure: Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06284577 id: 677186 briefTitle: Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis overallStatus: RECRUITING date: 2024-01-02 date: 2027-06-01 date: 2027-07-01 date: 2024-02-29 date: 2024-02-29 name: Oslo University Hospital class: OTHER briefSummary: The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients. conditions: Cystic Fibrosis in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ESTIMATED name: Multistrain Probiotic name: Placebo - maltodextrin measure: Changes in GI related QoL using the questionnaire PedsQL GI measure: Changes in microbiota measure: Changes in intestinal inflammation sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo country: Norway name: Magnhild P Kolsgaard, PhD role: CONTACT phone: 0047 41514045 email: uxpoma@ous-hf.no name: Camilla Styffe Sæland, Master role: CONTACT phone: 004793257798 email: casael@ous-hf.no name: Magnhild P Kolsgaard, PhD role: PRINCIPAL_INVESTIGATOR name: Camilla Styffe Sæland, Master role: SUB_INVESTIGATOR name: Linh Dieu Ngo, Master role: SUB_INVESTIGATOR lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06284564 id: 2023-0538 id: NCI-2024-03604 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2024-10-01 date: 2026-10-01 date: 2024-02-29 date: 2024-04-26 name: M.D. Anderson Cancer Center class: OTHER name: Bristol-Myers Squibb name: Cancer Prevention Research Institute of Texas name: United States Department of Defense briefSummary: To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied. conditions: Metastatic Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Evolocumab name: Nivolumab 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: Eric Jonasch, MD role: CONTACT phone: 713-563-7232 email: ejonasch@mdanderson.org name: Eric Jonasch, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06284551 id: 202111069RINB briefTitle: The Relationship Between Internet-use Behavior and Mental Health in Youth overallStatus: ENROLLING_BY_INVITATION date: 2022-02-08 date: 2024-02-15 date: 2025-01-27 date: 2024-02-29 date: 2024-02-29 name: National Taiwan University Hospital class: OTHER briefSummary: Introduction: WHO defines youth as 15-24 years age group. At this stage, the brain is still under development, with high impulsiveness, being fond of stimulation and yearning for peer life. Compared with traditional interpersonal interaction, modern youths use the Internet as a main interpersonal interaction platform and conduct lots of leisure activities on the Internet. Poor cognitive emotion regulation strategies and personal traits may extend to new types of mental health issues; and are associated with depression, anxiety, suicidal/self-injurious behaviors, and cyberbullying.

Objectives: (1) To investigate whether emotion regulation strategies while facing stressful events are highly related to with cyberbullying, social media, and internet gaming disorder. (2) To investigate the relation between cyberbullying and depression, anxiety, suicide/self-injury among Taiwanese youths. (3) To investigate the probability of cyberbullying, social media addiction, and internet gaming disorder occurring at the same time.

Method: This cross-sectional study recruits cases of youths from 15 to 24 years old and collects data through questionnaires survey. In addition to collection of basic data, Internet using habits, and medical history, self-rated questionnaires include Suicide/Self-Injury Ideation Questionnaire, The Beck Depression Inventory 2nd Edition, Multidimensional Anxiety Scale for Children-Taiwan version, Cognitive Emotion Regulation Questionnaire, Cyberbullying Questionnaire, and Internet Gaming Disorder Scale-Short Form. conditions: Mental Health Issue studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED measure: Cyberbullying Questionnaire measure: Beck's Depression Inventory (BDI-II) sex: ALL minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: National Taiwan University Hospital city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06284538 id: NA-01-23 briefTitle: Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds acronym: WOUND-H overallStatus: RECRUITING date: 2024-01-15 date: 2024-07-31 date: 2024-09-30 date: 2024-02-29 date: 2024-02-29 name: Nova Argentia S.r.l. class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds. The outcomes of the study are the improvement of wound healing assessed through the Clinical Healing score (score from 0 to 5), which includes the evaluation of: redness, edema, suppuration, healthy granulation tissue and signs of re-epithelialization; the percentage of patients with completely healed wounds at day 30 post-treatment; the pain perceived by the patient when changing the dressing; the frequency of adverse events. conditions: Wound Healing Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 112 type: ESTIMATED name: NOVA.EMOSTOP RE-EPITHELIZING measure: improvement in Clinical Healing score at visit 3 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Casa di cura riabilitativa Villa Sofia status: RECRUITING city: Acireale state: Catania zip: 95024 country: Italy name: Marco Daniele, PI role: CONTACT phone: 0957631997 email: marcodaniele@email.it name: Salvatore Balsamo role: SUB_INVESTIGATOR lat: 37.60886 lon: 15.16577 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-06-26 uploadDate: 2024-02-13T04:55 filename: Prot_SAP_000.pdf size: 2091803 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-02 uploadDate: 2024-02-21T04:35 filename: ICF_001.pdf size: 95177 hasResults: False

 nctId: NCT06284525 id: 2137420 briefTitle: Ankle Assistance and Resistance in Older Adults overallStatus: RECRUITING date: 2023-02-01 date: 2025-01 date: 2025-01 date: 2024-02-29 date: 2024-02-29 name: Northern Arizona University class: OTHER briefSummary: The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals. conditions: Sarcopenia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Ankle resistance and biofeedback measure: 6MWT measure: Metabolic power measure: Plantar flexor strength sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Northern Arizona University status: RECRUITING city: Flagstaff state: Arizona zip: 86011 country: United States name: Zach Lerner, PhD role: CONTACT phone: 928-523-1787 email: zachary.lerner@nau.edu lat: 35.19807 lon: -111.65127 hasResults: False

 nctId: NCT06284512 id: Uveal Melanoma 1942/2022 briefTitle: Uveal Melanoma - Comparative Study overallStatus: RECRUITING date: 2023-10-15 date: 2024-12-31 date: 2024-12-31 date: 2024-02-29 date: 2024-02-29 name: Medical University of Vienna class: OTHER briefSummary: The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography. conditions: Uveal Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Sonography, color fundus photography measure: Largest Basal Diameter sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Vienna, Department of Ophthalmology and Optometry status: RECRUITING city: Vienna zip: 1090 country: Austria name: Judith Kreminger, MD role: CONTACT phone: +4314040048470 email: judith.kreminger@meduniwien.ac.at name: Reinhard Told, MD, PhD, Priv.-Doz. role: CONTACT phone: +434040079690 email: reinhard.told@meduniwien.ac.at name: Adrian Reumueller, MD, Priv.-Doz role: SUB_INVESTIGATOR name: Roman Dunavölgyi, Assoc.-Prof. Priv.-Doz. Dr. role: SUB_INVESTIGATOR lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06284499 id: 26308819120 briefTitle: Effect of Different Fixed Lingual Retainers on Tooth Stability overallStatus: WITHDRAWN date: 2020-01-16 date: 2023-01-15 date: 2023-10-13 date: 2024-02-29 date: 2024-02-29 name: Mustafa Kemal University class: OTHER briefSummary: Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device.

Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower inter-canine region were treated with fixed orthodontic mechanics. At the completion of the orthodontic treatment, each patient was fitted with either Ortho FlexTech (Reliance; Group I), dead soft 8-braided (Bond-A-Braid, Reliance; Group II), or 5-stranded (PentaOne, Masel; Group III) LR wire. A control group consisting of people with a healthy periodontal condition and no bone loss was included (Control; Group C). The mobility of the lower anterior teeth on the right and left sides was measured using a Periotest® device before (T0), immediately after (T1), and 10 months after (T2) the application of the LR. Statistical analyses were performed using one-way ANOVA followed by post hoc LSD, repeated ANOVA with Bonferroni post hoc test, and Pearson χ2 tests. conditions: Effect of Lingual Retainers on Tooth Stability studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 0 type: ACTUAL name: measuring tooth stability after orthodontic treatment using a Periotest® device. measure: Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device sex: ALL minimumAge: 14 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Hatay Mustafa Kemal University, Faculty of Dentistry city: Hatay zip: 31060 country: Turkey lat: 38.40227 lon: 27.10486 hasResults: False

 nctId: NCT06284486 id: 2023-0794 id: NCI-2024-01721 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-12-30 date: 2028-12-30 date: 2024-02-29 date: 2024-03-27 name: M.D. Anderson Cancer Center class: OTHER name: Syndax Pharmaceuticals name: Break Through Cancer name: AbbVie briefSummary: To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Venetoclax name: Revumenib measure: Safety and adverse events (AEs) sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Ghayas Issa, MD role: CONTACT phone: 713-745-6798 email: gcissa@mdanderson.org name: Ghayas Issa, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06284473 id: 212154 briefTitle: Ketamine as a Supplement to Local Anesthesia for Minor Procedures acronym: INK-MP overallStatus: RECRUITING date: 2022-05-25 date: 2025-05-31 date: 2025-05-31 date: 2024-02-29 date: 2024-03-15 name: Loyola University class: OTHER briefSummary: This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS).

Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research conditions: Pain, Procedural conditions: Minor Laceration conditions: Abscess studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients presenting to the emergency department at Loyola University Medical Center for a minor medical procedure requiring local anesthesia will be randomly assigned to receive either standard local anesthesia with 0.7 mg/kg intranasal ketamine before the procedure or to standard local anesthesia with volume-based dose saline before the procedure using a 1:1 random block allocation. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All participants and study personnel are blinded except for the clinical pharmacist who prepares the intervention. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Ketamine name: Saline measure: Immediate pain measure: Acute pain measure: Delayed pain measure: Immediate agitation measure: Acute agitation measure: Delayed agitation measure: Immediate alertness measure: Acute alertness measure: Delayed alertness sex: ALL minimumAge: 7 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Loyola University Medical Center status: RECRUITING city: Maywood state: Illinois zip: 60153 country: United States name: Shannon Lovett, MD role: CONTACT phone: 847-951-2936 email: slovett@lumc.edu name: Trent Reed, DO role: CONTACT phone: 708-216-4117 email: treed1@lumc.edu lat: 41.8792 lon: -87.84312 hasResults: False

 nctId: NCT06284460 id: 2022-0622 id: NCI-2024-01692 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase I/II Study of a Combination of Decitabine and Cedazuridine (ASTX727) and ASTX029, an ERK Inhibitor, for Patients With RAS Pathway Mutant Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2025-12-01 date: 2027-12-01 date: 2024-02-29 date: 2024-04-03 name: M.D. Anderson Cancer Center class: OTHER briefSummary: The goal of Part 1 of this clinical research study is to find the highest tolerable dose of ASTX029 that can be given in combination with ASTX727 to participants who have RAS-mutant MDS or MDS/MPN. The goal of Part 2 of this clinical research study is to learn if the dose of ASTX029 found in Part 1 can help to control the disease when used in combination with ASTX727. conditions: Pathway Mutant Myelodysplastic Syndromes conditions: Myelodysplastic Neoplasm conditions: Myeloproliferative Neoplasm studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ASTX029 name: ASTX727 measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Cente city: Houston state: Texas zip: 77030 country: United States name: Guillermo Montalban Bravo, MD role: CONTACT phone: 713-794-3604 email: gmontalban1@mdanderson.org name: Guillermo Montalban Bravo, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06284447 id: 22-004500 id: NCI-2024-00181 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 22-004500 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Barriers to Cervical Cancer Screening overallStatus: RECRUITING date: 2023-03-23 date: 2025-03-31 date: 2025-03-31 date: 2024-02-29 date: 2024-02-29 name: Mayo Clinic class: OTHER briefSummary: This study evaluates barriers to cervical cancer screening among non-compliant women. conditions: Cervical Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200000 type: ESTIMATED name: Non-Interventional Study measure: Identify barriers to cervical cancer screening sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Brittany A. Strelow, DSMc, PA-C role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06284434 id: CHI2311 briefTitle: Liposomal Bupivacaine Use in Alveolar Bone Graft Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-02-29 date: 2024-03-04 name: Kerry O'Rourke class: OTHER name: Shriners Hospitals for Children briefSummary: The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:

* pain scores at hip and jaw sites
* opioid use in amount and frequency
* scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine. conditions: Cleft Lip and Palate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The design of this study is a randomized control trial, double-blinded. Patients who meet criteria and consent will be randomized to receive LB or standard bupivacaine. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Surgeons and patients will be unaware of which cohort the subject will be randomized to be part of. The pharmacist, anesthesiologist, and research coordinator may all be aware of which drug is administered. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Liposomal Bupivacaine name: Bupivacain name: Epinephrine measure: Visual Analog Pain Scores measure: Opioid Use measure: PROMIS Pediatric Mobility Questionnaire sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06284421 id: IRB23-1068 briefTitle: Durometer for Measuring Uterine Tone overallStatus: RECRUITING date: 2024-02-08 date: 2024-06-30 date: 2024-09-30 date: 2024-02-29 date: 2024-03-01 name: University of Chicago class: OTHER briefSummary: This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery. conditions: Uterine Tone Disorders conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Shore durometer measure: feasibility of a durometer measure: durometer reading measure: durometer reading measure: durometer reading measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Naida M Cole, MD role: CONTACT phone: 773-702-6700 email: nmcole@bsd.uchicago.edu name: Somayeh Mohammadi role: CONTACT phone: 17738343274 email: mohammadis@bsd.uchicago.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06284408 id: 2024-15683 briefTitle: Centralized Screening Unit (CSU) at Montefiore-Einstein overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-12 date: 2028-12 date: 2024-02-29 date: 2024-03-04 name: Albert Einstein College of Medicine class: OTHER name: American Cancer Society, Inc. briefSummary: This study proposes to increase Lung-cancer screening (LCS) in the Bronx, New York. Despite strong evidence that Lung-cancer screening (LCS) can reduce Lung cancer (LCa) deaths, low-dose computed tomography (LDCT) referral rates by clinicians are very low and there is poor adherence with LCS by patients. Both provider and patient barriers may be amenable to systemic improvements in support, coordination and infrastructure for screening. The investigator team hypothesizes that the implementation of a Central Screening Unit (CSU) that shifts routine workflow attributed to LCS (e.g., collection of smoking history, determination of eligibility, shared decision making and arranging follow-up) away from busy practices (usual care) and that offers patients an array of navigation and support services will increase the uptake of LCS guidelines and subsequent low-dose computed tomography (LDCT) screening scans in a low-income, predominately Hispanic and Black catchment area. The proposed study represents a unique opportunity to test this hypothesis in the context of the roll out of a CSU as a significant new component of the Montefiore-Einstein health system. The investigator team will examine whether and how the CSU facilitates LCS uptake and retention of patients. This study is powered to test whether CSU reduces proportion of late-stage lung cancer diagnoses in the Bronx, New York. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Systems-level intervention which using a mixed study design including stepped-wedge with a cluster randomized arm within the stepped-wedge. The implementation and evaluation of the CSU will be accomplished using cluster randomization to select 24 sites to be phased-into the CSU intervention according to a stepped-wedge design. Randomization will take place at the clinic level. The clinic clusters will be brought 'online' in a graded manner over the study period. 24 of the 35 NYC RING sites will be selected to enter the experimental (CSU) condition in three waves: Month 6, Month 12, or Month 18 after the start of the study. The remaining 11 sites will receive CSU support after completion of the third randomized group of clinics primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 9460 type: ESTIMATED name: Centralized Screening Unit Implementation measure: Participant Referrals measure: Proportion of participants with early stage lung cancer (LCa) sex: ALL minimumAge: 50 Years maximumAge: 77 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING) city: Bronx state: New York zip: 10467 country: United States name: Yocheved Halberstam, MPH role: CONTACT phone: 917-833-1070 email: yocheved.halberstam@einsteinmed.edu name: H. Dean Hosgood, PhD role: CONTACT phone: 203-215-3275 email: dean.hosgood@einsteinmed.edu lat: 40.84985 lon: -73.86641 hasResults: False

 nctId: NCT06284395 id: HGM1471-002/24 briefTitle: Two Schemes Response in Multiple Myeloma overallStatus: RECRUITING date: 2023-11-20 date: 2024-03-20 date: 2024-03-30 date: 2024-02-28 date: 2024-02-28 name: Hospital General de Mexico class: OTHER_GOV briefSummary: Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination. conditions: Response, Acute Phase conditions: Survivorship studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 83 type: ESTIMATED name: Bortezomib measure: Favorable Response measure: Time to next treatment measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital General de Mexico Dr. Eduardo Liceaga status: RECRUITING city: Mexico City state: Cdmx zip: 06720 country: Mexico name: Christian O Ramos Peñafiel, PhD role: CONTACT phone: 5523351588 email: leukemiachop33@gmail.com name: Adan G Gallardo Rodriguez role: CONTACT phone: +525584005072 email: nutriologo.agallardo8@gmail.com name: Juan M Cano Calderón, MD role: SUB_INVESTIGATOR name: Juan F Zazueta Pozos, MD role: SUB_INVESTIGATOR name: Adán G Gallardo Rodriguez, PhD role: SUB_INVESTIGATOR name: Carlos Martínez Murillo, PhD role: SUB_INVESTIGATOR name: Irma Olarte Carrillo, PhD role: SUB_INVESTIGATOR name: Adolfo Martínez Tovar, PhD role: SUB_INVESTIGATOR name: Christian O Ramos Peñafiel, PhD role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 hasResults: False

 nctId: NCT06284382 id: 2022-A02736-37 briefTitle: Interaction Between Early Trauma and Odor-induced Dopamine Release acronym: T-ODOR overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-06-01 date: 2024-02-28 date: 2024-02-28 name: Hôpital le Vinatier class: OTHER briefSummary: This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors. conditions: Trauma, Psychological studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, single-center, double-blind, parallel-group controlled trial with two arms. primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: High score at Childhood Trauma Questionnaire. name: Low score at Childhood Trauma Questionnaire. measure: Dopamine transmission measured with positron emission tomography measure: Odor hedonic appreciation. measure: Functional brain connectivity. measure: Effective brain connectivity sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False

 nctId: NCT06284369 id: Mongolia briefTitle: Video Messages for Smoking Cessation Campaign overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-03 date: 2025-04 date: 2024-02-28 date: 2024-03-04 name: Loma Linda University class: OTHER briefSummary: 240 adult smokers will be recruited. Subjects will be asked to view video messages that encourage smoking cessation. The effect of these videos will be assessed. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants don't know which video each subject is randomized to whoMasked: PARTICIPANT count: 240 type: ESTIMATED name: Developing, Evaluating and Testing Video Messages for a Smoking Cessation Campaign name: Health Message Framing measure: Message Engagement measure: Readiness to Quit Smoking sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False

 nctId: NCT06284356 id: IRB Session 2022/14 Protocol 6 briefTitle: Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy overallStatus: COMPLETED date: 2022-05-01 date: 2023-05-01 date: 2023-05-01 date: 2024-02-28 date: 2024-03-01 name: Kahramanmaras Sutcu Imam University class: OTHER name: Elazig Special Eastern Anatolian Hospital briefSummary: Morbid obesity emerges as a problem that causes serious complications and increased mortality rates. The most effective treatment for morbid obesity today is surgical treatment. The most preferred type of surgery in morbid obesity surgery in Turkey and around the world is Laparoscopic Sleeve Gastrectomy (LSG).

While postoperative complications are divided into early and late complications, complications that develop during surgery and in the postoperative period before discharge are defined as perioperative complications. Early surgical complications after LSG include complications such as staple line bleeding, leaks, pulmonary thromboembolism, and torsion of the remnant stomach. It is important to detect these complications, which can be controlled with early intervention in the perioperative period.

Monitoring blood parameters and monitoring inflammation are methods that are easily accessible and provide rapid evaluation. Platelet lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR), which are used in the evaluation and detection of postoperative complications, have shed light on studies in this direction. Pan immune inflammation value (PIV) is calculated from blood parameters and has been used to evaluate prognosis and chemotherapy results in colorectal cancer.

In this study, the diagnostic importance of changes in NLR, PLR, and PIV values in the preoperative and postoperative periods will be investigated in detecting complications that develop in the perioperative period before discharge in patients who underwent LSG. conditions: Morbid Obesity conditions: Laparoscopic Sleeve Gastrectomy conditions: Post Operative Complicaiton studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 159 type: ACTUAL name: Laparoscopic Sleeve Gastrectomy measure: Complication prediction after LSG with complete blood cell parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kahramanmaras SIU city: Kahramanmaraş zip: 46000 country: Turkey lat: 37.5847 lon: 36.92641 hasResults: False

 nctId: NCT06284343 id: 6414 briefTitle: Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study acronym: GynCAT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-09-30 date: 2026-09-30 date: 2024-02-28 date: 2024-02-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER name: Fondazione Umberto Veronesi briefSummary: Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk.

GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded.

The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRS≥3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population.

The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine \& Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes.

In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population. conditions: Cancer-associated Thrombosis conditions: Venous Thromboembolism conditions: Gynecologic Cancer conditions: Ovarian Cancer conditions: Cervix Cancer conditions: Endometrial Cancer conditions: Vaginal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1800 type: ESTIMATED name: Anticoagulant measure: Venous thromboembolism measure: Bleeding sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Rome zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06284330 id: STU-2023-0881 briefTitle: CHARGE Study: CHoice ARchitecture Genetic tEsting acronym: CHARGE overallStatus: RECRUITING date: 2024-02-16 date: 2025-03 date: 2025-08 date: 2024-02-28 date: 2024-04-05 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care. conditions: Hereditary Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 260 type: ESTIMATED name: Enhanced cascade testing measure: Rate of cascade genetic testing measure: Change in probands' family communication about genetic test results as measured by Proband survey measure: Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months measure: Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale measure: Proband's reaction to intervention materials as measured by proband survey. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Sukh Makhnoon, PhD, MS role: CONTACT phone: 214-648-3242 email: Chargestudy@utsouthwestern.edu name: Sukh Makhnoon, PhD, MS role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06284317 id: ETOP 25-23 briefTitle: A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer. acronym: ADOPT-lung overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2029-10 date: 2030-03 date: 2024-02-28 date: 2024-04-05 name: ETOP IBCSG Partners Foundation class: NETWORK name: AstraZeneca AG Switzerland briefSummary: ADOPT-LUNG is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 290 type: ESTIMATED name: Adjuvant durvalumab measure: Disease-free survival (DFS) measure: Response rate as per investigator assessment. measure: Proportion of patients undergoing surgery measure: Proportion of patients with surgical outcome R0 and R1 measure: pCR rate measure: Proportion of patients eligible for randomisation measure: Proportion of patients effectively randomised measure: Toxicity according to CTCAE v5.0 measure: DFS in patients with pCR measure: Overall survival (OS) in patients with/without pCR measure: DFS in patients with/without ctDNA clearance measure: Time to recurrence (TTR) in patients with/without pCR measure: Time to treatment discontinuation (TTD) in patients with/without pCR measure: Toxicity according to CTCAE v5.0 measure: Correlation between ctDNA clearance and pathological response measure: Correlation between ctDNA clearance and DFS measure: Correlation between ctDNA clearance and OS measure: Correlation between ctDNA clearance and initial PD-L1 assessment measure: Outcome (OS) measure: Outcome (event-free survival) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06284304 id: N22DES briefTitle: A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL acronym: DESTINATION overallStatus: RECRUITING date: 2024-02-29 date: 2025-04-01 date: 2027-04-01 date: 2024-02-28 date: 2024-03-05 name: The Netherlands Cancer Institute class: OTHER briefSummary: Trial design: A single centre phase II non-randomised study

Trial population: Men with intermediate risk localised prostate cancer

Recruitment target: 20 patients in total

Trial objectives:

* Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
* Secondary

  * To assess levels of acute GU and GI toxicity (CTCAE)
  * To assess levels of late GU and GI toxicity (CTCAE)
  * To assess late sexual quality of life (expanded EPIC, IIEF-5)
  * To assess biochemical relapse-free survival at 2 years

Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: De-escalated radiotherapy measure: Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac measure: Acute GU toxicity measure: Acute GI toxicity measure: Late GU toxicity measure: Late GI toxicity measure: PROMs measure: Biochemical free survival sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Netherlands Cancer Institute status: RECRUITING city: Amsterdam zip: 1066CX country: Netherlands name: Floris Pos, MD PhD role: CONTACT phone: +31 20 512 9111 email: f.pos@nki.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06284291 id: TMSpath id: RF-2021-12372804 type: OTHER_GRANT domain: Italian Ministry of Health briefTitle: Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies overallStatus: RECRUITING date: 2023-11-22 date: 2025-11-30 date: 2026-03-01 date: 2024-02-28 date: 2024-02-28 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Transcranial magnetic stimulation (TMS) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (TMS-EMG) or the entire cortical mantle (TMS-EEG). This study proposes TMS measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments. conditions: Epilepsy conditions: Genetic Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: transcranial magnetic stimulation (TMS) measure: Resting motor threshold measure: SICI measure: ICF measure: LICI measure: TEP amplitude measure: TEP latency sex: ALL minimumAge: 3 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Simona Balestrini, MD role: CONTACT email: simona.balestrini@meyer.it lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06284278 id: NCKU_PPGP_diaphragm briefTitle: Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain overallStatus: RECRUITING date: 2023-10-20 date: 2024-05-31 date: 2024-07-31 date: 2024-02-28 date: 2024-02-28 name: YI-JU TSAI class: OTHER briefSummary: The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain. conditions: Postpartum conditions: Pregnancy Related conditions: Pelvic Girdle Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Diaphragmatic breathing retraining name: Pelvic stabilization exercise name: pelvic anatomy education measure: Muscle function measures of lumbopelvic muscles measure: Diaphragm thickness measure: Diaphragm mobility measure: Diaphragm strength measure: Mechanical Property of Thoracolumbar Fascia measure: Functional performance of ASLR fatigue task measure: Functional performance of timed up and go test measure: Functional performance of 6m timed walk test measure: pain intensity measure of Numeric Rating Scale (NRS) measure: Disability Level: measure of pelvic girdle questionnaire(PGQ) measure: Health-related Quality of Life: Short Form-36 (SF36) measure: Fear Avoidance Belief: Tampa Scale of Kinesiophobia measure: Self-Efficacy: Pain Self-efficacy Questionnaire measure: Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF) measure: Self-perceived Change: Global Rating of Change Scale (GROC) sex: FEMALE minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University status: RECRUITING city: Tainan zip: 701 country: Taiwan name: Tsai Yi-Ju role: CONTACT phone: 06-2353535 phoneExt: 5930 email: lulilutsai@gmail.com lat: 22.99083 lon: 120.21333 hasResults: False

 nctId: NCT06284265 id: MMH-407-007 briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis overallStatus: RECRUITING date: 2023-10-16 date: 2026-12-31 date: 2026-12-31 date: 2024-02-28 date: 2024-04-19 name: Materia Medica Holding class: INDUSTRY briefSummary: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis conditions: Cystitis Chronic conditions: Cystitis Bacterial conditions: Recurrence of Chronic Bacterial Cystitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 632 type: ESTIMATED name: Raphamin name: Placebo measure: Time to the first recurrence of chronic bacterial cystitis measure: Percentage of patients with a reduction of recurrences of chronic bacterial cystitis measure: Average duration of episodes of recurrences of chronic bacterial cystitis measure: Average number of recurrences of chronic bacterial cystitis measure: Severity of chronic bacterial cystitis recurrences measure: Change in the severity of chronic bacterial cystitis recurrences measure: VAS score at the end of the follow-up period measure: The Presence of Adverse Events (AEs). measure: Changes in Vital Signs (Blood Pressure measured in mm Hg) measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute) measure: Changes in Vital Signs (Respiration Rate (Breathing Rate) measured in breaths per minute) measure: Proportion of patients with clinically significant laboratory abnormalities sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Center for Family Health and Human Reproduction Problems/Reproductive Health Department status: RECRUITING city: Irkutsk zip: 664003 country: Russian Federation name: Larisa Suturina, Prof. role: CONTACT name: Larisa Suturina, Prof. role: PRINCIPAL_INVESTIGATOR lat: 52.29778 lon: 104.29639 facility: Kazan State Medical University/Professor's clinic status: NOT_YET_RECRUITING city: Kazan zip: 420012 country: Russian Federation name: Ruslan Fatykhov, MD, PhD role: CONTACT name: Ruslan Fatykhov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.78874 lon: 49.12214 facility: LLC "Fenareta" Women's and Men's Health Clinic" status: RECRUITING city: Kemerovo zip: 650000 country: Russian Federation name: Natalia Artymuk, Prof. role: CONTACT name: Natalia Artymuk, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.33333 lon: 86.08333 facility: City Clinical Hospital #15 named after O.M. Filatov Department of Health of Moscow status: RECRUITING city: Moscow zip: 111539 country: Russian Federation name: Vladimir Kuzmin, Prof. role: CONTACT name: Vladimir Kuzmin, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 13/Gynecology Department # 1 status: RECRUITING city: Moscow zip: 115280 country: Russian Federation name: Felix Grigoryan, PhD role: CONTACT name: Felix Grigoryan, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Clinical Hospital # 85 of the Federal Medical and Biological Agency/Central polyclinic status: RECRUITING city: Moscow zip: 115409 country: Russian Federation name: Sergey Levakov, Prof. role: CONTACT name: Sergey Levakov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Research Institute of Rheumatology named after V.A. Nasonova status: RECRUITING city: Moscow zip: 115522 country: Russian Federation name: Victoria Gelashvili, MD role: CONTACT name: Victoria Gelashvili, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: National Medical Research Center for Obstetrics, Gynecology and Perinatology named after V.I. Kulakov/Department of Aesthetic Gynecology and Rehabilitation status: RECRUITING city: Moscow zip: 117198 country: Russian Federation name: Inna Apolikhina, Prof. role: CONTACT name: Inna Apolikhina, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Peoples' Friendship University of Russia/Department of Obstetrics and Gynecology with a course in perinatology status: WITHDRAWN city: Moscow zip: 117198 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Russian National Research Medical University named after N.I. Pirogov/Department of Obstetrics and Gynecology, Faculty of Medicine status: RECRUITING city: Moscow zip: 117997 country: Russian Federation name: Yulia Dobrokhotova, Prof. role: CONTACT name: Yulia Dobrokhotova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 1 named after. N.I. Pirogov of the Moscow City Health Department status: RECRUITING city: Moscow zip: 119049 country: Russian Federation name: Sergey Kotov, PhD, MD role: CONTACT name: Sergey Kotov, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: United hospital with clinic of the Administration of the President of the Russian Federation status: NOT_YET_RECRUITING city: Moscow zip: 119285 country: Russian Federation name: Nikolay Keshishev, MD, PhD role: CONTACT name: Nikolay Keshishev, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 67 named after L.A. Vorokhobov status: NOT_YET_RECRUITING city: Moscow zip: 121423 country: Russian Federation name: Olga Perevozkina, MD, PhD role: CONTACT name: Olga Perevozkina, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: JSC "MEDSI Group of Companies" status: WITHDRAWN city: Moscow zip: 123056 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Moscow State Medical and Dental University named after A.I. Evdokimov/Department of Urologya status: RECRUITING city: Moscow zip: 127473 country: Russian Federation name: Dmitry Pushkar, Prof. role: CONTACT name: Dmitry Pushkar, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Privolzhsky District Medical Center status: RECRUITING city: Nizhny Novgorod zip: 603001 country: Russian Federation name: Vagif Atduev, Prof. role: CONTACT name: Vagif Atduev Vagif, Prof. role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: National Medical Research Center for Radiology/Research Institute of Urology and Interventional Radiology named after. N.A. Lopatkin status: NOT_YET_RECRUITING city: Obninsk zip: 105425 country: Russian Federation name: Tatyana Perepanova, Prof. role: CONTACT name: Tatyana Perepanova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.09681 lon: 36.61006 facility: City Clinical Hospital status: NOT_YET_RECRUITING city: Pyatigorsk zip: 357500 country: Russian Federation name: Alexander Bardin, MD role: CONTACT name: Alexander Bardin, MD role: PRINCIPAL_INVESTIGATOR lat: 44.04861 lon: 43.05944 facility: Clinical and Diagnostic Center "Health" in Rostov-on-Don status: RECRUITING city: Rostov-on-Don zip: 344011 country: Russian Federation name: Igor Aboyan, Prof. role: CONTACT name: Igor Aboyan, Prof. role: PRINCIPAL_INVESTIGATOR lat: 47.23135 lon: 39.72328 facility: Rostov State Medical University/Department of Urology and Human Reproductive Health with a course of pediatric urology-andrology status: RECRUITING city: Rostov-on-Don zip: 344022 country: Russian Federation name: Mikhail Kogan, Prof. role: CONTACT name: Mikhail Kogan, Prof. role: PRINCIPAL_INVESTIGATOR lat: 47.23135 lon: 39.72328 facility: Rostov Central District Hospital status: NOT_YET_RECRUITING city: Rostov zip: 152155 country: Russian Federation name: Ariz Gyulmamedov, MD role: CONTACT name: Ariz Gyulmamedov, MD role: PRINCIPAL_INVESTIGATOR lat: 57.1914 lon: 39.41394 facility: JSC "Polyclinic Complex" status: WITHDRAWN city: Saint Petersburg zip: 190013 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Medical Center Capital-Polis" status: NOT_YET_RECRUITING city: Saint Petersburg zip: 190013 country: Russian Federation name: Dmitry Gorelov, MD role: CONTACT name: Dmitry Gorelov, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "BioTechService" status: RECRUITING city: Saint Petersburg zip: 190121 country: Russian Federation name: Alexander Parshin, PhD role: CONTACT name: Alexander Parshin, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City clinic # 44 status: NOT_YET_RECRUITING city: Saint Petersburg zip: 192071 country: Russian Federation name: Farzali Farzaliev, MD role: CONTACT name: Farzali Farzaliev, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: All-Russian Center for Emergency and Radiation Medicine named after A.M. Nikiforov/Urology department status: RECRUITING city: Saint Petersburg zip: 194044 country: Russian Federation name: Vladislav Grigoriev, PhD role: CONTACT name: Vladislav Grigoriev, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: St. Luke's Clinical Hospital status: RECRUITING city: Saint Petersburg zip: 194044 country: Russian Federation name: Orlov Igor, PhD role: CONTACT name: Orlov Igor, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Multidisciplinary Hospital # 2/Urology department status: WITHDRAWN city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Llc "Medical Clinic" status: RECRUITING city: Saint Petersburg zip: 194356 country: Russian Federation name: Maxim Bushara, MD role: CONTACT name: Maxim Bushara, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Medical and sanitary unit No. 70 - branch of the St. Petersburg State Unitary Enterprise of Passenger Road Transport status: RECRUITING city: Saint Petersburg zip: 195197 country: Russian Federation name: Vadim Zubarev, PhD, MD role: CONTACT name: Vadim Zubarev, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Research Center Eco-Safety" status: TERMINATED city: Saint Petersburg zip: 196143 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Jsc "Northwestern Center of Evidence-Based Medicine" status: WITHDRAWN city: Saint Petersburg zip: 196158 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: City Hospital # 15 status: NOT_YET_RECRUITING city: Saint Petersburg zip: 198205 country: Russian Federation name: Konstantin Dunets, MD role: CONTACT name: Konstantin Dunets, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott/Department of Gynecology and Endocrinology status: RECRUITING city: Saint Petersburg zip: 199034 country: Russian Federation name: Maria Yarmolinskaya, Prof. role: CONTACT name: Maria Yarmolinskaya, Prof. role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Pokrovskaya Hospital/Department of Urology status: RECRUITING city: Saint Petersburg zip: 199106 country: Russian Federation name: Andrey Gorelov, Prof. role: CONTACT name: Andrey Gorelov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Sertolovo City Hospital status: NOT_YET_RECRUITING city: Sertolovo zip: 188650 country: Russian Federation name: Alexander Shvets, MD role: CONTACT name: Alexander Shvets, MD role: PRINCIPAL_INVESTIGATOR lat: 60.1444 lon: 30.20165 facility: Siberian State Medical University/Faculty clinics of Siberian State Medical University status: NOT_YET_RECRUITING city: Tomsk zip: 634050 country: Russian Federation name: Victor Latypov, MD, PhD role: CONTACT name: Victor Latypov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.49771 lon: 84.97437 facility: Bashkir State Medical University/Department of Obstetrics and Gynecology # 1 status: WITHDRAWN city: Ufa zip: 450008 country: Russian Federation lat: 54.74306 lon: 55.96779 facility: Voronezh State Medical University named after N.N. Burdenko/Department of Urology status: RECRUITING city: Voronezh zip: 394036 country: Russian Federation name: Andrey Kuzmenko, Prof. role: CONTACT name: Andrey Kuzmenko, Prof. role: PRINCIPAL_INVESTIGATOR lat: 51.67204 lon: 39.1843 facility: Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery status: RECRUITING city: Vsevolozhsk zip: 188643 country: Russian Federation name: Nikolay Kanareikin, MD role: CONTACT name: Nikolay Kanareikin, MD role: PRINCIPAL_INVESTIGATOR lat: 60.01512 lon: 30.67314 facility: Yaroslavl State Medical University/Department of Urology and Nephrology status: NOT_YET_RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Igor Shormanov, Prof. role: CONTACT name: Igor Shormanov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Clinic of Modern Medicine Dr. Bogorodskaya" status: NOT_YET_RECRUITING city: Yaroslavl zip: 150001 country: Russian Federation name: Andrey Soloviev, MD, PhD role: CONTACT name: Andrey Soloviev, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Medical Center for Diagnosis and Prevention Plus" status: RECRUITING city: Yaroslavl zip: 150040 country: Russian Federation name: Svetlana Isakova, MD role: CONTACT name: Svetlana Isakova, MD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: Regional Clinical Hospital/Urology department status: RECRUITING city: Yaroslavl zip: 150062 country: Russian Federation name: Dmitry Komlev, PhD role: CONTACT name: Dmitry Komlev, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 hasResults: False

 nctId: NCT06284252 id: TÜBİTAK-323S135 briefTitle: Virtual Game Simulation on Nursing Students' Physical Examination Skills overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2025-01-15 date: 2025-02-15 date: 2024-02-28 date: 2024-02-28 name: Necmettin Erbakan University class: OTHER name: TÜBİTAK briefSummary: The project is unique in that it will use virtual game simulation, a new learning method, and it will address the physical examination skills of nursing students, an area that has not been researched before. In the project, a randomized controlled research design with a pretest-posttest control group will be used. The population will consist of 200 second-year students enrolled in the Physical Examination in Nursing course at Necmettin Erbakan University, Faculty of Nursing, Department of Nursing, in the 2024-2025 Fall Semester. 120 students from the population who meet the research inclusion criteria will be randomly assigned to control (n=60) and experimental (n=60) groups according to their general academic success score. In collecting data; Introductory characteristics form, skill checklist for physical examination of the heart, skill checklist for physical examination of the abdomen, skill checklist for physical examination of the respiratory system and an evaluation form for the effect of virtual game simulation on skill practice for physical examination will be used. In the project, three different virtual game simulations will be developed for physical examinations of the heart, abdomen and respiratory system. During the fall semester, theoretical and laboratory demonstration applications will be carried out by the project team. A pre-test will be administered to all students, and then virtual game simulations will be made available to students in the experimental group for three weeks. Then, the virtual games will be closed to the students and a post-test will be administered to the experimental and control group students. After the final test application, virtual game simulations will be made available to students in the control group. In pre- and post-test applications, students will practice physical examination skills on simulated patients at three different stations (heart, abdomen and respiratory system) and will be evaluated by the project team according to skill checklists. After the skill evaluations, the students in the experimental group will be given a form to evaluate the effect of the virtual game simulation for physical examination on skill practice and will be asked to fill it out. conditions: Simulation of Physical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control group and intervention group primaryPurpose: OTHER masking: TRIPLE maskingDescription: Participant blinding: In order to ensure participant blinding, all students will register to the site where virtual game simulations will be hosted.

Statistics blinding: In order to blind the statistics expert, at the end of data collection, the website expert will share the collected data with the statistics expert as group A and B data. The statistician will perform statistical analyzes without knowing which group is the control and which group is the experiment.

Researcher blinding: In order to ensure researcher blinding, the expert who designed the web page for virtual game simulations selected the students who registered on the website, using the "A" and "B" codes, according to the list he received from the statistics expert, on the website with a random group as control and one group as experiment. will assign it to the site. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Virtual Gaming Simulation measure: Skill assessment for physical examination of the abdomen (Pretest) measure: Skill assessment for physical examination of the heart(Pretest) measure: Evaluation of physical examination skills of the respiratory system(Pretest) measure: Skill assessment for physical examination of the abdomen (Posttest) measure: Skill assessment for physical examination of the heart(Posttest) measure: Evaluation of physical examination skills of the respiratory system(Posttest) sex: ALL minimumAge: 19 Years maximumAge: 25 Years stdAges: ADULT hasResults: False

 nctId: NCT06284239 id: Tell Me Game briefTitle: Using Games in Teaching Nursing History overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-06 date: 2024-02-28 date: 2024-03-21 name: Necmettin Erbakan University class: OTHER briefSummary: Innovative learning methods can be used in teaching nursing history. One of the most preferred among these methods is learning through games. It is known that today's Generation Z students prefer active learning methods and want to learn by having fun instead of learning by rote. It is reported that learning through games improves students' knowledge and skills and increases retention. One of the methods of learning through games is the "tell me" game. The "Tell Me" game involves the narrator explaining the words prepared specifically for the subject to a group of students without using prohibited words. Other students in the group try to know the word explained. Thus, both the student narrator and the student trying to know actively use their critical thinking and decision-making skills. This research aims to determine the effect of the tell-all game used in teaching nursing history on students' learning and opinions. conditions: Education Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It refers to the intervention group in which the "Tell Me" game will be played. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Participants will be informed about the research. However, participants will not know which group they belong to. At the same time, the statistical analysis of the research will be carried out by an independent statistician. Thus, blinding of both the participant and the outcome assessor will be ensured. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Tell me about the game. measure: Nursing History Knowledge Test measure: Nursing History Teaching Evaluation Form sex: ALL minimumAge: 20 Years maximumAge: 24 Years stdAges: ADULT hasResults: False

 nctId: NCT06284226 id: CCT-ANK-11 briefTitle: An Exploratory Clinical Study to Evaluate the Safety and Efficacy of NK Cells (Combined With Standard Therapy) in the Treatment of Solid Tumor Patients acronym: CCT-ANK-11 overallStatus: WITHDRAWN date: 2022-03-25 date: 2025-06-30 date: 2025-12-31 date: 2024-02-28 date: 2024-04-16 name: Beijing Kejing Biotechnology Co., Ltd. class: INDUSTRY briefSummary: An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients conditions: Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer) studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 0 type: ACTUAL name: Allogeneic NK（CCT-ANK-11) measure: To evaluate the safety and the efficacy sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06284213 id: 5U24NS100591 type: NIH link: https://reporter.nih.gov/quickSearch/5U24NS100591 briefTitle: Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium acronym: MarkVCID overallStatus: RECRUITING date: 2021-09-29 date: 2027-07 date: 2027-07 date: 2024-02-28 date: 2024-02-28 name: Massachusetts General Hospital class: OTHER name: Duke University name: Johns Hopkins University name: University of New Mexico name: University of Southern California name: University of Kentucky name: Rush University Medical Center name: University of Maryland, Baltimore name: University of California, San Francisco name: University of California, Los Angeles name: University of California, Davis name: University of Texas name: The University of Texas Health Science Center at San Antonio name: The University of Texas Health Science Center, Houston name: Mayo Clinic name: University of Mississippi Medical Center name: Washington University School of Medicine name: Olive View-UCLA Education & Research Institute briefSummary: Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is an NIH-funded consortium dedicated to finding biomarkers involved in age-related thinking and memory problems. Alzheimer's disease and other dementias leave signatures on brain scans or in the blood called biomarkers. The MarkVCID study will measure a panel of candidate biomarkers in 1800 participants and watch them closely to see what they tell us about changes in brain function and risk of memory loss.

Age-related problems in thinking and memory represent some of the greatest risks to public health in the US and globally. Diseases that affect small blood vessels in the brain have been shown to be major contributors to these changes. However, research and patient care can be held back by limited biomarkers that identify who should be treated.

The MarkVCID Consortium includes 17 US medical centers, a Coordinating Center, an External Advisory Committee, and NIH leadership. Data and biospecimens collected as part of this research study will be stored in a research database and biorepositories, so that researchers can use this information to study brain function. conditions: Cognitive Impairment conditions: Dementia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1800 type: ESTIMATED name: No interventions measure: SVD progression as measured by decline in global cognition measure: SVD progression as measured by decline in executive function sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southern California status: RECRUITING city: Los Angeles state: California zip: 90033 country: United States name: Danny JJ Wang, PhD, MSCE role: CONTACT phone: 323-442-7246 email: JJ.Wang@loni.usc.edu lat: 34.05223 lon: -118.24368 facility: University of California Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Jason Hinman, MD, PhD role: CONTACT phone: 310-794-1195 email: JHinman@mednet.ucla.edu lat: 34.05223 lon: -118.24368 facility: University of California Davis status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Pauline Maillard, PhD role: CONTACT phone: 916-734-3588 email: pmaillard@ucdavis.edu lat: 38.58157 lon: -121.4944 facility: University of California San Francisco status: RECRUITING city: San Francisco state: California zip: 94158 country: United States name: Joel Kramer, PsyD role: CONTACT phone: 415-476-5572 email: Joel.Kramer@ucsf.edu lat: 37.77493 lon: -122.41942 facility: Olive View - UCLA Medical Center status: RECRUITING city: Sylmar state: California zip: 91342 country: United States name: Keith Vossel, MD role: CONTACT phone: 310-794-1195 email: KVossel@mednet.ucla.edu lat: 34.30778 lon: -118.44925 facility: Mayo Clinic Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Gregory Day role: CONTACT phone: 904-953-0856 email: Day.Gregory@mayo.edu lat: 30.33218 lon: -81.65565 facility: Rush University Medical Center & Illinois Institute of Technology status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Konstantinos Arfanakis, PhD role: CONTACT phone: 312-567-3864 email: Konstantinos_Arfanakis@rush.edu lat: 41.85003 lon: -87.65005 facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40536 country: United States name: Gregory Jicha, MD, PhD role: CONTACT phone: 859-257-1000 email: gregory.jicha@uky.edu lat: 37.98869 lon: -84.47772 facility: University of Maryland, Baltimore status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Peiying Liu, PhD role: CONTACT phone: 410-706-2441 email: PeiyingLiu@som.umaryland.edu lat: 39.29038 lon: -76.61219 facility: Johns Hopkins University status: RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Hanzhang Lu, PhD role: CONTACT phone: 410-955-1431 email: hlu3@jhmi.edu lat: 39.29038 lon: -76.61219 facility: Mayo Clinic Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55901 country: United States name: Ronald Petersen, MD, PhD role: CONTACT phone: 507-284-1588 email: peter8@mayo.edu lat: 44.02163 lon: -92.4699 facility: University of Mississippi Medical Center status: RECRUITING city: Jackson state: Mississippi zip: 39216 country: United States name: Gwen Windham, MD role: CONTACT phone: 601-984-5610 email: gwindham@umc.edu lat: 32.29876 lon: -90.18481 facility: Washington University in St. Louis status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Jin-Moo Lee, MD, PhD role: CONTACT phone: 314-362-7382 email: leejm@wustl.edu lat: 38.62727 lon: -90.19789 facility: University of New Mexico status: RECRUITING city: Albuquerque state: New Mexico zip: 87131 country: United States name: Gary Rosenberg, MD role: CONTACT phone: 505-272-3315 email: GRosenberg@salud.unm.edu lat: 35.08449 lon: -106.65114 facility: University of Texas Southwestern status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Rong Zhang, PhD role: CONTACT phone: 214-345-4619 email: RongZhang@texashealth.org lat: 32.78306 lon: -96.80667 facility: University of Texas Health Science Center Houston status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Sean Savitz, MD role: CONTACT phone: 713-500-7083 email: Sean.I.Savitz@uth.tmc.edu lat: 29.76328 lon: -95.36327 facility: University of Texas Health Science Center San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Claudia Satizabal, PhD role: CONTACT phone: 210-450-8417 email: satizabal@uthscsa.edu lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06284200 id: sarcopenia eRA briefTitle: Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis overallStatus: RECRUITING date: 2023-06-23 date: 2024-03-23 date: 2024-06-23 date: 2024-02-28 date: 2024-02-28 name: Kayseri City Hospital class: OTHER_GOV briefSummary: introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared.

Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study. conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 48 type: ESTIMATED measure: Evaluation of Muscle Mass measure: Evaluation of Muscle Strength measure: Evaluation of Muscle Performance measure: Rheumatoid Arthritis Quality of Life Scale measure: Health Assessment Questionnaire (HAQ) measure: Hospital Anxiety and Depression Scale (HADS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty status: RECRUITING city: Kocasinan state: Kayseri zip: 38125 country: Turkey name: MEHMET KÖKSAL, M.D. role: CONTACT phone: +905514043114 email: dr.mhmtkksl@gmail.com hasResults: False

 nctId: NCT06284187 id: KhonKaenH briefTitle: Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis overallStatus: COMPLETED date: 2023-01-01 date: 2023-10-31 date: 2023-12-31 date: 2024-02-28 date: 2024-02-28 name: Khon Kaen Hospital class: OTHER_GOV briefSummary: BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.

OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture. conditions: Tuberculosis conditions: Pulmonary studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 120 type: ACTUAL measure: Number of participants with pulmonary TB by Allplex™ MTB/MDRe sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Thananit Sangkomkamhang city: Khon Kaen zip: 40000 country: Thailand lat: 16.44671 lon: 102.833 hasResults: False

 nctId: NCT06284174 id: B-BR-109-054-T briefTitle: Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking. overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This study aims to assess the efficacy of intraoperative wound irrigation with iodine-containing and chlorhexidine-containing solutions in reducing bacterial colonization during spine surgery, and to determine which solution is more effective. Additionally, we aim to evaluate any side effects associated with the use of these two antiseptic solutions for wound irrigation. conditions: Spine Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This research will include patients diagnosed with lumbar spinal stenosis causing nerve compression, who are scheduled for open spinal decompression and fusion surgery. Patients will be randomly assigned to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics. Before wound closure, each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline. Samples from deep and superficial tissues and implants will be taken for bacterial culture and molecular biochip analysis. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Patients will be randomly assigned by computer to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics.

All patients understood the experimental process and signed the consent form. The patients did not know the group they were assigned to during the whole process. The bacterial culturers, examiners and clinical outcome assessors did not know the patient group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: Povidone-iodine solution; chlorhexidine gluconate measure: Bacteria culture and Polymerase chain reaction exam measure: Post operative infection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University Hospital status: RECRUITING city: Tainan zip: 704 country: Taiwan name: Wei-Ren Su, M.D., M.Sc. role: CONTACT phone: 886-6-2766689 email: suwr@ms28.hinet.net lat: 22.99083 lon: 120.21333 hasResults: False

 nctId: NCT06284161 id: RBHP 2020 GUY id: 2020-A02765-34 type: OTHER domain: ANSM briefTitle: QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up acronym: PEM-SLA overallStatus: RECRUITING date: 2022-06-28 date: 2025-06-28 date: 2026-02-28 date: 2024-02-28 date: 2024-02-28 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems.

The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis.

The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis. conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Quadriceps Combined Test measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France name: Lise Laclautre role: CONTACT phone: +33473754963 email: promo_interne_drci@chu-clermontferrand.fr name: Nathalie Guy role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 hasResults: False

 nctId: NCT06284148 id: Pro00093964 id: 5R18HS025654-03 type: AHRQ link: https://reporter.nih.gov/quickSearch/5R18HS025654-03 briefTitle: Confidential IPV Screening Tool overallStatus: COMPLETED date: 2010-10-06 date: 2023-07-31 date: 2023-07-31 date: 2024-02-28 date: 2024-02-28 name: Medical University of South Carolina class: OTHER name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: Intimate partner violence (IPV) against women in the US is a serious public health problem and a human rights issue. Our research team has developed confidential screening tools using exam-room computer for intimate partner violence to be used in primary care. conditions: Violence, Domestic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order. primaryPurpose: SCREENING masking: NONE count: 19655 type: ACTUAL name: Screening for intimate partner violence name: Assessment and referral measure: IPV positive (Yes/No) measure: Screening completed (Yes/No) measure: Severity of risk measure: Physician compliance with IPV management tools sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Biomedical Informatics Center city: Charleston state: South Carolina zip: 29403 country: United States lat: 32.77657 lon: -79.93092 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-01 uploadDate: 2024-02-20T12:06 filename: Prot_SAP_000.pdf size: 179261 hasResults: False

 nctId: NCT06284135 id: 2017-PS-03 id: PV6099 type: OTHER domain: Martini-Klinik briefTitle: MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles overallStatus: COMPLETED date: 2017-06-19 date: 2019-10-16 date: 2021-05-31 date: 2024-02-28 date: 2024-02-28 name: Martini-Klinik am UKE GmbH class: OTHER briefSummary: A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention. conditions: Lymphocele After Surgical Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 1080 type: ACTUAL name: Michl-stitch measure: rate of lymphoceles requiring intervention after RARP measure: total lymphocele rate after RARP measure: other complications ≥ grade IIIa according to Clavien-Dindo after RARP measure: continence rates after RARP sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Martini-Klinik am UKE GmbH city: Hamburg zip: 20246 country: Germany lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06284122 id: MorningLyte briefTitle: Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5 acronym: MorningLyte overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-11 date: 2034-04 date: 2024-02-28 date: 2024-03-15 name: The Lymphoma Academic Research Organisation class: OTHER name: Lymphoma Study Association name: Swiss Group for Clinical Cancer Research name: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea briefSummary: This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma. conditions: Follicular Lymphoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 790 type: ESTIMATED name: Mosunetuzumab name: Lenalidomide name: Rituximab name: Obinutuzumab name: Cyclophosphamide name: Doxorubicin name: Vincristin name: Prednisone name: Rituximab name: Obinutuzumab name: Bendamustin measure: Progression Free Survival (PFS) measure: Progression Free Survival (PFS) measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Best Overall Response (CMR + PMR) rate measure: Best Overall Response (CMR + PMR) rate measure: Progression of disease within 2 years (POD24) measure: PFS measure: PFS measure: Event Free Survival (EFS) by Lugano 2014 measure: Event Free Survival (EFS) by Lugano 2014 measure: Time to Next Anti-Lymphoma Treatment (TTNLT) measure: Time to Next Anti-Lymphoma Treatment (TTNLT) measure: Duration of response measure: Duration of response measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Duration of complete response measure: Duration of complete response measure: Overall Survival (OS) measure: Overall Survival (OS) measure: Incidence and severity of Adverse Events (AE) including Serious and Special Interest AE (SAEs and AESIs) measure: Incidence and severity of AEs including SAEs and AESIs measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation measure: Incidence of Second Primary Malignancies (SPM) measure: Incidence of Second Primary Malignancies (SPM) measure: anti-drug antibodies (ADA) to mosunetuzumab measure: Time to deterioration in physical functioning measure: Time to deterioration in lymphoma symptoms measure: Maximum serum concentration of mosunetuzumab - Cmax measure: Minimum serum concentration of mosunetuzumab - Cmin measure: Area under the curve of serum concentration of mosunetuzumab - AUC measure: Maximum serum concentration of lenalidomide - Cmax measure: Minimum serum concentration of lenalidomide - Cmin measure: Area under the curve of serum concentration of lenalidomide - AUC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie city: Brugge zip: 8000 country: Belgium name: Sylvia SNAUWAERT, Pr role: CONTACT lat: 51.20892 lon: 3.22424 facility: INSTITUT JULES BORDET - Service Hématologie city: Bruxelles zip: 1070 country: Belgium name: Marie MAEREVOET, MD role: CONTACT lat: 50.85045 lon: 4.34878 facility: UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie city: Bruxelles zip: 1200 country: Belgium name: Eric VAN DEN NESTE, Pr role: CONTACT lat: 50.85045 lon: 4.34878 facility: GRAND HOPITAL DE CHARLEROI - Service Hématologie city: Charleroi zip: 6000 country: Belgium name: Delphine PRANGER, MD role: CONTACT lat: 50.41136 lon: 4.44448 facility: UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie city: Gent zip: 9000 country: Belgium name: Ciel DE WRIENDT, MD role: CONTACT lat: 51.05 lon: 3.71667 facility: CHU DE LIEGE - Service Hématologie city: Liège zip: 4000 country: Belgium name: Christophe BONNET, Pr role: CONTACT lat: 50.63373 lon: 5.56749 facility: CHR VERVIERS - LA TOURELLE - Service Hématologie city: Verviers zip: 4800 country: Belgium name: Gaetan VANSTRAELEN, MD role: CONTACT lat: 50.58907 lon: 5.86241 facility: CHU UCL NAMUR - SITE GODINNE - Service Hématologie city: Yvoir zip: 5530 country: Belgium name: Gilles CROCHET, MD role: CONTACT lat: 50.3279 lon: 4.88059 facility: CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie city: Avignon zip: 84000 country: France name: Hacène ZERAZHI, MD role: CONTACT lat: 43.94834 lon: 4.80892 facility: CH DE LA COTE BASQUE - Service Hématologie city: Bayonne zip: 64100 country: France name: Sophie BERNARD, MD role: CONTACT lat: 43.48333 lon: -1.48333 facility: CHU JEAN MINJOZ - Service Hématologie city: Besançon zip: 25030 country: France name: Adrien CHAUCHET, MD role: CONTACT lat: 47.24878 lon: 6.01815 facility: INSTITUT BERGONIE - Service d'Oncologie Médicale city: Bordeaux zip: 33076 country: France name: Fontanet BIJOU, MD role: CONTACT lat: 44.84044 lon: -0.5805 facility: CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie city: Cahors zip: 46005 country: France name: Martin GAUTHIER, MD role: CONTACT lat: 44.4491 lon: 1.43663 facility: CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie city: Chambéry zip: 73011 country: France name: Arthur DONY, MD role: CONTACT lat: 45.56667 lon: 5.93333 facility: CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique city: Clermont-Ferrand zip: 63003 country: France name: Romain GUIEZE, Pr role: CONTACT lat: 45.77966 lon: 3.08628 facility: HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes city: Créteil zip: 94010 country: France name: François LEMONNIER, MD role: CONTACT lat: 48.78333 lon: 2.46667 facility: CHU DIJON BOURGOGNE - Service Hématologie Clinique city: Dijon zip: 21000 country: France name: Amandine DURAND, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: CHD DE VENDEE - Service Hématologie city: La Roche-sur-Yon zip: 85925 country: France name: Nadine MORINEAU, MD role: CONTACT lat: 46.66667 lon: -1.43333 facility: CHU DE GRENOBLE - Service Hématologie city: La Tronche zip: 38700 country: France name: Sylvain CARRAS, MD role: CONTACT lat: 45.20429 lon: 5.73645 facility: HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie city: Lille zip: 59020 country: France name: Sandy AMORIM, MD role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie city: Lille zip: 59037 country: France name: Franck MORSCHHAUSER, Pr role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire city: Limoges zip: 87042 country: France name: Julie ABRAHAM, MD role: CONTACT lat: 45.83153 lon: 1.25781 facility: INSTITUT PAOLI CALMETTES - Service Hématologie city: Marseille zip: 13273 country: France name: Gabriel BRISOU, MD role: CONTACT lat: 43.29551 lon: 5.38958 facility: CHU DE MONTPELLIER - Département d'Hématologie Clinique city: Montpellier zip: 34090 country: France name: Guillaume CARTRON, Pr role: CONTACT lat: 43.61092 lon: 3.87723 facility: GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie city: Mulhouse zip: 68100 country: France name: Bernard DRENOU, MD role: CONTACT lat: 47.75 lon: 7.33333 facility: CHU DE NANTES - Service Hématologie city: Nantes zip: 44093 country: France name: Thomas GASTINNE, MD role: CONTACT lat: 47.21725 lon: -1.55336 facility: CENTRE HOSPITALIER DE NIORT - Médecine interne city: Niort zip: 79021 country: France name: Gaëlle OLIVIER, MD role: CONTACT lat: 46.32313 lon: -0.45877 facility: HOPITAL SAINT-LOUIS - Service Hématologie city: Paris zip: 75475 country: France name: Catherine THIEBLEMONT, Pr role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire city: Pessac zip: 33604 country: France name: François-Xavier GROS, MD role: CONTACT lat: 44.81011 lon: -0.64129 facility: CHU LYON-SUD - Hématologie city: Pierre-Bénite zip: 69495 country: France lat: 45.7009 lon: 4.82511 facility: CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie city: Poissy zip: 78303 country: France name: Mohammed BOUDERBALA, MD role: CONTACT lat: 48.92902 lon: 2.04952 facility: CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire city: Poitiers zip: 86021 country: France name: Stéphanie GUIDEZ, MD role: CONTACT lat: 46.58333 lon: 0.33333 facility: CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie city: Pringy zip: 74374 country: France name: Hannah MOATTI, MD role: CONTACT lat: 45.94622 lon: 6.12608 facility: CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie city: Reims zip: 57092 country: France name: Eric DUROT, MD role: CONTACT lat: 49.25 lon: 4.03333 facility: CHU PONTCHAILLOU - Hématologie Clinique city: Rennes zip: 35033 country: France name: Roch HOUOT, Pr role: CONTACT lat: 48.11198 lon: -1.67429 facility: CENTRE HENRI BECQUEREL - Service Hématologie city: Rouen zip: 76038 country: France lat: 49.44313 lon: 1.09932 facility: INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie city: Saint-Cloud zip: 92210 country: France name: Clémentine SARKOZY, MD role: CONTACT lat: 48.84598 lon: 2.20289 facility: Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie city: Saint-Priest-en-Jarez zip: 42270 country: France name: Ludovic FOUILLET, MD role: CONTACT lat: 45.47501 lon: 4.37614 facility: INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique city: Strasbourg zip: 67033 country: France name: Luc-Matthieu FORNECKER, Pr role: CONTACT lat: 48.58392 lon: 7.74553 facility: IUCT ONCOPOLE - Service Hématologie city: Toulouse zip: 31059 country: France name: Loïc YSEBAERT, MD role: CONTACT lat: 43.60426 lon: 1.44367 facility: CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire city: Tours zip: 37044 country: France name: Laurianne DRIEU LA ROCHELLE, MD role: CONTACT lat: 47.38333 lon: 0.68333 facility: CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie city: Valenciennes zip: 59322 country: France name: Sabine TRICOT, MD role: CONTACT lat: 50.35 lon: 3.53333 facility: CHU BRABOIS - Service Hématologie city: Vandœuvre-lès-Nancy zip: 54511 country: France name: Pierre FEUGIER, Pr role: CONTACT lat: 48.65 lon: 6.18333 facility: CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie city: Vannes zip: 56017 country: France name: Antoine BONNET, MD role: CONTACT lat: 47.66667 lon: -2.75 facility: GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique city: Villejuif zip: 94085 country: France name: Vincent RIBRAG, MD role: CONTACT lat: 48.7939 lon: 2.35992 facility: UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III city: Regensburg zip: 93053 country: Germany name: Stephanie MAYER, MD role: CONTACT lat: 49.01513 lon: 12.10161 facility: UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie city: Ulm zip: 89081 country: Germany name: Christian BUSKE, Pr role: CONTACT lat: 48.39841 lon: 9.99155 facility: INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia city: Lisboa zip: 1099 country: Portugal name: Maria GOMES DA SILVA, Pr role: CONTACT lat: 38.71667 lon: -9.13333 facility: HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia city: Salamanca zip: 37007 country: Spain name: Alejandro MARTIN GARCIA-SANCHO, MD role: CONTACT lat: 40.96882 lon: -5.66388 hasResults: False

 nctId: NCT06284109 id: 23-1036 briefTitle: Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-04-23 name: The Cleveland Clinic class: OTHER name: Pacira Pharmaceuticals, Inc briefSummary: Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre-Operative Patients will receive cryoanalgesia or sham cryoanalgesia before amputation. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: All participants will receive nerve blocks with Local anesthetic. Participants will be Randomized on a 1:1 fashion to cryoanalgesia or sham cryoanalgesia, based on computer-generated codes and use random-sized blocks. Patients will not be told which group they are in. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Cryoanalgesia name: Sham Cryoanalgesia measure: Phantom limb pain score measure: Mobility measure: General physical and emotional disability measure: Opioid consumption measure: Residual limb pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06284096 id: 2023/391 briefTitle: The Personal Recovery Based Psychoeducation For Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-03-07 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This project aims to introduce a new psychoeducation program that helps individuals with schizophrenia to recover subjectively. The program's effectiveness will be evaluated through a randomized controlled research design. The goal is not only to emphasize clinical recovery but also to highlight the importance of individual recovery and promote its implementation. In this context, the following hypotheses have been formulated.

Research Question:

1) Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission?

Hypotheses:

H0a: Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission.

H0b: Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission.

H0c: Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission.

H1a: Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission.

H1b: Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission.

H1c: Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission. conditions: Mental Health Recovery conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Psychoeducation measure: Personal Recovery levels of individuals diagnosed with schizophrenia measure: Psychological resilience levels of individuals diagnosed with schizophrenia measure: Hope levels of individuals diagnosed with schizophrenia sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Umraniye Community Mental Health Center affiliated with the Ministry of Health. city: Istanbul state: Umraniye zip: 34760 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06284083 id: Cumhuriyet University Hospital briefTitle: Measuring Various Variables in Obstructive Sleep Apnea acronym: OUAS overallStatus: COMPLETED date: 2018-12-18 date: 2021-01-15 date: 2022-02-07 date: 2024-02-28 date: 2024-02-28 name: Cumhuriyet University class: OTHER briefSummary: This study included 90 volunteer Obstructive Sleep Apnea Syndrome patients. Only 7 mL blood samples collected from patients. Some biochemicals parameters analyzed in blood serum/plasma. conditions: Obstructive Sleep Apnea-hypopnea Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study group consisted of 90 newly diagnosed OSAS patients who were admitted to the Clinic for Chest Diseases of the Research and Practice Hospital of Sivas Cumhuriyet University Faculty of Medicine. For the definitive diagnosis of OSAS, the patients were hospitalized overnight in the Sleep Center and polysomnography test was performed. OSAS patients, who were randomly selected without discrimination in terms of age and gender, were connected to the PSG device for one night and various measurements were taken and the values were recorded. The apnea/hypopnea index (AHI) was defined as the sum of the apnea and hypopnea number per hour of sleep. Volunteer patients were grouped into three based on apnea-hypopnea index (AHI) scores: mild OSAS (n=30; 5 ≤ AHI ≤ 13.70), moderate (n=30; 15.80 ≤ AHI ≤ 26.60) and severe (n=30; 34.10 ≤ AHI ≤ 86.30). The mean SpO2 percentages of the PSG device were measured from the fingertip with a system-defined pulse oximeter. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: taking a blood sample measure: Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity. measure: Polysomnographic measurement sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sivas Cumhuriyet University city: Sivas state: Centre zip: 58140 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False

 nctId: NCT06284070 id: 202433 briefTitle: Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2029-12-31 date: 2029-12-31 date: 2024-02-28 date: 2024-02-28 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations. conditions: Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Diagnostic efficacy measure: SUV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Xiao Chen, Ph.D role: CONTACT phone: 15922970174 email: xiaochen229@foxmail.com name: Xiao Chen, Ph.D role: PRINCIPAL_INVESTIGATOR name: Jinju Sun, MSc role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06284057 id: CopperHealthCentre3 briefTitle: Lower Silesia Culotte Bifurcation Registry (LSCBR). acronym: LSCBR overallStatus: RECRUITING date: 2013-04-01 date: 2028-04-01 date: 2028-04-01 date: 2024-02-28 date: 2024-03-06 name: Regional Cardiology Center, The Copper Health Centre (MCZ), class: OTHER name: Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland. briefSummary: The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis. conditions: Safety Issues conditions: Efficacy, Self studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte measure: Target lesion failure (TLF) measure: MACE measure: Stent thrombosis measure: Stent restenosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Cardiology, Provincial Specialized Hospital in Legnica, status: RECRUITING city: Legnica state: Lower Silesia zip: 59-220 country: Poland name: Mateusz Barycki, M.D role: CONTACT phone: +48767211446 email: mateusz.barycki@gmail.com name: Piotr Rola, M.D. Ph.D role: CONTACT phone: +48767211446 email: piotr.rola@gmail.com name: Mateusz Barycki, MD role: PRINCIPAL_INVESTIGATOR name: Piotr Rola, MD PhD role: SUB_INVESTIGATOR lat: 51.21006 lon: 16.1619 facility: Department of Cardiology, The Copper Health Centre (MCZ) status: RECRUITING city: Lubin state: Lower Silesia zip: 59-300 country: Poland name: Adrian Włodarczak, Assoc Prof. role: CONTACT phone: +48768460300 email: wlodarczak.adrian@gmail.com name: Szymon Włodarczak, MD role: CONTACT phone: +4876 846 03 00 email: wlodarczak.szy@gmail.com name: Adrian Włodarczak, Assoc Prof. role: PRINCIPAL_INVESTIGATOR name: Szymon Włodarczak, MD role: SUB_INVESTIGATOR lat: 51.40089 lon: 16.20149 hasResults: False

 nctId: NCT06284044 id: NIHR204885 briefTitle: Facilitating Safe Transition to Home for Preterm Infants - a National Database Study overallStatus: RECRUITING date: 2023-12-01 date: 2024-11-30 date: 2024-11-30 date: 2024-02-28 date: 2024-03-27 name: University Hospitals of Derby and Burton NHS Foundation Trust class: OTHER briefSummary: Preterm infants (i.e. born before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Readiness for discharge home typically requires a level of physiological maturity, such that an infant is: 1) able to breathe spontaneously without additional support; 2) able to maintain body temperature; 3) able to take all nutritional requirements orally; 4) weighs ≥1700 grams and is consistently gaining weight.

Staying in the hospital longer than necessary can be detrimental to infants, stressful for families, and costly to the NHS. Reducing the length of stay by just one day would be meaningful to parents and could save the UK National Health Service (NHS) almost £25million per year. Currently little is known about whether, how long and why preterm infants stay in hospital beyond the point at which they are physiologically ready for discharge.

This study will use data from babies' medical records from the whole of England and Wales to identify the age and postmenstrual age when preterm infants reach each of the physiological barriers to discharge and identify which physiological discharge barrier requires preterm infants to remain in hospital the longest. The study will quantify the difference between the time preterm infants become physiologically ready for discharge and actual discharge home and describe factors associated with extended stays. conditions: Premature Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250000 type: ESTIMATED measure: Age and postmenstrual age when each of three physiological barriers are reached measure: Final barrier to discharge home measure: Number of days in hospital after surpassing all physiological discharge barriers sex: ALL minimumAge: 22 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: University Hospitals of Derby and Burton status: RECRUITING city: Derby state: Derbyshire zip: DE22 3DT country: United Kingdom name: Janine Abramson, BSc Hon role: CONTACT phone: 01332 724690 email: janine.abramson@nottingham.ac.uk lat: 52.92277 lon: -1.47663 hasResults: False

 nctId: NCT06284031 id: Brachy Study briefTitle: Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions overallStatus: RECRUITING date: 2023-06-26 date: 2026-06 date: 2026-12 date: 2024-02-28 date: 2024-02-28 name: National University Hospital, Singapore class: OTHER briefSummary: Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient setting

Primary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)

Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5 conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: 3 fractions HDR brachytherapy measure: Local control rate measure: Loco-regional control rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Long term toxicities sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University Hospital status: RECRUITING city: Singapore zip: 119074 country: Singapore name: Fatin Aliyah, BSc role: CONTACT phone: +6581005851 email: fatin_hussin@nuhs.edu.sg name: Syadwa Abdul Shukor, MD role: SUB_INVESTIGATOR name: Yiat Horng Leong, MD role: SUB_INVESTIGATOR name: Shing Fung Lee, MD role: SUB_INVESTIGATOR name: Michelle Tseng, MD role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06284018 id: postnatal low back pain briefTitle: Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-02-24 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-29 name: Cairo University class: OTHER briefSummary: This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: intervention The design of the study was randomized controlled study. The patients were divided randomly into two equal groups (A\&B). Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks. Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Progressive Muscle Relaxation Exercises name: Pilates Exercises measure: Pressure Algometer measure: Oswestry Disability Index sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT facility: faculty of physical therapy: Cairo university city: Giza zip: 12662 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06284005 id: MOTU ATP - Studio clinico briefTitle: Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb at the Transfemoral Level acronym: MOTU-ATP overallStatus: COMPLETED date: 2020-07-27 date: 2022-11-10 date: 2022-12-22 date: 2024-02-28 date: 2024-02-28 name: Fondazione Don Carlo Gnocchi Onlus class: OTHER briefSummary: The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees.

The main question it aims to answer are:

* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.

Participants will perform:

* walking tests inside parallel bars on flat and/or inclined terrain;
* walking tests on treadmill;
* stair climbing/descent tests. conditions: Amputation conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 4 type: ACTUAL name: WRL ATP measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Don Carlo Gnocchi city: Firenze state: FI zip: 50143 country: Italy lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06283992 id: 2024p000095 id: K23MD016439 type: NIH link: https://reporter.nih.gov/quickSearch/K23MD016439 briefTitle: Digital Health Navigation for Latino Patients With Type II Diabetes overallStatus: RECRUITING date: 2024-03-31 date: 2026-05-31 date: 2027-05-31 date: 2024-02-28 date: 2024-03-28 name: Brigham and Women's Hospital class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Researchers will compare effectiveness between two arms: 1) patient education using a digital navigator on using digital tools after discharge and 2) usual care (educational sheet). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Digital Navigation measure: Proportion of Participants Who Login to the Portal measure: Proportion of Participants that Perform Distinct Portal Functions measure: Proportion of participants that complete a telehealth measure: Proportion of participants that are re-admitted sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02120 country: United States name: Jorge A Rodriguez, MD role: CONTACT lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06283979 id: 199723 briefTitle: A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. acronym: BLADE OPU2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-12-01 date: 2024-02-28 date: 2024-02-29 name: Biocomposites Ltd class: INDUSTRY name: MCRA briefSummary: The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers. conditions: Pressure Ulcer, Stage IV conditions: Osteomyelitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: STIMULAN VG name: Standard of Care measure: Individual patient success and findings at the 8 week follow-up visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283966 id: D5989C00001 briefTitle: A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease acronym: THARROS overallStatus: RECRUITING date: 2024-02-21 date: 2028-03-06 date: 2028-03-06 date: 2024-02-28 date: 2024-03-12 name: AstraZeneca class: INDUSTRY briefSummary: This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk. conditions: COPD (Chronic Obstructive Pulmonary Disease) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 5000 type: ESTIMATED name: BGF MDI 320/14.4/9.6 μg name: GFF MDI 14.4/9.6 μg measure: Time to first severe cardiac or COPD event measure: Time to first severe COPD exacerbation event measure: Time to first severe cardiac event measure: Time to cardiopulmonary death measure: Moderate/severe COPD exacerbation rate measure: Time to Myocardial Infarction (MI) hospitalization or cardiac death measure: Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death measure: Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Athens state: Alabama zip: 35611 country: United States lat: 34.80243 lon: -86.97219 facility: Research Site status: NOT_YET_RECRUITING city: Cullman state: Alabama zip: 35058 country: United States lat: 34.17482 lon: -86.84361 facility: Research Site status: RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: Research Site status: NOT_YET_RECRUITING city: Huntsville state: Alabama zip: 35801 country: United States lat: 34.7304 lon: -86.58594 facility: Research Site status: NOT_YET_RECRUITING city: Mobile state: Alabama zip: 36608 country: United States lat: 30.69436 lon: -88.04305 facility: Research Site status: NOT_YET_RECRUITING city: Sheffield state: Alabama zip: 35660 country: United States lat: 34.76509 lon: -87.69864 facility: Research Site status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85296 country: United States lat: 33.35283 lon: -111.78903 facility: Research Site status: NOT_YET_RECRUITING city: Glendale state: Arizona zip: 85308 country: United States lat: 33.53865 lon: -112.18599 facility: Research Site status: RECRUITING city: Mesa state: Arizona zip: 85206 country: United States lat: 33.42227 lon: -111.82264 facility: Research Site status: NOT_YET_RECRUITING city: Mesa state: Arizona zip: 85213 country: United States lat: 33.42227 lon: -111.82264 facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85006 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Tempe state: Arizona zip: 85281 country: United States lat: 33.41477 lon: -111.90931 facility: Research Site status: NOT_YET_RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 facility: Research Site status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Research Site status: NOT_YET_RECRUITING city: Apple Valley state: California zip: 92307 country: United States lat: 34.50083 lon: -117.18588 facility: Research Site status: NOT_YET_RECRUITING city: Banning state: California zip: 92220 country: United States lat: 33.92557 lon: -116.87641 facility: Research Site status: NOT_YET_RECRUITING city: Canoga Park state: California zip: 91303 country: United States lat: 34.20112 lon: -118.59814 facility: Research Site status: NOT_YET_RECRUITING city: Garden Grove state: California zip: 92844 country: United States lat: 33.77391 lon: -117.94145 facility: Research Site status: NOT_YET_RECRUITING city: Gardena state: California zip: 90247 country: United States lat: 33.88835 lon: -118.30896 facility: Research Site status: NOT_YET_RECRUITING city: Inglewood state: California zip: 90301 country: United States lat: 33.96168 lon: -118.35313 facility: Research Site status: NOT_YET_RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: Research Site status: NOT_YET_RECRUITING city: La Palma state: California zip: 90623 country: United States lat: 33.8464 lon: -118.04673 facility: Research Site status: NOT_YET_RECRUITING city: Lomita state: California zip: 90717 country: United States lat: 33.79224 lon: -118.31507 facility: Research Site status: NOT_YET_RECRUITING city: Los Alamitos state: California zip: 90720 country: United States lat: 33.80307 lon: -118.07256 facility: Research Site status: NOT_YET_RECRUITING city: Newport Beach state: California zip: 92660 country: United States lat: 33.61891 lon: -117.92895 facility: Research Site status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 facility: Research Site status: NOT_YET_RECRUITING city: North Hollywood state: California zip: 91602 country: United States lat: 34.17223 lon: -118.37897 facility: Research Site status: NOT_YET_RECRUITING city: Panorama City state: California zip: 91402 country: United States lat: 34.22473 lon: -118.44981 facility: Research Site status: NOT_YET_RECRUITING city: Pomona state: California zip: 91768 country: United States lat: 34.05529 lon: -117.75228 facility: Research Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95823 country: United States lat: 38.58157 lon: -121.4944 facility: Research Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95831 country: United States lat: 38.58157 lon: -121.4944 facility: Research Site status: NOT_YET_RECRUITING city: Salinas state: California zip: 93901 country: United States lat: 36.67774 lon: -121.6555 facility: Research Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92111 country: United States lat: 32.71533 lon: -117.15726 facility: Research Site status: NOT_YET_RECRUITING city: San Dimas state: California zip: 91773 country: United States lat: 34.10668 lon: -117.80673 facility: Research Site status: NOT_YET_RECRUITING city: Santa Ana state: California zip: 92704 country: United States lat: 33.74557 lon: -117.86783 facility: Research Site status: NOT_YET_RECRUITING city: Tarzana state: California zip: 91356 country: United States lat: 34.17334 lon: -118.55397 facility: Research Site status: NOT_YET_RECRUITING city: Thousand Oaks state: California zip: 91360 country: United States lat: 34.17056 lon: -118.83759 facility: Research Site status: NOT_YET_RECRUITING city: Vista state: California zip: 92081 country: United States lat: 33.20004 lon: -117.24254 facility: Research Site status: NOT_YET_RECRUITING city: Westminster state: California zip: 92683 country: United States lat: 33.75918 lon: -118.00673 facility: Research Site status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80012 country: United States lat: 39.72943 lon: -104.83192 facility: Research Site status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80224 country: United States lat: 39.73915 lon: -104.9847 facility: Research Site status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80228 country: United States lat: 39.73915 lon: -104.9847 facility: Research Site status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 20016 country: United States lat: 38.89511 lon: -77.03637 facility: Research Site status: NOT_YET_RECRUITING city: Boynton Beach state: Florida zip: 33435 country: United States lat: 26.52535 lon: -80.06643 facility: Research Site status: NOT_YET_RECRUITING city: Bradenton state: Florida zip: 34208 country: United States lat: 27.49893 lon: -82.57482 facility: Research Site status: NOT_YET_RECRUITING city: Cape Coral state: Florida zip: 33990 country: United States lat: 26.56285 lon: -81.94953 facility: Research Site status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33756 country: United States lat: 27.96585 lon: -82.8001 facility: Research Site status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33765 country: United States lat: 27.96585 lon: -82.8001 facility: Research Site status: NOT_YET_RECRUITING city: Crystal River state: Florida zip: 34429 country: United States lat: 28.90248 lon: -82.5926 facility: Research Site status: NOT_YET_RECRUITING city: Cutler Bay state: Florida zip: 33189 country: United States lat: 25.5783 lon: -80.3377 facility: Research Site status: NOT_YET_RECRUITING city: Edgewater state: Florida zip: 32132 country: United States lat: 28.98888 lon: -80.90228 facility: Research Site status: NOT_YET_RECRUITING city: Fort Lauderdale state: Florida zip: 33308 country: United States lat: 26.12231 lon: -80.14338 facility: Research Site status: NOT_YET_RECRUITING city: Fort Myers state: Florida zip: 33912 country: United States lat: 26.62168 lon: -81.84059 facility: Research Site status: NOT_YET_RECRUITING city: Hialeah state: Florida zip: 33013 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site status: NOT_YET_RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Research Site status: NOT_YET_RECRUITING city: Kissimmee state: Florida zip: 34741 country: United States lat: 28.30468 lon: -81.41667 facility: Research Site status: NOT_YET_RECRUITING city: Kissimmee state: Florida zip: 34746 country: United States lat: 28.30468 lon: -81.41667 facility: Research Site status: NOT_YET_RECRUITING city: Lake City state: Florida zip: 32055 country: United States lat: 30.18968 lon: -82.63929 facility: Research Site status: NOT_YET_RECRUITING city: Lake Worth state: Florida zip: 33467 country: United States lat: 26.61708 lon: -80.07231 facility: Research Site status: NOT_YET_RECRUITING city: Lakeland state: Florida zip: 33813 country: United States lat: 28.03947 lon: -81.9498 facility: Research Site status: NOT_YET_RECRUITING city: Loxahatchee Groves state: Florida zip: 33470 country: United States lat: 26.68368 lon: -80.27977 facility: Research Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States lat: 25.90871 lon: -80.30866 facility: Research Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: RECRUITING city: Miami state: Florida zip: 33175 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33256 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: NOT_YET_RECRUITING city: Naples state: Florida zip: 34102 country: United States lat: 26.14234 lon: -81.79596 facility: Research Site status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34470 country: United States lat: 29.1872 lon: -82.14009 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32819 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32825 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Ormond Beach state: Florida zip: 32174 country: United States lat: 29.28581 lon: -81.05589 facility: Research Site status: NOT_YET_RECRUITING city: Pembroke Pines state: Florida zip: 33024 country: United States lat: 26.00315 lon: -80.22394 facility: Research Site status: NOT_YET_RECRUITING city: Plantation state: Florida zip: 33324 country: United States lat: 26.13421 lon: -80.23184 facility: Research Site status: NOT_YET_RECRUITING city: Saint Petersburg state: Florida zip: 33713 country: United States lat: 27.77086 lon: -82.67927 facility: Research Site status: NOT_YET_RECRUITING city: Sun City Center state: Florida zip: 33573 country: United States lat: 27.71809 lon: -82.35176 facility: Research Site status: NOT_YET_RECRUITING city: Tamarac state: Florida zip: 33321 country: United States lat: 26.21286 lon: -80.24977 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33606 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33625 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30349 country: United States lat: 33.749 lon: -84.38798 facility: Research Site status: NOT_YET_RECRUITING city: Buford state: Georgia zip: 30519 country: United States lat: 34.12066 lon: -84.00435 facility: Research Site status: NOT_YET_RECRUITING city: Peachtree Corners state: Georgia zip: 30092 country: United States lat: 33.9701 lon: -84.22159 facility: Research Site status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31406 country: United States lat: 32.08354 lon: -81.09983 facility: Research Site status: NOT_YET_RECRUITING city: Boise state: Idaho zip: 83706 country: United States lat: 43.6135 lon: -116.20345 facility: Research Site status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: Research Site status: NOT_YET_RECRUITING city: Winfield state: Illinois zip: 60190 country: United States lat: 41.8617 lon: -88.1609 facility: Research Site status: NOT_YET_RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States lat: 41.47309 lon: -87.06114 facility: Research Site status: NOT_YET_RECRUITING city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: Research Site status: NOT_YET_RECRUITING city: Wichita state: Kansas zip: 67218 country: United States lat: 37.69224 lon: -97.33754 facility: Research Site status: NOT_YET_RECRUITING city: Lexington state: Kentucky zip: 40503 country: United States lat: 37.98869 lon: -84.47772 facility: Research Site status: NOT_YET_RECRUITING city: Paducah state: Kentucky zip: 42001 country: United States lat: 37.08339 lon: -88.60005 facility: Research Site status: NOT_YET_RECRUITING city: Lafayette state: Louisiana zip: 70508 country: United States lat: 30.22409 lon: -92.01984 facility: Research Site status: NOT_YET_RECRUITING city: Monroe state: Louisiana zip: 71201 country: United States lat: 32.50931 lon: -92.1193 facility: Research Site status: RECRUITING city: Shreveport state: Louisiana zip: 71105 country: United States lat: 32.52515 lon: -93.75018 facility: Research Site status: NOT_YET_RECRUITING city: Zachary state: Louisiana zip: 70791 country: United States lat: 30.64852 lon: -91.1565 facility: Research Site status: NOT_YET_RECRUITING city: Oxon Hill state: Maryland zip: 20745 country: United States lat: 38.80345 lon: -76.9897 facility: Research Site status: NOT_YET_RECRUITING city: Potomac state: Maryland zip: 20854 country: United States lat: 39.01817 lon: -77.20859 facility: Research Site status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Research Site status: NOT_YET_RECRUITING city: Flint state: Michigan zip: 48504 country: United States lat: 43.01253 lon: -83.68746 facility: Research Site status: NOT_YET_RECRUITING city: Lathrup Village state: Michigan zip: 48076 country: United States lat: 42.49642 lon: -83.22271 facility: Research Site status: NOT_YET_RECRUITING city: Southfield state: Michigan zip: 48034 country: United States lat: 42.47337 lon: -83.22187 facility: Research Site status: RECRUITING city: Gulfport state: Mississippi zip: 39503 country: United States lat: 30.36742 lon: -89.09282 facility: Research Site status: NOT_YET_RECRUITING city: Olive Branch state: Mississippi zip: 38654 country: United States lat: 34.96176 lon: -89.82953 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64116 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Liberty state: Missouri zip: 64068 country: United States lat: 39.24611 lon: -94.41912 facility: Research Site status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63136 country: United States lat: 38.62727 lon: -90.19789 facility: Research Site status: RECRUITING city: Missoula state: Montana zip: 59808 country: United States lat: 46.87215 lon: -113.994 facility: Research Site status: NOT_YET_RECRUITING city: Fremont state: Nebraska zip: 68025 country: United States lat: 41.43333 lon: -96.49808 facility: Research Site status: NOT_YET_RECRUITING city: Grand Island state: Nebraska zip: 68803 country: United States lat: 40.92501 lon: -98.34201 facility: Research Site status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States lat: 41.25626 lon: -95.94043 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89101 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89119 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Lawrence Township state: New Jersey zip: 08648 country: United States lat: 40.29588 lon: -74.72009 facility: Research Site status: NOT_YET_RECRUITING city: Mullica Hill state: New Jersey zip: 08062 country: United States lat: 39.73928 lon: -75.22407 facility: Research Site status: NOT_YET_RECRUITING city: Toms River state: New Jersey zip: 08755 country: United States lat: 39.95373 lon: -74.19792 facility: Research Site status: WITHDRAWN city: Union City state: New Jersey zip: 07087 country: United States lat: 40.77955 lon: -74.02375 facility: Research Site status: WITHDRAWN city: Albuquerque state: New Mexico zip: 87109 country: United States lat: 35.08449 lon: -106.65114 facility: Research Site status: NOT_YET_RECRUITING city: Albany state: New York zip: 12205 country: United States lat: 42.65258 lon: -73.75623 facility: Research Site status: NOT_YET_RECRUITING city: Bronxville state: New York zip: 10708 country: United States lat: 40.93815 lon: -73.83208 facility: Research Site status: RECRUITING city: Bronx state: New York zip: 10455 country: United States lat: 40.84985 lon: -73.86641 facility: Research Site status: NOT_YET_RECRUITING city: Massapequa state: New York zip: 11758 country: United States lat: 40.68066 lon: -73.47429 facility: Research Site status: NOT_YET_RECRUITING city: New Windsor state: New York zip: 12553 country: United States lat: 41.47676 lon: -74.02375 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10036 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: Vestal state: New York zip: 13850 country: United States lat: 42.08507 lon: -76.05381 facility: Research Site status: NOT_YET_RECRUITING city: Fayetteville state: North Carolina zip: 28303 country: United States lat: 35.05266 lon: -78.87836 facility: Research Site status: NOT_YET_RECRUITING city: Greensboro state: North Carolina zip: 27405 country: United States lat: 36.07264 lon: -79.79198 facility: Research Site status: NOT_YET_RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Research Site status: NOT_YET_RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States lat: 35.41069 lon: -80.84285 facility: Research Site status: NOT_YET_RECRUITING city: Morehead City state: North Carolina zip: 28557 country: United States lat: 34.72294 lon: -76.72604 facility: Research Site status: NOT_YET_RECRUITING city: Raleigh state: North Carolina zip: 27612 country: United States lat: 35.7721 lon: -78.63861 facility: Research Site status: NOT_YET_RECRUITING city: Salisbury state: North Carolina zip: 28144 country: United States lat: 35.67097 lon: -80.47423 facility: Research Site status: NOT_YET_RECRUITING city: Statesville state: North Carolina zip: 28625 country: United States lat: 35.78264 lon: -80.8873 facility: Research Site status: NOT_YET_RECRUITING city: Statesville state: North Carolina zip: 28677 country: United States lat: 35.78264 lon: -80.8873 facility: Research Site status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Research Site status: NOT_YET_RECRUITING city: Beavercreek state: Ohio zip: 45431 country: United States lat: 39.70923 lon: -84.06327 facility: Research Site status: NOT_YET_RECRUITING city: Blue Ash state: Ohio zip: 45242 country: United States lat: 39.232 lon: -84.37827 facility: Research Site status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44130 country: United States lat: 41.4995 lon: -81.69541 facility: Research Site status: RECRUITING city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43235 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Marion state: Ohio zip: 43302 country: United States lat: 40.58867 lon: -83.12852 facility: Research Site status: NOT_YET_RECRUITING city: Toledo state: Ohio zip: 43617 country: United States lat: 41.66394 lon: -83.55521 facility: Research Site status: NOT_YET_RECRUITING city: Norman state: Oklahoma zip: 73071 country: United States lat: 35.22257 lon: -97.43948 facility: Research Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73134 country: United States lat: 35.46756 lon: -97.51643 facility: Research Site status: NOT_YET_RECRUITING city: Tulsa state: Oklahoma zip: 74133 country: United States lat: 36.15398 lon: -95.99277 facility: Research Site status: NOT_YET_RECRUITING city: Grants Pass state: Oregon zip: 97527 country: United States lat: 42.43933 lon: -123.33067 facility: Research Site status: NOT_YET_RECRUITING city: Medford state: Oregon zip: 97504 country: United States lat: 42.32652 lon: -122.87559 facility: Research Site status: NOT_YET_RECRUITING city: Roseburg state: Oregon zip: 97471 country: United States lat: 43.2165 lon: -123.34174 facility: Research Site status: NOT_YET_RECRUITING city: Camp Hill state: Pennsylvania zip: 17011 country: United States lat: 40.23981 lon: -76.91997 facility: Research Site status: NOT_YET_RECRUITING city: DuBois state: Pennsylvania zip: 15801 country: United States lat: 41.11923 lon: -78.76003 facility: Research Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19140 country: United States lat: 39.95233 lon: -75.16379 facility: Research Site status: RECRUITING city: Anderson state: South Carolina zip: 29621 country: United States lat: 34.50344 lon: -82.65013 facility: Research Site status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29414 country: United States lat: 32.77657 lon: -79.93092 facility: Research Site status: NOT_YET_RECRUITING city: Columbia state: South Carolina zip: 29201 country: United States lat: 34.00071 lon: -81.03481 facility: Research Site status: RECRUITING city: Gaffney state: South Carolina zip: 29340 country: United States lat: 35.07179 lon: -81.64982 facility: Research Site status: NOT_YET_RECRUITING city: Spartanburg state: South Carolina zip: 29303 country: United States lat: 34.94957 lon: -81.93205 facility: Research Site status: RECRUITING city: Union state: South Carolina zip: 29379 country: United States lat: 34.71541 lon: -81.62371 facility: Research Site status: NOT_YET_RECRUITING city: North Sioux City state: South Dakota zip: 57049 country: United States lat: 42.52722 lon: -96.48309 facility: Research Site status: NOT_YET_RECRUITING city: Rapid City state: South Dakota zip: 57701 country: United States lat: 44.08054 lon: -103.23101 facility: Research Site status: NOT_YET_RECRUITING city: Chattanooga state: Tennessee zip: 37421 country: United States lat: 35.04563 lon: -85.30968 facility: Research Site status: NOT_YET_RECRUITING city: Elizabethton state: Tennessee zip: 37643 country: United States lat: 36.34872 lon: -82.21069 facility: Research Site status: NOT_YET_RECRUITING city: Franklin state: Tennessee zip: 37067 country: United States lat: 35.92506 lon: -86.86889 facility: Research Site status: NOT_YET_RECRUITING city: Morristown state: Tennessee zip: 37813 country: United States lat: 36.21398 lon: -83.29489 facility: Research Site status: RECRUITING city: Tullahoma state: Tennessee zip: 37388 country: United States lat: 35.36202 lon: -86.20943 facility: Research Site status: NOT_YET_RECRUITING city: Abilene state: Texas zip: 79606 country: United States lat: 32.44874 lon: -99.73314 facility: Research Site status: NOT_YET_RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Research Site status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78704 country: United States lat: 30.26715 lon: -97.74306 facility: Research Site status: NOT_YET_RECRUITING city: Brownsville state: Texas zip: 78520 country: United States lat: 25.90175 lon: -97.49748 facility: Research Site status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75225 country: United States lat: 32.78306 lon: -96.80667 facility: Research Site status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75235 country: United States lat: 32.78306 lon: -96.80667 facility: Research Site status: NOT_YET_RECRUITING city: Denison state: Texas zip: 75020 country: United States lat: 33.75566 lon: -96.53666 facility: Research Site status: NOT_YET_RECRUITING city: El Paso state: Texas zip: 79902 country: United States lat: 31.75872 lon: -106.48693 facility: Research Site status: NOT_YET_RECRUITING city: Forney state: Texas zip: 75126 country: United States lat: 32.74818 lon: -96.47193 facility: Research Site status: NOT_YET_RECRUITING city: Georgetown state: Texas zip: 78633 country: United States lat: 30.63269 lon: -97.67723 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77002 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77024 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77025 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77029 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: 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zip: 250 01 country: Czechia lat: 50.18356 lon: 14.67244 facility: Research Site status: NOT_YET_RECRUITING city: Olomouc zip: 772 00 country: Czechia lat: 49.59552 lon: 17.25175 facility: Research Site status: NOT_YET_RECRUITING city: Ostrava zip: 702 00 country: Czechia lat: 49.83465 lon: 18.28204 facility: Research Site status: NOT_YET_RECRUITING city: Praha 1 zip: 110 00 country: Czechia lat: 50.08804 lon: 14.42076 facility: Research Site status: NOT_YET_RECRUITING city: Rokycany zip: 337 22 country: Czechia lat: 49.7427 lon: 13.59459 facility: Research Site status: NOT_YET_RECRUITING city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 facility: Research Site status: NOT_YET_RECRUITING city: Esbjerg zip: 6700 country: Denmark lat: 55.47028 lon: 8.45187 facility: Research Site status: NOT_YET_RECRUITING city: Hvidovre zip: 2650 country: Denmark lat: 55.65719 lon: 12.47364 facility: Research Site status: NOT_YET_RECRUITING city: København NV zip: 2400 country: Denmark 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 nctId: NCT06283953 id: 2023P001695 id: IHS-2022C1-26100 type: OTHER_GRANT domain: Patient Centered Outcomes Research Institute (PCORI) briefTitle: Boosting Resources for Tracheostomy Care at Home acronym: BREATHE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-01 date: 2027-10-01 date: 2024-02-28 date: 2024-02-28 name: Massachusetts General Hospital class: OTHER name: Children's Hospital Medical Center, Cincinnati name: Children's Hospital of Philadelphia name: Children's Hospitals and Clinics of Minnesota name: Children's National Research Institute name: Rady Children's Hospital, San Diego name: Patient-Centered Outcomes Research Institute briefSummary: The goal of this trial is to advance our understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:

* How can we support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
* How can we leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?

Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm. conditions: Tracheostomy conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Blinding of care team delivering the interventions and of caregiver participants receiving the interventions is not possible for this study.

The outcome assessors collecting the readmission data and statistician conducting analyses will be blinded to the assignment. whoMasked: OUTCOMES_ASSESSOR count: 480 type: ESTIMATED name: Trach@Home name: Trach Me Home measure: Caregiver Burden measure: Medical Complications Associated with Tracheostomy measure: 6-month Readmission Rate measure: Frequency of pediatrician communication measure: Primary care pediatrician satisfaction measure: Medical Complications Associated with Tracheostomy measure: Caregiver Burden measure: Number of readmissions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of San Diego Rady Children's Hospital city: La Jolla state: California zip: 92093 country: United States name: Matthew Brigger, MD role: CONTACT email: mbrigger@rchsd.org name: Matthew Brigger, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Children's National Medical Center, Children's Research Institute city: Silver Spring state: Maryland zip: 20910 country: United States name: Habib Zalzal, MD role: CONTACT email: hzalzal@cnmc.org name: Habib Zalzal, MD role: PRINCIPAL_INVESTIGATOR lat: 38.99067 lon: -77.02609 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Karen Sepucha, PhD role: CONTACT email: ksepucha@mgh.harvard.edu name: Christopher Hartnick, MD role: CONTACT lat: 42.35843 lon: -71.05977 facility: Children's Hospitals and Clinics of Minnesota city: Minneapolis state: Minnesota zip: 55404 country: United States name: Asitha Jayawardena, MD role: CONTACT email: asitha.jayawardena@childrensmn.org name: Asitha Jayawardena, MD role: PRINCIPAL_INVESTIGATOR lat: 44.97997 lon: -93.26384 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States name: Matthew Smith, MD role: CONTACT email: matthew.smith@cchmc.org name: Matthew Smith, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19146 country: United States name: Luv Javia, MD role: CONTACT email: javia@chop.edu name: Luv Javia, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06283940 id: 281694 briefTitle: Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation acronym: TAVI overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-01 date: 2026-01 date: 2024-02-28 date: 2024-04-24 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation (TAVI). TAVI is a growing treatment in Sweden, allowing previously inoperable older patients with AS, who are often frail and have comorbidities, to receive intervention. This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI. Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI have shown that participation in PT-X can improve physical fitness (the highest measured oxygen uptake (VO2peak)), walking distance, walking speed, and health-related quality of life (HR-QoL). However, the included studies are limited, and there is selection bias, resulting in low evidence. Therefore, access to PT-X is currently almost non-existent in Sweden. As more patients undergo TAVI, it is crucial to investigate whether PT-X after TAVI can further improve physical fitness, HR-QoL, and reduce hospital admissions in older individuals with AS.

Objective: Primary, to investigate whether participation in PT-X after TAVI can impact physical fitness, physical activity level, and health-related quality of life. Secondary, to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI.

Expected outcome: If patients with AS who have undergone TAVI can improve physical fitness, it could potentially strengthen the evidence and optimize the patient's physical capabilities. Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions. This would decrease healthcare consumption and improve the patient's quality of life. conditions: Aortic Valve Stenosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group and matched controls based on age, gender and exercise capacity in watt. primaryPurpose: TREATMENT masking: NONE maskingDescription: Data collection will be conducted by a physiotherapist not involved in the intervention. count: 135 type: ESTIMATED name: Physiotherapist-led exercise based cardiac rehabilitation (PT-X) measure: Exercise capacity in watt measure: Rating of perceived exertion Borg RPE scale 6-20 measure: Exercise capacity in Watt measure: Rating of perceived exertion Borg RPE scale 6-20 measure: Muscular endurance test, shoulder flexion measure: Muscular endurance test, shoulder flexion measure: Muscle endurance test, shoulder abduction measure: Muscle endurance test, shoulder abduction measure: Muscle endurance test, unilateral heel-lift measure: Muscle endurance test, unilateral heel-lift measure: Lower extremity function measure: Lower extremity function measure: Physical activity measure: Physical activity measure: Self-assessed level of physical activity measure: Self-assessed level of physical activity measure: Health Related Quality of Life measure: Health Related Quality of Life measure: Frailty measure: Frailty measure: Hospital admission measure: Hospital admission sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283927 id: MEC-2020-0812-5 briefTitle: The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) acronym: RECSUR overallStatus: RECRUITING date: 2023-01-01 date: 2027-01-01 date: 2028-01-01 date: 2024-02-28 date: 2024-02-28 name: Jasper Gerritsen class: OTHER name: Haaglanden Medical Centre name: Universitaire Ziekenhuizen KU Leuven name: University Hospital Heidelberg name: Technical University of Munich name: Insel Gruppe AG, University Hospital Bern name: Massachusetts General Hospital name: University of California, San Francisco briefSummary: Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.

This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. conditions: Glioblastoma conditions: Glioblastoma Multiforme conditions: Glioblastoma, IDH-wildtype conditions: Glioblastoma Multiforme of Brain conditions: Glioblastoma Multiforme, Adult conditions: Recurrent Glioblastoma conditions: Astrocytoma, Malignant conditions: Astrocytoma of Brain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 464 type: ESTIMATED name: Re-resection name: Temozolomide name: Lomustine name: Re-irradiation name: Experimental therapy name: Best supportive care measure: Overall survival measure: Neurological morbidity at 6 weeks measure: Neurological morbidity at 3 months measure: Neurological morbidity at 6 months measure: Progression-free survival measure: Residual tumor volume measure: Quality of life at 6 weeks (EORTC QLQ C30) measure: Quality of life at 3 months (EORTC QLQ C30) measure: Quality of life at 6 months (EORTC QLQ C30) measure: Quality of life at 6 weeks (EORTC QLQ BN20) measure: Quality of life at 3 months (EORTC QLQ BN20) measure: Quality of life at 6 months (EORTC QLQ BN20) measure: Quality of life at 6 weeks (EQ-5D) measure: Quality of life at 3 months (EQ-5D) measure: Quality of life at 6 months (EQ-5D) measure: Serious Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Mitchel Berger, MD PhD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Brian Nahed, MD PhD role: CONTACT lat: 42.35843 lon: -71.05977 facility: University Hospital Leuven status: RECRUITING city: Leuven country: Belgium name: Steven De Vleeschouwer, MD PhD role: CONTACT lat: 50.87959 lon: 4.70093 facility: University Hospital Heidelberg status: RECRUITING city: Heidelberg country: Germany name: Christine Jungk, Dr. med. role: CONTACT lat: 49.40768 lon: 8.69079 facility: Technical University Munich status: NOT_YET_RECRUITING city: Munich country: Germany name: Arthur Wagner, MD role: CONTACT lat: 48.13743 lon: 11.57549 facility: Erasmus MC status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 CE country: Netherlands name: Arnaud Vincent, MD PhD role: CONTACT phone: +31639428949 email: a.vincent@erasmusmc.nl name: Jasper Gerritsen, MD role: CONTACT phone: +31629119553 email: j.gerritsen@erasmusmc.nl lat: 51.9225 lon: 4.47917 facility: Medical Center Haaglanden status: RECRUITING city: The Hague state: Zuid-Holland zip: 2261 CP country: Netherlands name: Marike Broekman, MD PhD role: CONTACT phone: +31639758253 email: m.broekman@haaglandenmc.nl lat: 52.07667 lon: 4.29861 facility: Inselspital Universitätsspital Bern status: NOT_YET_RECRUITING city: Bern country: Switzerland name: Philippe Schucht, MD PhD role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06283914 id: BIO-2024-0011 briefTitle: Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-09-01 date: 2024-02-28 date: 2024-02-28 name: American University of Beirut Medical Center class: OTHER briefSummary: The goal of this is prospective cohort study is to to study the relationship between PaO2 and SpO2 in the overall population undergoing general anesthesia in the OT. Secondary aims include studying the relationship between PaO2 and SpO2 in elderly and obese patients undergoing general anesthesia in the OT, validating the derivation of PaO2 from SpO2 using formulas derived by Rice et al. (2009), Pandharipande et al. (2009), and Gadrey et al. (2019) in patients undergoing general anesthesia in the OT, and, if the derivation formulas were not valid, to derive a formula for patients undergoing general anesthesia in the OT.

The included blood samples are arterial blood sample collected for ABGs analysis through either an arterial catheter or an arterial blood puncture in adult patients (Age \>18 years) undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency, or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients undergoing cardiac or thoracic surgeries will be excluded. conditions: Oxygen Saturation conditions: Respiratory Distress Syndrome conditions: Anesthesia, General studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: PaO2 measure: SpO2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283901 id: NL82013.018.22 briefTitle: Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness acronym: IMPROVE-DOC overallStatus: RECRUITING date: 2023-01-02 date: 2025-01-01 date: 2025-09-01 date: 2024-02-28 date: 2024-02-28 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome. conditions: Traumatic Brain Injury conditions: Intracranial Hemorrhages conditions: Subarachnoid Hemorrhage conditions: Meningitis conditions: Encephalitis conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED measure: Glasgow Outcome Scale Extended measure: Glasgow Outcome Scale Extended sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud UMC status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 GA country: Netherlands name: Astrid Hoedemaekers role: CONTACT lat: 51.8425 lon: 5.85278 facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105 AZ country: Netherlands name: Wolmet Haksteen, MD role: CONTACT phone: +31 020 - 566 9111 email: w.e.haksteen@amsterdamumc.nl lat: 52.37403 lon: 4.88969 facility: Haaglanden MC, locatie Westeinde status: RECRUITING city: Den Haag state: Zuid-Holland zip: 2512 VA country: Netherlands name: Sefanja Achterberg role: CONTACT lat: 52.07667 lon: 4.29861 facility: Erasmus MC status: NOT_YET_RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands name: Mathieu van der Jagt role: CONTACT lat: 51.9225 lon: 4.47917 facility: UMC Groningen status: NOT_YET_RECRUITING city: Groningen zip: 9713 GZ country: Netherlands name: Joukje van der Naalt role: CONTACT lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06283888 id: PRECISE-PCI briefTitle: CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention overallStatus: RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2028-12-01 date: 2024-02-28 date: 2024-03-20 name: Zunyi Medical College class: OTHER briefSummary: In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice. conditions: ACS - Acute Coronary Syndrome conditions: CYP2C19 Polymorphism studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1200 type: ESTIMATED name: CYP2C19 Genotype Guided DAPT name: Conventional DAPT measure: NACE (net adverse clinical event) measure: Incidence of clinically significant bleeding measure: Incidence of MACCE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Zunyi Medical University status: RECRUITING city: Zunyi state: Guizhou zip: 563003 country: China name: Cai De Jin, MD role: CONTACT phone: 86+173-8576-9997 email: jincaide@zmu.edu.cn name: Yan Yan Jin, MD, PhD role: CONTACT phone: 86+157-7229-0925 email: jinyanyan850925@163.com name: Cai De Jin, MD role: PRINCIPAL_INVESTIGATOR name: Ran Zun Zhao, MD role: SUB_INVESTIGATOR lat: 27.68667 lon: 106.90722 hasResults: False

 nctId: NCT06283875 id: PROMISEPLUS-301 briefTitle: The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-01-30 date: 2029-01-30 date: 2024-02-28 date: 2024-02-28 name: Geneplus-Beijing Co. Ltd. class: INDUSTRY briefSummary: This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS. conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: DFS of enrolled patients for 2 years sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215006 country: China name: Jinhua Zhou role: CONTACT phone: +86 13914024750 email: jsjhzh@126.com name: Songbing Qin role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06283862 id: HUM00231159b id: VMR2022-03 type: OTHER_GRANT domain: Michigan, State of, Licensing and Regulatory Affairs, Department of 573000 briefTitle: MIVetsCan: Can-Coach Trial (Phase 2) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-02 date: 2027-02 date: 2024-02-28 date: 2024-02-28 name: University of Michigan class: OTHER name: Michigan, State of, Licensing and Regulatory Affairs briefSummary: The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to immediately receive 4 sessions of tailored guidance or to receive it after 12 weeks, as a waitlist control condition. primaryPurpose: PREVENTION masking: NONE count: 468 type: ESTIMATED name: Educational Session measure: Patient Global Impression of Change (PGIC) score measure: Self-report of pain (intensity or severity) from a numerical rating scale of 0-10 measure: Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1 measure: Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1 measure: Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1 measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48105 country: United States name: Vivian Kurtz role: CONTACT phone: 734-998-7156 email: vkurtz@med.umich.edu name: Kevin Boehnke role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06283849 id: SON-2024-32671 briefTitle: Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-02-28 date: 2024-02-28 name: University of Minnesota class: OTHER briefSummary: The disparate burden of Type 2 Diabetes (T2D) faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated cardiovascular (CV) complications, essential.

Similar to differences in cardiovascular disease (CVD) rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in physical activity PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.

The disparate burden of T2D faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated CV complications, essential.

Similar to differences in CVD rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.

The goal is to develop a deeper understanding of individuals' experiences of sedentary behavior (SB) and collaborate to design strategies to reduce SB. Using the Center for Chronic Disease Reduction and Equity Promotion Across Minnesota (C2DREAM) conceptual model, social-ecological framework, and COM-B model, the study will seek to understand the relationship between SB and individual, relationship, community, and societal factors. The study will also examine the context of SB and strategies that participants have used and could or would consider using to break up the time they spend sitting. conditions: Cardiovascular Diseases conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Explanatory sequential mixed methods study of N=30 Black adults aged 55 and older with T2D. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: strategies to break up SB measure: sedentary time sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55414 country: United States name: Mary O Whipple, PhD, RN, PHN role: CONTACT phone: 612-625-4470 email: whipp042@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06283836 id: Dexrem ATI 4-6 briefTitle: Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-15 date: 2024-02-28 date: 2024-02-28 name: Iuliu Hatieganu University of Medicine and Pharmacy class: OTHER briefSummary: Dexmedetomidine continuous intravenous infusion vs. remifentanil target-controlled infusion conscious sedation for stapedotomy/stapedectomy- a prospective, single-center, double-masked randomized trial

The goal of this clinical trial is to compare monitored anesthesia care with continuous intravenous dexmedetomidine vs. remifentanil target-controlled infusion in patients undergoing stapedotomy or stapedectomy for otosclerosis. The aims of this research are:

* to assess the patient's satisfaction with each sedation regimen
* the surgeon will also grade their satisfaction regarding the surgical field The investigators will monitor and analyze the vitals during and after the intervention and document any intra- and postoperative complications.

Participants will be randomly assigned to receive either dexmedetomidine or remifentanil, and the patient, the surgeon, and the investigator will not be aware of the treatment administered. conditions: Otosclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Dexmedetomidine name: Remifentanil measure: Patient satisfaction measure: Surgeon satisfaction measure: mean arterial pressure measure: Heart Rate measure: the need for adjuncts during intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cluj County Clinical Emergency Hospital city: Cluj Napoca state: Cluj zip: 400006 country: Romania name: Caius Mihai Breazu, MD, PhD role: CONTACT phone: +40743010012 email: csbreazu@yahoo.com name: ioan florin marchis, MD, PhD role: CONTACT phone: +40757065205 email: mosku17@yahoo.com lat: 46.76667 lon: 23.6 hasResults: False

 nctId: NCT06283823 id: 41821 briefTitle: Morphological Changes of Removable Orthodontic Retainers During the Use overallStatus: RECRUITING date: 2021-12-21 date: 2024-04-01 date: 2024-12-21 date: 2024-02-28 date: 2024-03-01 name: University of L'Aquila class: OTHER briefSummary: The retention is one of the stages of orthodontic treatment that aims to keep the teeth in the correct positions after orthodontic treatment. Without a retention phase, there is a tendency for the teeth to return to their initial position (relapse). To prevent relapse, at the end of orthodontic therapy the use of retaining devices to keep the teeth in their ideal position is required. The aim of the study is to analyse whether intraoral aging of removable retention devices can lead to morphological or dimensional changes, and whether or not these changes are related to orthodontic relapse, expressed as a change in the Peer Assessment Rating (PAR) index. The PAR index is an index that allows us to evaluate the relapse after orthodontic treatment. In this study the PAR index will be measured at the start of the retention period (T0), at the three-months follow-up (T1) and at the six months follow-up (T2). In particular, two types of thermoformed retainers with different cutouts will be evaluated to determine whether the presence of higher margins in a type of retainers allows to maintain greater stability over time and, therefore, to confer a mechanical and clinical advantage. conditions: Orthodontic Retainer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: Thermoformed orthodontic retainer measure: Peer Assessment Rating (PAR) index measure: Volumetric superimposition of digital models measure: Thickness sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of L'Aquila status: RECRUITING city: L'Aquila zip: 67100 country: Italy name: Michele Tepedino, DDS role: CONTACT phone: +39 340 276 1456 email: michele.tepedino@univaq.it lat: 42.35055 lon: 13.39954 hasResults: False

 nctId: NCT06283810 id: 2023/168 briefTitle: The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-09-30 date: 2024-02-28 date: 2024-03-06 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Midwives, who have an important place in the health system, are expected to be equipped to meet the health care needs of women (Fışkın \& Doğan, 2020). Therefore, midwifery students, who are known to play a role in promoting women's health, should have good interpersonal relationships, good problem-solving skills, and high self-reflection and insight, which are assumed to be effective in both, in order to fulfill these responsibilities.

Translated with DeepL.com (free version) conditions: Midwifery Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: psychotherapy of interpersonal relationships name: laughter therapy name: Plasebo measure: self-reflection skills measure: problem solving skills measure: interpersonal relationship skills sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Istanbul University-Cerrahpasa status: RECRUITING city: Istanbul zip: 34320 country: Turkey name: Betül Uncu role: CONTACT phone: +095078421227 email: betul.uncu@iuc.edu.tr name: Nurten Kaya role: SUB_INVESTIGATOR name: Betül Uncu role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06283797 id: RECHMPL22_0346 id: 2023-A01661-44 type: OTHER domain: ANSM briefTitle: Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes acronym: APATDIAGNOSIS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2027-05 date: 2024-02-28 date: 2024-02-28 name: University Hospital, Montpellier class: OTHER name: Hopital Universitaire Robert-Debre name: University Hospital, Tours name: University Hospital, Angers name: University of Virginia briefSummary: The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use.

The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.

An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase. conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control study in parallel groups, followed by a non randomized extension primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: OmniPod 5 name: Dexcom G6 name: PAID questionnaires measure: Glycated hemoglobin (HbA1c) level measure: Percent of time spent in the 70-180 mg/dl glucose range measure: Percent of time spent in the 70-140 mg/dl glucose range measure: Mean glucose level measure: Percent of time spent with glucose level below 70 mg/dl measure: Percent of time spent with glucose level below 54 mg/dl measure: Percent of time spent with glucose level above 180 mg/dl measure: Percent of time spent with glucose level above 250 mg/dl measure: Coefficient of glucose variability measure: Score of PAID questionnaire for parents measure: Score of PAID questionnaire for children measure: Stimulated plasma C-peptide level 10-min after 1mg IV glucagon measure: Number of needed interventions by the parents/guardians or care providers measure: Change of HbA1c level between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent in the 70-180 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent in the 70-140 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of mean glucose level between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level below 70 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level below 54 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level above 180 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level above 250 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of coefficient of glucose variability between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of score of PAID questionnaire for parents between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of score of PAID questionnaire for children between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of stimulated plasma C-peptide level 10-min after 1mg IV glucagon between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of number of needed interventions by the parents/guardians or care providers between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Difference in the HbA1c level between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent in the 70-180 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent in the 70-140 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period measure: Difference in the mean glucose level between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level below 70 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level below 54 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level above 180 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level above 250 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the coefficient of glucose variability between the 2 initially randomized groups at the end of the extension period measure: Difference in the score of PAID questionnaire for parents between the 2 initially randomized groups at the end of the extension period measure: Difference in the score of PAID questionnaire for children between the 2 initially randomized groups at the end of the extension period measure: Difference in the stimulated plasma C-peptide level 10-min after 1mg IV glucagon between the 2 initially randomized groups at the end of the extension period measure: Difference in the number of needed interventions by the parents/guardians or care providers between the 2 initially randomized groups at the end of the extension period measure: Incidence of treatment-emergent SUSARs, SAEs, ARs and AEs measure: Relatedness of treatment-emergent SUSARs, SAEs, ARs and AEs measure: Severity of treatment-emergent SUSARs, SAEs, ARs and AEs sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University Hospital, Angers city: Angers country: France name: Régis Coutant, MD role: CONTACT phone: 02 41 35 56 55 phoneExt: +33 email: recoutant@chu-angers.fr lat: 47.46667 lon: -0.55 facility: University Hospital, Montpellier city: Montpellier country: France name: Eric Renard, MD role: CONTACT phone: 04 67 33 83 82 phoneExt: +33 email: e-renard@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: Robert Debré Hospital, AP-HP city: Paris country: France name: Elise Bismuth Reisman, MD role: CONTACT phone: 01 40 03 20 67 phoneExt: +33 email: elise.bismuth@aphp.fr lat: 48.85341 lon: 2.3488 facility: University Hospital, Tours city: Tours country: France name: Yannis Chartier, MD role: CONTACT phone: 06 85 67 93 35 phoneExt: +33 email: Y.CHARTIER@chu-tours.fr lat: 47.38333 lon: 0.68333 hasResults: False

 nctId: NCT06283784 id: YOVIS Capsules briefTitle: Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients overallStatus: COMPLETED date: 2021-09-05 date: 2021-11-02 date: 2022-05-18 date: 2024-02-28 date: 2024-03-18 name: Biofarma class: INDUSTRY name: Hippocrates Research briefSummary: This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days.

The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days) conditions: Diarrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double blind, randomized, placebo-controlled study. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: YOVIS, the Investigational Food Supplement (IFS), is an oral formulation (capsules) containing definite mix of live probiotics. Placebo is an oral formulation of inert capsules. Placebo and YOVIS are identical in shape, size, colour and taste. Product test and placebo capsules will be indistinguishable.

Investigational food supplement products will be packed in an individual way for each subject included in the investigation. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ACTUAL name: Yovis Capsules name: Placebo measure: Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy measure: Severity and duration of AAD measure: Severity and duration of AAD measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Impact of bowel habits on QoL measure: Effects of YOVIS, versus placebo, at each visit on the overall health status measure: Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo measure: Global Patient's self-reported acceptance at the end of study measure: Global acceptability (investigator) at the end of study sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Practitioner Ambulatory city: Sanremo state: Italy/Imperia zip: 18038 country: Italy lat: 43.81725 lon: 7.7772 hasResults: False

 nctId: NCT06283771 id: TU-BOZKUL-007 briefTitle: The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-09-15 date: 2025-05-15 date: 2024-02-28 date: 2024-03-01 name: Tarsus University class: OTHER name: Mersin University briefSummary: In this study, it is aimed to reveal the effect of the use of heated socks to be developed as wearable technology by providing temperature control on body temperature, comfort perception level and shivering development in healthy volunteers and this purpose constitutes the unique value of the project. The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study. The population of the study will consist of 4th year nursing students consisting of an average of 250 people who will enroll in the fall semester of the 2024-2025 academic year. As a result of the power analysis performed in the G\*Power program, the sample will consist of 70 healthy volunteers, at least 35 in each group. In the study, data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form (Shivering Level Diagnosis Form and Temperature Comfort Perception Scale)" which includes the descriptive information of healthy volunteers. Healthy volunteers will fill out the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before being taken to the Faculty of Nursing Skills Laboratory for the application. Before the volunteers are taken to the single rooms in the laboratory, the environment will be cooled for 30 minutes with the air conditioner in the room so that the temperature is 21oC. The study group will wear socks developed with wearable technology and the control group will wear socks with the same appearance. The healthy volunteer will be asked to lie motionless on the bed for 60 minutes in a single room. Body temperature (with Braun tympanic thermometer), shivering level and temperature comfort perception will be recorded on the "Hypothermia Monitoring Form" when all healthy volunteers are taken to the Skills Laboratory, at 15 minutes, 30 minutes and 60 minutes, and when they leave the laboratory. The research data will be analyzed in a computer environment. Descriptive variables of healthy volunteers included in the study will be expressed as mean±standard deviation and median (maximum minimum), percentage and frequency. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analysis as further analy conditions: Wearable Technology conditions: Hypothermia conditions: Shivering conditions: Thermal Comfort Perception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study primaryPurpose: OTHER masking: TRIPLE maskingDescription: An independent biostatistician, who is not involved in the study, will select 70 individuals from the list of students enrolled between 1-250 by computer-generated randomization. The information that the volunteers included in the research sample were assigned to group A (experimental) and B (control) according to the randomization table will be kept by the researcher and the socks with the same appearance, with and without heating feature will be numbered from 1 to 70 according to the randomization table and given to the researcher. Thus, the practitioner will be blinded as he/she does not know which sock has a heating feature and which one does not. Healthy volunteers will be blinded because they do not know which group they are in. The data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will also be blinded to group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Heated socks to be developed with wearable technology measure: Body temperature measure: Shivering level measure: Thermal comfort perception measure: Descriptive Characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283758 id: PARADISE HTN-III briefTitle: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-07 date: 2026-10 date: 2024-02-28 date: 2024-03-04 name: Suzhou Municipal Hospital class: OTHER name: The Affiliated Jiangning Hospital of Nanjing Medical University name: The First Affiliated Hospital with Nanjing Medical University name: Affiliated Hospital of Nantong University briefSummary: This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control. conditions: Hypertension conditions: Blood Pressure conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: focused power ultrasound mediate inferior perirenal adipose tissue modification name: Sham-control group measure: Ambulatory Blood Pressure measure: Ambulatory Blood Pressure measure: Office Systolic Blood Pressure measure: Office Systolic Blood Pressure measure: Ambulatory Blood Pressure measure: Ambulatory Blood Pressure measure: Home Blood Pressure measure: Home Blood Pressure measure: Blood pressure control rate measure: Antihypertensive drug load index measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Affiliated Jiangning Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Yuqing Zhang role: CONTACT phone: 13851672168 name: Qin Tao role: CONTACT phone: 1585062208 name: Yuqing Zhang role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: The first Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Fang Zhou role: CONTACT phone: 13815401066 email: zhoufang7408@163.com name: Wei Sun role: CONTACT phone: 13815860536 email: shunwee@126.com name: Fang Zhou role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Affiliated Hospital of Nantong University city: Nantong state: Jiangsu zip: 210000 country: China name: Hongzhuan Sheng role: CONTACT phone: 13515203348 name: Jian Zhuo role: CONTACT phone: 18206297131 name: Hongzhuan Sheng role: PRINCIPAL_INVESTIGATOR lat: 32.03028 lon: 120.87472 facility: Suzhou Municipal Hospital city: Suzhou state: Jiangsu zip: 210000 country: China name: Yanhui Sheng role: CONTACT phone: 13851647530 email: yhshengnjmu@163.com name: Yang Hua role: CONTACT phone: 13851624359 email: 759150674@qq.com name: Yanhui Sheng role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06283745 id: 73225 briefTitle: Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia overallStatus: NOT_YET_RECRUITING date: 2024-03-23 date: 2027-03-22 date: 2027-03-22 date: 2024-02-28 date: 2024-02-28 name: Stanford University class: OTHER briefSummary: This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia. conditions: Paraosmia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PRP injections will be given to one arm while sham saline injections will be given to the other arm. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Platelet-rich Plasma (PRP) name: Saline measure: Change in Sniffin Sticks Parosmia Test (SSParoT) measure: Change in questionnaire of olfactory disorders (QOD) scale score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Sinus Center / Stanford University School of Medicine city: Palo Alto state: California zip: 94304 country: United States name: Homer Abaya, BS role: CONTACT phone: 650-725-6500 email: habaya@stanford.edu name: Maxime Fieux, MD, PhD role: CONTACT phone: +33621611643 email: fieuxma@stanford.edu name: Zara Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False

 nctId: NCT06283732 id: 20392 briefTitle: A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience. overallStatus: COMPLETED date: 2023-11-15 date: 2024-02-15 date: 2024-02-15 date: 2024-02-28 date: 2024-03-05 name: Amway Corp class: INDUSTRY name: Citruslabs briefSummary: The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires. conditions: Digestive System Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 70 type: ACTUAL name: Greens powder measure: Digestive Health Improvement measure: Quality of Life and Well-being Enhancement sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Citruslabs city: Santa Monica state: California zip: 90404 country: United States lat: 34.01945 lon: -118.49119 hasResults: False

 nctId: NCT06283719 id: ZG006-002 briefTitle: Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-28 date: 2024-02-28 name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd class: INDUSTRY briefSummary: This is a multicenter, open-label phase I/II study, divided into 2 parts:

Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.

Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer. conditions: Small Cell Lung Cancer conditions: Neuroendocrine Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 105 type: ESTIMATED name: ZG006 measure: Objective response rate (ORR) measure: Number of participants with adverse events (AEs) measure: Number of participants with serious adverse events (SAEs) measure: Duration of response (DOR) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai country: China name: Shun Lu role: CONTACT name: Shun Lu, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06283706 id: 1000081113 briefTitle: The Tryptophan Requirement in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-01 date: 2025-12-01 date: 2024-02-28 date: 2024-03-01 name: The Hospital for Sick Children class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress.

The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need. conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: Tryptophan measure: Determination of tryptophan requirement in adults >60 years of age. sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283693 id: RojdaBAYARYILDIRIM briefTitle: The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-05-10 date: 2025-06-10 date: 2024-02-28 date: 2024-02-28 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Purpose of the Study This study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol.

Materials and Method It will be conducted in a randomized controlled experimental design. This randomized controlled trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. conditions: Dependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels conditions: Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled classical experimental study primaryPurpose: OTHER masking: SINGLE maskingDescription: Computer-assisted randomization will be used in the study, and participants will be randomized to an intervention or control list control group in a 1:1 ratio by entering the number of samples to be reached through the program whose URL address is https://www.randomizer.org. Women who apply to the infertility outpatient clinic by the researcher and volunteer for the study who meet the sample selection criteria will be given numbers according to the order of outpatient clinic registration. A randomization sequence will be created according to these numbers and women will be assigned to the intervention and control groups by computer-assisted randomization. Since the study is a thesis, blinding will not be possible due to its nature. whoMasked: PARTICIPANT count: 86 type: ESTIMATED name: mindfulness-based stress reduction measure: Informed Voluntary Consent Form (Annex 1) measure: Identifying Characteristics Information Form (Annex 2) measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Saglık Bilimleri Universitesi city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06283680 id: 2024 briefTitle: The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-28 date: 2024-04-28 date: 2024-05-31 date: 2024-02-28 date: 2024-04-08 name: Aylin Seylam Küşümler class: OTHER name: Koşuyolu Yüksek İhtisas Training and Research Hospital briefSummary: The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list. conditions: Lung Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 213 type: ESTIMATED name: Lung transplantation measure: BMI measure: Nutrition risk index sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OkanU city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06283667 id: NN9536-4872 id: U1111-1266-3863 type: OTHER domain: World Health Organization (WHO) briefTitle: Special Use - Results Surveillance on Long-term Use With Wegovy® overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2025-06-30 date: 2028-01-31 date: 2024-02-28 date: 2024-02-28 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks). conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Semaglutide measure: Number of Adverse Reactions (ARs) measure: Number of Adverse Events (AEs) measure: Number of serious adverse events (SAEs) measure: Number of Serious Adverse Reactions (SARs) measure: Change in body weight (Percent (%)) measure: Change in body weight (Kilograms (Kg)) measure: Change in waist circumference measure: Change in BMI (Body Mass Index) measure: Change in body weight after treatment discontinuation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novo Nordisk Investigational Site city: Tokyo state: Chiyoda City zip: 100-0005 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False

 nctId: NCT06283654 id: VUmc 2018.539 briefTitle: Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation acronym: relievED overallStatus: COMPLETED date: 2018-09-30 date: 2021-09-30 date: 2023-01-31 date: 2024-02-28 date: 2024-04-26 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common procedure known as pulmonary vein isolation (PVI). This procedure is often used to treat AF, but following it patients frequently visit the ED due to concerns about their heart rhythm, which can strain healthcare resources. The researchers proved a group of patients with a 1-lead ECG device , which allowed users to check their heart rhythm at any time. The researchers compared the ED utilization over a year with that of patients who received standard care after PVI. The hope was that by using the 1-lead ECG device, patients could better manage their condition from home and only seek medical help when truly necessary. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 204 type: ACTUAL name: 1-lead ECG measure: number of ED visits measure: ratio of the number of cardioversions emergency vs planned sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC -vumc city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06283641 id: NN8022-7780 id: U1111-1289-9747 type: OTHER domain: World Health Organization (WHO) briefTitle: Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan. overallStatus: ENROLLING_BY_INVITATION date: 2024-02-23 date: 2025-02-28 date: 2025-02-28 date: 2024-02-28 date: 2024-04-04 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.

The study will last for about 26 weeks. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 288 type: ESTIMATED name: Liraglutide measure: Incidence of adverse events (AEs) by preferred term (PT) measure: Number of adverse drug reaction (ADRs) measure: Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) measure: Number of unexpected AEs and unexpected ADRs measure: Number of unexpected SAEs and unexpected SADRs measure: Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label measure: Body weight loss Percent (%) (Adult) measure: Body weight loss (%) (Adult) measure: Body weight loss Kilogram(Kg) (Adult) measure: Body weight loss (kg) (Adult) measure: The proportion of adult subjects losing at least 5% of baseline body weight measure: The proportion of adult subjects losing at least 5% of baseline body weight measure: The proportion of adult subjects losing more than 10% of baseline body weight measure: The proportion of adult subjects losing more than 10% of baseline body weight measure: The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda® measure: Change in body mass index (BMI) (kg/m^2) (Adolescent) measure: Change in body mass index (BMI) (kg/m^2) (Adolescent) measure: Change in body mass index (BMI) (%) (Adolescent) measure: Change in body mass index (BMI) (%) (Adolescent) measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent) measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent) measure: Body weight loss (%) (Adolescent) measure: Body weight loss (%) (Adolescent) measure: Body weight loss (kg) (Adolescent) measure: Body weight loss (kg) (Adolescent) measure: The proportion of adolescent subjects losing at least 4% of baseline BMI measure: The proportion of adolescent subjects losing at least 4% of baseline BMI measure: The proportion of adolescent subjects losing at least 10% of baseline BMI measure: The proportion of adolescent subjects losing at least 10% of baseline BMI measure: The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda® sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital city: Taipei City zip: 100229 country: Taiwan lat: 25.04776 lon: 121.53185 facility: National Taiwan University Hospital city: Taipei City zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06283628 id: STUDY00023737 briefTitle: Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves acronym: LMB-RFA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: Milton S. Hershey Medical Center class: OTHER briefSummary: The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation. conditions: Lumbar Spondylosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The subjects with bilateral low back pain will undergo radiofrequency ablation of the lumbar medial branch nerves using one approach (traditional) on one side and different approach (parasagittal) on the other side. One arm will use the traditional approach on the left and the parasagittal approach on the right. The other arm will use parasagittal approach on the left and the traditional approach on the right, primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: We will do computer randomization for the sides for each approach for all the subjects. The subjects will be assigned numbers, and the particular procedural approach for each side will be concealed in the numbered envelopes. The numbers on the envelopes will correspond to the numbers assigned to the patients. The envelopes will be opened by a treating physician in the procedure room. The patient and the assessor (who will not be the treating physician) will not know which procedural approach was used for the sides. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: Radiofrequency ablation of lumbar medial branch nerves. measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: Oswestry Disability index (ODI) measure: Oswestry Disability index (ODI) measure: Oswestry Disability index (ODI) measure: Number of subjects who ceased requiring analgesia measure: Number of subjects who ceased requiring analgesia measure: Number of subjects who ceased requiring analgesia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Penn State Hershey College of Medicine city: Hershey state: Pennsylvania zip: 17033 country: United States name: Nancy Ruth Jarbadan, BS role: CONTACT phone: 717-531-6135 email: njarbadan@pennstatehealth.psu.edu lat: 40.28592 lon: -76.65025 hasResults: False

 nctId: NCT06283615 id: 2024-01-01 briefTitle: Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency overallStatus: RECRUITING date: 2024-03-12 date: 2024-11-30 date: 2024-11-30 date: 2024-02-28 date: 2024-03-22 name: Jinling Hospital, China class: OTHER briefSummary: Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.

The primary and secondary outcomes will be collected. conditions: Intestinal Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Vitamin D measure: Quality of life score measure: Muscle function status measure: Serum vitamin D levels measure: Hepatic and renal function measure: Bone mineral density measure: Thyroid and parathyroid-related hormones measure: Nutritional status indicators measure: Number of participants with treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinying Wang status: RECRUITING city: Nanning state: Jiangsu zip: 210002 country: China name: Xinying Wang, MD role: CONTACT phone: +86 13913028866 email: wangxinying@nju.edu.cn name: Xuejin Gao, MD role: CONTACT phone: +86 18251937684 email: 547625433@qq.com name: Xinying Wang, MD role: PRINCIPAL_INVESTIGATOR name: Xuejin Gao, MD role: SUB_INVESTIGATOR lat: 22.81667 lon: 108.31667 hasResults: False

 nctId: NCT06283602 id: 2020/17 briefTitle: Oral Health in Children and Adolescents With Obesity and Normal Weight overallStatus: COMPLETED date: 2020-01-01 date: 2021-03-05 date: 2021-04-29 date: 2024-02-28 date: 2024-02-28 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.

82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD). conditions: Pediatric Obesity conditions: Pediatric Dentistry studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 82 type: ACTUAL name: oral health status measure: the results of DMFT, plaque and gingival indies measure: the results of dmft, BEWE, ICDAS-II, probing dept measure: Comparison of demographic attributes between obese and normal weights measure: biochemical parameters of obese individuals measure: other biochemical parameters of obese individuals sex: ALL minimumAge: 6 Years maximumAge: 16 Years stdAges: CHILD facility: Aslı Soğukpınar Önsüren city: Mersin country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06283589 id: INZ701-401 briefTitle: The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis overallStatus: RECRUITING date: 2024-02-12 date: 2024-07-19 date: 2024-08-19 date: 2024-02-28 date: 2024-02-28 name: Inozyme Pharma class: INDUSTRY briefSummary: The purpose of this study is to determine if multiple doses of INZ-701, given once per week over 4 weeks are safe and increase pyrophosphate (PPi) levels in hemodialysis-dependent (HD) end stage kidney disease (ESKD) study participants who have low PPi levels. In addition, the effect of hemodialysis on the PK of INZ-701 and PPi levels will be evaluated. conditions: Calciphylaxis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The SEAPORT 1 (INZ701-401) study is a Phase 1, open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of INZ-701, given once per week over 4 weeks, in study participants with end-stage kidney disease undergoing hemodialysis. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: INZ-701 measure: Determine if INZ-701 increases PPi levels measure: Assess the Time to Maximum Serum Concentration (Tmax) measure: Assess the Maximum Serum Concentration (Cmax) of INZ-701 measure: Assess the Area under the concentration-time curve over the dosing interval (AUCtau) measure: Assess the Clearance after extravascular administration of drug (CL/F) sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Florida Nephrology Research status: RECRUITING city: Coral Springs state: Florida zip: 33071 country: United States name: Ashgar Chaudhry, MD role: CONTACT phone: 954-510-7620 email: info@flkidney.com lat: 26.27119 lon: -80.2706 facility: Elixia Health status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States name: Steven Zeig role: CONTACT phone: 954-900-1101 email: info@elixiacrc.com lat: 26.0112 lon: -80.14949 hasResults: False

 nctId: NCT06283576 id: PANCAID-00-08 briefTitle: Pancreatic Cancer Initial Detection Via Liquid Biopsy acronym: PANCAID overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2027-12-31 date: 2027-12-31 date: 2024-02-28 date: 2024-04-24 name: Karolinska University Hospital class: OTHER name: Umeå University briefSummary: The overall rationale of PANCAID is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. With a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. For the entire series of these studies, the following groups are planned: 1) Histologically proven early-stage pancreatic cancer (e.g. T1a/b and T2 carcinomas \[N0M0\]); 2) Intraductal papillary mucinous neoplasia (IPMN) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct IPMN; 4) individuals at risk (IAR) with and without IPMN, with and without known hereditary cancer gene (e.g. BRCA2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 PY), with newly onset diabetes mellitus (NODM). conditions: Pancreatic Cancer conditions: IPMN, Pancreatic conditions: Individuals at Risk conditions: Chronic Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Liquid biopsy measure: Cancer detection measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gastrocentrum, KarolinskaUniversity Hospital city: Stockholm zip: 14186 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06283563 id: 2023/5474 briefTitle: Online Physical Activity Tracking in Patients With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2025-02-15 date: 2025-02-28 date: 2024-02-28 date: 2024-02-28 name: Inonu University class: OTHER briefSummary: This study aims to investigate the effects of regular remote monitoring of physical activity levels of individuals with multiple sclerosis on physical activity levels, psychological health, fatigue and quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Physical activity tracking name: No physical activity tracking measure: Smartphone pedometer measure: Smartphone pedometer measure: International Physical Activity Questionnaire - Short Form measure: International Physical Activity Questionnaire - Short Form measure: Beck Depression Inventory II measure: Beck Depression Inventory II measure: Beck Anxiety Inventory measure: Beck Anxiety Inventory measure: Fatigue Severity Scale measure: Fatigue Severity Scale measure: Multiple Sclerosis Quality of Life-54 measure: Multiple Sclerosis Quality of Life-54 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283550 id: INNO-6052 briefTitle: Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-08 date: 2024-02-28 date: 2024-02-29 name: Innovaderm Research Inc. class: OTHER briefSummary: This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping. conditions: Chronic Hand Eczema studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Abrocitinib 200 mg name: Abrocitinib 100 mg name: Placebo measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) measure: Reduction from baseline in hand Physician's Global Assessment (PGA) measure: Change from baseline in Hand Eczema Severity Index (HECSI) measure: Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE) measure: Patient Global Assessment (PaGA) measurements measure: Change from baseline in hand Dermatology Life Quality Index (DLQI) measure: Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) measure: Change from baseline in pain Numerical Rating Scale (NRS) measure: Change from baseline in itch Numerical Rating Scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Innovaderm Research Inc. city: Montréal state: Quebec zip: H2X 2V1 country: Canada name: Rosanna Ottoni, BSc role: CONTACT phone: 514-521-4285 phoneExt: 107 email: rottoni@innovaderm.com lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06283537 id: KÜBAP-01/2023-39 briefTitle: Online Episiotomy Simulation Training for Midwifery Students overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-05-30 date: 2024-02-28 date: 2024-02-28 name: Kastamonu University class: OTHER briefSummary: Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.

Method: This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the research, all third-year students in the midwifery department (n=60) will be divided into 30 students into the online education group and 30 students into the face-to-face education group using a random sampling model. "Student Information Form", "Episiotomy Skill Evaluation Form" and "Student Satisfaction and Self-Confidence in Learning Scale" will be used to collect data. conditions: Training Group, Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A comparative randomized controlled trial primaryPurpose: OTHER masking: SINGLE maskingDescription: After all students in the face-to-face education and online education groups complete their applications, the students will practice on the material one by one in the school environment and will be evaluated through the Episiotomy Skill Evaluation Form. In the evaluation, a blinding technique will be used to prevent the person conducting the study interventions from making an evaluation in favor of the intervention group. For this purpose, the faculty member conducting the research initiatives will not take part in the evaluation, instead the evaluation will be made by two different field experts. The experts to be consulted for the evaluation will consist of people working as academicians in the field of obstetrics, nursing and midwifery. After the evaluation, students will have to fill out the survey (Student Information Form) and scale (Student Satisfaction and Self-Confidence in Learning Scale). whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Effect of training method measure: episiotomy skill performances measure: Satisfaction with education measure: Self-confidence in learning sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283524 id: ETNA-TrainMS briefTitle: Eye-tracking Investigation of Clinical Measures in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-10-18 date: 2026-03-18 date: 2024-02-28 date: 2024-02-28 name: Innodem Neurosciences class: INDUSTRY briefSummary: The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in MS patients to train machine learning algorithms that will support the development and performance assessment of a sensitive and non-invasive eye-tracking software application. The training of our machine learning classifying algorithms to identify which eye-tracking metrics-or combination thereof-can serve as reliable markers of MS disease severity and cognitive status. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Eye-Tracking measure: Predictive power of eye-movement biomarkers (EMBs) for MS severity in relationship to Expanded Disability Status Scale (EDSS) measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Symbol Digit Modalities Test (SDMT) as part of the Brief International Cognitive Assessment for MS (BICAMS). measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Rey Auditory Verbal Learning Test (RAVLT) as part of the Brief International Cognitive Assessment for MS (BICAMS). measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Brief Visuospatial Memory Test-Revised (BVMT-R) as part of the Brief International Cognitive Assessment for MS (BICAMS). measure: Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC). measure: Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Genge Partners, Inc. city: Montréal state: Quebec zip: H4A 3T4 country: Canada name: Yousri Benchaar role: CONTACT phone: 514-906-3876 phoneExt: 6026 email: YBenchaar@gengepartners.com name: Alexander Saveriano, MD role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06283511 id: IJB-RESTART briefTitle: Evaluation of the RESTART Survival Programme overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-08 date: 2026-12 date: 2024-02-28 date: 2024-02-28 name: Jules Bordet Institute class: OTHER briefSummary: The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme. conditions: Invasive Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: educational workshops measure: Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions. measure: assessment of quality of life measure: assessemnt of health literacy via HLQ questionnaire measure: assessment of professional status measure: assessment of level of physical activity measure: assessment of emotionnal distress measure: assessment of the intensity of residual fatigue measure: assessment of sleep quality measure: Measuring the rate of participation in the programme measure: assessment of quality of life measure: assessment of emotionnal distress sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283498 id: DO612574A briefTitle: Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder overallStatus: ENROLLING_BY_INVITATION date: 2023-11-10 date: 2025-11 date: 2026-07 date: 2024-02-28 date: 2024-03-01 name: InMode MD Ltd. class: INDUSTRY briefSummary: The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder

The main questions it aims to answer are:

•Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\]

Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis.

Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment. conditions: Overactive Bladder Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Device Morpheus8V measure: Change in urgency incontinence episodes after 3 month measure: Change in urgency incontinence episodes after 1 month measure: Change in urgency incontinence episodes measure: Change in urgency incontinence episodes measure: Analysis to assess the urinary frequency measure: Analysis to assess urinary frequency measure: Analysis to assess the urinary frequency. measure: Analysis to assess the urinary frequency. measure: Assessment of the impact of the treatment on Overactive Bladder symptoms measure: Assessment of the impact of the treatment on Overactive Bladder symptoms measure: Assessment of the impact of the treatment on Overactive Bladder symptoms measure: Assessment of the impact of the treatment on Overactive Bladder symptoms measure: Patient-reported Pain assessment measure: Patient-reported outcome measure measure: Patient-reported outcome measure measure: Patient-reported outcome measure measure: Patient-reported outcome measure sex: FEMALE minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mickey Karram MD city: Corona Del Mar state: California zip: 92625 country: United States lat: 33.59808 lon: -117.87311 facility: Institute for Female Pelvic Medicine city: Knoxville state: Tennessee zip: 37932 country: United States lat: 35.96064 lon: -83.92074 hasResults: False

 nctId: NCT06283485 id: Study Artificial intelligence briefTitle: Real-time Anatomy Recognition Tool Accuracy Research for Ultrasound-guided PENG and Suprainguinal Fascia Iliaca Blocks overallStatus: RECRUITING date: 2023-12-15 date: 2024-04-01 date: 2024-05-25 date: 2024-02-28 date: 2024-02-28 name: Konya City Hospital class: OTHER name: Betül Afşar briefSummary: Background and rationale: Ultrasound-guided regional anesthesia is a widely used pain control method today. A critical aspect of the procedure is accurate visualization of anatomical structures on ultrasound to precisely define target areas. Distinguishing surrounding tissues with an imaging model that automatically recognizes sonoanatomy in ultrasound images will reduce unintended intraneural injections or injury to other anatomical structures in close proximity and increase patient safety.

Research question; How can we improve the ultrasound images we frequently use in regional blocks by integrating them with artificial intelligence to reduce complications and improve applications? And what is the accuracy of the developed artificial intelligence support during imaging?

Research purpose; This work; We aim to further increase the safety of different regional block positions, minimize the risk of complications, and improve ultrasound visualization by developing an artificial intelligence model (AI Model-Artificial Intelligence) that automatically identifies and segments anatomical landmarks, provides visual guidance for inexperienced colleagues, and improves the performance of the developed model during application. aims to demonstrate its accuracy.

Hypothesis; Numerous studies have shown that the use of ultrasound and neurostimulators in practice increases the success, onset and quality of nerve blocks, but due to the low incidence of major complications and the absence of comparable randomized studies, no definitive statement can be made as to whether ultrasound reduces the overall rate of nerve damage. An imaging model that automatically marks sonoanatomy with artificial intelligence in ultrasound images can reduce unintended intraneural injections or injury to other anatomical structures in close proximity and improve patient safety. conditions: Artificial Intelligent conditions: Ultrasound Therapy; Complications conditions: Nerve Block studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: ultrasound examination measure: Artificial intelligence Program size measure: Score of assessment the pictures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasin Tire status: RECRUITING city: Konya state: Meram zip: 42140 country: Turkey name: Yasin Tire role: CONTACT phone: +905055367970 email: dryasintire@hotmail.com name: Betül Afşar role: CONTACT lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06283472 id: 1805574553; Aims 14-16 id: 2P60AA007611-403343 type: OTHER_GRANT domain: National Institute on Alcohol Abuse and Alcoholism id: 2P60AA007611 type: NIH link: https://reporter.nih.gov/quickSearch/2P60AA007611 briefTitle: Enhancing Prospective Thinking in Early Recovery (BEAM) acronym: BEAM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-01 date: 2027-02-01 date: 2024-02-28 date: 2024-03-01 name: Indiana University class: OTHER briefSummary: The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:

* Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues?
* Will high-intensity EFT cues effect greater treatment-seeking interest?
* Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity)
* Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS?
* Will the novel behavioral SS decision-making task activate the nucleus accumbens?

Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups. whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: High-Intensity Cue name: Low-Intensity Cue measure: Increase Prospective Thinking measure: Delayed Rewards sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06283459 id: 301-23-101 briefTitle: Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2025-09-30 date: 2024-02-28 date: 2024-04-05 name: Imunon class: INDUSTRY briefSummary: This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365). conditions: SARS CoV 2 Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 74 type: ESTIMATED name: IMNN-101 measure: Number of participants with local and systemic reactogenicity adverse events and all adverse events measure: Number of participants with geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain. measure: Number of participants with GMT of serum spike binding IgG antibodies measure: Number of participants with a magnitude and phenotype of cytokine producing S protein-specific T cells, as measured by flow cytometry and/or ELISpot. measure: Number of participants with seroresponse rate (SRR). sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center city: Boston state: Massachusetts zip: 02215 country: United States name: Elizabeth Oginni role: CONTACT email: ooginni@bidmc.harvard.edu name: Ai-Ris Y Collier, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: DM Clinical Research city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Kyle Bramble role: CONTACT email: kyle.bramble@dmclinical.com name: Kem Yenal, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06283446 id: 1805574553; Aims 11-13 id: 1R21AA029760-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AA029760-01 briefTitle: Enhancing Prospective Thinking in Early Recovery acronym: NERF overallStatus: RECRUITING date: 2023-12-20 date: 2024-07-31 date: 2024-07-31 date: 2024-02-28 date: 2024-02-28 name: Indiana University class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:

Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues? Will high-intensity EFT cues effect greater treatment-seeking interest? Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS? Will the novel behavioral SS decision-making task activate the nucleus accumbens? Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups. whoMasked: PARTICIPANT count: 98 type: ESTIMATED name: High-Intensity Cue name: Low-Intensity Cue measure: Increase Prospective Thinking measure: Delayed Rewards sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Indiana University School of Medicine - Goodman Hall status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: Sarah Turo, BA role: CONTACT phone: 317-963-7220 email: sturo@iu.edu name: Colton Lind, BS role: CONTACT phone: 317-963-2554 email: cmlind@iu.edu name: Brandon G Oberlin, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 hasResults: False

 nctId: NCT06283433 id: NL83813.078.23 briefTitle: A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT acronym: ADVANCEDOPAT overallStatus: RECRUITING date: 2023-10-25 date: 2024-11 date: 2024-11 date: 2024-02-28 date: 2024-02-28 name: Erasmus Medical Center class: OTHER briefSummary: The Outpatient Parenteral Antibiotic Therapy (OPAT) service consists of providing antimicrobial therapy through parenteral infusion without hospitalization. This service is provided to stable patients otherwise ready for hospital discharge. Generally, the clinical monitoring for this patient population is minimal. However, clinical monitoring of vancomycin, an antibiotic widely used during OPAT, can be intensive primarily due to therapeutic drug monitoring. To ensure optimal treatment and minimize nephrotoxicity and microbial resistance, TDM and monitoring of serum creatinine levels are crucial during vancomycin therapy. TDM of vancomycin with OPAT presents a challenge for patients who must frequently travel to blood sampling facilities or the hospital for measurements. An alternative sampling method for TDM is the dried blood spot (DBS) method, which involves collecting a small drop of capillary blood from a finger prick onto filter paper. By implementing the DBS sampling method, the amount of outpatient visits regarding vancomycin treatment in OPAT can be reduced. Furthermore, the addition of measuring a biochemical parameter, such as renal function with serum creatinine, could lead to even less outpatient visits during OPAT. To date, studies investigating the effectiveness of DBS sampling of vancomycin and creatinine in terms of reducing outpatient visits have not yet been conducted in the OPAT population. conditions: Infection, Bacterial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 84 type: ESTIMATED name: Finger Prick name: Venipuncture measure: To compare the number of outpatient visits in the control group versus the intervention group at day 28 measure: Outcomes regarding outpatient visit measure: Sampling outcomes measure: Satisfaction with blood sampling based on the theoretical framework of acceptability questionnaire (TFA) measure: Cost outcomes measure: Clinical outcomes measure: TDM outcomes measure: Logistical outcomes sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC status: RECRUITING city: Rotterdam country: Netherlands name: Birgit Koch, PharmD role: CONTACT lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06283420 id: CarDia_WP5_P1_IRB:25059/23 briefTitle: Metabolic Response to Iniciation of Heart Failure Therapy acronym: GliF overallStatus: NOT_YET_RECRUITING date: 2024-02-21 date: 2025-12-20 date: 2026-12-20 date: 2024-02-28 date: 2024-02-28 name: Vojtech Melenovsky, MD, PhD class: OTHER_GOV briefSummary: This protocol is part of the CarDia project - National Institute for Metabolic and Cardiovascular Disease Research (EXCELES Program, ID: LX22NPO5104), funded by the European Union - Next Generation EU. The protocol is part of Work Package 5 (WP5): metabolic disorders in heart failure.

The goal of this observational protocol is to monitor the biochemical and metabolomic response to the initiation of therapy for heart failure with standard drugs (SGLT2i, sGC stimulators, ARNI) and whether this early response (within first 3 months) predicts the further course of the disease.

The protocol will examine how parameters reflecting neurohumoral activation, response to hypoxia, systemic metabolism of energy substrates, parameters of iron metabolism, HIF1A activation in peripheral blood behave over time after starting standard heart failure terapiy (baseline, 1 day, 1 week, 1 month, 3 month). This project can provide valuable information on how to identify people who respond more poorly to the treatment being introduced and are more at risk of an adverse course of the disease. Patients will be compared to patients who have no change of therapy over early observation period (3 mo), who will serve as controls. This is observational study, so decision to inicialize therapy will be based on medical indication.

Patients with heart failure treated at the IKEM Cardiocenter will have blood drawn at several defined intervals before and after the start of clinically indicated treatment. Some patients will also undergo genetic DNA testing to determine the variability of genes regulating the metabolic neurohumoral response to heart failure. Patients will be contacted at intervals of 1 and 2 years and the incidence of clinical events will be monitored. The study is observational in nature and inclusion in the study does not affect the course of care provided or the choice of pharmacotherapy. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: hematocrit measure: HIF response measure: hepcidin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical end Experimental Medicine - IKEM city: Prague country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06283407 id: ICF briefTitle: ICF-based Comparison on Musculoskeletal Health in Poland and Spain overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-06-03 date: 2024-11-04 date: 2024-02-28 date: 2024-03-01 name: University of Rzeszow class: OTHER name: Sanidad de Castilla y León briefSummary: Musculoskeletal conditions are a major cause of disability worldwide. These conditions are often associated with chronicity, which is a challenge for healthcare systems to address. Health care must be person-centred and take into account the individual perspective from which the disease is experienced. The lived experience of health conditions depends to a large extent on contextual factors. Comparison between different contexts helps to identify which aspects are most relevant in the experience of the disease. The International Classification of Functioning, Disability and Health (ICF) provides a unified language that allows such comparisons to be made. The aim of this study is to identify differences in musculoskeletal health between the Polish and Spanish populations using the ICF as a frame of reference. conditions: Musculoskeletal Diseases or Conditions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 800 type: ESTIMATED name: ICF-based cross-country comparative analysis measure: Brief International Classification of Functioning, Disability and Health (ICF) core set for post-acute musculoskeletal conditions measure: Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rzeszow city: Rzeszów zip: 35-959 country: Poland name: Agnieszka Wiśniowska-Szurlej role: CONTACT lat: 50.04132 lon: 21.99901 hasResults: False

 nctId: NCT06283394 id: 854803 briefTitle: AHA (American Heart Association) Food is Medicine Test of Choice Architecture and Salience of Incentives overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-06-01 date: 2024-02-28 date: 2024-04-19 name: University of Pennsylvania class: OTHER briefSummary: The goal of this interventional study is to test ways to improve the effectiveness of a healthy foods prescription program in increasing the purchase of healthy foods for patients who have both obesity (BMI \> 30) and diabetes (last A1C\>8 in the last 90 days). The main questions it aims to answer are:

Aim 1: Examine feasibility and engagement among participants by assessing percent enrollment among those identified as eligible, rates of Instacart platform use, amount of the subsidy used each week, and amounts of healthy foods ordered.

Aim 2: Examine strategies to optimize the user experience of trial participation, including communication strategies and on-boarding, to increase uptake and engagement in this and subsequent studies.

Usual Care (Control): Participants in the usual care arm will not receive weekly subsidies on Instacart, and they will not receive any modifications to the virtual storefront on Instacart. They will have access to the standard Instacart platform and Instacart + memberships with $5 per week to cover service and delivery fees and delivery tips for 3 months.

Intervention Arms: The four treatment groups will also each receive a $160 subsidy per month for 3 months to be used on produce (fruits and vegetables). conditions: Obesity conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Storefront Choice Architecture name: Fresh Funds name: Loss Framing measure: The primary outcome will be the percentage of food purchasing expenditures spent on eligible healthy foods. measure: Percentage of the $160 subsidy used each month in the intervention arms. measure: Change in hemoglobin A1c measure: Qualitative results sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283381 id: 4264 briefTitle: The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty acronym: ESGIS overallStatus: RECRUITING date: 2024-02-01 date: 2025-01-31 date: 2026-06-30 date: 2024-02-28 date: 2024-02-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:

* Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.
* Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).

The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG conditions: Obesity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Esomeprazole measure: The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: IVO BOSKOSKI role: CONTACT phone: +390630155701 email: ivo.boskoski@policlinicogemelli.it name: IVO BOSKOSKI role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06283368 id: 2021/11-06 briefTitle: Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Malignant Thyroid Nodules overallStatus: COMPLETED date: 2016-01 date: 2021-01 date: 2021-01 date: 2024-02-28 date: 2024-03-01 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: Thyroid surgery is the most common type of surgery among endocrine surgeries. This surgery is performed for patients with suspected malignancy, patients diagnosed with malignancy, and toxic nodular goiter. In addition to vocal cord injury, which is the most important complication of thyroid surgery, hypocalcemia due to hypoparathyroidism and surgical wound complications (such as hematoma, and fistula) can also be observed, and malignancy surgery increases the risk of recurrent laryngeal nerve injury. Therefore, it is important to differentiate these groups using non-invasive methods before surgery.

Tumor-related inflammation is activated as a result of bone marrow and inflammation induced by malignancies. Insufficiently controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Lymphocyte monocyte ratio and red blood cell distribution are parameters (RDW, RDW-CW) previously studied in terms of cancers.

Our aim in this study is to reveal the RDW, RDW-CW, and LMR calculated from complete blood count parameters in the preoperative period, as an indicator of malignant inflammatory response, in a non-invasive and inexpensive way before surgery or biopsy is performed to distinguish nodular goiter and thyroid malignancy. conditions: Thyroid Neoplasms Benign conditions: Thyroid Nodule conditions: Thyroid Cancer conditions: Thyroid Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 172 type: ACTUAL name: Thyroidectomy, Bilaterally Total name: Thyroidectomy, Unilaterally Total name: Thyroidectomy, Complementary name: Thyroidectomy, Near Total measure: Determining benign thyroid nodules measure: Determining malignant thyroid nodules sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283355 id: IRB00433691 briefTitle: Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-06-01 date: 2025-12-31 date: 2024-02-28 date: 2024-02-28 name: Johns Hopkins University class: OTHER briefSummary: This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity. conditions: Staphylococcus Aureus conditions: Microbial Colonization conditions: Neonatal Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 175 type: ESTIMATED name: Nasal Microbiota Transplant (NMT) name: Placebo measure: Neonatal nasal microbiome diversity after intervention sex: ALL minimumAge: 0 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21287 country: United States name: Danielle Koontz role: CONTACT phone: 443-287-9040 email: dkoontz1@jhmi.edu name: Aaron Milstone role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06283342 id: Konya Pediatric Hematology briefTitle: Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency overallStatus: COMPLETED date: 2018-01-01 date: 2019-01-01 date: 2019-02-01 date: 2024-02-28 date: 2024-02-28 name: Konya Meram State Hospital class: OTHER briefSummary: This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy. conditions: Iron Deficiency Anemia in Childbirth conditions: Infant Nutrition Disorders conditions: Iron Deficiencies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2 type: ACTUAL measure: Ferritine level measure: Hemoglobin level measure: Prophylactic iron use rate measure: Iron-sufficient supplementary food intake rate of babies measure: Breast milk usage rate sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Konya Training and Research Hospital city: Konya zip: 42090 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06283329 id: echographic VC curarization briefTitle: Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints overallStatus: COMPLETED date: 2023-12-01 date: 2023-12-31 date: 2023-12-31 date: 2024-02-28 date: 2024-02-28 name: General Administration of Military Health, Tunisia class: NETWORK briefSummary: Through recent studies residual curarization (RC) remains frequent but serious event, that could be easily avoided in the presence of a paraclinical monitoring and by antagonization of curares. However, conventional monitors focus only on peripheral muscles, whereas ultrasonography allows direct visualization of laryngeal muscles, particularly the vocal cords, which are directly influenced by neuromuscular blocking agents. The aim of the study was to evaluate the ultrasound mobility of the vocal cords after awakening and extubation of general anesthesia compared to their preoperative mobility and its correlation with clinical and paraclinical diagnostic criteria (DG) for RC. conditions: Residual Curarization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ACTUAL name: vocal cords echography measure: Echographic mobility of vocal cords at different times in post extubation sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elaskri Haythem city: Tunis zip: 1008 country: Tunisia lat: 36.81897 lon: 10.16579 hasResults: False

 nctId: NCT06283316 id: 11347 briefTitle: Systemic Treatments for Alopecia Areata Registry acronym: STA2R overallStatus: RECRUITING date: 2024-01-17 date: 2099-12-31 date: 2099-12-31 date: 2024-02-28 date: 2024-02-28 name: Erasmus Medical Center class: OTHER briefSummary: A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes. conditions: Alopecia Areata conditions: Alopecia Totalis conditions: Alopecia Universalis conditions: Hair Loss conditions: Hair Diseases conditions: Alopecia conditions: Alopecia Drugs conditions: Autoimmune Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Effectiveness of systemic treatments measure: Safety of systemic treatments measure: Epidemiological data measure: Physician Reported - Severity of Alopecia Tool (SALT Score) measure: Dermatology Life Quality Index (DLQI, 10 items) measure: Alopecia Areata Symptom Impact Scale (AASIS, 13 items) sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus University Medical Center status: RECRUITING city: Rotterdam country: Netherlands name: DirkJan Hijnen, MD, PhD role: CONTACT phone: 0031 10 704 01 10 email: d.hijnen@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06283303 id: MVR-T3011-HAI-01 briefTitle: A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2025-11-30 date: 2025-11-30 date: 2024-02-28 date: 2024-02-29 name: China Medical University, China class: OTHER name: Immvira Co., Limited briefSummary: This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: T3011 hepatic artery infusion name: toripalimab name: regorafenib measure: Treatment Emergent Adverse Event（TEAE） measure: Objective response rate (ORR) measure: Overall survival (OS) measure: Progression-free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283290 id: D3250R00122 briefTitle: PROPE Severe Asthma Study in Egypt overallStatus: RECRUITING date: 2024-03-12 date: 2024-07-31 date: 2024-07-31 date: 2024-02-28 date: 2024-04-19 name: AstraZeneca class: INDUSTRY briefSummary: Asthma is a syndrome characterized by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness. Patients present clinically with recurrent wheezing, shortness of breath, cough, and chest tightness. Asthma is a leading cause of morbidity with a global prevalence of approximately 300 million; it is estimated that the number of people with asthma may increase to 400 to 450 million people worldwide by 2025.

Severe asthma is not considered a single disease; instead, it is divided into several phenotypes, owing to the variety of inflammatory, clinical, and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied by a high concentration of eosinophils require greater healthcare resource use, greater disease management costs, and a much more impaired QoL than those who do not present with raised eosinophilia.

While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses, and inflammatory processes involved represent an added challenge for health care professionals. Thus, severe asthma management is a complex endeavor, and a thorough and up-to-date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making.

This cross-sectional, multicenter study aims to determine the prevalence of oral corticosteroid (OCS) use among severe asthma patients who attend to different sites specialized in the management of severe asthma across Egypt. In addition, the prevalence of eosinophilic phenotype of blood eosinophil count ≥ 150 cells/mm3, prevalence of atopic phenotype, and asthma control will also be studied. conditions: Severe Asthma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED measure: To describe the prevalence (frequency) of OCS use among severe asthma patients as defined by chronic treatment and/or bursts of OCS use. measure: To describe the demographic characteristics of severe eosinophilic asthma patients. measure: To describe the clinical characteristics of severe eosinophilic asthma patients. measure: To discover the average OCS dose per year used among severe asthma patients. measure: To determine the prevalence of the eosinophilic phenotype measure: To determine the prevalence of the eosinophilic phenotype measure: To determine the prevalence of the total serum IgE measure: To determine the annual severe asthma exacerbation rate in the past twelve months among severe asthma patients in Egypt measure: To evaluate asthma control of severe asthma patients measure: To evaluate comorbidities related to OCS use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Mansoura state: Dakahlia country: Egypt lat: 31.03637 lon: 31.38069 facility: Research Site status: RECRUITING city: Zagazig state: Sharkia country: Egypt lat: 30.58768 lon: 31.502 facility: Research Site status: RECRUITING city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 facility: Research Site status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 facility: Research Site status: NOT_YET_RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06283277 id: fetal macrosomia briefTitle: Fetal Clavicular Measurement to Predict Fetal Macrosomia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-10-30 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.

The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia. conditions: Macrosomia, Fetal conditions: Large for Gestational Age conditions: Shoulder Dystocia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 240 type: ESTIMATED name: Obstetric Ultrasound measure: Third trimester clavicle length measurement measure: Establish the relationship between third-trimester clavicle length and shoulder dystocia measure: Mode of delivery measure: Gestational age at the time of delivery. measure: Neonatal Apgar score. measure: Neonatal bi-acromial diameter measure: Neonatal birth weight measure: Neonatal need for NICU measure: Neonatal actual clavicle length sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06283264 id: Coeliac Disease in type2 DM briefTitle: Assessment of Coeliac Disease in Patients With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-12-01 date: 2026-12-30 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: This study aims to screen and diagnose coeliac disease in patients with type 2 diabetes and monitor the effect of gluten-free diet on the metabolic status conditions: Celiac Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: 1-Prevalence of coeliac disease among diabetic type 2 patient 2-its effect on glycemic control sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283251 id: 23-590 briefTitle: PediRISE Feasibility overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Dana-Farber Cancer Institute class: OTHER name: American Cancer Society, Inc. name: Children's Cancer Research Fund briefSummary: The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.

The names of the study groups in this research study are:

* PediRISE Program Group
* Usual Care Group conditions: Pediatric Cancer conditions: Financial Stress conditions: Financial Hardship conditions: Disparities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: PediRISE Resource Program measure: Rate of Participant Consent measure: 6-Month Follow Up Rate for PediRISE Program Group measure: 6-Month Follow Up Rate for Usual Care Group sex: ALL maximumAge: 17 Years stdAges: CHILD facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Kira Bona, MD, MPH role: CONTACT phone: 617-632-4688 email: Kira_Bona@dfci.harvard.edu name: Kira Bona, 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: Kira Bona, MD, MPH role: CONTACT phone: 617-632-4688 email: Kira_Bona@dfci.harvard.edu name: Kira Bona, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06283238 id: Pro00115121 briefTitle: Biobanking Upper Gastrointestinal Tumors to Evaluate Response (BURGER With BACON) overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-03-25 date: 2027-03-25 date: 2024-02-28 date: 2024-02-28 name: Duke University class: OTHER briefSummary: The goal of this observational study is to examine genetic changes that may contribute to immunotherapy resistance in gastroesophageal cancer. This information can potentially lead to the identification of new immunotherapeutic targets as well as improve the ability to identify those patients more likely to respond to immunotherapy.

This study does not include any treatment or investigational drugs.

Participants will be asked:

* to enroll before beginning standard care of treatment for their cancer
* for blood, archived tumor tissue, and fresh tumor tissue Researchers will compare participants who are not getting immunotherapy to identify potential differences in expression levels of a gene. conditions: GastroEsophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED name: Immune checkpoint inhibitor (ICI) or chemotherapy alone measure: Number of participants with Complete Response (CR) measure: Number of participants with Partial Response (PR) measure: Number of participants with Stable Disease measure: Number of participants with Progressive Disease sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06283225 id: RCT004_PilotPia briefTitle: Pilot Study to Investigate the Effect of a Dysmenorrhoea App overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-07 date: 2024-07 date: 2024-02-28 date: 2024-03-01 name: Endo Health GmbH class: INDUSTRY briefSummary: The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants. conditions: Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: intervention group and control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Pia-App measure: Dysmenorrhea Symptom Interference Scale (DSI) measure: Moos Menstrual Distress Questionnaire, Form C (MDQ) measure: Visual analog scale (VAS) measure: Depression Anxiety Stress Scale mit 21 Items (DASS-21) measure: German Version of Pain Self-Efficacy Questionnaire (FESS) measure: Fatigue Severity Scale (FSS) measure: Pain Disability Index (PDI) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283212 id: ETX-DS-005 briefTitle: A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome acronym: UK Only overallStatus: RECRUITING date: 2024-04 date: 2029-12 date: 2029-12 date: 2024-02-28 date: 2024-04-17 name: Encoded Therapeutics class: INDUSTRY briefSummary: EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to \< 48 months. The study follows and open-label, dose-escalation design. conditions: Dravet Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 4 type: ESTIMATED name: ETX101 measure: Proportions of participants experiencing any treatment-emergent adverse events (AEs), serious adverse events (SAEs), related AEs, AEs with severity Grade ≥ 3, AEs resulting in study discontinuation, and AEs with fatal outcome. measure: Change from baseline in the standard score of the Vineland Adaptive Behavior Scales - Third Edition Adaptive Behavior Composite at Week 52. measure: Percent change in monthly countable seizure frequency (MCSF) to Week 52, with countable seizures defined as generalized tonic-clonic/clonic, focal motor with clearly observable clinical signs, tonic bilateral, and atonic seizures. measure: Change from baseline in the raw score of the Bayley Scales of Infant and Toddler Development® 4th Edition receptive language sub-domain at Week 52. sex: ALL minimumAge: 6 Months maximumAge: 47 Months stdAges: CHILD facility: Queen Elizabeth Hospital status: RECRUITING city: Glasgow zip: G51 4TF country: United Kingdom name: Patricia Clark role: CONTACT phone: 0141 232 7600 email: Patricia.Clark2@ggc.scot.nhs.uk lat: 55.86515 lon: -4.25763 facility: Great Ormond Street Hospital status: NOT_YET_RECRUITING city: London zip: WC1N3JH country: United Kingdom name: Helen Cross, MD role: CONTACT email: helen.cross10@nhs.net lat: 51.50853 lon: -0.12574 facility: Sheffield Children's Hospital status: NOT_YET_RECRUITING city: Sheffield zip: S10 2TH country: United Kingdom name: Research Team role: CONTACT email: research.sheffchild@nhs.net lat: 53.38297 lon: -1.4659 hasResults: False

 nctId: NCT06283199 id: ORL-ORT-025 briefTitle: Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases. overallStatus: RECRUITING date: 2021-04-06 date: 2027-12-31 date: 2027-12-31 date: 2024-02-28 date: 2024-03-01 name: Ente Ospedaliero Cantonale, Bellinzona class: OTHER briefSummary: Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.

After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month. conditions: Musculoskeletal Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED measure: Difference in pain level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna country: Italy name: Alessandro Di Martino, MD role: CONTACT phone: 0039 051 6366567 email: alessandro.dimartino@ior.it lat: 44.49381 lon: 11.33875 facility: EOC - Orthopaedics and Traumatology Service status: RECRUITING city: Lugano zip: 6900 country: Switzerland name: Christian Candrian, Prof.Dr.med role: CONTACT phone: +41 (0) 91 811 61 23 email: christian.candrian@eoc.ch lat: 46.01008 lon: 8.96004 hasResults: False

 nctId: NCT06283186 id: CSEULS-PI-004/2024 briefTitle: Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals overallStatus: RECRUITING date: 2024-04-23 date: 2025-07-31 date: 2025-07-31 date: 2024-02-28 date: 2024-04-24 name: Centro Universitario La Salle class: OTHER briefSummary: This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Aerobic exercise name: Aerobic exercise measure: Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle measure: International Physical Activity Questionnaire (IPAQ) measure: Fatigue Assessment Scale (FAS) measure: Heart rate measure: Rate of perceived exertion (RPE) measure: Physical Activity Readiness Questionnaire (PAR-Q) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: CSEU LaSalle status: RECRUITING city: Madrid zip: 28023 country: Spain name: Álvaro Reina-Varona, MSc role: CONTACT phone: 0034 + 649001863 email: alvaroreina93@gmail.com name: Álvaro Reina-Varona, MSc role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06283173 id: 23-401 briefTitle: HRIPT for Collagen Dressing overallStatus: COMPLETED date: 2024-01-31 date: 2024-03-22 date: 2024-03-22 date: 2024-02-28 date: 2024-04-16 name: Covalon Technologies Inc. class: INDUSTRY name: ALS Beauty and Personal Care briefSummary: The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site. conditions: Skin Sensitisation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This will be a single center, with no randomization or blinding, study design in 50 healthy adult subjects, age 18-70 years. Based on prior experience approximately 75 subjects will be enrolled to ensure 50 subjects complete the study. primaryPurpose: OTHER masking: NONE count: 57 type: ACTUAL name: ColActive Plus Collagen Matrix Dressing measure: Skin sensitization reaction using Berger and Bowman scale measure: Skin irritation reaction using Berger and Bowman scale measure: Skin sensitization reaction using Berger and Bowman scale measure: Skin sensitization reaction using Berger and Bowman scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ALS Beauty and Personal Care city: Torrance state: California zip: 90501 country: United States lat: 33.83585 lon: -118.34063 hasResults: False

 nctId: NCT06283160 id: 2023/834 briefTitle: Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy acronym: PROMETHEE overallStatus: RECRUITING date: 2024-03-01 date: 2026-05-30 date: 2026-05-30 date: 2024-02-28 date: 2024-04-12 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: Pancreaticoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.

The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.

Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling). conditions: Pancreatic Fistula conditions: Acute Pancreatitis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Besançon status: RECRUITING city: Besançon zip: 25000 country: France name: Alexandre Doussot, MD, PhD role: CONTACT lat: 47.24878 lon: 6.01815 hasResults: False

 nctId: NCT06283147 id: 2023.530 briefTitle: Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care overallStatus: RECRUITING date: 2024-04-01 date: 2025-11-30 date: 2026-04-01 date: 2024-02-28 date: 2024-03-22 name: Chinese University of Hong Kong class: OTHER briefSummary: The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.

Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):

1. RAMP Knee-OA group
2. Usual care group

Outcomes will be measured at baseline, week 16, week 32, and week 52. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: All data collection will be performed by trained research assistants blinded to the allocation status of the patients, and statistician will analyse data without referring to allocation information. whoMasked: OUTCOMES_ASSESSOR count: 228 type: ESTIMATED name: Risk assessment and Management Programme - Knee Osteoarthritis measure: Knee pain measure: Physical Function measure: Physical function measure: Lower limb muscle mass measure: Level of physical activity measure: Self-Management efficacy measure: Level of Anxiety measure: Level of Depression measure: Insomnia measure: Loneliness measure: Health related Quality of Life measure: Demographic data sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lek Yuen GOPC status: RECRUITING city: Hong Kong country: Hong Kong name: Cheryl Fung role: CONTACT phone: 26095050 phoneExt: +852 email: cheryllcfung@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06283134 id: BJCT-CMU1H-02 briefTitle: A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2027-12-01 date: 2027-12-01 date: 2024-02-28 date: 2024-02-29 name: China Medical University, China class: OTHER name: Beijing Bio-Targeting Therapeutics Technology Co., Ltd briefSummary: This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: BioTTT001 hepatic artery infusion name: toripalimab name: regorafenib measure: Incidence of adverse events measure: MTD measure: Overall survival(OS) measure: Progression-free survival (PFS) measure: Objective response rate (ORR) measure: Plasma adenovirus (ADV) copies measure: ADV copies in various sites measure: Serum IL-12 level measure: Serum neutralizing antibody level sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283121 id: BJCT-CMU1H-01 briefTitle: A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2027-11-30 date: 2027-11-30 date: 2024-02-28 date: 2024-02-29 name: China Medical University, China class: OTHER name: Beijing Bio-Targeting Therapeutics Technology Co., Ltd briefSummary: This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer. conditions: Gastric Cancer, Metastatic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: BioTTT001 intraperitoneal infusion name: SOX regimen name: toripalimab measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06283108 id: 23-1183 briefTitle: Gurney Journey: Virtual Reality Distraction overallStatus: RECRUITING date: 2024-03-01 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-03-08 name: Children's Hospital Colorado class: OTHER briefSummary: The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program. conditions: Dental Caries in Children conditions: Dental Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 58 type: ESTIMATED name: Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience) name: Standard Child Life Preparation and Support measure: Induction Compliance Checklist measure: modified Yale Preoperative Anxiety Scale measure: The Pediatric Behavioral Induction Assessment sex: ALL minimumAge: 5 Years maximumAge: 17 Years stdAges: CHILD facility: Children's Hospital Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Claire Simonsen, BA role: CONTACT phone: 720-777-5313 email: claire.simonsen@childrenscolorado.org name: Joseph Albietz, MD role: PRINCIPAL_INVESTIGATOR name: Jennifer Staab, MS role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06283095 id: OSA briefTitle: Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty overallStatus: RECRUITING date: 2023-11-01 date: 2025-11-01 date: 2026-11-01 date: 2024-02-28 date: 2024-02-28 name: ET Zarief class: OTHER briefSummary: The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS. conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: expansion palatoplasty measure: Evaluation the outcome of expansion palatoplasty in management of OSAS. measure: Expansion palatoplasty in Obstructive sleep apnea patients sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASSUIT status: RECRUITING city: Assuit zip: 1 country: Egypt name: Enas T Zarief, physician role: CONTACT phone: 01226270800 email: enas.tharwat23@gmail.com lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06283082 id: 69HCL23_0617 id: ID-RCB type: OTHER domain: 2023-A01406-39 briefTitle: Oxalate Excretion Profile in Patients With a Heterozygous Mutation of the AGXT (Alanine-glyoxylate Aminotransferase) Gene acronym: HETEROX overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-02-28 date: 2024-02-28 name: Hospices Civils de Lyon class: OTHER briefSummary: Primary hyperoxaluria type I (PH1) is a rare genetic disorder responsible for severe lithiasis leading to progressive deterioration of renal function and end-stage renal failure. PH1 is linked to a deficiency in glyoxylate amino transferase (AGXT), which leads to increased endogenous oxalate synthesis and hyperoxaluria. In the urine, urinary oxalate precipitates with calcium, forming insoluble crystals, leading to lithiasis and the development of nephrocalcinosis.

Non-genetic etiologies of oxalic nephropathy are well known, in particular enteric causes (malabsorptions, bypass, calcium deficiencies, etc.) and sometimes linked to increased oxalate intake in the form of nutritional or vitamin supplements, reinforcing the hypothesis of probably underestimated favouring factors of hyperoxaluria.

Until now, heterozygous patients with a mutation in the AGXT gene were considered asymptomatic. However, there have been several cases of patients with heterozygous AGXT mutations presenting with lithiasis.

Consequently, the characteristics of symptomatic and asymptomatic heterozygous patients will be studied in order to define the elements that would explain the expression of the disease (particularities of the AGXT mutation, presence of another heterozygous mutation or favorable living conditions).

The hypothesis is that there is an increase in hepatic oxalate production in heterozygous patients, which explains why they remain asymptomatic under usual conditions, but could favor stone formation under favorable conditions such as severe calcium deficiency or malabsorption. conditions: Hyperoxaluria (Disorder) studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 25 type: ESTIMATED name: Lithiasis assessment measure: Urinary oxalate and glycolate excretion measure: The prevalence of stones measure: Lithiasis disease severity measure: Lithiasis disease severity measure: Lithiasis disease severity measure: Lithiasis disease severity measure: Predisposing conditions for lithiasis disease measure: Predisposing conditions for lithiasis disease sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CLIMA, pavillon R, Hôpital Edouard Herriot city: Lyon zip: 69003 country: France name: Laurence Derain, MD,PhD role: CONTACT phone: 04 72 11 91 17 phoneExt: +33 email: laurence.derain@chu-lyon.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06283069 id: 45C301 briefTitle: Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters acronym: RICH overallStatus: RECRUITING date: 2023-05-01 date: 2024-12-31 date: 2033-04-30 date: 2024-02-28 date: 2024-02-28 name: Istituto Auxologico Italiano class: OTHER briefSummary: The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies. conditions: Cardiovascular Diseases conditions: Lifestyle conditions: Nutrition, Healthy conditions: Physical Inactivity conditions: Stress conditions: Sleep studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 100 type: ESTIMATED name: compilation of a questionnaire about LifeStyle measure: weekly physical activity volume measure: nutrition quality measure: weight measure: height measure: blood pressure measure: perception of stress, fatigue, and somatic symptoms measure: glycemia measure: cholesterol measure: creatinine measure: waist circumference measure: heart rate sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan country: Italy name: Luca Giovanelli, MD role: CONTACT phone: +3902619112808 email: luca.giovanelli@unimi.it name: Daniela Lucini, Prof role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06283056 id: DO611073A briefTitle: RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite overallStatus: RECRUITING date: 2022-06-16 date: 2024-06-01 date: 2025-06-01 date: 2024-02-28 date: 2024-02-28 name: InMode MD Ltd. class: INDUSTRY briefSummary: The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits. conditions: Cellulitis of Leg studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open-label clinical study. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Device treatment measure: Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale measure: Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale measure: Subject assessment of improvement measure: Subject assessment of improvement measure: Subject assessment of improvement measure: Subject assessment of satisfaction measure: Subject assessment of satisfaction measure: Subject assessment of satisfaction measure: Investigator assessment of the skin appearance improvemen measure: Investigator assessment of the skin appearance improvement measure: Investigator assessment of the skin appearance measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment measure: Adverse Event rate measure: Pain Scale sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dermatology & Laser Surgery Center of New York status: ACTIVE_NOT_RECRUITING city: New York state: New York zip: 10028 country: United States lat: 40.71427 lon: -74.00597 facility: Dallas Plastic Surgeon status: RECRUITING city: Dallas state: Texas zip: 75225 country: United States name: Lily Hays role: CONTACT phone: 214-821-9114 email: Lily Hays <lily.hays@dpsi.org> lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06283043 id: 2022/3749 briefTitle: Effect of Motor Function, Depression and Sleep Quality on Attention in Parkinson's Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-03-01 date: 2024-03-05 date: 2024-02-28 date: 2024-02-28 name: Inonu University class: OTHER briefSummary: Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements. conditions: Movement Disorders (Incl Parkinsonism) conditions: Parkinsonian Disorders conditions: Attention Impaired conditions: Movement Disorders, Functional studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 54 type: ESTIMATED measure: TUG measure: 10 m walking test measure: 30 sec sit-stand test measure: berg balance test measure: one leg stance test measure: functional reach test measure: hand dinamometer measure: mobil application measure: Pittsburg Sleep Quality İndex measure: Beck Depression measure: P300 sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu University city: Malatya state: Battalgazi zip: 44280 country: Turkey lat: 38.35018 lon: 38.31667 hasResults: False

 nctId: NCT06283030 id: IM-001 briefTitle: Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea overallStatus: COMPLETED date: 2021-12-01 date: 2023-09-25 date: 2023-09-25 date: 2024-02-28 date: 2024-03-07 name: Invicta Medical Inc. class: INDUSTRY name: Vanderbilt University Medical Center briefSummary: This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed. conditions: Sleep Apnea conditions: Sleep Apnea, Obstructive conditions: Sleep Apnea Syndromes conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ACTUAL name: Hypoglossal nerve stimulation measure: Identification and access of the target outcomes measure: Tongue protrusion outcomes measure: Characterization of electrode array outcomes measure: Electrode array placement and removal outcomes measure: Safety outcomes sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt Bill Wilkerson Centre city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06283017 id: IM-002 briefTitle: Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-01 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-03-13 name: Invicta Medical Inc. class: INDUSTRY name: Adelaide Institute for Sleep Health, Flinders University briefSummary: This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed. conditions: Sleep Apnea conditions: Sleep Apnea, Obstructive conditions: Sleep Disorder conditions: Sleep Apnea Syndromes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ACTUAL name: Hypoglossal nerve stimulation measure: Target identification and access outcomes measure: Tongue protrusion outcomes measure: Characterization of lead placement outcomes measure: Lead placement and removal outcomes measure: Safety outcomes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Adelaide Institute for Sleep Health, Flinders University city: Adelaide state: South Australia zip: 5042 country: Australia lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06283004 id: 2024-1/30 briefTitle: Investigation of Walking Training With Different Slope Types in COPD Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-06-01 date: 2026-06-01 date: 2024-02-28 date: 2024-02-28 name: Acibadem University class: OTHER name: Bezmialem Vakif University briefSummary: Chronic obstructive pulmonary disease (COPD) is a disease that continues to generate a great deal of research and this research must continue, both because it is not completely curable and because of the large patient population. The importance and benefits of exercise training in COPD patients are clear. One of the most preferred types of exercise training is the so-called aerobic exercise training, which typically takes the form of walking. A typical walking training does not use a slope or may include an uphill slope. However, recently there have been publications about downhill walking and its benefits in COPD. Walking on a level, uphill, and downhill slope may have the potential to result in different gains by using different muscle groups more. Therefore, this study aimed to compare the effects of walking training on exercise capacity, respiratory functions, muscle strength, and functional status in COPD patients with three different slope types: level, uphill, and downhill. conditions: Pulmonary Disease, Chronic Obstructive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 51 type: ESTIMATED name: Downhill walking training name: Level walking training name: Uphill walking training measure: 6 Minutes Walking Distance (6MWD) measure: Spirometric measurements (Forced vital capacity) measure: Spirometric measurements (First second forced expiratory volume) measure: Spirometric measurements (FEV1/FVC ratio) measure: Spirometric measurements (Peak Expiratory Flow) measure: Spirometric measurements (Maximum Intermediate Expiratory Flow) measure: Muscle strength measurements (skeletal muscles) measure: Muscle strength measurements (respiratory muscles) measure: 30-second sit and stand test measure: Functional performance inventory measure: Dyspnea measure: Fatigue measure: Level of exertion sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282991 id: B7461028 briefTitle: A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled overallStatus: COMPLETED date: 2020-07-22 date: 2021-01-18 date: 2021-01-18 date: 2024-02-28 date: 2024-02-28 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.

This study is seeking participants who:

* have lung cancer that could not be controlled.
* have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work.
* have received at least 1 treatment before.

All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective. conditions: Non-Small Cell Lung Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 73 type: ACTUAL name: Lorlatinib measure: The treatment pattern from initial diagnosis to current lorlatinib treatment. measure: objective response rate (ORR) measure: overall survival measure: progression-free survival measure: 1-year OS rate measure: time-to-treatment failure for all NSCLC measure: time-to-treatment failure of lorlatinib measure: The clinical nature, incidence, duration, and severity of lorlatinib-related safety profile sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch city: Kaohsiung City zip: 83301 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Chung Shan Medical University Hospital city: Taichung zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Taichung Veterans General Hospital city: Taichung zip: 407219 country: Taiwan lat: 24.1469 lon: 120.6839 facility: National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Taipei Veterans General Hospital city: Taipei zip: 11217 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Chang Gung Memorial Hospital - Linkou Branch city: Taoyuan City zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06282978 id: GEM-RANTAB id: 2023-504273-21 type: EUDRACT_NUMBER briefTitle: Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes overallStatus: RECRUITING date: 2023-11-23 date: 2025-05 date: 2029-12 date: 2024-02-28 date: 2024-03-06 name: PETHEMA Foundation class: OTHER briefSummary: The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.

Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.

Safety refers to the measurement of:

i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests).

ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infections

The study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study. conditions: Multiple Myeloma in Relapse studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open label, multicenter, phase II study of Elranatamab as single agent. The primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy as evaluated with the rate of complete Response and Undetectable Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators. primaryPurpose: TREATMENT masking: NONE maskingDescription: None (Open Label) count: 50 type: ESTIMATED name: Elranatamab (PF-06863135) measure: To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate annually by NGF until loss of response, the rate of Undetectable Measurable Residual Disease (% of patients with MRD negative by NGF method and with a sensitivity level of 10-5) of elranatamab in patients with R/R multiple myeloma. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in physical examination and ECOG performance status scale (0-5). measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in 12-lead ECG. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in Echocardiogram / MUGA. measure: To determine Circulating Tumor Cells (CTC) at baseline to evaluate its prognostic value. measure: To determine serum BCMA levels and its correlation with response. measure: To do gene expression techniques (RNA sequencing and single cell sequencing studies) coupled with intelligent clinical and molecular data analysis (i.e. machine learning) to identify factors that could predict response to elranatamab. measure: To determine MRD value with alternative methods measure: To characterize patients' immune system measure: To define genomic determinants of response/resistance measure: To evaluate Overall Response Rate of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate Duration of Response of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate Time to first and best response of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate Progression-free survival (PFS) of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate Overall survival (OS) of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate PFS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate OS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate the Incidence of neurologic effects related to elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate the Incidence of cytopenias and infections related to elranatamab in patients with relapsed/refractory multiple myeloma. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Santiago ~ CHUS status: NOT_YET_RECRUITING city: Santiago De Compostela state: A Coruña zip: 15706 country: Spain name: Marta Sonia Gonzalez Perez, MD role: CONTACT name: Marta Sonia Gonzalez Perez, MD role: PRINCIPAL_INVESTIGATOR lat: 42.88052 lon: -8.54569 facility: Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol status: NOT_YET_RECRUITING city: Badalona state: Barcelona zip: 08916 country: Spain name: Albert Oriol Rocafiguera, MD role: CONTACT name: Albert Oriol Rocafiguera, MD role: PRINCIPAL_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals status: NOT_YET_RECRUITING city: L'Hospitalet De Llobregat state: Barcelona zip: 08908 country: Spain name: Ana Sureda, MD role: CONTACT name: Ana Sureda, MD role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 facility: Hospital Universitario Marqués de Valdecilla status: NOT_YET_RECRUITING city: Santander state: Cantabria zip: 39008 country: Spain name: Enrique M Ocio San Miguel, MD role: CONTACT name: Enrique M Ocio San Miguel, MD role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 facility: Hospital Universitario de Jerez de la Frontera status: NOT_YET_RECRUITING city: Jerez De La Frontera state: Cádiz zip: 11407 country: Spain name: Sebastian Garzon Lopez, MD role: CONTACT name: Sebastian Garzon Lopez, MD role: PRINCIPAL_INVESTIGATOR lat: 36.68645 lon: -6.13606 facility: Hospital Son Llàtzer status: NOT_YET_RECRUITING city: Palma De Mallorca state: Illes Balears zip: 07198 country: Spain name: Joan LL Bargay, MD role: CONTACT name: Joan LL Bargay, MD role: PRINCIPAL_INVESTIGATOR lat: 39.56939 lon: 2.65024 facility: CHU de Gran Canaria Doctor Negrín status: NOT_YET_RECRUITING city: Las Palmas De Gran Canaria state: Las Palmas zip: 35010 country: Spain name: Alexia T Suarez Cabrera, MD role: CONTACT name: Alexia T Suarez Cabrera, MD role: PRINCIPAL_INVESTIGATOR lat: 28.09973 lon: -15.41343 facility: Hospital HM Sanchinarro status: NOT_YET_RECRUITING city: Sanchinarro state: Madrid zip: 28050 country: Spain name: Jaime Perez de Oteysa, MD role: CONTACT name: Jaime Perez de Oteysa, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Clínico Universitario Virgen de la Arrixaca status: NOT_YET_RECRUITING city: El Palmar state: Murcia zip: 30120 country: Spain name: Begoña Navarro de Almenzar, MD role: CONTACT name: Begoña Navarro de Almenzar, MD role: PRINCIPAL_INVESTIGATOR lat: 37.93939 lon: -1.16095 facility: Clinica Universidad Navarra (CUN) status: NOT_YET_RECRUITING city: Pamplona state: Navarra zip: 31008 country: Spain name: Jesus San Miguel Izquierdo, MD role: CONTACT phone: +34 948 296 296 email: sanmiguel@unav.es name: Paula Rodriguez Otero, MD role: PRINCIPAL_INVESTIGATOR lat: 42.81687 lon: -1.64323 facility: H. Clínic i Provincial de Barcelona status: NOT_YET_RECRUITING city: Barcelona zip: 08036 country: Spain name: Joan Bladé, MD role: CONTACT phone: +34 932275428 email: jblade@clinic.cat name: Laura Rossiñol, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital de Cabueñes status: RECRUITING city: Gijón zip: 33394 country: Spain name: María Esther González García, MD role: CONTACT phone: + 34 985 18 50 00 name: María Esther González García, MD role: PRINCIPAL_INVESTIGATOR lat: 43.53573 lon: -5.66152 facility: Instituto de Investigación Sanitaria Hospital 12 de Octubre status: NOT_YET_RECRUITING city: Madrid zip: 28041 country: Spain name: Juan Jose Lahuerta, MD role: CONTACT phone: +34 91 779 28 39 email: jjlahuerta@telefonica.net lat: 40.4165 lon: -3.70256 facility: Hospital Clínico Universitario Salamanca status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Mª Victoria Mateos, MD role: CONTACT phone: +34 923 291 100 phoneExt: 55384 email: mvmateos@usal.es name: Verónica González de la Calle, MD role: CONTACT phone: +34 923 291 100 phoneExt: 55629 email: vgcalle@saludcastillayleon.es name: Mª Victoria Mateos, MD role: PRINCIPAL_INVESTIGATOR lat: 40.96882 lon: -5.66388 facility: C.H. de Toledo (Virgen de la Salud) status: NOT_YET_RECRUITING city: Toledo zip: 45005 country: Spain name: Luis Felipe Casado Montero, MD role: CONTACT name: Luis Felipe Casado Montero, MD role: PRINCIPAL_INVESTIGATOR lat: 39.8581 lon: -4.02263 hasResults: False

 nctId: NCT06282965 id: AngT-001 briefTitle: Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury acronym: ANGel T overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-09 date: 2027-09 date: 2024-02-28 date: 2024-02-28 name: University of Arizona class: OTHER name: United States Department of Defense briefSummary: The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).

The main questions this trial aims to answer are:

* Is Angiotensin (1-7) safe?
* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?

Participants will:

* Complete 21 days of study treatment consisting of a once-daily injection.
* Provide blood samples.
* Undergo two magnetic resonance imaging (MRI) scans of the brain.
* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.

Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Investigators, study site staff, participants, and caregivers will be unaware of the participant treatment assignments for the duration of the study. The pharmacist will prepare the study treatment and will be unmasked. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Angiotensin (1-7) name: Sterile saline measure: Number of participants with adverse events measure: Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) measure: Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA) measure: Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) measure: Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau) measure: Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days measure: Effects of Angiotensin (1-7) on brain white matter integrity measure: Effects of Angiotensin (1-7) on length of hospital stay measure: Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM) measure: Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282952 id: 198/2023 briefTitle: NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT acronym: NEMO-FMT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2028-12-31 date: 2024-02-28 date: 2024-02-28 name: Oulu University Hospital class: OTHER name: University of Oulu name: University of Turku name: Turku University Hospital name: University of Helsinki name: Academy of Finland name: Biocenter Oulu briefSummary: The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section to obese mothers and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:

* Could fecal transplant be used improve gut microbiota and prevent overweight or obesity.
* Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant. conditions: Fecal Microbiota Transplantation conditions: Cesarean Section conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The eligible women are randomized into two groups in which their newborns receive either fecal microbiota transplant from 1) their own mother (50 newborns) or 2) the Microbiome Biobank (50 newborns). The randomization 1:1 is done in blocks of 4 mothers. The study is double blinded. If mother has Group B streptococcus colonization or other infectious disease described in table 1, and microbiota transplant cannot be given or if mother will have non-elective-CS and the microbiome transplant is not available, the mother is included in 3) the observational cohort, which is "open" (not blinded). primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The research statistician performs the computer-generated randomization. The study nurse prepares the fecal transplant according to the randomization. Study participants or investigators are not aware of study group. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Fecal transplant measure: Microbial composition profiles in fecal sample measure: Height in centimeters measure: Height z-score measure: Weight in kilograms measure: Weight-for-length (%) measure: The source of colonization by exclusively shared genes (ESGs) sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT hasResults: False

 nctId: NCT06282939 id: 20234314 briefTitle: Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry acronym: OPTIMA overallStatus: RECRUITING date: 2023-11-01 date: 2026-12-01 date: 2027-12-01 date: 2024-02-28 date: 2024-02-28 name: HCA Healthcare Research Institute class: OTHER name: Balt USA briefSummary: This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System.

The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures. conditions: Intracranial Aneurysm studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: OPTIMA and OPTIMAX Coils manufactured by Balt USA measure: Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score measure: Assess coiling alone or in combination with adjunctive devices for approximately 400 patients measure: Evaluate Coiling with flow diversion for approximately 200 subjects measure: Subgroup analyses will be performed examining: measure: Analyze outcomes of small aneurysms defined as smaller than 5mm measure: Adequate occlusion measure: Packing density measure: Complete occlusion measure: Complete occlusion measure: Recanalization rate measure: Retreatment rate measure: Change in degree of disability measure: The number of coils used in an aneurysm measure: Procedural fluoroscopic time measure: Primary Safety Endpoint measure: Secondary Safety Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Med City Plano status: RECRUITING city: Plano state: Texas zip: 75075 country: United States name: Albert Yoo role: CONTACT phone: 972-566-5411 email: ajyoo74@gmail.com name: Pauline Matheri role: CONTACT phone: 615-329-7274 email: Pauline.Matheri@HCAhealthcare.com lat: 33.01984 lon: -96.69889 hasResults: False

 nctId: NCT06282926 id: 324811 briefTitle: Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER name: Manchester Metropolitan University briefSummary: The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.

As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).

Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.

The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase. conditions: Tetralogy of Fallot studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 72 type: ESTIMATED name: Echocardiography assessment measure: Evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair. measure: Evaluate the effects of chronic RV volume overload in this population within one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurement of GLS. measure: Compare TTE-3DKBR evaluation to the conventional 2D echocardiography measurements used in routine clinical practice (TAPSE, TDI, FAC, and GLS). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282913 id: ---Oncology-Nursing-2024--- briefTitle: The Effect of Mindfulness Meditation overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: Gulhane Training and Research Hospital class: OTHER_GOV briefSummary: Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units. conditions: Burnout conditions: Compassion Fatigue conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Mindfulness Meditation measure: compassion fatigue measure: burnout measure: psychological well-being measure: compassion fatigue measure: burnout measure: psychological well-being sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282900 id: 2024-1/15 briefTitle: Pain and Screen Addiction in University Students overallStatus: RECRUITING date: 2024-03-04 date: 2024-05 date: 2024-06 date: 2024-02-28 date: 2024-03-08 name: Acibadem University class: OTHER briefSummary: One of the most important factors why young people spend inactive time is the time they spend in front of the screen. Sedentary screen time refers to time spent using a screen-based device, such as a computer, television, smartphone, or tablet while being sedentary in any environment. The last decade has seen a disturbing increase in the amount of time young people spend in front of screens. Research shows that musculoskeletal disorders in the hand, wrist, arm, and neck occur at a high rate due to long-term and repetitive use of the smartphone, one of the electronic devices. People with musculoskeletal pain often complain of more than one area of pain.

The primary purpose of this study is to investigate the relationship between university students' use of various screen-based devices, the time they spend in front of the screen, and the number of painful areas they report on the body. Our secondary aim is to evaluate the relationship between pain, and screen time, and physical activity level. conditions: Student studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: University students measure: Investigating the use of screen-based devices measure: Musculoskeletal system evaluation measure: Physical activity assessment sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Acibadem University status: RECRUITING city: Istanbul state: None Selected zip: 34752 country: Turkey name: Elif E Safran, asst. prof. role: CONTACT phone: 500 4047 phoneExt: 216 email: elif.bayraktar@acibadem.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06282887 id: 2021-IIT-002 briefTitle: Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and A Relevant Mediator overallStatus: RECRUITING date: 2021-11-09 date: 2024-11-10 date: 2024-11-10 date: 2024-02-28 date: 2024-02-28 name: Guangzhou Concord Cancer Center class: OTHER briefSummary: The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation. conditions: Psycho-Oncology studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: All participants will be wearing a headphone, and they will not know if there will be music until they experience and finish the scan process.

Radiographers are blinding to avoid biases. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 80 type: ESTIMATED name: Music therapy measure: Anxiety measure: Symptom distress measure: Relaxation measure: Pulse rates measure: Respiration rate measure: Scanning efficiency measure: Patient satisfaction level measure: Patient attention to music (only for the music therapy group) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: GuangZhou Concord Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510700 country: China name: Juan Nie, Masters role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06282874 id: CTONG2303 briefTitle: Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-07-01 date: 2027-03-01 date: 2024-02-28 date: 2024-02-28 name: Guangdong Association of Clinical Trials class: OTHER briefSummary: This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases. conditions: Carcinoma, Non-Small-Cell Lung conditions: Brain Metastases conditions: Leptomeningeal Metastasis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Lorlatinib measure: intracranial objective response rate（iORR） measure: Progression-free survival (PFS) and intracranial PFS（iPFS） measure: Obiective response rate (ORR) measure: Disease control rate (DCR) and intracranial disease control rate (iDCR) measure: Overall survival measure: Number of participants with adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial Perople's Hospital city: Guangzhou state: Other (Non U.s.) zip: 510080 country: China name: Chang Lu role: CONTACT phone: 02083827812 email: luchang@gdpg.org.cn name: Jin-Ji Yang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06282861 id: ANTES B+ id: 2023-507304-32 type: EUDRACT_NUMBER briefTitle: ANTES B+ Clinical Trial acronym: ANTES B+ overallStatus: RECRUITING date: 2024-02-29 date: 2025-09 date: 2025-09 date: 2024-02-28 date: 2024-03-05 name: Fundacio Privada Mon Clinic Barcelona class: OTHER name: GlaxoSmithKline briefSummary: Current guidelines recommend initial treatment with dual long-acting bronchodilator therapy (LABA-LAMA) in patients with Chronic Obstructive Pulmonary Disease (COPD) of group B (defined by CAT≥10 and none or 1 moderate exacerbation). However, the investigators hypothesize that there is a subgroup of B patients (B+) at a particularly high risk for poor clinical control, characterized by the following:

* 1 moderate exacerbation in the previous year
* CAT≥10 despite current treatment with LABA -LAMA
* Blood eosinophil levels of ≥150 cells/ml

the investigators further hypothesize that B+ patients could benefit from triple therapy treatment (LABA-LAMA + Inhaled Corticosteroids). Therefore, the main goal of this clinical trial is to compare the efficacy of Trelegy (triple therapy) in improving clinical control in GOLD B+ patients with chronic obstructive disease when compared to standard double therapy (LABA -LAMA).

The clinical control is a validated composite endpoint that includes two domains, the patient's stability, and the impact of the disease.

1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month follow-up trial. primaryPurpose: PREVENTION masking: NONE count: 1028 type: ESTIMATED name: Trelegy Ellipta 100/62.5/25Mcg Inh 30D name: Brimica name: Duaklir name: Ultibro name: Ulunar name: Xoterna name: Anoro name: Laventair name: Spiolto Respimat name: Yanimo name: Foradil name: Broncoral name: Formoterol stada name: Oxis name: Formatris name: Formoterol Aldo name: Onbrez name: Oslif name: Hirobriz name: Striverdi name: Beglan name: Betamican name: Inaspir name: Serevent name: Soltel name: Eklira name: Bretaris name: Seebri name: Tovanor name: Enurev name: Spiriva name: Tavulus name: Sirkava name: Braltus name: Gregal name: Incruse name: Rolufta measure: Clinical Control (CC) measure: Clinical Important Deterioration (CID) measure: Patients persistently controlled measure: Time to deterioration measure: Time to no control event of CC - Stability Domain measure: Time to no control event of CC - Impact Domain measure: Time to deterioration event of CID-CAT Exacerbations measure: Time to deterioration event of CID-CAT Spirometry measure: Exacerbation rate measure: Time to first Exacerbation measure: Spirometry changes measure: Independent predictors sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic Barcelona status: RECRUITING city: Barcelona state: Catalunya zip: 08036 country: Spain name: Àlvar Agustí role: CONTACT phone: 93 227 57 79 email: aagusti@clinic.cat name: Nestor Soler role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06282848 id: HongKongPU_Optometry4 briefTitle: Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate overallStatus: RECRUITING date: 2024-01-01 date: 2026-12 date: 2026-12 date: 2024-02-28 date: 2024-03-07 name: The Hong Kong Polytechnic University class: OTHER name: The University of Hong Kong briefSummary: The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:

* the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates
* the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.

Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.

Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Double-blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Atropine 0.05% name: DIMS lens measure: Subjective refraction measure: Axial length measure: mfERG responses measure: Retinal and choroidal thickness sex: ALL minimumAge: 7 Years maximumAge: 9 Years stdAges: CHILD facility: School of Optometry, Hong Kong Polytechnic University status: RECRUITING city: Hong Kong zip: 00000 country: Hong Kong name: Henry HL Chan, PhD role: CONTACT phone: 85227667937 email: henryhl.chan@polyu.edu.hk name: Kaiyip Choi, PhD role: CONTACT phone: 85234002934 email: kaiyip.choi@polyu.edu.hk lat: 22.27832 lon: 114.17469 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-03-02 uploadDate: 2024-02-21T22:59 filename: ICF_000.pdf size: 234773 hasResults: False

 nctId: NCT06282835 id: 2023KY242 briefTitle: Eravacycline Combination Therapy for MRAB overallStatus: RECRUITING date: 2024-01-26 date: 2024-10-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Fujian Medical University Union Hospital class: OTHER briefSummary: The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.

Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time conditions: Pulmonary Infection conditions: Pneumonia, Bacterial conditions: Acinetobacter Baumannii studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Eravacycline Injection measure: Clinical Responded Rate measure: The microbiological clearance rate measure: The all-cause mortality rate within 28 days measure: "Incidence Rate of Adverse Event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350000 country: China name: Hui Zhang, Phd role: CONTACT phone: 13015723860 email: xhzh@fjmu.edu.cn lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06282822 id: HFpEF-SWE briefTitle: Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-31 date: 2025-03-01 date: 2024-02-28 date: 2024-02-28 name: First Hospital of China Medical University class: OTHER briefSummary: The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF. conditions: Shear Wave Elastography conditions: Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Transthoracic echocardiography measure: Shear wave velocity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282809 id: CSP3325 briefTitle: The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy acronym: GANNON overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2026-01 date: 2024-02-28 date: 2024-04-11 name: HistoSonics, Inc. class: INDUSTRY briefSummary: The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy. conditions: Pancreas Cancer conditions: Adenocarcinoma of the Pancreas conditions: Pancreatic Cancer conditions: Tumor of Pancreas studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multi-center, single-arm, feasibility trial. primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy measure: Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de la Santa Creu i Sant Pau city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06282796 id: EPW-CABC-01 briefTitle: Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2028-12-31 date: 2024-02-28 date: 2024-02-28 name: First Hospital of China Medical University class: OTHER briefSummary: This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Echocardiography measure: Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy. measure: Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy. sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Cancer Hospital status: RECRUITING city: Fuzhou state: Fujian country: China name: Weiqin Huang role: CONTACT lat: 26.06139 lon: 119.30611 facility: Dalian Friendship Hospital status: RECRUITING city: Dalian state: Liaoning country: China name: Bo Zhang role: CONTACT lat: 38.91222 lon: 121.60222 facility: Dalian Municipal Central Hospital status: RECRUITING city: Dalian state: Liaoning country: China name: Qingxiong Yue role: CONTACT lat: 38.91222 lon: 121.60222 facility: Liaoning Cancer Hospital & Institute status: RECRUITING city: Shenyang state: Liaoning country: China name: Xiaoxue Zhang role: CONTACT lat: 41.79222 lon: 123.43278 facility: The Third People's Hospital Of Chengdu status: RECRUITING city: Chengdu state: Sichuan country: China name: Min Xu role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06282783 id: 2024-511532-27-00 briefTitle: Studying Topiramate for Re-Activating the HIV-1 Reservoir acronym: STAR overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-04 date: 2025-08 date: 2024-02-28 date: 2024-02-28 name: Erasmus Medical Center class: OTHER briefSummary: Even with current HIV treatments, HIV is still a lifelong disease because it hides in some long-lasting cells in the body. One of the strategies to find a cure for HIV works by finding the virus in these cells, making it visible, and then getting rid of it. This is called the 'shock and kill' approach.

So far, the drugs tested can find the virus, but they don't get rid of it completely. That's why there need to be new drugs that can do this more effectively. The Erasmus MC HIV Eradication Group (EHEG) has been testing new drugs in the lab and found a drug called topiramate can wake up the virus without harming the cells. The aim of this study is to test topiramate in people living with HIV.

Most of the people that participate in HIV cure studies are men, even though most people living with HIV around the world are women. Previous research has shown that men and women might respond differently to these treatments. So, in this study, topiramate will be investigated in both men and women. This could help us find a cure that works for everyone. conditions: HIV-1-infection conditions: Hiv conditions: HIV Infections conditions: HIV I Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Topiramate measure: Effect of topiramate as measured by cell-associated HIV RNA measure: Number of treatment-related adverse events as assessed by CTCAE v4.0 measure: Influence of sex on the primary outcome measures measure: The effect of topiramate on the size of the HIV reservoir measured by relevant assays sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Centre city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06282770 id: IRB#23-000444 briefTitle: Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery overallStatus: RECRUITING date: 2023-07-01 date: 2024-07-01 date: 2025-07-01 date: 2024-02-28 date: 2024-02-28 name: University of California, Los Angeles class: OTHER briefSummary: After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.

Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace. conditions: Spinal Fusion conditions: Chronic Lower Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients will come into clinic for consultation and enrollment in the study. They will have their first study visit where they will be given either and laser diode brace or a placebo brace. They will follow up with the physician after 2 weeks and then at 3, 6, 9 months and at 1 year to evaluate function and symptoms . primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants in this study will not be told which belt is the sham diode brace or which is the functional diode brace. The assessor of the study will also be blinded to which belt each subject has, and data will be analyzed blindly based on patient ID alone. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Laser Diode Brace name: Sham Laser Diode Brace measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI measure: Stony Brook Scar Evaluation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Semel Institute of Neuroscience at UCLA status: RECRUITING city: Los Angeles state: California zip: 90024 country: United States name: Daniel Lu, MD, PhD role: CONTACT phone: 310-267-2975 email: DCLu@mednet.ucla.edu name: Mark Yamamoto, BS role: CONTACT phone: 424-535-9634 email: MTYamamoto@mednet.ucla.edu lat: 34.05223 lon: -118.24368 facility: UCLA Clinical and Translational Research Center status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Daniel Lu, MD, PhD role: CONTACT phone: 310-267-2975 email: DCLu@mednet.ucla.edu name: Adreanne Rivera, BS role: CONTACT phone: 424-946-5712 email: adreannerivera@mednet.ucla.edu lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06282757 id: 202302 briefTitle: Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-05-01 date: 2024-02-28 date: 2024-03-07 name: HAN University of Applied Sciences class: OTHER briefSummary: Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP

Study design: Web-based randomized controlled trial.

Study population: 100 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ). conditions: Communication conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Video placebo communication name: Video nocebo communication measure: Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ) measure: Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ) measure: Change in openness to VR measured using a single question measure: Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HAN University of Applied Sciences city: Nijmegen state: Overijssel zip: 6525EN country: Netherlands name: Syl Slatman, MSc role: CONTACT phone: +31629684200 email: syl.slatman@han.nl lat: 51.8425 lon: 5.85278 hasResults: False

 nctId: NCT06282744 id: OPTIMAL Arabic version briefTitle: Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log acronym: OPTIMAL overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03 date: 2024-04 date: 2024-02-28 date: 2024-02-28 name: Cairo University class: OTHER briefSummary: Purpose of the study:

To translate, culturally adapt, and to test the validity and reliability of the Outpatient Physical Therapy Improvement in Movement Assessment Log in Arabic speaking language. conditions: Physical Performance conditions: Outpatients studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 880 type: ESTIMATED name: Outpatient physical therapy improvement in movement assessment log measure: validity and reliability of the Egyptian Arabic language version of Outpatient Physical Therapy Improvement Movement Assessment Log on physical therapy outpatients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282731 id: ECKIRB1020407 briefTitle: The Changes of Urine Growth Factors Level overallStatus: COMPLETED date: 2013-05-31 date: 2016-09-01 date: 2017-04-27 date: 2024-02-28 date: 2024-02-28 name: En Chu Kong Hospital class: OTHER briefSummary: The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 74 type: ACTUAL name: Silodosin measure: Urine growth factors level measure: Urine growth factors level measure: Urine growth factors level sex: MALE minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: En Chu Kong Hospital city: New Taipei City zip: 23702 country: Taiwan lat: 25.01111 lon: 121.44583 hasResults: False

 nctId: NCT06282718 id: POS-ARI-PC CORE and AUDIT id: 965313 type: OTHER_GRANT domain: European Union id: 10204126 type: REGISTRY domain: ISRCTN id: 55487 type: OTHER domain: NIHR CPMS id: 324504 type: OTHER domain: IRAS briefTitle: A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe acronym: POS-ARI-PC overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-03 date: 2026-03 date: 2024-02-28 date: 2024-02-28 name: European Clinical Research Alliance for Infectious Diseases (ECRAID) class: OTHER name: UMC Utrecht name: University of Oxford name: Universiteit Antwerpen briefSummary: Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC). The POS-ARI-PC study is a long-term study, with the aim of describing the nature of ARI in adults and children presenting to PC across Europe. The POS-ARI-PC study will provide critically important data on the presentation and management of ARI, and build a research-ready infrastructure for studies related to the treatment, diagnosis, and prevention of ARI in primary care settings. Additional observational studies will be embedded and use the infrastructure developed in POS-ARI-PC. conditions: Acute Respiratory Tract Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Age Bands measure: The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI) measure: Overall illness severity rating measure: Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens. measure: Proportion undergoing POC (with results) and lab-based investigations measure: Details of prescriptions given on presentation of ARI measure: Details of tests ordered on presentation of ARI measure: Return to usual daily activities measure: Feeling recovered from RTI measure: Use of prescription medication measure: Use of over the counter medications measure: Complications reported associated to ARI presentation measure: Variation in practice and advice from national guidelines, to be fed back to national teams measure: Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients. measure: An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings. measure: An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials measure: Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282705 id: 306347 briefTitle: Dose Response Effect of Drop Jumps on Bone Characteristics overallStatus: COMPLETED date: 2023-01-06 date: 2023-12-13 date: 2023-12-13 date: 2024-02-28 date: 2024-02-28 name: Nottingham Trent University class: OTHER briefSummary: The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Estimated load being applied to the bone, will be assessed using non-invasive biomechanical procedures (Inertial Measurement Units, motion analysis, force plates) during drop jumps. Participants will be assigned a drop jump height of 0 cm, 30 cm or 60 cm based on a significant difference in external load at these heights or assigned to a control group where no jumps will be performed. Groups will be matched for body mass to ensure that jump height produces the load. The participants will be asked to perform 40 jumps (20 each side), 4 times per week ensuring jumping bouts are separated by 24 hours. Bone characteristics will be assessed via whole body dual-energy X-ray absorptiometry (DXA) scans and bilateral peripheral Quantitative Computed Tomography (pQCT) scans. Lab based jumping will take place on week 0, week 6, week 12, and week 16 to understand the loading applied during the different jump height groups. pQCT scans will take place on week 0, week 12, week 16 and DXA scans will take place week 0 and week 16. The reasoning of week 12 for pQCT being it may show a significant timepoint for bone formation during the remodelling cycle. During visits participants will complete a health screen, the Bone specific Physical Activity Questionnaire (BPAQ), a food frequency questionnaire and Pittsburgh sleep quality questionnaire alongside consent as tools to monitor any changes to participant lifestyle across the study. Differences in bone characteristics, lab measures and jump heights will be analysed between and within participants.

The present study aims to use varied drop jump heights to identify an osteogenic dose response effect. Drop jumps have been previously used to expose osteogenic effects in research due to the load produced at impact. Is it possible to identify an optimum height for bone response during impact? If so do we then find anything above this height actually has negative or no effect on a group of individuals? conditions: Healthy Participants conditions: Low Activity Level studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Semi-randomised, matched model. primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ACTUAL name: Diagonal Drop Jumps 0cm name: Diagonal Drop Jumps 40cm name: Diagonal Drop Jumps 60cm measure: BMD as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: BMC as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: Total bone area as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: Trabecular density as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Cortical thickness as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Periosteal circumference as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Axial bone strength (SSIX) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Axial bone strength (SSIY) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Polar bone strength (SSIPOL) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Cortical density as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Peak impact load as assessed by force plates. measure: Impulse as assessed by force plates. measure: Load rate as assessed by force plates. measure: Jump height as assessed by force plates. measure: Centre of Mass (CoM) velocity as assessed by force plates. measure: Peak acceleration as assessed by Inertial measurement units (IMU). measure: Stiffness as assessed by motion capture. measure: Moments as assessed by motion capture. sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Nottingham Trent University city: Nottingham state: Nottinghamshire zip: Ng11 8NS country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06282692 id: UNAIR-MP-INAKTIF-R-005 briefTitle: INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old overallStatus: RECRUITING date: 2023-06-19 date: 2024-05-19 date: 2024-07-19 date: 2024-02-28 date: 2024-02-28 name: Dr. Soetomo General Hospital class: OTHER_GOV name: Indonesia-MoH name: Universitas Airlangga name: PT Biotis Pharmaceuticals, Indonesia briefSummary: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.

INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents. conditions: COVID-19 Pandemic conditions: COVID-19 Vaccines studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE maskingDescription: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose.

The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. count: 400 type: ESTIMATED name: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg measure: Vaccine Neutralizing Antibody Profile measure: Incidence of Adverse Events measure: Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum measure: Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA measure: Cellular Immunogenicity Profile measure: Persistence of Antibody Level measure: Whole Genome Sequencing (WGS) of SARS-CoV-2 sex: FEMALE minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Dr. Soetomo General Hospital status: RECRUITING city: Surabaya state: Jawa Timur zip: 67161 country: Indonesia name: Dominicus Husada, MD role: CONTACT phone: +6281232266377 email: dominicushusada@yahoo.com name: Damayanti Tinduh, MD role: CONTACT phone: +6281703293335 email: damayanti.tinduh@fk.unair.ac.id name: Dominicus Husada, MD role: PRINCIPAL_INVESTIGATOR name: Damayanti Tinduh, MD role: SUB_INVESTIGATOR name: Gatot Soegiarto, MD role: SUB_INVESTIGATOR name: Leny Kartina, MD role: SUB_INVESTIGATOR name: Laksmi Wulandari, MD role: SUB_INVESTIGATOR name: Deasy Fetarayani, MD role: SUB_INVESTIGATOR name: Novira Widajanti, MD role: SUB_INVESTIGATOR name: Yudi H Oktaviano, MD role: SUB_INVESTIGATOR name: Aryati Aryati, MD role: SUB_INVESTIGATOR name: Fitriah Munawaroh, MD role: SUB_INVESTIGATOR name: Neneng D Kurniati, MD role: SUB_INVESTIGATOR name: Budi Utomo, MD role: SUB_INVESTIGATOR name: Eko B Khoendori, MD role: SUB_INVESTIGATOR name: Jusak Nugroho, MD role: SUB_INVESTIGATOR name: Maria I Lusida, MD role: SUB_INVESTIGATOR lat: -7.24917 lon: 112.75083 hasResults: False

 nctId: NCT06282679 id: KY20220701-03 briefTitle: Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea overallStatus: RECRUITING date: 2022-04-01 date: 2024-03-01 date: 2024-06-28 date: 2024-02-28 date: 2024-02-28 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea. conditions: Rosacea conditions: Botulinum Toxin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Botulinum Toxin Type A Injection [Botox] measure: CEA score measure: GAIS score measure: VISIA red zone score measure: Dermatology Quality of Life Score (DLQI) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Jie Dai status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: jie dai role: CONTACT phone: 02552271117 email: karry_dj@126.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06282666 id: KE-0254/150/2019 briefTitle: Lumbar ESPB in Hip Replacement Surgery acronym: ESPB_HIP overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-02-01 date: 2025-08-01 date: 2024-02-28 date: 2024-02-28 name: Medical University of Lublin class: OTHER briefSummary: In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed. conditions: Coxarthrosis conditions: Pain, Postoperative conditions: Pain, Acute conditions: Pain, Chronic conditions: Postoperative Pain, Chronic conditions: Analgesia conditions: Quality of Life conditions: Anesthesia conditions: Spinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups will be randomly allocated to Epidural and ESPB (1:1) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation.

Physiotherapists assessing outcomes will not be aware of patient allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Spinal anesthesia name: lumbar erector spinae plane block name: Epidural analgesia name: patient-controlled analgesia name: Timed Up and Go test name: neuropathic pain symptom inventory name: Lovett test name: Visual analog scale name: Quality of Recovery 40 name: Ability to sit, stand upright, and walk measure: Opiod consumtion with PCA measure: Pain at rest measure: Pain upon activity measure: Lovett test measure: TUG measure: QoR-40 measure: NPSI sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: II Department of Anesthesia and Intensive Care city: Lublin zip: 20-081 country: Poland name: Michał A Borys, M.D. Ph.D role: CONTACT phone: 506350569 phoneExt: +48 email: michalborys1@gmail.com name: Paweł Kutnik, M.D. role: CONTACT phone: 608769410 phoneExt: +48 email: pe.kutnik@gmail.com lat: 51.25 lon: 22.56667 hasResults: False

 nctId: NCT06282653 id: Endo-ergonomics briefTitle: Postural and Muscle Fatigue Analysis of Endodontic Residents overallStatus: RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2025-11-01 date: 2024-02-28 date: 2024-02-28 name: Universidad Europea de Madrid class: OTHER briefSummary: Musculoskeletal disorders (MSDs) are a significant occupational health problem for dentists and have been linked to a decline in quality of life, often leading to stress-related illnesses and early retirement. Poor posture, poor movement or imbalances in the neck or shoulders can lead to the three most common pain syndromes in dentistry. The objectives of this study were to evaluate the working position adopted during an endodontic procedure and to determine the perception of symptoms of musculoskeletal disorders in first and second year students of the Master in Advanced Endodontics at the European University of Madrid (UEM), using the standardised Nordic Kuorinka questionnaire supplemented by a form with socio-demographic variables. This study has a descriptive cross-sectional observational design and included 10 students selected by convenience sampling. A video camera was used to record the procedures from three different angles for a maximum of 5 minutes. The information was processed using Microsoft Excel spreadsheet software, and the video recordings were assessed using Rodgers' Muscular Fatigue Analysis (RMFA) and Rapid Upper Limb Assessment (RULA). conditions: Musculoskeletal System Disease conditions: Position Sense Disorders conditions: Symptoms and Signs conditions: Postural; Defect conditions: Endodontic Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 10 type: ESTIMATED measure: Symptom Perception sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Europea de Madrid status: RECRUITING city: Villaviciosa De Odón state: Madrid country: Spain name: Antonio Conde, PhD role: CONTACT lat: 40.35692 lon: -3.90011 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-20 uploadDate: 2024-02-20T05:22 filename: Prot_000.pdf size: 96217 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-20 uploadDate: 2024-02-20T05:30 filename: ICF_001.pdf size: 77805 hasResults: False

 nctId: NCT06282640 id: 567 briefTitle: Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome overallStatus: COMPLETED date: 2021-12-30 date: 2022-06-30 date: 2022-08-30 date: 2024-02-28 date: 2024-02-28 name: Dr. Ayşe Güç class: OTHER_GOV name: Kayseri City Hospital briefSummary: Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. conditions: Carpal Tunnel Syndrome conditions: Vitamin D Deficiency studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 87 type: ACTUAL name: Vitamin D measure: electrophysiological scale. measure: monofilament test measure: Boston symptom severity scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kayseri City Hospital city: Kayseri country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06282627 id: 10430012010023 briefTitle: The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients acronym: COVID-HOME overallStatus: COMPLETED date: 2020-03-20 date: 2022-07-30 date: 2022-08-30 date: 2024-02-28 date: 2024-02-28 name: University Medical Center Groningen class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: Background. Guidelines on COVID-19 management are developed as we learn from this pandemic. However, most research has been done on hospitalised patients and the impact of the disease on non-hospitalised and their role in transmission are not yet well understood.

The COVID HOME study conducts research among COVID-19 patients and their family members who were not hospitalised during acute disease, to guide patient care and inform public health guidelines for infection prevention and control in the community and household.

Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatients was established in March 2020 at the beginning of the COVID-19 pandemic in the Netherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that did not merit hospitalisation, and their household (HH) members, were enrolled after written informed consent. Enrolled participants were visited at home within 48 hours after initial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a blood sample for biochemical parameters/cytokines and serological determination; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (if consenting) to test for SARS-CoV-2 by RT-PCR (viral shedding) and for viral culturing. Weekly nasopharyngeal/throat swabs and stool samples, plus a blood sample on days 0 and 21 were also taken from HH members to determine whether and when they became infected. All participants were invited to continue follow-up at 3-, 6-, 12- and 18-months post-infection to assess long-term sequelae and immunological status. conditions: COVID-19 conditions: Post-COVID-19 Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 256 type: ACTUAL name: Observational study measure: SARS-CoV-2 infection measure: Long-term sequelae sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen city: Groningen zip: 9713 GZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06282614 id: MUCO245 id: 2023-A02081-44 type: OTHER domain: ID-RCB briefTitle: Performance and Safety of MUCOGYNE® Ovule as a Moisturizer acronym: MOVHYDA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2025-01 date: 2024-02-28 date: 2024-02-28 name: Biocodex class: INDUSTRY name: Voisin Consulting Life Science (VCLS) briefSummary: The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness. conditions: Vaginal Dryness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, multicenter (France), open label without comparator study primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Mucogyne Ovule measure: Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing itching measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness measure: Assessment of the patient's sexual function measure: Assessment of the patient's satisfaction measure: Assessment of changes in patient's clinical status measure: Assessment by investigator of changes in patient's clinical status measure: Assessment of the safety of MUCOGYNE® Ovule measure: Assessment of the device deficiencies of MUCOGYNE® Ovule measure: Assessment of the usability of MUCOGYNE® Ovule sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: JEAN Christian's medical office city: Nogent-sur-Marne zip: 94130 country: France lat: 48.83333 lon: 2.48333 facility: Dr Ramez GHADRI's medical office city: Orléans zip: 45100 country: France name: Ramez GHADRI, MD role: CONTACT name: Ramez GHADRI, MD role: PRINCIPAL_INVESTIGATOR lat: 47.90289 lon: 1.90389 facility: Dr Raïssa APERANO-MAS's medical office city: Rennes zip: 35000 country: France name: Raïssa APERANO-MAS, MD role: CONTACT name: Raïssa APERANO-MAS, MD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 hasResults: False

 nctId: NCT06282601 id: GUIGOU - Defaye 2023 briefTitle: STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS acronym: AMORCAGE MUSIC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-02-28 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.

However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.

In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.

This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children. conditions: Presbyacousie studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 27 type: ESTIMATED name: Audiogram name: Musical priming for the syntax test name: Test MMSE name: Barcelona Music Reward Questionnaire measure: linguistic performance test focusing on syntax. sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282588 id: CTO21042GZA briefTitle: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers acronym: THUNDER overallStatus: RECRUITING date: 2023-12-13 date: 2030-07-31 date: 2030-12-31 date: 2024-02-28 date: 2024-02-28 name: Cancer Research Antwerp class: OTHER name: Bayer name: Veracyte, Inc. briefSummary: This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity.

The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (\> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome.

The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase 2: non randomised, 1 treatment arm, open label Phase 3: randomized 1:1 between two treatment arms, blinded primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Phase 3 trial: blinded Phase 2 trial: open label whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 493 type: ESTIMATED name: Darolutamide name: Darolutamide matched placebo name: Radiotherapy name: Zoladex 3.6Mg Implant name: Zoladex LA name: Decapeptyl sustained release 22.5 mg name: Decapeptyl sustained release 11.25 mg name: Depo-Eligard 45 mg name: Depo-Eligard 22.5 mg name: Depo-Eligard 7.5 mg name: Firmagon 120 MG Injection name: Firmagon 80 MG Injection name: Docetaxel measure: Phase 3: PSMA PET metastasis free survival (ppMFS) measure: Phase 2: quality of life (sexual subdomain) measure: Phase 2: quality of life (hormonal subdomain) measure: Overall survival measure: Prostate-cancer specific survival measure: Biochemical progression-free survival measure: Time to next systemic therapy measure: Frequency and severity of adverse events sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GZA Sint-Augustinus status: RECRUITING city: Wilrijk state: Antwerp zip: 2610 country: Belgium name: Piet Ost, MD, PhD role: CONTACT email: cancertrials@gza.be name: Piet Ost role: PRINCIPAL_INVESTIGATOR lat: 51.16734 lon: 4.39513 facility: OLVZ Aalst status: NOT_YET_RECRUITING city: Aalst zip: 9300 country: Belgium name: Samuel Br role: CONTACT name: Samuel Bral role: PRINCIPAL_INVESTIGATOR lat: 50.93604 lon: 4.0355 facility: AZ Sint-Jan status: NOT_YET_RECRUITING city: Brugge zip: 8000 country: Belgium name: Sabine Meersschout role: CONTACT name: Sabine Meersschout role: PRINCIPAL_INVESTIGATOR lat: 51.20892 lon: 3.22424 facility: Saint Luc status: NOT_YET_RECRUITING city: Bruxelles zip: 1200 country: Belgium name: Ad Vanderm role: CONTACT name: Ad Vandermeulen role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: UZA status: NOT_YET_RECRUITING city: Edegem zip: 2600 country: Belgium name: Karen Fransis role: CONTACT name: Karen Fran role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 facility: UZ Gent status: NOT_YET_RECRUITING city: Gent zip: 9000 country: Belgium name: Valérie Fonteyne role: CONTACT name: Valérie Fonteyne role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: AZ Sint-Lucas status: NOT_YET_RECRUITING city: Gent zip: 900 country: Belgium name: Lien Van De Voorde role: CONTACT name: Lien Van De Voor role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: AZ Groeninge status: NOT_YET_RECRUITING city: Kortrijk zip: 8500 country: Belgium name: Nick Liefhooghe role: CONTACT name: Nick Liefhooghe role: PRINCIPAL_INVESTIGATOR lat: 50.82803 lon: 3.26487 facility: CHU Liège status: NOT_YET_RECRUITING city: Liège zip: 4000 country: Belgium name: Brieuc Suatois role: CONTACT name: Brieuc Sautois role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: AZ Delta status: NOT_YET_RECRUITING city: Roeselare zip: 8800 country: Belgium name: Benedikt Engels role: CONTACT name: Benedikt Enge role: PRINCIPAL_INVESTIGATOR lat: 50.94653 lon: 3.12269 facility: VITAZ status: NOT_YET_RECRUITING city: Sint-Niklaas zip: 9100 country: Belgium name: Bart De Troyer role: CONTACT name: Bart De Troyer role: PRINCIPAL_INVESTIGATOR lat: 51.16509 lon: 4.1437 hasResults: False

 nctId: NCT06282575 id: JZP598-302 id: 2023-508219-21-00 type: OTHER domain: CTIS briefTitle: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer overallStatus: RECRUITING date: 2024-04-30 date: 2028-07-01 date: 2029-11-01 date: 2024-02-28 date: 2024-04-08 name: Jazz Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. conditions: Biliary Tract Cancer conditions: HER2 Gene Mutation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 286 type: ESTIMATED name: Zanidatamab name: Cisplatin name: Gemcitabine name: Pembrolizumab name: Durvalumab measure: Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors measure: Overall survival (OS) in participants with IHC 3+ tumors measure: Progression Free Survival for all participants measure: OS for all participants measure: Number of participants achieving Confirmed objective response rate (cORR) measure: Duration of response (DOR) measure: Number of Patients reporting Treatment-Emergent Adverse Events (TEAE) measure: Maximum serum concentration of Zanidatamab measure: Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab measure: Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30 measure: TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30 measure: TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis) measure: TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Mountain Cancer Centers, LLP status: RECRUITING city: Lone Tree state: Colorado zip: 80124 country: United States lat: 39.55171 lon: -104.8863 facility: Norton Cancer Institute - Audubon status: NOT_YET_RECRUITING city: Louisville state: Kentucky zip: 40217 country: United States lat: 38.25424 lon: -85.75941 facility: Minnesota Oncology Hematology, P.A. status: RECRUITING city: Maple Grove state: Minnesota zip: 55369 country: United States lat: 45.07246 lon: -93.45579 facility: SCRI Oncology Partners status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: Texas Oncology - DFW status: RECRUITING city: Dallas state: Texas zip: 75246 country: United States lat: 32.78306 lon: -96.80667 facility: Hospital Oncologico, Puerto Rico Medical Center status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 hasResults: False

 nctId: NCT06282562 id: NL84223.018.23 briefTitle: FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients acronym: FeelFit overallStatus: RECRUITING date: 2024-03 date: 2026-08-15 date: 2026-08-15 date: 2024-02-28 date: 2024-03-06 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients. conditions: Brain Tumor, Primary conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: High-Intensity Interval Training (HIIT) measure: Self-reported physical fitness measure: Self-reported fitness measure: VO2max measure: Daily physical activity measure: Health-related quality of life questionnaire measure: Perceived functional impairments measure: Self-efficacy measure: Mastery measure: Brain tumor specific quality of life questionnaire measure: Subjective Happiness measure: Subjective cognitive functioning measure: Subjective cognitive failure measure: Fatigue questionnaire measure: Sleep questionnaire measure: Anxiety questionnaire measure: Self-reported depression questionnaire measure: Depression questionnaire measure: Muscle strength measure: Subjective physical fitness measure: Objective neurocognitive functioning measure: Objective neurological functioning measure: Brain imaging (optional) measure: Brain activity (optional) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VU University Medical Centers, location VUmc status: RECRUITING city: Amsterdam zip: 1081 HV country: Netherlands name: Marieke Blom, Msc role: CONTACT phone: +31621522442 email: gripopfitheid@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06282549 id: YMC046 briefTitle: Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension overallStatus: RECRUITING date: 2022-06-08 date: 2027-03-31 date: 2027-03-31 date: 2024-02-28 date: 2024-02-28 name: Yuhan Corporation class: INDUSTRY briefSummary: This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination. conditions: Essential Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1210 type: ESTIMATED name: Telmisartan/Amlodipine/Chlorthalidone(Truset) measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage measure: Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP) measure: Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP) measure: Percentage of patients who terminated the treatment sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Busan Veterans Hospital status: RECRUITING city: Busan zip: 46996 country: Korea, Republic of name: Jonghyun Choi role: CONTACT lat: 35.10278 lon: 129.04028 facility: Daegu Veterans Hospital status: RECRUITING city: Daegu zip: 42835 country: Korea, Republic of name: Sangwook Kang role: CONTACT lat: 35.87028 lon: 128.59111 facility: Gwangju Veterans Hospital status: RECRUITING city: Gwangju zip: 62284 country: Korea, Republic of name: Seowon Choi role: CONTACT lat: 35.15472 lon: 126.91556 facility: Konkuk University Medical Center status: RECRUITING city: Seoul zip: 05030 country: Korea, Republic of name: Chanhee Kwon role: CONTACT lat: 37.566 lon: 126.9784 facility: Veterans Health Service Medical Center status: RECRUITING city: Seoul zip: 05368 country: Korea, Republic of name: Changhoon Lee role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06282536 id: LungMate-018 briefTitle: Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2029-12 date: 2024-02-28 date: 2024-02-28 name: Shanghai Pulmonary Hospital, Shanghai, China class: OTHER briefSummary: Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer. conditions: Potentially Resectable ALK Positive Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All enrolled patients received Iruplinalkib neoadjuvant therapy. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Iruplinalkib name: surgery measure: Objective response rate (ORR) measure: Pathologic complete response (PCR) rate measure: Major pathologic response (MPR) rate measure: Overall survival (OS) measure: Event-free survival (EFS) measure: Treatment-related adverse event (TRAE) measure: 5-year overall survival (OS) measure: 1-year event-free survival (EFS) rate measure: Health related quality of life (HRQol) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282523 id: 2023-1773 id: A171600 type: OTHER domain: UW- Madison id: EDUC/COUNSELING PSYCH type: OTHER domain: UW- Madison id: Protocol Version 12/27/23 type: OTHER domain: UW- Madison briefTitle: Healthy Minds Comparison Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-04-25 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.

Participants will complete a four-week well-being program and complete surveys via an app on their phone. Participants can expect to participate in the study for four months. conditions: Depression conditions: Anxiety conditions: Depression/Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 460 type: ESTIMATED name: HMP app name: HMRP web app measure: Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety measure: HMP App Utilization: Days measure: HMP App Utilization: Number of Activities measure: HMP App Utilization: Minutes measure: Change in Healthy Minds Index (HM Index): Awareness measure: Change in Healthy Minds Index (HM Index): Connection measure: Change in Healthy Minds Index (HM Index): Purpose measure: Change in Healthy Minds Index (HM Index): Insight measure: Change in Subjective Happiness Scale measure: Change in Satisfaction with Life Scale (SWLS) measure: Change in Perceived Stress Scale (PSS-10) measure: Change in Flourishing Measure measure: Change in Digital Working Alliance Inventory (DWAI) measure: Change in Experiences Questionnaire (EQ) Decentering Subscale measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale measure: Change in NIH Toolbox Loneliness measure: Change in Wellbeing Growth Mindset measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Simon Goldberg, PhD role: CONTACT phone: 608-265-8986 email: sbgoldberg@wisc.edu name: Simon Goldberg, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06282510 id: 23053003 briefTitle: Nasal Antisepsis for C. Auris Prevention overallStatus: RECRUITING date: 2024-01-29 date: 2026-12 date: 2028-12 date: 2024-02-28 date: 2024-02-28 name: Mary K Hayden class: OTHER name: Rush University Medical Center name: RML Specialty Hospital briefSummary: This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris. conditions: Candida Auris Infection conditions: Colonization, Asymptomatic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Povidone Iodine Topical measure: Detection of C. auris from the anterior nares measure: Detection of C. auris from body sites other than anterior nares measure: Detection of C. auris from environmental surfaces measure: Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares measure: Detection of MRSA from environmental surfaces measure: Non-susceptibility of C. auris to povidone iodine measure: Change in microbiome community sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Sarah E Sansom, DO role: CONTACT phone: 312-563-6201 email: sarah_e_sansom@rush.edu name: Mary K Hayden, MD role: CONTACT phone: 312-942-8727 email: mhayden@rush.edu lat: 41.85003 lon: -87.65005 facility: RML Specialty Hospital status: RECRUITING city: Chicago state: Illinois zip: 60624 country: United States name: Nidhi Undevia, MD role: CONTACT phone: 630-286-4000 email: nundevia@rmlspecialtyhospital.org name: Lisa Duffner role: CONTACT phone: 630-286-4000 email: LMikolajewski@rmlspecialtyhospital.org lat: 41.85003 lon: -87.65005 facility: RML Specialty Hospital status: RECRUITING city: Hinsdale state: Illinois zip: 60521 country: United States name: Nidhi Undevia, MD role: CONTACT phone: 630-286-4000 email: nundevia@rmlspecialtyhospital.org name: Lisa Duffner role: CONTACT phone: (630) 286-4000 email: LMikolajewski@rmlspecialtyhospital.org lat: 41.80086 lon: -87.93701 hasResults: False

 nctId: NCT06282497 id: ZSCPH-003 briefTitle: Xerostomia-optimised IMRT Versus Standard IMRT in NPC overallStatus: RECRUITING date: 2023-10-23 date: 2026-10-23 date: 2029-10-23 date: 2024-02-28 date: 2024-02-28 name: Zhongshan People's Hospital, Guangdong, China class: OTHER briefSummary: This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 524 type: ESTIMATED name: Optimised neck CTV name: standard neck CTV measure: Regional recurrence free survival measure: Overall survival measure: Local recurrence free survival measure: Distant metastasis-free survival measure: Progression free survival measure: Acute toxicities measure: Late toxicities sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan City People's Hospital status: RECRUITING city: Zhongshan state: Guangdong zip: 528403 country: China name: Gui-qiong Xu, MD role: CONTACT phone: +8613528109888 email: donna_shee@163.com lat: 21.31992 lon: 110.5723 hasResults: False

 nctId: NCT06282484 id: KY20232348-C-1 briefTitle: A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions overallStatus: COMPLETED date: 2022-09-01 date: 2023-06-01 date: 2023-09-29 date: 2024-02-28 date: 2024-02-28 name: Xijing Hospital of Digestive Diseases class: OTHER briefSummary: To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer. conditions: Gastric Xanthoma conditions: Helicobacter Pylori Infection conditions: Gastric Cancer conditions: Intestinal Metaplasia conditions: Precancerous Lesions studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1260 type: ACTUAL measure: corelation between the gastric xanthoma and gastric mucosa diseases sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hosipital of Digestive Disease city: Xi'an state: Shaanxi zip: 710032 country: China lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06282471 id: MCC-23-20794 id: HM20028614 type: OTHER domain: Virginia Commonwealth University briefTitle: EW and Self-Guided PST in Cancer Survivors and Caregivers overallStatus: RECRUITING date: 2024-02-21 date: 2026-03-31 date: 2026-03-31 date: 2024-02-28 date: 2024-02-29 name: Virginia Commonwealth University class: OTHER briefSummary: To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers conditions: Cancer Survivors conditions: Informal Caregivers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Expressive Writing and Problem-Solving Therapy (EW+PST) measure: Consent Rate measure: Study Retention measure: Completed Journal Entries measure: Patient Satisfaction Questionnaire measure: Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks measure: Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks measure: Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks measure: Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks measure: Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks measure: Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks measure: Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks measure: Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks measure: Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 23298 country: United States name: Kendra Rowe role: CONTACT phone: 804-828-1965 email: rowek2@vcu.edu name: Massey CPC Team role: CONTACT phone: 804-828-1965 email: MasseyCPC@vcu.edu name: Susan Hong, MD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06282458 id: V2000101 briefTitle: Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-12-20 date: 2025-04-30 date: 2024-02-28 date: 2024-04-24 name: Veru Inc. class: INDUSTRY briefSummary: The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists. conditions: Muscle Loss conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study.

The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists. A safety follow-up visit will occur approximately 30 days after last dose of study drug. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double Blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Enobosarm name: Semaglutide measure: The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days. measure: The percent change from baseline in total fat mass sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pinnacle Trials city: Anniston state: Alabama zip: 36207 country: United States name: April Bolt role: CONTACT phone: 256-460-6379 email: Abolt@Pinnacletrials.com name: Almena Free role: PRINCIPAL_INVESTIGATOR lat: 33.65983 lon: -85.83163 facility: Cullman Clinical Trials city: Cullman state: Alabama zip: 35055 country: United States name: Cheryl Hargrove role: CONTACT phone: 256-708-2826 email: cheryl@cullmanclinicaltrials.com name: Randall Quinn role: PRINCIPAL_INVESTIGATOR lat: 34.17482 lon: -86.84361 facility: Velocity Clinical Research, CA city: Los Angeles state: California zip: 90057 country: United States name: Jenny Francisco role: CONTACT phone: 213-413-2500 email: JFrancisco@velocityclinical.com name: David Guzman role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Artemis Institute for Clinical Research city: San Diego state: California zip: 92103 country: United States name: Analicia Murillo role: CONTACT phone: 858-867-3557 email: analicia.murillo@artemis-research.com name: Stacy Layle role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Universal Axom Clinical Research city: Doral state: Florida zip: 33122 country: United States name: Diana Marinez role: CONTACT phone: 305-677-9267 phoneExt: 24 email: Dmarinez@uaclinical.com name: Luis Martinez role: PRINCIPAL_INVESTIGATOR lat: 25.81954 lon: -80.35533 facility: Altus Research city: Lake Worth state: Florida zip: 33461 country: United States name: Junieth Leyes role: CONTACT phone: 561-641-0404 email: jleyes@altusresearch.com name: Samuel Lederman role: PRINCIPAL_INVESTIGATOR lat: 26.61708 lon: -80.07231 facility: MARC Research Center city: Louisville state: Kentucky zip: 40213 country: United States name: Laken Heitz role: CONTACT phone: 502-214-3925 email: lheitz@lmarc.com name: Harold Bays role: PRINCIPAL_INVESTIGATOR lat: 38.25424 lon: -85.75941 facility: Pennington Biomedical city: Baton Rouge state: Louisiana zip: 70810 country: United States name: Aubrey Windham role: CONTACT phone: 225-763-2618 email: aubrey.windham@pbrc.edu name: Steven Heysmfield role: PRINCIPAL_INVESTIGATOR lat: 30.45075 lon: -91.15455 facility: DelRicht Research - New Orleans city: New Orleans state: Louisiana zip: 70115 country: United States name: Emily Krambeck role: CONTACT phone: 504-336-2667 email: ekrambeck@delricht.com name: Patrick Dennis role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Centennial Medical Group (CMG) city: Elkridge state: Maryland zip: 21075 country: United States name: Tyler Stine role: CONTACT phone: 443-698-8678 email: TSTINE@centennialmedical.com name: Steven Geller role: PRINCIPAL_INVESTIGATOR lat: 39.21261 lon: -76.71358 facility: SKY Integrative Medical Center city: Ridgeland state: Mississippi zip: 39157 country: United States name: Bob Hutchins role: PRINCIPAL_INVESTIGATOR lat: 32.42848 lon: -90.13231 facility: Clinvest Headlands LLC city: Springfield state: Missouri zip: 65807 country: United States name: Kealon Cox role: CONTACT phone: 417-883-7889 email: kealon.cox@clinvest.com name: David True role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: Palm Research Center city: Las Vegas state: Nevada zip: 89119 country: United States name: Sasha Sandry role: CONTACT phone: 702-736-5161 email: sasha@palmresearchcenter.com name: Samer Nakhle role: PRINCIPAL_INVESTIGATOR lat: 36.17497 lon: -115.13722 facility: Lillestol Research LLC city: Fargo state: North Dakota zip: 58104 country: United States name: Michael Lillestol role: CONTACT phone: 701-232-7705 email: lillestolmd@lillestolresearch.com name: Michael Lillestol role: PRINCIPAL_INVESTIGATOR lat: 46.87719 lon: -96.7898 hasResults: False

 nctId: NCT06282445 id: K2024035 briefTitle: Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-31 date: 2024-02-28 date: 2024-02-28 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Adebrelimab name: Oxaliplatin name: Capecitabine name: Bevacizumab measure: Progression-free survival measure: Organ retention rate measure: Overall survival measure: Disease Control Rate measure: Surgical conversion rate measure: TRAEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine status: RECRUITING city: Jinhua state: Zhejiang zip: 322000 country: China name: Qijia Xuan, MD&Phd role: CONTACT lat: 29.10678 lon: 119.64421 hasResults: False

 nctId: NCT06282432 id: RP-L201-0121-LTFU briefTitle: Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) overallStatus: ENROLLING_BY_INVITATION date: 2022-03-09 date: 2037-03 date: 2037-03 date: 2024-02-28 date: 2024-02-28 name: Rocket Pharmaceuticals Inc. class: INDUSTRY briefSummary: This Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) is a continuation of a Phase 1/2 clinical study to evaluate the safety and efficacy of the infusion of autologous hematopoietic stem cells transduced with a lentiviral vector encoding the ITGB2 gene conditions: Leukocyte Adhesion Deficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 9 type: ESTIMATED measure: Hematopoietic stem cell transplant (HSCT) free survival measure: Incidence of hospitalizations measure: Incidence of significant infections measure: Resolution of LAD-I-related skin rash measure: Resolution of LAD-I-related periodontal abnormalities measure: Event free survival measure: Overall Survival measure: Long-term genetic correction in peripheral blood mononuclear cells (PBMCs) measure: Long-term genetic correction in PB CD15+ granulocytes measure: Long-term CD18 neutrophil expression by flow cytometry measure: Long-term CD11 neutrophil expression by flow cytometry measure: Improvement or resolution of LAD-I related neutrophilia measure: Improvement or resolution of LAD-I-related leukocytosis. measure: Incidence of Investigational Product (IP) related serious adverse events (SAEs) measure: Incidence of hematologic malignancy sex: ALL minimumAge: 3 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Los Angeles (UCLA) city: Los Angeles state: California zip: 90095-1489 country: United States lat: 34.05223 lon: -118.24368 facility: Hospital Infantil Universitario Niño Jesús city: Madrid zip: 28009 country: Spain lat: 40.4165 lon: -3.70256 facility: University College London Great Ormond Street Institute of Child Health (GOSH) city: London zip: WC1N 1EH country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06282419 id: B.30.2.ATA.0.01.00/542 briefTitle: The Effect of Visual and Audio Stimulus Offered to Father-to-be overallStatus: RECRUITING date: 2023-08-21 date: 2024-03-31 date: 2025-12-31 date: 2024-02-28 date: 2024-03-01 name: Ataturk University class: OTHER briefSummary: It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program. conditions: Ultrasonography Prenatal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a study that evaluates the effects on mothers by involving fathers in the pregnancy follow-up process through the use of mobile ultrasound. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 132 type: ESTIMATED name: USE OF MOBILE ULTRASOUND name: ultrasound image taken from the internet measure: Introductory Information Form (For Women) measure: Spouse Support Scale Perceived by Women During Early Postpartum Period measure: Breastfeeding Self-Efficacy Scale-Short Form measure: Breastfeeding Adaptation Scale measure: Edinburgh Postpartum Depression Scale measure: Introductory Information Form (For Men) measure: Fathers' Breastfeeding Attitude and Participation Scale measure: Edinburgh Postpartum Depression Scale for Men sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atatürk University status: RECRUITING city: Erzurum country: Turkey name: Merve Çakıl role: CONTACT phone: +905310854245 email: mervecakil92@gmail.com name: Ayla KANBUR role: CONTACT email: aylakanbur28@hotmail.com lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06282406 id: N4532-R id: I0X1RX004532 type: OTHER_GRANT domain: U.S. Department of Veterans Affairs briefTitle: Pupil-Indexed Noninvasive Neuromodulation overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-04-03 date: 2028-08-05 date: 2024-02-28 date: 2024-02-28 name: VA Office of Research and Development class: FED briefSummary: Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning. conditions: Paresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning. primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Transcutaneous Electrical Stimulation name: Sham measure: Force Control Change sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA city: Pittsburgh state: Pennsylvania zip: 15240 country: United States name: Elizabeth B Toth, BA role: CONTACT phone: 412-954-5382 email: elizabeth.toth2@va.gov name: Kimberly A Toland role: CONTACT phone: (412) 215-5084 email: Kimberly.Toland@va.gov name: Michael A. Urbin, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06282393 id: Z-2023072 briefTitle: FibriCheck Data Registry acronym: FDR overallStatus: RECRUITING date: 2024-01-31 date: 2026-02 date: 2026-03 date: 2024-02-28 date: 2024-02-28 name: Qompium NV class: INDUSTRY briefSummary: The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders. conditions: Cardiac Arrhythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: FibriCheck recordings measure: Alignment PPG measurement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost Limburg status: RECRUITING city: Genk state: Limburg zip: 3600 country: Belgium name: Pieter Vandervoort, MD role: CONTACT phone: 089/325050 email: pieter.vandervoort@zol.be lat: 50.965 lon: 5.50082 hasResults: False

 nctId: NCT06282380 id: FDA-AF study briefTitle: Fibricheck Detection cApabilities for Atrial Fibrillation acronym: FDA-AF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-02-28 name: Qompium NV class: INDUSTRY briefSummary: Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 250 type: ESTIMATED name: FibriCheck Mobile Application measure: Accuracy of the FibriCheck Mobile Application measure: Sensitivity of the FibriCheck Mobile Application measure: Specificity of the FibriCheck Mobile Application sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282367 id: JOSE AGURTO TELLO HOSPITAL briefTitle: Bowel Preparation for Colonoscopy With Oral Lactulose overallStatus: COMPLETED date: 2021-07-01 date: 2023-04-01 date: 2023-04-01 date: 2024-02-28 date: 2024-02-28 name: Josue Aliaga class: OTHER_GOV briefSummary: Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.

Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects. conditions: Colonoscopy conditions: Colonoscopy Preparation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 222 type: ACTUAL measure: Degree of bowel cleansing using the Boston score measure: adenomas detection rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jose Agurto Tello Hospital city: Lima zip: 05001 country: Peru lat: -12.04318 lon: -77.02824 hasResults: False

 nctId: NCT06282354 id: NP4035/2023 briefTitle: Telemedicine for Postoperative Follow-up After Oncological Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-15 date: 2025-02-15 date: 2024-02-28 date: 2024-02-28 name: Instituto do Cancer do Estado de São Paulo class: OTHER briefSummary: The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form. conditions: Urologic Cancer conditions: Satisfaction, Patient conditions: Surgery conditions: Postoperative Adhesion studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Type of post-operative appointment measure: Patient satisfaction in the post-operative return measure: unattended arrivals at the institution measure: Postoperative complications measure: Appointment's time measure: Number of exams requested measure: Total cost involved per service measure: Environmental impact sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282341 id: 23CH132 briefTitle: Fatigue and Recovery: a Comparison Between Trail and Marathon acronym: MARA-TRAIL overallStatus: RECRUITING date: 2023-12-28 date: 2025-08 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert...) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective study on healthy volunteers, comparing the neurophysiological, physiological and biomechanical effects at the end of a marathon compared with an equivalent effort trail in the open air, or simulated on a treadmill, in runners specialising in each of the 2 disciplines primaryPurpose: SCREENING masking: NONE count: 90 type: ESTIMATED name: Race: Simulated marathon name: Race: Simulated trail name: Race: Trail in nature measure: Change in knee extensors maximal isometric torque output measure: Change in plantar flexor maximal isometric torque output measure: Recovery of quadriceps maximal isometric torque output the month after the race measure: Voluntary activation level measure: Force assessed in dynamic measure: Velocity assessed in dynamic measure: Power assessed in dynamic measure: Muscular power and stretch-shortening cycle assessed through squat jumps measure: Muscular power and stretch-shortening cycle assessed through countermovement jump measure: Muscular power and stretch-shortening cycle assessed through drop jump measure: Muscle electrical activity measure: The kinetics of energy cost measure: Racing kinematics measure: Ground reaction force (in Newton) measure: Center of pressure (in Newton) measure: Muscle damage blood markers measure: Resting heart rate variability parameters measure: Effort perception measure: fatigue assessment measure: Muscular pain sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Unités de Myologie et de Médecine du Sport status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: Léonard FEASSON, Phd role: CONTACT phone: 04 77 12 03 83 email: leonard.feasson@chu-st-etienne.fr name: Diana RIMAUD role: CONTACT email: diana.rimaud@chu-st-etienne.fr name: Clément FOSCHIA, Dr role: SUB_INVESTIGATOR name: Pascal EDOUARD, Dr role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06282328 id: CET 26-2024 briefTitle: HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting acronym: HIV-HOTE overallStatus: RECRUITING date: 2024-02-14 date: 2025-11-01 date: 2026-03-01 date: 2024-02-28 date: 2024-03-18 name: Castagna Antonella class: OTHER briefSummary: This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors.

This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason.

The overall study duration is 24 months, with recruitment lasting 20 months. Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization.

Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside.

In case of a positive rapid capillary HIV test result, antigen/antibody testing and Western Blot for HIV confirmation will be performed on venous blood samples on the same day. conditions: Hiv conditions: HIV Infections conditions: AIDS studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: HIV test measure: Prevalence of HIV infection measure: Number of HIV-IC measure: Number of Behavioral Risk Factors measure: CD4+ lymphocytes measure: HIV-RNA sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Scientific Institute status: RECRUITING city: Milan zip: 20127 country: Italy name: Elisabetta Carini role: CONTACT phone: +0039 0226437934 email: carini.elisabetta@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06282315 id: REALISE briefTitle: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2026-02 date: 2026-06 date: 2024-02-28 date: 2024-02-28 name: Insud Pharma class: INDUSTRY name: Ghana Health Services name: Kenya Medical Research Institute name: Bridges to Development name: Sanger Institute name: Barcelona Institute for Global Health name: European Union name: Swiss Confederation name: Mundo Sano briefSummary: An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children. conditions: Soil-Transmitted Helminths studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open-label, randomized at the school level, and each eligible participant within a school will receive only one of the study treatments (ALB or IVM). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is an open study. Participants and the study investigators assessing drug safety will not be blinded to treatment arms. Only the laboratory-based effectiveness measurement will be performed by blinded operators. whoMasked: OUTCOMES_ASSESSOR count: 20000 type: ESTIMATED name: Pre-screening Phase name: Screenig Phase name: Randomization name: Baseline Effectiveness Cohort name: Day 0 Trial Intervention name: Active Surveillance (study visit Day 1, Day 2 and Day 7) name: Passive Surveillance name: Post-Treatment Effectiveness Evaluation measure: AEs and SAEs record of participants treated with FDC compared to ALB. measure: Reduction in T. trichiura prevalence in participants treated with FDC compared with ALB. measure: Exploratory 1: Reduction in Strongyloides stercoralis seroprevalence in participants treated with FDC compared with ALB. measure: Exploratory 2: Reduction in hookworms and A. lumbricoides prevalence in participants treated with FDC compared with ALB. measure: Exploratory 3: Reduction in A. lumbricoides prevalence in participants treated with FDC compared with ALB. measure: Exploratory 4: Describe the frequency of scabies before and after the intervention in the two treatment arms. measure: Exploratory 5: (i) Genetic diversity within and between T. trichiura populations, relative to the FDC or ALB study participants. measure: Exploratory 5: (ii) Genetic diversity in candidate genes and identification of genes and/or regions in the genome of T. trichiura under selective pressure due to the treatment with FDC and/or ALB; measure: Exploratory 5: (iii) Relative abundance of mixed parasite species within and between populations and in response to treatment in the FDC or ALB study participants. measure: Exploratory 6: (i) Characterization of the microbiome composition at baseline and its implication in MDA effectiveness measure: Exploratory 6: (ii) Determine the Impact of MDA with ALB or FDC on the microbiome composition at population level measure: Exploratory 6: (iii) Measure the Recovery of the baseline microbiome composition at 11 months post-treatment and its role in reinfection with STH. sex: ALL minimumAge: 5 Years maximumAge: 17 Years stdAges: CHILD facility: Ghana Health Service (GHS) city: Accra country: Ghana name: Abraham Oduro, PM role: CONTACT phone: +233 (0) 50 469 8534 email: aroduro@gmail.com name: Joseph Opare, PI role: CONTACT email: kwadwolarbiopare@gmail.com lat: 5.55602 lon: -0.1969 facility: Kenya Medical Research Institution (KEMRI) city: Nairobi zip: 00200 country: Kenya name: Benson Singa, PI role: CONTACT phone: +254-720018880 email: singabo2008@gmail.com/bsinga@kemri.go.ke name: Stella Kepha, PM role: CONTACT email: stellakepha2005@yahoo.com lat: -1.28333 lon: 36.81667 hasResults: False

 nctId: NCT06282302 id: 6030/22 briefTitle: Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People overallStatus: RECRUITING date: 2024-01-20 date: 2024-03-18 date: 2024-04-30 date: 2024-02-28 date: 2024-02-28 name: Instituto de Cardiologia do Rio Grande do Sul class: OTHER briefSummary: Introduction: Adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. The effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. Objective: To verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals. conditions: Hypertension,Essential conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The RCT will involve thirty-six elderly volunteers (≥ 60 years of age) with systemic arterial hypertension, aiming to compare two types of physical exercise sessions, isometric wall squats and an aerobic exercise session on an exercise bike, on the 24-hour blood pressure levels. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Group control name: Isometric Exercise name: Aerobic Exercise measure: 24-hour Ambulatory Blood Pressure Monitoring sex: ALL minimumAge: 60 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Cardiology status: RECRUITING city: Porto Alegre state: RS zip: 900.620-000 country: Brazil name: Lidiane P Stochero role: CONTACT phone: 5554981301920 email: lidistochero3@gmail.com lat: -30.03306 lon: -51.23 hasResults: False

 nctId: NCT06282289 id: 2023-077 id: 2023-A01798-37 type: OTHER domain: ID RCB briefTitle: Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants acronym: AV-SSR-I overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09-21 date: 2025-09-21 date: 2024-02-28 date: 2024-03-06 name: Institut Pasteur class: INDUSTRY name: Institut de l'Audition briefSummary: The goal of this study is to investigate the preferential responses of speech neural systems in infants.

The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary).

Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz. conditions: Speech studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 64 type: ESTIMATED name: Magnetoencephalography (MEG) name: Cognition development questionnaire measure: Significance of correlation between the delta (i.e. difference) of synchronization power estimated at 10- and 6-months of age and the delta of vocabulary level measured at 18months of age. measure: The equation for linear regression analysis used to estimate the amount of neuronal synchronization between auditory and visual perception systems according to the Coherence and the Synchrony of AV inputs measure: The equation for linear regression analysis used to estimate the variation in the amount of neuronal synchronization between 4 experimental conditions according to the Coherence and the Synchrony of AV inputs sex: ALL minimumAge: 6 Months maximumAge: 10 Months stdAges: CHILD hasResults: False

 nctId: NCT06282276 id: 012922HYMC briefTitle: Anti-fat Attitudes and Weight Stigma Among Orthopedic Surgeons overallStatus: COMPLETED date: 2022-10-01 date: 2023-01-01 date: 2023-01-01 date: 2024-02-28 date: 2024-02-28 name: Hillel Yaffe Medical Center class: OTHER_GOV briefSummary: Evidence shows that anti-fat attitudes and weight stigma are prevalent among healthcare professionals and may affect treatment decisions regarding patients with obesity. The present study aimed to examine the presence of anti-fat attitudes and weight stigma among orthopedic surgeons and their correlation to the therapeutic approach to patients with obesity. In this cross-sectional survey, 150 orthopedic surgeons will complete a web-based questionnaire. the questionnaire is based on Antifat Attitudes Questionnaire (AFA), developed by Crandall in 1994. In addition, the questionnaire will include a questionnaire developed by Bocquier in 200521 to explore weight stigma among physicians. conditions: Weight Stigma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 150 type: ACTUAL name: cross sectional survey measure: anti fat attitudes measure: Weight stigma measure: Therapeutic approach sex: ALL minimumAge: 25 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hillel Yaffe Medical Center city: Hadera zip: 38000 country: Israel lat: 32.44192 lon: 34.9039 hasResults: False

 nctId: NCT06282263 id: 1292 briefTitle: The Effect of the Awareness Development Program on Suicide Prevention for Oncology Nurses acronym: RCT overallStatus: COMPLETED date: 2023-05-25 date: 2023-11-02 date: 2023-11-02 date: 2024-02-28 date: 2024-02-28 name: Sevda Ozturk class: OTHER briefSummary: The goal of this clinical trial is to investigate the effect of the Awareness Development Programme on Suicide Prevention for Oncology Nurses on the levels of knowledge, stigma and perception of efficacy towards suicide in oncology nurses. The main questions it aims to answer are:

1. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the knowledge levels of nurses about suicide according to the pre-programme and control group?
2. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the perception of efficacy levels of nurses regarding suicide according to the pre-programme and control group.
3. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the stigma levels of nurses towards suicide according to the pre-programme and control group.
4. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test and post-test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology.
5. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test-follow-up test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology.

Participants will participate the Awareness Development Programme on Suicide Prevention for Oncology Nurses. Oncology Nurses are expected to complete the pre-test, post-test and follow-up tests.

Researchers will compare control group to see if effect of "the Awareness Development Programme on Suicide Prevention" conditions: Suicide Prevention conditions: Nurses studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was a pre-test, post-test, follow-up design and control group intervention study conducted to examine the effect of "Awareness Development Programme on Suicide Prevention for Oncology Nurses" on oncology nurses' knowledge, stigma and perception of efficacy regarding suicide risk management. primaryPurpose: OTHER masking: NONE count: 86 type: ACTUAL name: "Awareness Development Program on Suicide Prevention for Oncology Nurses" measure: the Literacy of Suicide Scale measure: Efficacy Perception Scale For Suicide Risk Management measure: The Stigma of Suicide Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06282250 id: in progress briefTitle: Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder overallStatus: RECRUITING date: 2024-05 date: 2025-06 date: 2025-12 date: 2024-02-28 date: 2024-04-11 name: Geestelijke Gezondheidszorg Eindhoven (GGzE) class: OTHER briefSummary: In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied.

Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues. conditions: Bipolar Disorder conditions: Mood Swing conditions: Prodromal Symptoms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy name: Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy name: Psycho-education + Imagery focused Cognitive Therapy measure: Change in depressive symptom scores on the IDS-SR measure: Change in hyperactive symptom scores on the ASRM measure: Change in anxiety symptom scores on the BAI measure: Change in sleep quality subjective rating on 11-point Likert scale measure: Change in activity levels subjective rating on 11-point Likert scale sex: ALL minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Geestelijke Gezondheidszorg Eindhoven (GGzE) status: RECRUITING city: Eindhoven state: Noord-Brabant zip: 5626ND country: Netherlands name: Else Treffers, MSc role: CONTACT phone: +31622559192 email: else.treffers@ggze.nl lat: 51.44083 lon: 5.47778 hasResults: False

 nctId: NCT06282237 id: 2022.143 briefTitle: Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study acronym: 1206 overallStatus: RECRUITING date: 2023-07-01 date: 2025-07-01 date: 2026-07-01 date: 2024-02-28 date: 2024-02-28 name: Fondazione Policlinico Universitario Campus Bio-Medico class: OTHER name: Fondazione Don Carlo Gnocchi Onlus briefSummary: The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.

Primary objectives:

* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;
* Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;
* Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).

Secondary endpoints will be:

1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);

• The change in walking performance before and after the rehabilitation treatment. conditions: Sarcoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 13 type: ESTIMATED name: survey measure: Improvement in the Toronto Extremity Salvage Score (TESS) measure: Pain evaluation measure: Motor performance evaluation measure: Evaluation of Quality of Life measure: Pain evaluation measure: Pain evaluation measure: Evaluation of Quality of Life sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Campus Biomedico status: RECRUITING city: Roma zip: 00128 country: Italy name: Sergio Valeri, MD role: CONTACT phone: 06225411626 email: s.valeri@policlinicocampus.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06282224 id: XMFHIIT-2023SL066 briefTitle: Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2025-01-11 date: 2026-01-11 date: 2024-02-28 date: 2024-02-28 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: "For lesions in the skull base, including meningiomas, chordomas and pituitary tumors, endoscopic surgery has replaced traditional microscopes as the mainstream procedure. Although neurosurgeons can enlarge the surgical area using a neuroendoscope, it does not provide any information on the morphology and location of anatomical structures beneath visible surfaces. Due to the complex anatomical relationships of adjacent structures in the skull base, lesions occurring here are often located deep within anatomy that is difficult to fully expose and remove with endoscopic surgery alone. Especially when dealing with larger tumors that surround major arteries and nerves, limited visibility at surface level can easily damage blood vessels or nerves causing complications such as bleeding during or after surgery, deformities or functional impairments. The purpose of this study is to explore how augmented reality (AR) technology can highlight important anatomical structures in a neuroendoscope's field of view to optimize surgical visibility beyond what is possible with just an endoscope alone. This will make it easier for surgeons to distinguish deeper anatomical structures and reduce intraoperative and postoperative complications associated with endoscopic surgery." conditions: Pituitary Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Performing endoscopic transnasal skull base surgery with AR-integrated endoscope measure: Postoperative Recovery of Transnasal Surgery measure: Postoperative complication sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282211 id: CHASE 005 briefTitle: the Efficacy and Safety of Ondansetron Oral Soluble Pellicles overallStatus: RECRUITING date: 2024-02-20 date: 2024-03-01 date: 2024-12-29 date: 2024-02-28 date: 2024-02-28 name: The First Affiliated Hospital of Xinxiang Medical College class: OTHER briefSummary: The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy. conditions: Nausea and Vomiting studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 184 type: ESTIMATED name: Ondansetron Oral Soluble Pellicles measure: Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups measure: Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups measure: Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups measure: Incidence of adverse events and serious adverse reactions throughout the study period sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Keya Zhi status: RECRUITING city: Weihui state: None Selected zip: 453100 country: China name: Yana Zhang role: CONTACT phone: 15093230340 email: Drzhangyana@hotmail.com lat: 34.79333 lon: 108.93833 hasResults: False

 nctId: NCT06282198 id: UCHCEU-13/02/24 briefTitle: Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses acronym: IMU-DFM overallStatus: RECRUITING date: 2018-02-01 date: 2024-06-01 date: 2024-06-01 date: 2024-02-28 date: 2024-02-28 name: Cardenal Herrera University class: OTHER briefSummary: The primary aim of this study is to compare spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals without prostheses. conditions: Distal Femoral Musculoskeletal Tumors studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED measure: Gait Symmetry index measured in percentage (%) measure: Sagittal range of movement of the knee measured with a goniometer measure: Muscular strength sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad CEU Cardenal Herrera status: RECRUITING city: Valencia country: Spain name: JF Lisón, PhD role: CONTACT lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06282185 id: CanisiusWH briefTitle: SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy acronym: Superman overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-05-01 date: 2024-02-28 date: 2024-02-28 name: Canisius-Wilhelmina Hospital class: OTHER briefSummary: The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are:

* What is the impact of exercise on quality of life
* What is the impact of exercise on physical fitness

Participants will have an individual training program with supervised training by physiotherapists.

Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program. conditions: Prostatic Neoplasms conditions: Metastasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial with an intervention arm and an usual care group primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Physiotherapy measure: change of quality of life assessed with EPIC26 (0-100 points) measure: change of quality of life assessed with EPIC26 (0-100 points) measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min measure: change of physical fitness in fat percentage measure: change of physical fitness in fat percentage measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) sex: MALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282172 id: BTL-785_CTUS1600 briefTitle: Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue overallStatus: COMPLETED date: 2023-07-25 date: 2023-10-31 date: 2023-12-18 date: 2024-02-28 date: 2024-02-28 name: BTL Industries Ltd. class: INDUSTRY briefSummary: This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat. conditions: Fat Burn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 8 type: ACTUAL name: Treatment with BTL-785-7 measure: Investigation of the effect of the BTL-785F device (with BTL-785-7 applicator) on submental subcutaneous fat tissue. measure: Investigation of post-treatment adipocyte apoptosis measure: Incidence of Treatment-related Adverse Events measure: Comfort Evaluation Assessed by Therapy Comfort Questionnaire sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schweiger Dermatology PC, Research Division city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 hasResults: False

 nctId: NCT06282159 id: DNTH103-MG-201 briefTitle: A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) acronym: MAGIC overallStatus: RECRUITING date: 2024-02-23 date: 2025-12 date: 2027-12 date: 2024-02-28 date: 2024-04-22 name: Dianthus Therapeutics class: INDUSTRY briefSummary: The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG). conditions: Myasthenia Gravis, Generalized studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: DNTH103 name: Placebo measure: Incidence, severity, and relationship of TEAEs (including treatment discontinuation due to adverse events [AEs]) [Time Frame: Baseline (Day 1) to Safety Follow-Up Visit (up to Week 40)] measure: Incidence, severity, and relationship of adverse events of special interest (AESI) measure: Number of participants with changes from baseline in ECG parameters measure: Number of participants with changes in clinical laboratory values over time measure: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score measure: Change from baseline in Quantitative Myasthenia Gravis (QMG) scale score measure: Serum concentrations of DNTH103 measure: Change from baseline in complement total blood test (CH50) measure: Antidrug antibody (ADA) levels against DNTH103 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bradenton Research Center status: RECRUITING city: Bradenton state: Florida zip: 34205 country: United States name: Gloria Carlbert role: CONTACT email: gloriacarlbert@bradentonresearch.com lat: 27.49893 lon: -82.57482 facility: Texas Neurology status: RECRUITING city: Dallas state: Texas zip: 75206 country: United States name: Haley Rucker role: CONTACT email: hrucker@texasneurology.com lat: 32.78306 lon: -96.80667 facility: West Texas Neurology Clinic status: RECRUITING city: Lubbock state: Texas zip: 79414 country: United States name: Christie Long role: CONTACT email: research@westtexasneurologyclinic.com lat: 33.57786 lon: -101.85517 hasResults: False

 nctId: NCT06282146 id: 2024P000252 briefTitle: Testing a Transdiagnostic TMS Treatment Target acronym: T5 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-02-28 date: 2024-02-28 name: Brigham and Women's Hospital class: OTHER briefSummary: The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function. conditions: Major Depressive Disorder conditions: Depression conditions: Psychiatric Disorder conditions: Mood Disorders conditions: Mental Disorder conditions: Anxiety Disorders conditions: OCD conditions: PTSD studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: transcranial magnetic stimulation measure: Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire measure: Feasibility as measured by number of the 50 treatments completed measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC) measure: World Health Organization Disability Assessment Schedule II (WHODAS 2.0) measure: Beck Depression Inventory (BDI) measure: Beck Anxiety Inventory (BAI) measure: Adult Attention Deficit/Hyperactivity Disorder Self-Report Scale (AARS) measure: Clinical Global Impression Scale (CGI) measure: Illness Intrusiveness Rating Scale (IIRS) measure: Perceived Stress Scale (PSS) measure: Positive and Negative Symptom Scale (PANSS) measure: Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) measure: Social Readjustment Rating Scale (SRRS) measure: Yale Brown Obsessive-Compulsive Scale (Y-BOCS) measure: Temperament and Character Inventory, Revised 140-item measure: Emotional Conflict Resolution Test measure: Learning, Multi-Source Interference Task (MSIT) measure: Penn Emotion Recognition Task (ER-40) measure: Death Suicide IAT measure: Young Mania Rating Scale (YMRS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282133 id: 2024-1862 briefTitle: Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study acronym: EC-II-Ado-P overallStatus: RECRUITING date: 2024-02-01 date: 2024-07-01 date: 2025-01-01 date: 2024-02-28 date: 2024-02-28 name: Universite du Quebec en Outaouais class: OTHER briefSummary: Generalized Anxiety Disorder (GAD) is a chronic condition characterized by excessive and uncontrollable worry and anxiety. In adolescents, this condition can seriously impact their development, academic performance, and social relationships. In Canada, 3 to 4% of the population (between 0.9% and 2.7% among adolescents) suffers from GAD at any given time in their lives. These young individuals experience a reduced quality of life and are at risk for numerous medical conditions, as well as additional psychological issues. Research suggests that both pharmacological and psychological approaches are effective in treating GAD in the short term. However, psychological treatments appear to offer the greatest long-term benefits. There are a number of effective psychological treatments for GAD, most of which fall under cognitive-behavioural therapy (CBT) adapted for this age group.

In the 1990s, a group of Canadian researchers developed a CBT protocol for GAD that included four components. Data from six clinical trials in adults suggest that one of the four components is particularly important for treatment success: exposing oneself to uncertainty rather than avoiding it in daily life. In other words, learning to tolerate and manage uncertainty seems to be the key to reducing worry and anxiety.

Given this discovery, researchers developed a new treatment that exclusively targets intolerance to uncertainty and then adapted it for adolescents: Behavioural Experiments for Intolerance to Uncertainty in Adolescents (EC-IIA). The aim of the current pilot study is to test the effectiveness of EC-IIA in adolescent individuals. A total of 8 participants with a primary diagnosis of GAD will receive EC-IIA and will be evaluated at 4 different times ranging from pre-treatment to a 6-month follow-up. Conditions will be compared in terms of treatment efficacy and mechanisms. Researchers will also examine predictors of change during the 6 months following treatment. The proposed study will produce data on the effectiveness and mechanisms of a treatment for GAD that is less costly, less complex, and easier to disseminate than currently available treatments. conditions: Generalized Anxiety Disorder conditions: Adolescent - Emotional Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open trial primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Behavioural Experiments for Intolerance of Uncertainty measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) measure: Worry and Anxiety Questionnaire (WAQ) measure: Penn State Worry Questionnaire (PSWQ) measure: Beck Anxiety Inventory (BAI) measure: Beck Depression Inventory-II (BDI-II) measure: Intolerance of Uncertainty Scale (IUS) measure: Safety Behaviors Questionnaire (SBQ) measure: Treatment Acceptance and Adherence Scale (TAAS) measure: Working Alliance Inventory (WAI) sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universite du Quebec en Outaouais status: RECRUITING city: Gatineau state: Quebec zip: J8X 3X7 country: Canada name: Sylvain C Lemay, B.A. role: CONTACT phone: +1 819-595-3900 phoneExt: 2501 email: sylvainclaude.lemay@uqo.ca lat: 45.47723 lon: -75.70164 hasResults: False

 nctId: NCT06282120 id: CSPC-DNY-BTC briefTitle: Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-05 date: 2026-01-01 date: 2024-02-28 date: 2024-02-28 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER name: CSPC Ouyi Pharmaceutical Co., Ltd. briefSummary: The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are:

* To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer
* To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer. conditions: Metastatic Biliary Tract Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy measure: Progression Free Survival measure: Overall Survival measure: Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1 measure: EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0) 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: 300000 country: China name: Huikai Li, Doctor role: CONTACT phone: 18622228639 email: vianvianvip@163.com name: Xihao Zhang, Master role: CONTACT phone: 15510801035 email: zxh15510801035@163.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06282107 id: BiSAAE-RHT briefTitle: Effectiveness and Safety of BiSAAE for Resistant Hypertension. overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2025-06-30 date: 2026-12-31 date: 2024-02-28 date: 2024-02-28 name: First Affiliated Hospital of Chengdu Medical College class: OTHER briefSummary: Hypertension is a common problem, affecting \>1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (SAAE) is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH. conditions: Resistant Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: BiSAAE name: traditional triple antihypertensive treatment measure: Change of 24-h average systolic blood pressure measure: Change of 24-h average systolic blood pressure measure: Change of 24-h average systolic blood pressure measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measure: Change of home systolic and diastolic pressure measure: Change of home systolic and diastolic pressure measure: Change of home systolic and diastolic pressure measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group measure: Change of plasma aldosterone measure: Change of plasma aldosterone measure: Change of plasma aldosterone measure: Change of plasma cortisol measure: Change of plasma cortisol measure: Change of plasma cortisol measure: Change of plasma renin measured measure: Change of plasma renin measured measure: Change of plasma renin measured measure: Change of liver enzymes measure: Change of liver enzymes measure: Change of liver enzymes measure: Change of kidney function measure: Change of kidney function measure: Change of kidney function measure: Change of fasting blood glucose measure: Change of fasting blood glucose measure: Change of fasting blood glucose measure: Change of lipids profiles measure: Change of lipids profiles measure: Change of lipids profiles measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) measure: Change of 24-h urine microalbumin measure: Change of 24-h urine microalbumin measure: Change of 24-h urine microalbumin measure: Change of 24-h urine creatinine measure: Change of 24-h urine creatinine measure: Change of 24-h urine creatinine measure: Change of echocardiography parameters (LVEF) measure: Change of echocardiography parameters (LVEF) measure: Change of echocardiography parameters (LVEF) measure: Change of carotid intima-media thickness measure: Change of carotid intima-media thickness measure: Change of carotid intima-media thickness sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282094 id: LUX briefTitle: ViSiGi LUX Bariatric Sizing and Calibration System overallStatus: RECRUITING date: 2024-01-26 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-03-13 name: Boehringer Labs LLC class: INDUSTRY briefSummary: This study investigates the new ViSiGi LUX. conditions: Bariatric Surgery Candidate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Physician Feedback sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: WellSpan status: RECRUITING city: York state: Pennsylvania zip: 17405 country: United States name: Faiz Shariff role: CONTACT lat: 39.9626 lon: -76.72774 hasResults: False

 nctId: NCT06282081 id: ML 45098 briefTitle: Serum Neurofilament Light in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-28 date: 2024-02-28 name: Dent Neuroscience Research Center class: OTHER name: Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG name: Monogram Biosciences (LabCorp Specialty Testing Group) briefSummary: This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy. conditions: Multiple Sclerosis conditions: Relapsing Remitting Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 42 type: ESTIMATED name: Serum Neurofilament Light measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' understanding of patient's clinical status before sNfL results are received vs. after sNfL results are received measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' opinion as to how sNfL results could guide clinical practice measure: Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements. measure: Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements. measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. measure: Describe patient demographics measure: Describe patient comorbidities measure: Describe patient concomitant medications measure: Describe patient MS medications measure: Describe patient reasons for MS medication changes measure: Describe patient MS relapses including date of relapse measure: Describe patient MS relapses including clinical findings measure: Describe patient MS relapses including radiologic findings measure: Describe patient MS relapses including severity measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' understanding of their disease before sNfL results are received vs. after sNfL results are received via a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. measure: Compare sNfL levels after initiation of a new MS disease-modifying therapy (DMT; when patient is treated with a DMT) vs. prior to MS DMT initiation (when patient is not treated with any DMT) where available. measure: Compare sNfL levels at scheduled sampling time points between patients initiating any new MS DMT vs. patients who do not change MS DMT where available. measure: Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not. measure: Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Describe changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. measure: Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Compare changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. measure: Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282068 id: CS2-23178 briefTitle: AI Determine Malignancy of GGO on Chest CT overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2026-02-28 date: 2026-02-28 date: 2024-02-28 date: 2024-02-28 name: Chung Shan Medical University class: OTHER briefSummary: Research Objectives To use AI computer-aided detection software to assist physicians in reading CT scans of lung nodules, providing auxiliary diagnostic tools for medical decision-making. The software can mark nodule locations and related information during routine physician reading. This study will obtain prospective consent to use patient CT images for software reading and compare with clinical physician diagnosis, in order to enhance software training and improve recognition of lung lesions for early diagnosis and treatment.

Study Design Collect CT images of untreated lung nodules 4-30mm in size that are scheduled for surgery. No limits on age, gender, disease type, with image resolution \<2.5mm. AI and clinicians will judge nodule characteristics separately. Surgical resection followed by comparison with pathology reports will evaluate diagnostic accuracy.

Study Procedures A double-blinded method will be used. AI and physicians will record nodules as likely benign or malignant separately. After surgical resection, the lesions will undergo pathological staging and the diagnostic accuracy of both groups will be compared.

Expected Results Compare the diagnostic accuracy of AI and clinicians to improve AI training quality, achieve early diagnosis and treatment goals, and provide patients with better medical care quality.

Monitoring Method AI and clinicians will read separately, adhering to shared decision making without affecting patient access to diagnosis and treatment.

Keywords: lung nodules, early lung cancer, artificial intelligence, chest CT, minimally invasive surgery, lung image analysis software conditions: Lung Nodules, Early Lung Cancer, Artificial Intelligence, Chest CT, Minimally Invasive Surgery, Lung Image Analysis Software studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: AI computer-aided detection software measure: The accuricy of the diagnostic power. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung Shan Medical University Hospital city: Taichung state: South zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06282055 id: TIMES briefTitle: Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes acronym: TIMES overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2026-03-01 date: 2024-02-28 date: 2024-02-28 name: DCB Research AG class: OTHER briefSummary: Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements (insulin pump or smart pen data), glucose variability (CGM data), nutritional information, and menstrual cycle information (cycle tracking app, LH tests, and premenstrual symptoms)) to identify categories of cycle trajectories. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: No intervention measure: Identify different trajectories of insulin sensitivity throughout the menstrual cycle measure: Total daily Insulin dose throughout the menstrual cycle measure: Coefficient of glucose variability throughout the menstrual cycle measure: Estimated insulin sensitivity throughout the menstrual cycle measure: Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle measure: Correlations between insulin sensitivity trajectories and confounders sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06282042 id: EMCAMI briefTitle: Early Transcatheter Mitral Valve Repair After Myocardial Infarction acronym: EMCAMI overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2027-06-16 date: 2028-06-16 date: 2024-02-28 date: 2024-04-24 name: Fundación para la Investigación Biosanitaria del Principado de Asturias class: OTHER name: Meditrial Europe Ltd. briefSummary: To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up. conditions: Acute Mitral Regurgitation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Early transcatheter edge-to-edge mitral valve repair (TEER). name: MitraClip name: Optimal medical treatment measure: All-cause death or Cumulative Heart Failure hospitalizations sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shaare Zedek Medical Center city: Jerusalem state: Jerusalen zip: 9103102 country: Israel name: Mony Shuvy role: CONTACT name: Dr. Mony Shuvy role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center city: Petah tikva zip: 4941492 country: Israel name: Leor Perl role: CONTACT name: Dr. Leor Perl role: PRINCIPAL_INVESTIGATOR lat: 32.08707 lon: 34.88747 facility: Sheba Medical Center city: Ramat Gan country: Israel lat: 32.08227 lon: 34.81065 facility: Civil Hospital of Brescia city: Brescia zip: 25123 country: Italy name: Marianna Adamo role: CONTACT name: Dra. Marianna Adamo role: PRINCIPAL_INVESTIGATOR lat: 45.53558 lon: 10.21472 facility: San Raffaele Hospital city: Milano zip: 20132 country: Italy name: Cosmo Godino role: CONTACT name: Dr. Cosmo Godino role: PRINCIPAL_INVESTIGATOR name: Dr. Francesco Maisano role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Policlínico San Donato city: San Donato Milanese zip: 20097 country: Italy name: Francesco Bedogni role: CONTACT name: Dr. Francesco Bedogni role: PRINCIPAL_INVESTIGATOR lat: 45.41047 lon: 9.26838 facility: Amsterdam University Medical Center city: Amsterdam zip: 1081 HV country: Netherlands name: R. Delewi role: CONTACT name: Dr. R. Delewi role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Amphia Hospital city: Breda zip: 4818 CK country: Netherlands name: B. van der Branden role: CONTACT name: Dr. B. van der Branden role: PRINCIPAL_INVESTIGATOR lat: 51.58656 lon: 4.77596 facility: Catharina Ziekenhuis Hospital city: Eindhoven zip: 5623 EJ country: Netherlands name: P. Tonino role: CONTACT name: Dr. P. Tonino role: PRINCIPAL_INVESTIGATOR lat: 51.44083 lon: 5.47778 facility: Leiden University Medical Center city: Leiden zip: 2333 ZA country: Netherlands name: F. van der Kley role: CONTACT name: Dr. F. van der Kley role: PRINCIPAL_INVESTIGATOR lat: 52.15833 lon: 4.49306 facility: Maastricht University Medical Center city: Maastricht zip: 6229 HX country: Netherlands name: P.A. Vriesendorp role: CONTACT name: Dr. P.A. Vriesendorp role: PRINCIPAL_INVESTIGATOR lat: 50.84833 lon: 5.68889 facility: St. Antonius Hospital city: Nieuwegein zip: 3435 CM country: Netherlands name: L. Timmers role: CONTACT name: Dr. L. Timmers role: PRINCIPAL_INVESTIGATOR lat: 52.02917 lon: 5.08056 facility: Erasmus University Medical Center city: Rotterdam zip: 3015 GD country: Netherlands name: N. van Mieghem role: CONTACT name: Dr. N. van Mieghem role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: Isala Hospital city: Zwolle zip: 8025 AB country: Netherlands name: R. Hermanides role: CONTACT name: Dr. R. Hermanides role: PRINCIPAL_INVESTIGATOR lat: 52.5125 lon: 6.09444 facility: Hospital Universitario Marqués de Valdecilla city: Santander state: Cantabria zip: 39008 country: Spain name: Jose María de la Torre, MD, PhD role: CONTACT name: Dr. Jose María de la Torre, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 facility: Hospital Universitario Doctor Negrin city: Las Palmas de Gran Canaria state: Las Palmas zip: 35010 country: Spain name: Pedro Martín, MD, PhD role: CONTACT name: Dr. Pedro Martín, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 28.09973 lon: -15.41343 facility: Hospital Álvaro Cunqueiro city: Vigo state: Pontevedra zip: 36312 country: Spain name: Rodrigo Estévez-Loureiro, MD, PhD role: CONTACT name: Dr. Rodrigo Estévez-Loureiro, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.23282 lon: -8.72264 facility: Hospital General Universitario Dr. Balmis city: Alicante zip: 03010 country: Spain name: Juan M. Ruiz-Nodar, MD, PhD role: CONTACT name: Juan M. Ruiz-Nodar, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.34517 lon: -0.48149 facility: Hospital de la Santa Creu i Sant Pau city: Barcelona zip: 08025 country: Spain name: Dabit Arzamendi, MD, PhD role: CONTACT name: Dabit Arzamendi, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Vall d'Hebrón city: Barcelona zip: 08035 country: Spain name: Bruno García del Blanco, MD, PhD role: CONTACT name: Dr. Bruno García del Blanco, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Clínic Barcelona city: Barcelona zip: 08036 country: Spain name: Xavier Freixa Rofastes, MD, PhD role: CONTACT name: Dr. Xavier Freixa Rofastes, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Reina Sofía city: Córdoba zip: 14004 country: Spain name: Manuel Pan Álvarez, MD, PhD role: CONTACT name: Dr. Manuel Pan Álvarez, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.89155 lon: -4.77275 facility: Hospital Universitario Ramón y Cajal city: Madrid zip: 28034 country: Spain name: Ángel Sánchez-Recalde, MD, PhD role: CONTACT name: Dr. Ángel Sánchez-Recalde, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Clínico Universitario San Carlos city: Madrid zip: 28040 country: Spain name: Luis Nombela, MD, PhD role: CONTACT name: Dr. Luis Nombela, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Puerta de Hierro city: Madrid zip: 28222 country: Spain name: María del Trigo, MD, PhD role: CONTACT name: Dra. María del Trigo, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Virgen de la Victoria city: Málaga zip: 29010 country: Spain name: Juan H. Alonso Briales, MD, PhD role: CONTACT name: Dr. Juan H. Alonso Briales, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.72016 lon: -4.42034 facility: Hospital Clínico Universitario de Valladolid city: Valladolid zip: 47003 country: Spain name: Ignacio Amat-Santos, MD, PhD role: CONTACT name: Dr. Ignacio Amat-Santos, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.65518 lon: -4.72372 hasResults: False

 nctId: NCT06282029 id: I-2720-0018-0003 briefTitle: ACT-group for Stroke Survivors (Pilot Study) overallStatus: RECRUITING date: 2024-02-01 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-02-28 name: Bielefeld University class: OTHER name: Bielefeld Young Researchers' Fund briefSummary: The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are:

* Is the group therapy feasible?
* Is the group therapy accepted by stroke survivors and therapists?
* Are there first indications on the efficacy of the group therapy to improve mental health?

Participants will take part in 8 weekly group therapy sessions of 90 minutes each. conditions: Stroke conditions: Intracerebral Hemorrhage conditions: Depressive Symptoms conditions: Anxiety conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This pilot study includes a pre-/post test of a small intervention sample without control group. primaryPurpose: OTHER masking: NONE count: 12 type: ESTIMATED name: Group Therapy measure: Drop-out rate measure: Session adherence measure: Homework completion measure: Completion of outcome measures measure: Treatment fidelity measure: Group therapy session questionnaire - patients (Zoubek, 2013; Plain German) measure: Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German) measure: Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German) measure: Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German) measure: Valuing Questionnaire (Smout, 2014; Plain German) measure: Self-as-context scale (Zettle, 2018; Plain German) measure: Patient Health Questionnaire-9 (Kroenke, 2001; Plain German) measure: Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Neuropsychological Outpatient Clinic status: RECRUITING city: Bielefeld zip: 33607 country: Germany name: Simon Ladwig, PhD role: CONTACT phone: 017664716035 email: simon.ladwig@uni-bielefeld.de lat: 52.03333 lon: 8.53333 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-12 uploadDate: 2024-02-12T06:57 filename: Prot_SAP_000.pdf size: 260777 hasResults: False

 nctId: NCT06282016 id: BKR-2024-001 briefTitle: Risk Factors for Neuroendocrine Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2025-07 date: 2024-02-28 date: 2024-03-06 name: Bavarian Cancer Registry class: OTHER_GOV name: Bavarian Association of Statutory Health Insurance Accredited Physicians briefSummary: Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors. conditions: Neuroendocrine Neoplasm of Lung conditions: Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 7200 type: ESTIMATED name: Case-control study (no intervention) measure: Depression/Persistent mood disorder measure: Obesity measure: Metabolic syndrome measure: Previous malignant neoplasm measure: Alcohol buse measure: Diabetes measure: Ulcerative colitis measure: Crohn disease measure: Allergic rhinitis measure: Asthma measure: Area deprivation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06282003 id: 380-59-10106-21-111/148 briefTitle: Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications overallStatus: RECRUITING date: 2023-10-10 date: 2024-06-30 date: 2024-09-30 date: 2024-02-28 date: 2024-02-28 name: Masa Kontic class: OTHER_GOV name: Prof.Dinko Tonković, MD, PhD Head of Department of Anesthesiology, Reanimatology and Intensive Care Medicine and Pain Therapy, University Hospital Centre Zagreb name: Assist. Prof. Slavica Sović, MD, PhD Department of Medical Statistics, Epidemiology and Medical Informatics, School of Public Health Andrija Štampar name: Prof. Goran Šimić, MD, PhD Professor of Neuroscience and Anatomy, Chair, Department of Neuroscience, Croatian Institute for Brain Research, University of Zagreb name: Prof. Anamarija Jazbec, Faculty of Forestry and Wood Technology, University of Zagreb name: Marijan Jedvaj, MD Anesthesiologist and ICU physician (Consultant), Head of Department of Anesthesia and IC, General Hospital Zabok briefSummary: Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Mitigating PPCs under anesthesia is a goal, but effective strategies are yet to be defined. Conventional ventilation (CV) procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance. The protective lung ventilation (PV) procedure, on the other hand, includes high positive end-expiratory pressure, lung recruitment maneuver, oxygen saturation levels above 94%, lower inspired oxygen levels, and continuous positive airway pressure before the tube is removed. In this study, 56 consecutive patients undergoing abdominal surgery were randomly assigned, with 30 in the CV and 23 in the PV group, while 3 were lost during the follow-up. We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs, recommending these strategies be adopted as the standard practice in general anesthesia. conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A crossover design should be utilized in addition to the randomization procedure to properly address outcome variability. This study was a prospective, single-center, randomized controlled, patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective (optimized) ventilation procedure (PV group of patients) compared to the conventional (standard) method of lung ventilation (CV) during general anesthesia. primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: The procedure of protective lung ventilation measure: Oxygentation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General hospital Zabok status: RECRUITING city: Zabok zip: 49210 country: Croatia name: Maša Kontić, Medical Doctor role: CONTACT phone: 00385 98 97 95 648 email: mkontic.konti@gmail.com lat: 46.02944 lon: 15.915 hasResults: False

 nctId: NCT06281990 id: BAUN-SBF-PO-01 briefTitle: Education and Information for Bariatric Surgery Patients overallStatus: COMPLETED date: 2022-12-01 date: 2023-11-01 date: 2024-01-05 date: 2024-02-28 date: 2024-02-28 name: Balikesir University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs. conditions: Bariatric Surgeries conditions: Education of Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups in the research: control and intervention groups. primaryPurpose: OTHER masking: DOUBLE maskingDescription: The researcher (YY) provided education in the outpatient clinic. The nurses and surgical team members working in the surgical ward were blinded (FÇ in the research group was blinded). whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 68 type: ACTUAL name: Education measure: Data collection form measure: Visual Analog Scale (VAS) measure: State-Trait Anxiety Inventory (STAI) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pınar Ongün city: Balıkesir zip: 38000 country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False

 nctId: NCT06281977 id: ES613 briefTitle: Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm acronym: SEDATE overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-03-12 date: 2027-07-01 date: 2024-02-28 date: 2024-04-08 name: Ottawa Heart Institute Research Corporation class: OTHER briefSummary: The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit. conditions: Ventricular Tachycardia conditions: Ventricular Arrhythmias conditions: Ventricular Fibrillation conditions: Recurrent Ventricular Tachycardia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 192 type: ESTIMATED name: Dexmedetomidine name: Normal saline measure: The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation. measure: All-cause in-hospital death measure: Ventricular arrhythmia requiring treatment after study drug initiation measure: Resuscitated cardiac arrest after study drug initiation measure: Renal failure requiring new initiation of renal replacement therapy after study drug initiation measure: Intubation following study drug initiation measure: Length of stay in the intensive care unit measure: Length of stay in hospital measure: Need for mechanical circulatory support device after study drug initiation measure: Ventricular Arrhythmia requiring treatment only during active study drug treatment measure: Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06281964 id: PLB1004-III-01 briefTitle: Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2026-01-30 date: 2026-12-30 date: 2024-02-28 date: 2024-02-28 name: Avistone Biotechnology Co., Ltd. class: INDUSTRY briefSummary: Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion. conditions: Non-Small-Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 327 type: ESTIMATED name: PLB1004 name: Pemetrexed+（carboplatin or Cisplatin）with or without Sintilimab measure: Progression-Free Survival (PFS) by BICR measure: Progression-Free Survival (PFS) by the investigator measure: Intracranial Overall Response Rate（ORR） measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Overall Survival (OS) measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) measure: Plasma concentrations of PLB1004 and metabolites may be combined with data from other clinical studies measure: intracranial Progression-Free Survival（PFS） measure: second progression-free survival (PFS2) measure: Assess the Quality of Healthy Living About Patients measure: EGFR Ex20ins status in tumor tissues and its relevance to the clinical efficacy of drugs measure: Gene mutation status in plasma ctDNA before and after medication, and its correlation with clinical efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06281951 id: 2022/0271/HP briefTitle: Nebulized Fentanyl in Healthy Volunteers acronym: AEROfen overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-01 date: 2026-09-01 date: 2024-02-28 date: 2024-02-29 name: University Hospital, Rouen class: OTHER briefSummary: Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study conditions: Analgesia conditions: Emergencies studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Fentanyl - Inhalation by facial nebulization name: Fentanyl - Nebulisation measure: Measurement of [F] bioavailability via facial nebulization and intranasal inhalation. measure: Measurement of maximum decrease in PUAL (pupillary under ambient light) between facial nebulization and intranasal inhalation. measure: Measurement of the difference between observed and predicted PUAL values by a PK/PD model. measure: Time required to achieve >30% decrease in PUAL compared to baseline. measure: Measurement of dose required to achieve >30% decrease in PUAL compared to baseline. measure: Measurement of administration comfort score using a visual analog scale ranging from 0 (maximum discomfort) to 10 (optimal comfort) (unitless). sex: ALL minimumAge: 18 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital, Rouen city: Rouen zip: 76031 country: France lat: 49.44313 lon: 1.09932 hasResults: False

 nctId: NCT06281938 id: 1617209 briefTitle: Machine Learning and 3D Image-based Modeling for Body Weight Estimation. overallStatus: NOT_YET_RECRUITING date: 2026-06 date: 2027-06 date: 2027-09 date: 2024-02-28 date: 2024-03-04 name: Florida Atlantic University class: OTHER briefSummary: The goal of this randomized controlled clinical trial is to \[learn about, test, compare etc.\] in critically ill or injured cohorts of patients presenting to the Emergency Department. The main question\[s\] it aims to answer are:

* Are weight estimates from a 3D camera system more accurate than standard methods of weight estimation?
* Do patients who receive weight estimates with a 3D camera system have fewer drug dosing errors than patients receiving standard care?

Participants will either receive a weight estimate using a 3D camera system, or standard methods of care.

Researchers will compare the 3D camera group to those with standard care to see if the weight estimates are more accurate, to see if drug dosing is more accurate, and to compare the incidence of adverse events related to medications in each group. conditions: No Specific Conditions conditions: Weight, Body conditions: Drug Dose conditions: Weight-Estimation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention cohort and control cohort will be used primaryPurpose: OTHER masking: DOUBLE maskingDescription: Investigators and outcomes assessors will be blinded to the arm. Coded data will be used for masking. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 320 type: ESTIMATED name: Weight estimation using 3D camera name: Standard care weight estimation measure: Weight estimation accuracy measure: Time to obtain weight estimate measure: Drug dosing accuracy measure: Correct dosing scalar used measure: Accuracy of in-bed scales sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06281925 id: 22-01363 briefTitle: Cryotherapy & Oxaliplatin overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10-31 date: 2025-12-31 date: 2024-02-28 date: 2024-03-29 name: NYU Langone Health class: OTHER briefSummary: The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy. conditions: Colon Cancer conditions: Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Cryotherapy Gloves measure: Proportion of Participants with Peripheral Neuropathy at Visit 2 measure: Proportion of Participants with Peripheral Neuropathy at Visit 3 measure: Proportion of Participants with Peripheral Neuropathy at Visit 4 measure: Proportion of Participants with Peripheral Neuropathy at Visit 5 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: Mineola state: New York zip: 11501 country: United States lat: 40.74927 lon: -73.64068 facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06281912 id: 4504/23 briefTitle: Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients acronym: MELCAYA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-11 date: 2024-11 date: 2024-02-28 date: 2024-02-28 name: Azienda Ospedaliera di Perugia class: OTHER briefSummary: This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease conditions: Early Melanoma conditions: Advanced Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 70 type: ESTIMATED measure: rate of objective response measure: adverse event incidence sex: ALL minimumAge: 12 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Aix-Marseille Universite city: Marseille country: France lat: 43.29551 lon: 5.38958 facility: Institut Curie city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Ospedale universitario della Charité city: Berlino country: Germany lat: 52.52437 lon: 13.41053 facility: German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ) city: Heidelberg country: Germany lat: 49.40768 lon: 8.69079 facility: University Children's Hospital Tuebingen city: Tuebingen country: Germany lat: 48.52266 lon: 9.05222 facility: Universita Degli Studi Di Firenze city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Fondazione Irccs Istituto Nazionale Dei Tumori city: Milano country: Italy lat: 45.46427 lon: 9.18951 facility: Universita Cattolica Del Sacro Cuore city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie) city: Utrecht country: Netherlands lat: 52.09083 lon: 5.12222 facility: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Institut Catala D'Oncologia city: Barcellona country: Spain lat: 41.38879 lon: 2.15899 facility: Instituto de Investigaciones Biomédicas August Pi i Sunyer city: Barcellona country: Spain lat: 41.38879 lon: 2.15899 facility: Karolinska University Hospital city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06281899 id: 01/2022 briefTitle: Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus acronym: PRODAPA-CKD overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-31 date: 2025-03-31 date: 2024-02-28 date: 2024-02-28 name: Anemia Working Group Romania class: OTHER name: Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania name: Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania name: Carol Davila University of Medicine and Pharmacy briefSummary: This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus conditions: Chronic Kidney Diseases conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Dapagliflozin 10 mg Tab name: Low protein diet measure: Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death measure: Rate of decline in the estimated Glomerular Filtration Rate measure: Variation of albuminuria measure: Variation of HbA1C measure: Variation of serum cholesterol levels measure: Variation of serum bicarbonate levels measure: Variation of serum potassium levels measure: Variation of serum sodium levels measure: Variation of hemoglobin levels measure: Variation of hematocrit levels measure: All cause hospitalizations measure: Variation in body weight measure: Variation in BMI measure: Variation in handgrip strength measure: Variation in serum albumin levels measure: Variation in CRP levels measure: Changes in the quality of life measure: Compliance to the protein intake measure: Compliance to the energy intake measure: Compliance to carbohydrate intake sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Carol Davila University of Medicine and Pharmacy Bucharest status: RECRUITING city: Bucharest country: Romania name: Liliana Garneata, Assoc Prof role: CONTACT phone: +40722619358 email: lilianagarna@yahoo.com name: Elena Cuiban, MD role: CONTACT phone: +40748975315 email: elenacuiban@yahoo.com lat: 44.43225 lon: 26.10626 hasResults: False

 nctId: NCT06281886 id: GASTO-10107 briefTitle: Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2023-12-01 date: 2026-12-01 date: 2026-12-01 date: 2024-02-28 date: 2024-02-28 name: Sun Yat-sen University class: OTHER briefSummary: This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma conditions: Esophageal Squamous Cell Carcinoma conditions: Efficacy conditions: Toxicity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: Induction Immunotherapy-Toripalimab name: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin name: Radiotherapy name: Apatinib name: Capecitabine measure: Progression free survival rate measure: Overall survival measure: Objective response rate measure: Local-regional progression-free survival measure: Incidence of Treatment-related Adverse Events measure: Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer) measure: Distant metastasis-free survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Bo Qiu, Professor role: CONTACT phone: +86-020-87343031 email: qiubo@sysucc.org.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06281873 id: 0645 briefTitle: Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy overallStatus: COMPLETED date: 2023-03-27 date: 2023-09-01 date: 2024-02-07 date: 2024-02-28 date: 2024-02-28 name: Alexandria University class: OTHER briefSummary: the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis. conditions: Oroantral Fistula studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ACTUAL name: closure by PRF membrane measure: Evaluation of the soft tissue wound's healing measure: Secondary radiographic outcomes, assessment of bone formation sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry city: Alexandria zip: 562589 country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06281860 id: PITHAC id: 2023-00099 type: REGISTRY domain: BASEC briefTitle: Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration acronym: PITHAC overallStatus: RECRUITING date: 2023-11-24 date: 2025-12-01 date: 2026-02-01 date: 2024-02-28 date: 2024-02-28 name: Dr Jean Yannis PERENTES class: OTHER briefSummary: Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD). conditions: Mesothelioma, Malignant conditions: Carcinoma, Non-Small-Cell Lung conditions: Carcinoma Breast Stage IV conditions: Ovarian Cancer conditions: Esophageal Cancer conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Open-label, non-randomised monocentric Phase I clinical trial study with cisplatin dose escalation administered by PITHAC. primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Cisplatine Teva® measure: Dose Escalation and Maximum Tolerated Dose determination (Part A): measure: Expansion phase (Part B): measure: Dose Escalation and MTD determination (Part A): measure: Expansion phase (Part B): measure: Dose Escalation and MTD determination (Part A):Exploratory outcomes measure: Expansion phase (Part B):Exploratory outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire Vaudois status: RECRUITING city: Lausanne country: Switzerland name: Jean-Yannis PERENTES role: CONTACT name: Jean Yannis PERENTES role: PRINCIPAL_INVESTIGATOR lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06281847 id: CCTx-001-AML-001 briefTitle: An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia acronym: RESOLVE AML001 overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-07 date: 2041-08 date: 2024-02-28 date: 2024-02-28 name: Advesya SAS class: INDUSTRY briefSummary: The purpose of this adaptive Phase 1/2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r/r Acute Myeloid Leukemia (AML). CCTx-001 targets IL-1RAP, which is specifically expressed in leukemic cells. In preclinical studies, IL-1RAP-targeted Chimeric antigen receptors (CARs) have demonstrated encouraging activity in both in vitro and in vivo experiments in AML models. Based on these promising preclinical results, it is expected that CCTx-001 could potentially alter the natural course of r/r AML and provide a potential novel treatment option. conditions: Acute Myeloid Leukemia, in Relapse conditions: Acute Myeloid Leukemia Refractory studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study comprises 4 periods:

* The pre-treatment period will consist of screening for eligibility, leukapheresis and a pre-treatment evaluation (prior to Lymphodepleting Chemotherapy (LDC)).
* The treatment period will start with LDC, followed by CCTx-001 infusion 2 to 7 days after completion of LDC. A first response evaluation will be performed at approximately 28 days after CCTx-001 infusion.
* The post-treatment period will consist of further clinical activity and safety follow-up visits at regular timepoints after CCTx-001 infusion, starting after the Month 3 visit up to the Month 24 visit.
* The long-term follow-up period will start after the Month 24 visit up to 15 years post CCTx-001 infusion. primaryPurpose: TREATMENT masking: NONE count: 143 type: ESTIMATED name: CCTx-001 measure: Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001 measure: Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001 measure: Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001 measure: Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001 measure: Phase 2: To assess the safety of CCTx-001 measure: Phase 2: To assess HRQoL for patients treated with CCTx-001 measure: Phase 2: To assess HRQoL for patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Besançon Regional and University Hospital city: Besançon Cedex country: France name: Eric Deconinck role: CONTACT name: Eric Deconinck role: PRINCIPAL_INVESTIGATOR lat: 47.24878 lon: 6.01815 facility: Hospital Saint Louis city: Paris country: France name: Nicolas Boissel role: CONTACT name: Nicolas Boissel role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Ludwig-Maximilians University of Munich city: Munich country: Germany name: Marion Subklewe role: CONTACT name: Marion Subklewe role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 facility: University Hospital Ulm city: Ulm country: Germany name: Elisa Sala role: CONTACT name: Elisa Sala role: PRINCIPAL_INVESTIGATOR lat: 48.39841 lon: 9.99155 facility: Vall d'Hebron University Hospital city: Barcelona country: Spain name: Pere Barba role: CONTACT name: Pere Barba role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Karolinska University Hospital city: Stockholm country: Sweden name: Stephan Mielke role: CONTACT name: Stephan Mielke role: PRINCIPAL_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06281834 id: 2024P000306 briefTitle: Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-02 date: 2027-06 date: 2024-02-28 date: 2024-02-28 name: Brigham and Women's Hospital class: OTHER name: APIN Public Health Initiatives name: University of Cape Town briefSummary: Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population. conditions: Pediatric HIV Infection conditions: Latent Tuberculosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective single-arm, open-label, pharmacokinetic and safety study primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Rifapentine name: Dolutegravir measure: Dolutegravir AUC during weekly rifapentine/isoniazid measure: Rifapentine AUC measure: Proportion of participants experiencing severe (grade 3 or 4) clinical or laboratory adverse events sex: ALL minimumAge: 4 Weeks maximumAge: 11 Years stdAges: CHILD hasResults: False

 nctId: NCT06281821 id: 4947 [Study 2] briefTitle: Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study overallStatus: RECRUITING date: 2024-02-06 date: 2024-12-01 date: 2024-12-01 date: 2024-02-28 date: 2024-02-28 name: Boston University Charles River Campus class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention. conditions: Alcohol Drinking conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Compare an intervention to an assessment only control condition primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes assessor at follow-up timepoint is masked to condition. Baseline assessment occurs prior to randomization whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: mhealth-pc measure: Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale measure: Time Line Follow-Back-30 Day Weekly Drinking measure: Time Line Follow-Back 30-Day Heavy Episodic Drinking measure: Perceptions of Treatment Questionnaire measure: Systems Usability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Boston University status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Maya Kratzer, BA role: CONTACT phone: 857-225-8843 lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06281808 id: R490 briefTitle: Photon Counting Detector CT Image Quality overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2026-09-01 date: 2026-12-31 date: 2024-02-28 date: 2024-02-28 name: Reto Sutter, MD class: OTHER briefSummary: This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard. conditions: Diagnostic Imaging conditions: Tomography, X Ray Computed studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 200 type: ESTIMATED name: Photon Counting Detector CT measure: Image Quality PCD CT measure: Diagnostic Accuracy PCD CT sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06281795 id: 1.24. briefTitle: Neuromodulation of the Autonomic Nervous System in Athletes acronym: NANSA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-31 date: 2026-01-31 date: 2024-02-28 date: 2024-02-28 name: Bakulev Scientific Center of Cardiovascular Surgery class: OTHER_GOV name: Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION name: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION briefSummary: There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels. conditions: Efficacy, Self conditions: Fatigue; Muscle, Heart conditions: Fatigue, Mental conditions: Fatigue; Combat studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 randomization of active stimulation vs. sham stimulation primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 125 type: ESTIMATED name: tVNS measure: Dynamics of maximum oxygen consumption (VO2max). measure: The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism. measure: Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism. measure: The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism. measure: The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism. measure: The dynamics of RMSSD. measure: HF dynamics measure: Dynamics of the LF/HF ratio. sex: ALL minimumAge: 15 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION city: Krasnodar country: Russian Federation lat: 45.04484 lon: 38.97603 hasResults: False

 nctId: NCT06281782 id: PRP with topical retinoids briefTitle: Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris overallStatus: RECRUITING date: 2024-01-01 date: 2024-04 date: 2024-05 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.

Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .

Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.

Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.

For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.

PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment. conditions: Acne Vulgaris studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Topical retinoids versus topical retinoids wit PRP in acne vulgaris treatment primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: topical retinoids and platalet rich plasma measure: change of acne lasions sex: ALL minimumAge: 12 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine status: RECRUITING city: Assiut country: Egypt name: Howida Abdalla role: CONTACT email: d.howida@windowslive.com lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06281769 id: NL82101.000.22 briefTitle: Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision overallStatus: RECRUITING date: 2024-02-26 date: 2025-01-01 date: 2025-01-01 date: 2024-02-28 date: 2024-03-06 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER name: Angiogenesis Analytics briefSummary: The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway). conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 438 type: ESTIMATED name: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision name: MRI targeted biopsy pathway measure: Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI. measure: Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway. measure: Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway). measure: Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway. measure: Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC - location VUmc status: RECRUITING city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 facility: Andros Clinics status: RECRUITING city: Baarn country: Netherlands lat: 52.21167 lon: 5.2875 facility: Spaarne Gasthuis status: RECRUITING city: Hoofddorp country: Netherlands lat: 52.3025 lon: 4.68889 facility: St. Antonius status: RECRUITING city: Nieuwegein country: Netherlands lat: 52.02917 lon: 5.08056 facility: Fransiscus Gasthuis status: RECRUITING city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-15 uploadDate: 2024-01-12T04:56 filename: Prot_SAP_000.pdf size: 1638356 hasResults: False

 nctId: NCT06281756 id: STUDY00022285 id: 1UG3HL161342-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3HL161342-01A1 briefTitle: Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia overallStatus: RECRUITING date: 2024-03-14 date: 2027-02 date: 2028-02 date: 2024-02-28 date: 2024-03-20 name: Milton S. Hershey Medical Center class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems. conditions: Insomnia conditions: Insomnia Chronic conditions: Insomnia, Primary conditions: Blood Pressure conditions: Blood Pressure, High studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Both prescribing physicians and participants will be blind to phenotype and treatment groups. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 600 type: ESTIMATED name: Cognitive Behavioral Treatment for Insomnia (CBT-I) name: Trazodone name: Placebo measure: Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) measure: Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) measure: Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment measure: Insomnia Severity Index (ISI) Score following CBT-I measure: Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) measure: Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) measure: Evening Cortisol levels following CBT-I measure: Insomnia Severity Index (ISI) Score following RCT measure: PSG Total Sleep Time (TST) following RCT measure: Actigraphy Total Sleep Time (TST) following RCT measure: Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP) measure: Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP) measure: Evening Cortisol levels following RCT measure: Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Jewish Health status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80206-2761 country: United States name: Roxane Horberg role: CONTACT phone: 303-270-2850 email: horbergr@njhealth.org name: Rachel Johnson role: CONTACT phone: 303 398-1058 email: johnsonr@njhealth.org lat: 39.73915 lon: -104.9847 facility: Penn State University status: RECRUITING city: Hershey state: Pennsylvania zip: 17033 country: United States name: Carrie Criley role: CONTACT phone: 717-531-4123 email: ccriley@pennstatehealth.psu.edu lat: 40.28592 lon: -76.65025 facility: University of Pittsburgh status: NOT_YET_RECRUITING city: Pittsburgh state: Pennsylvania zip: 15213-3203 country: United States name: Laurie Brar role: CONTACT phone: 412-723-7998 email: brarlk@upmc.edu lat: 40.44062 lon: -79.99589 facility: Université Laval status: NOT_YET_RECRUITING city: Quebec zip: G1V 0A6 country: Canada name: Manon Lamy role: CONTACT phone: 418 656-2131 phoneExt: 412467 email: manon.lamy@psy.ulaval.ca lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06281743 id: LST-Ped Survey briefTitle: Attitudes to Decisions to Withdraw or Withhold Life-sustaining Treatments in Critically Ill Children acronym: LSTPedSurvey overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-12 date: 2024-02-28 date: 2024-03-15 name: Göteborg University class: OTHER briefSummary: The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians. conditions: Pediatric Disorder conditions: Critical Illness conditions: Ethics, Narrative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Survey measure: Attitudes and experiences -questionnaire sex: ALL minimumAge: 1 Year maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06281730 id: 23-009197 briefTitle: Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy overallStatus: RECRUITING date: 2024-05 date: 2044-02 date: 2044-02 date: 2024-02-28 date: 2024-04-09 name: Mayo Clinic class: OTHER briefSummary: The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA. conditions: In Utero Procedure Affecting Fetus or Newborn studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Karl Storz New Generation Fetoscope - curved 11508AAK name: Karl Storz New Generation Fetoscope - straight 11506AAK measure: Adverse events measure: Serious Adverse Events measure: Device malfunctions measure: Mean gestational age at delivery measure: Successful Completion measure: Satisfaction scores measure: Live births measure: Neonatal deaths sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Minnesota status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06281717 id: IRB-P00045047 briefTitle: A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2030-08-30 date: 2024-02-28 date: 2024-02-28 name: Alireza Shamshirsaz class: OTHER briefSummary: The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.

This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age. conditions: Congenital Diaphragmatic Hernia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Fetal Endotracheal Occlusion (FETO) measure: Successful Ballon Placement measure: Successful Balloon Removal measure: Balloon placement operative time measure: Balloon removal operative time measure: Type of FETO release measure: Maternal Complications measure: Gestational age at delivery measure: Fetal lung volume measure: O/E LHR measure: Infant survival measure: Oxygen dependency measure: Number of infants requiring ECMO measure: NICU stay measure: Ventilator support measure: Presence of periventricular leukomalacia measure: Presence of neonatal sepsis measure: Presence of intraventricular hemorrhage measure: Retinopathy of prematurity measure: Presence of gastro-esophageal reflux measure: CDH repair type measure: Pulmonary function measure: Infant Neurodevelopment measure: Route of delivery measure: Maternal hospitalization sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Brittany Gudanowski role: CONTACT phone: 617-919-6658 email: Brittany.Gudanowski@childrens.harvard.edu name: Maternal Fetal Care Center role: CONTACT phone: 617-355-6512 email: MFCCFetalResearchStudies-dl@childrens.harvard.edu name: Alireza Shamshirsaz, MD role: PRINCIPAL_INVESTIGATOR name: Eyal Krispin, MD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06281704 id: AK101-102 briefTitle: A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis overallStatus: COMPLETED date: 2020-11-26 date: 2022-05-17 date: 2022-12-31 date: 2024-02-28 date: 2024-02-28 name: Akeso class: INDUSTRY briefSummary: This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis. conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: AK101 IV name: AK101 SC name: Placebo name: AK101 IV/AK101 SC measure: Adverse Events measure: Adverse Events measure: Elimination half-life (T1/2) of AK101 measure: Mean residence time (MRT) of AK101 measure: Area under curve (AUC) of AK101 measure: Apparent distribution volume (VD/F) of AK101 measure: Systemic clearance (CL/F) of AK101 measure: Maximum (peak) plasma concentration (Cmax) of AK101 measure: Time to maximum plasma concentration (Tmax) of AK101 measure: Proportion of subjects with clinical response at Week8(per Adapted Mayo Score without physician's global assessment). measure: Proportion of subjects with clinical response at Week8(per the Mayo score). measure: Immunogenicity index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu state: Anhui zip: 233099 country: China lat: 32.94083 lon: 117.36083 facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Fujian Medical University city: Fuzhou state: Fujian zip: 350004 country: China lat: 26.06139 lon: 119.30611 facility: Nanfang Hospital city: Guangzhou state: Guangdong zip: 510515 country: China lat: 23.11667 lon: 113.25 facility: The Sixth Affiliated Hospital of Sun Yat-Sen University city: Guanzhou state: Guangdong zip: 510665 country: China facility: The Second Hospital of Hebei Medical University city: Shijiazhuang state: Hebei zip: 050004 country: China lat: 38.04139 lon: 114.47861 facility: People's Hospital of Wuhan University city: Wuhan state: Hubei zip: 430060 country: China lat: 30.58333 lon: 114.26667 facility: Nanjing First Hospital city: Nanjing state: Jiangsu zip: 210012 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Xuzhou Medical University city: Xuzhou state: Jiangsu zip: 221004 country: China lat: 34.18045 lon: 117.15707 facility: Shengjing Hospital of China Medical University city: Shengyang state: Liaoning zip: 110000 country: China facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 facility: Tianjing People's Hospital city: Tianjing state: Tianjing zip: 300122 country: China hasResults: False

 nctId: NCT06281691 id: GreenBladder briefTitle: GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit overallStatus: ENROLLING_BY_INVITATION date: 2023-04-28 date: 2024-07-01 date: 2025-11-30 date: 2024-02-28 date: 2024-02-28 name: Jørgen Bjerggaard Jensen class: OTHER name: Cepheid name: Laborie Medical Technologies Inc. name: Vingmed Danmark A/S name: OneMed A/S briefSummary: The goal of this observational study is to evaluate whether a urinary biomarker (Xpert® Bladder Cancer Detection Test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. Hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. With these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. With this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in Greenland. conditions: Urinary Bladder Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Xpert® Bladder Cancer Detection Test measure: Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, Aarhus University Hopsital city: Aarhus zip: 8000 country: Denmark lat: 56.15674 lon: 10.21076 facility: Queen Ingrid's Hospital city: Nuuk zip: 3900 country: Greenland lat: 64.18347 lon: -51.72157 hasResults: False

 nctId: NCT06281678 id: CIBI363A202 briefTitle: A Study of IBI363 in Subjects With Advanced Solid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-12-31 date: 2024-02-28 date: 2024-02-28 name: Innovent Biologics (Suzhou) Co. Ltd. class: INDUSTRY briefSummary: This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies. conditions: Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: IBI363 measure: Objective response rate (ORR) measure: Adverse Event （AE） measure: Dose-limiting Toxicity （DLT） sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medcial Center Research Institute city: Fairway state: Kansas zip: 66205 country: United States name: Saqib Abbasi role: CONTACT phone: 913-945-7545 email: sabbasi@kumc.edu lat: 39.02223 lon: -94.6319 hasResults: False

 nctId: NCT06281665 id: STUDY23080099 id: K23HL168356 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL168356 briefTitle: Treatment With Aspirin After Preeclampsia: TAP Trial acronym: TAP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2026-04-01 date: 2024-02-28 date: 2024-04-04 name: Alisse Hauspurg class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital. conditions: Hypertensive Disorder of Pregnancy conditions: Pre-Eclampsia conditions: Hypertension conditions: Eclampsia conditions: Gestational Hypertension conditions: Cardiovascular Diseases conditions: Toxemia conditions: Pregnancy Complications conditions: Vascular Diseases conditions: Hypertension, Pregnancy Induced conditions: Hypertension;Pre-Eclamptic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pilot randomized, single-center, double-blind placebo-control study of low-dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or similar-appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two additional study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring. primaryPurpose: OTHER masking: TRIPLE maskingDescription: Participants, Investigators and outcomes assessors will be blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Low-dose aspirin name: Placebo measure: Percent of participants eligible, enrolled and retained (feasibility) measure: Study visit systolic BP measure: Study visit diastolic BP measure: Study visit systolic BP measure: Study visit diastolic BP measure: Study visit mean arterial pressure measure: Study visit mean arterial pressure measure: Anti-hypertensive medication use measure: Anti-hypertensive medication use measure: Therapeutic intensity score measure: Therapeutic intensity score measure: Mean home systolic blood pressure measure: Mean home diastolic blood pressure measure: Mean home mean arterial pressure measure: Mean daytime systolic blood pressure measure: Mean nocturnal systolic blood pressure measure: Mean daytime diastolic blood pressure measure: Mean nocturnal diastolic blood pressure measure: Mean nocturnal mean arterial pressure measure: Mean daytime mean arterial pressure measure: Mean overall mean arterial pressure measure: Mean overall systolic blood pressure measure: Mean overall diastolic blood pressure measure: Classification of hypertension measure: Classification of hypertension measure: Endothelial function EC50% measure: Endothelial function EC50% measure: Endothelial function Emax measure: Endothelial function Emax measure: Endothelial function change in Emax measure: Endothelial function change in EC50% measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in mean arterial pressure sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: University of Pittsburgh Magee-Womens Hospital city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Sila Yavan, MS role: CONTACT phone: 412-417-4981 email: yavans@upmc.edu name: Alisse K Hauspurg, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06281652 id: Cognichess briefTitle: Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline acronym: Cognichess overallStatus: RECRUITING date: 2024-02-13 date: 2025-02-13 date: 2025-02-13 date: 2024-02-28 date: 2024-03-01 name: University of Milano Bicocca class: OTHER briefSummary: The goal of this clinical trial\]is to evaluate if learning to play traditional board games could improve cognition in subjects with mild cognitive impairment and subjective cognitive decline. The main questions it aims to answer are:

* Do Go and Chess improve cognition?
* Is a game better than the other? Is the effect of both games on cognition synergistic?
* Do Go and Chess improve quality of life?
* Do Go and Chess improve mood?
* Do Go and Chess improve lifestyle?

Participants will be randomized to one of four groups:

* Group intervention with Go, once a week, for 12 weeks
* Group intervention with Chess, once a week, for 12 weeks
* Group intervention with Go and Chess, twice a week, for 12 weeks
* Control group conditions: Mild Cognitive Impairment conditions: Subjective Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Go classes name: Chess classes measure: General cognition measure: Digit Span Forward measure: Digit Span Backwards measure: Trail Making Test - part A measure: Trail Making Test - part B measure: Semantic fluency measure: Quality of life indicator measure: Depression measure: Lifestyle sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS San Gerardo dei Tintori status: RECRUITING city: Monza state: Lombardia zip: 20900 country: Italy name: Lucio Tremolizzo, MD, PhD role: CONTACT phone: +390392339082 email: lucio.tremolizzo@unimib.it name: Federico Emanuele Pozzi, MD role: SUB_INVESTIGATOR lat: 45.58005 lon: 9.27246 hasResults: False

 nctId: NCT06281639 id: RAPID briefTitle: RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-02-28 date: 2024-02-28 name: University of Minnesota class: OTHER briefSummary: The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \&lt;1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box. conditions: Congenital Heart Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: RAPID measure: RAPID imaging quality sex: ALL maximumAge: 1 Year stdAges: CHILD facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55414 country: United States name: Gwenyth Fischer, MD role: CONTACT phone: 612-625-6678 email: fisch662@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06281626 id: 2024_RIPH_01_Preservatif briefTitle: Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25 acronym: Préservatif overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-10-01 date: 2024-02-28 date: 2024-02-28 name: Université de Reims Champagne-Ardenne class: OTHER briefSummary: For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.

In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022). conditions: Comdom studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED name: Data collection measure: use of free male condoms sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Ufr Medecine Urca city: Reims zip: 51100 country: France lat: 49.25 lon: 4.03333 facility: Université de Reims Champagne Ardenne city: Reims zip: 51100 country: France lat: 49.25 lon: 4.03333 hasResults: False

 nctId: NCT06281613 id: 2024-AMCOPTEO briefTitle: Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-03 date: 2024-04-01 date: 2024-04-05 date: 2024-02-28 date: 2024-03-08 name: University of Pavia class: OTHER briefSummary: The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.

Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.

Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1). conditions: Skeletal Malocclusion studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 40 type: ESTIMATED name: AMCOP group name: High-pull headgear measure: Change in cephalometric angular measurements measure: Linear regressions measure: Change in cephalometric linear measurements sex: ALL minimumAge: 7 Years maximumAge: 11 Years stdAges: CHILD facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06281600 id: REC: 23/SW/0042 id: 326109 type: OTHER domain: IRAS ID briefTitle: An Intervention Study Using HMOs to Improve IBS Symptoms acronym: GUT-HEAL-IBS overallStatus: RECRUITING date: 2024-02-20 date: 2025-08-20 date: 2025-09-20 date: 2024-02-28 date: 2024-02-29 name: Glenn Gibson class: OTHER name: Royal Berkshire NHS Foundation Trust briefSummary: There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. This study will investigate microbial components and activities associated with the gut microbiome, using a global systems biology approach to explore the capacity of a human milk carbohydrate intervention in modulating this microbial community to target IBS, with the primary objective of improving IBS symptoms.

IBS is a highly prevalent gastrointestinal (GI) disorder with significant negative impact on quality of life of patients and high healthcare costs. Although prognosis of IBS is benign, it is a disorder that poses a considerable burden on the individual sufferer and society. Patients typically present with chronic abdominal pain and an altered bowel habit, frequently accompanied by bloating and distension. Often, IBS will afflict sufferers for life, with flares of activity followed by periods of remission. Incidence commonly peaks in the third and fourth decades of life.

IBS is suggested to be a disorder of gut-brain interaction, and alterations of the microbiota-host interactions at the mucosal border may cause symptoms such as those previously mentioned. Therefore, microbiota-targeted interventions may benefit some people with IBS by beneficially modulating the gut microbiome. Several studies have confirmed that prebiotics, such as galactooligosaccharides (GOS), are able to successfully stimulate gut bifidobacteria and alleviate symptoms in IBS. Prebiotics are defined as "a substrate that is selectively utilised by host microorganisms conferring a health benefit" \[8\]. These studies suggest that prebiotics may have potential as therapeutic agents in IBS.

Breastmilk is known to play a crucial role in the development of infants, providing key nutrients and immunological compounds important for initial protection against pathogens \[9\]. Among these compounds, human milk oligosaccharides (HMOs) represent the third most important component of breastmilk after lipids and lactose. HMOs have also been investigated for potential health benefits in adults, including their potential role as prebiotics for improved gut microbiota modulation.

Studies looking specifically at HMO interventions in humans with IBS are sparse. These include a phase II, parallel, RCT in 58 IBS volunteers by Iribarren et al. and an open-label trial with 245 IBS participants from 17 sites across USA by Palsson et al.. None have been sufficiently powered to a degree which could influence clinical practice, but crucially tolerability and safety profiles of HMOs investigated, to date, have been consistently high.

Using the global systems biology approach not yet applied to this research question, a pre-competitive approach to selecting a candidate HMO, and a crossover feasibility trial design, the investigators hope to forge a new direction in establishing the merits of HMO use in IBS.

This study will look specifically at patients with all IBS subtypes, an area where there is a real therapeutic gap and clinical need for safe, effective therapy to improve quality of life. Participants will be randomly allocated to be given either the HMO or a placebo, with neither the patient nor the researchers knowing which they are receiving (randomised and double blind design). They will take this HMO or placebo for 28 days (randomly distributed), and then stop taking it in a 'washout' period of 28 days, allowing the gut microbiota to return to baseline. Then, the participants will take the other intervention (placebo or prebiotic, whichever they did not take in the first half of the study) for 28 days, then have a further washout period of 14 days. The study will then be over.

With this proposal, the aim is to explore how HMOs affect the gut microbiota and whether they can do so in a manner that positively influences patients with IBS. The investigators also hope to develop molecular profiling as part of a research toolkit for gut microbiome-based HMO supplement studies. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a 16-week, randomised, placebo-controlled, double-blinded crossover trial. We aim to recruit 44 participants with IBS. These participants will be screened and classified into a particular IBS subtype. After a 14-day baseline period, participants will be randomised to orally consume either 5g of HMO for 28 days, or a placebo for 28 days. This will be administered at the University of Reading. All participants will then stop taking the product for 28 days (wash out period) and then swap treatment type and have 28 days of either placebo or HMO. This is then followed by another 14 days without any product. During the study, participants will be asked to complete a 24-hour food recall weeks 0 and 16. Additionally, participants will complete validated questionnaires (IBS-Symptom Severity Score, anxiety and depression score and Pittsburgh Sleep Quality Index (PSQI) every time they provide urine and faecal samples at each visit. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Every individual involved in undertaking this trial will be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: Human milk oligosaccharide name: Maltodextrin placebo measure: IBS-SSS measure: Change in anxiety and depression scores (ADS) measure: Improvement of the Pittsburgh Sleep Quality Index (PSQI). measure: Changes in faecal microbiota e.g. Bifidobacterium sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The University of Reading status: RECRUITING city: Reading state: Berkshire zip: RG6 6LA country: United Kingdom name: Patricia Sanz Morales role: CONTACT phone: +447843865554 email: p.sanzmorales@pgr.reading.ac.uk name: Glenn Gibson, Prof. role: SUB_INVESTIGATOR lat: 51.45625 lon: -0.97113 hasResults: False

 nctId: NCT06281587 id: SNFyodorov briefTitle: Pathogenetic Risk Factors for Corneal Graft Rejection overallStatus: COMPLETED date: 2011-01 date: 2019-01 date: 2019-01 date: 2024-02-28 date: 2024-02-28 name: The S.N. Fyodorov Eye Microsurgery State Institution class: OTHER_GOV briefSummary: There are many predictors that may influence the development of corneal graft rejection after penetrating keratoplasty. In our study investigators analysed the results of keratoplasty and the risk factors for graft rejection.

Investigators analysed data from 493 patients who underwent penetrating keratoplasty between 2011 and 2019. Keratoplasty outcomes were followed up at subsequent clinic visits until December 2021. Then, 93 medical records were selected (taking into account the completeness of the medical records) and divided into two groups based on the primary diagnosis that was an indication for keratoplasty: high-risk and low-risk patients. Investigators then estimated the survival time (clear graft) of the corneal graft using Kaplan-Meier statistical survival analysis. Investigators also investigated the factors that influence corneal graft opacity. conditions: Graft Rejection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 93 type: ACTUAL name: penetrating keratoplasty measure: Cohort group Kaplan-Meier survival analysis (clear graft engraftment) sex: ALL minimumAge: 13 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT city: Krasnodar zip: 350012 country: Russian Federation lat: 45.04484 lon: 38.97603 hasResults: False

 nctId: NCT06281574 id: S67346 briefTitle: What Are the Determinants for RTW After SA acronym: RTW after SA overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-13 date: 2025-02-01 date: 2025-02-01 date: 2024-02-28 date: 2024-03-06 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. During the last decades however, there was an improvement of surgical techniques and implants which resulted in the fact that these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.

Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.

This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW. conditions: Shoulder Arthroplasty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Questionnaires measure: Return to work measure: Type of shoulder arthroplasty measure: WORQ-UP (work-related questionnaire for upper extremity disorders) measure: SSV (Subjective Shoulder Value) measure: SST (Dutch translation of the Simple Shoulder Test) measure: OSS (Oxford Shoulder Score) measure: Self-made questionnaire measure: Belgisch Kenniscentrum over welzijn op het werk (BeSWIC) sex: ALL minimumAge: 18 Years maximumAge: 63 Years stdAges: ADULT facility: UZ Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06281561 id: FirstAHXiamenU-YB briefTitle: Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-30 date: 2024-12-31 date: 2024-02-28 date: 2024-04-16 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance.

Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery.

Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality. conditions: Postoperative Sleep Disturbance 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: Normal Saline name: Dexmedetomidine measure: Change from baseline sleep quality at after intervention measure: Pittsburgh sleep quality index(PSQI) measure: Early recovery evaluated by Aldrete rating scale measure: Later Recovery evaluated by QoR-40 questionnaire sex: FEMALE minimumAge: 23 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06281548 id: 23-2937 id: 1F31DA058452 type: NIH link: https://reporter.nih.gov/quickSearch/1F31DA058452 briefTitle: Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs overallStatus: RECRUITING date: 2024-02-29 date: 2024-04-30 date: 2024-04-30 date: 2024-02-28 date: 2024-03-06 name: University of North Carolina, Chapel Hill class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.

This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement. conditions: Stigma, Social conditions: Substance Use studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: RESTART measure: Change in Stigma Resistance Scale (SRS) Score measure: Change in Substance Abuse Self-Stigma Scale (SASSS) Score measure: Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment) measure: Percentage of Prospective Participants Recruited into Study (Feasibility - Enrollment) measure: Time to Sample Saturation (Feasibility - Recruitment) measure: Percentage of Participants Retained in Study (Feasibility - Retention) measure: Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User) measure: Percentage of Participants with High Text Message Frequency (Feasibility - User) measure: Percentage of Participants with High Text Messaging Comfort (Feasibility - User) measure: Percentage of Participants with Cell Phone Device Challenges (Feasibility - User) measure: Percentage of Participants with Cell Phone Plan Challenges (Feasibility - User) measure: Percentage of Participants who Read Messages Daily (Feasibility - User) measure: Change in Adult Dispositional Hope Scale Score measure: Change in Rosenberg Self-Esteem Scale Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SHRPS Syringe Service Program status: RECRUITING city: Portsmouth state: Ohio zip: 45662 country: United States name: Adams L Sibley, MPH role: CONTACT phone: 423-227-9198 email: asibley@live.unc.edu name: Abby Spears role: CONTACT phone: 740-357-9773 email: abby@sciotoconnect.org lat: 38.73174 lon: -82.99767 hasResults: False

 nctId: NCT06281535 id: 21789 briefTitle: Early Versus Conventional Loading for Fully Guided Immediate Implant Placement overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-05-31 date: 2024-06-15 date: 2024-02-28 date: 2024-02-28 name: Ain Shams University class: OTHER name: Assiut University briefSummary: Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Implant loading measure: Implant stability sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06281522 id: University of Health Sciences briefTitle: The Importance of Inflammatory Markers Calculated From Preoperative and Postoperative Peripheral Blood Results in the Diagnosis and Treatment of Patients Operated for Hydatid Cyst of the Lung (Lung Echinococcus Granulosus) acronym: Echinococcusis overallStatus: RECRUITING date: 2023-12-18 date: 2024-03-30 date: 2024-06-30 date: 2024-02-28 date: 2024-02-28 name: Abdullah Adiyaman class: OTHER briefSummary: This study aims to investigate the role of these laboratory findings in the differential diagnosis and management of pulmonary hydatid cyst (PHC) by examining the number of euzonophils, neutrophils, lymphocytes, platelets and neutrophil/lymphocyte ratio, platelet/lymphocyte ratio and systemic immune inflammatory index values in the peripheral blood of patients diagnosed with pulmonary hydatid cyst (PHC) in the preoperative period and post-operative 3rd month. Although we have extensive data on hydatid liver cysts, there is limited information in the literature on the laboratory values of patients with PHC. This study aims to provide more scientific basis for the diagnosis and management of PHC and is considered as an inexpensive, reproducible and easily calculable method to improve the accurate diagnosis and management of AKH in clinical practice. conditions: Lung Hydatid Cyst studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 54 type: ESTIMATED name: Operated patients with hydatid cyst of the lung measure: Calculation of laboratory markers sex: ALL minimumAge: 18 Years maximumAge: 83 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences, Van Training and Research Hospital status: RECRUITING city: Van country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False

 nctId: NCT06281509 id: S68374 briefTitle: Palmaris Longus Muscle and Dupuytren acronym: Palmaris overallStatus: RECRUITING date: 2024-02-16 date: 2025-02-01 date: 2025-02-01 date: 2024-02-28 date: 2024-03-07 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Dupuytren disease is a medical condition characterized by the painless formation of nodules in the palm of the hand. Cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand. This fascia is seen as the vestigial remnant of the palmaris longus tendon. The PLM attaches to the fascia palmaris. A muscle that not everyone has and can therefore be clearly missed. This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures. To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition. conditions: Dupuytren's Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups: Patients with Dupuytren Disease and healthy control group. They will be age matched (50 years of age or higher) with the objective to have a proportionate division (50/50) between the genders. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: No masking will be done in this study count: 240 type: ESTIMATED name: Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands. name: Ultrasound measure: PLM in the DD versus control measure: PML in mild versus severe DD-group measure: PLM presence in DD affected group measure: PLM presence in control group measure: Dominant versus non-dominant hand measure: Male versus female population sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitaire Ziekenhuizen KU Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Ilse Degreef, Prof. Dr. role: CONTACT phone: +32 16 33 88 43 email: ilse.degreef@uzleuven.be name: Anna Tarasiuk role: CONTACT phone: +32 16 33 88 18 email: orthopedie.research@uzleuven.be lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06281496 id: Rigshospitalet, Hematology briefTitle: AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation acronym: AlloCare overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-10-01 date: 2026-12-01 date: 2024-02-28 date: 2024-02-29 name: Rigshospitalet, Denmark class: OTHER name: Danish Cancer Society briefSummary: A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase. conditions: Hematological Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One site, two arm randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: AlloCare measure: EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100) measure: Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark name: Mette Schaufuss Engedal, MSc role: CONTACT phone: +45 51896699 email: mette.schaufuss.engedal@regionh.dk name: Mary Jarden, Professor role: CONTACT email: mary.jarden@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06281483 id: APCs in chronic skin ulcers briefTitle: PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-01 date: 2024-02-28 date: 2024-02-28 name: Kafrelsheikh University class: OTHER name: Helwan University briefSummary: To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment. conditions: Chronic Non-healing Skin Ulcers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: platelet-rich plasma name: platelet-rich fibrin name: Surgical debridement, normal saline washing and dressing coverage measure: Objective assessment of ulcer size for effectiveness, using Image J software. measure: Pain assessment measure: Any adverse effects related to treatment modality sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Badr Hospital - Helwan University and Kafrelseikh University Hospital status: RECRUITING city: Cairo country: Egypt name: Mohamed Aboshabana Hussein, Assistant Lecturer role: CONTACT phone: 01007981008 email: dr.mohamedaboshabana@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06281470 id: WS016-Ⅰ-01 briefTitle: The Safety and Tolerability of WS016 in Healthy Chinese Volunteers overallStatus: COMPLETED date: 2023-02-13 date: 2023-06-15 date: 2023-06-15 date: 2024-02-28 date: 2024-02-28 name: Waterstone Pharmaceutical (Wuhan) Co., LTD. class: INDUSTRY briefSummary: This clinic trial evaluates the safety and tolerability of single- and multiple- ascending doses of WS016 in healthy adult participants. There will be about 64 participants,48 active and 16 placebo. conditions: Hyperkalemia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ACTUAL name: WS016 Single Dose(6g) name: WS016 Single Dose(12g) name: WS016 Single Dose(24g) name: WS016 Single Dose(36g) name: WS016 Single Dose(48g) name: SAD matching placebo name: WS016 Multiple Dose(12g) name: WS016 Multiple Dose(24g) name: WS016 Multiple Dose(48g) name: MAD matching placebo measure: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single- and multiple- ascending dose sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Zhejiang Xiaoshan Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06281457 id: 5-24-0030: 2.1 id: R01EY035300 type: NIH link: https://reporter.nih.gov/quickSearch/R01EY035300 briefTitle: Probing the Role of Feature Dimension Maps in Visual Cognition: Impact of Task Demands (Expt 2.1) overallStatus: RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-04-18 name: University of California, Santa Barbara class: OTHER name: National Eye Institute (NEI) briefSummary: How does one know what to look at in a scene? Imagine a "Where's Waldo" game - it's challenging to find Waldo because there are many 'salient' locations in the picture, each vying for one's attention. One can only attend to a small location on the picture at a given moment, so to find Waldo, one needs to direct their attention to different locations. One prominent theory about how one accomplishes this claims that important locations are identified based on distinct feature types (for example, motion or color), with locations most unique compared to the background most likely to be attended. An important component of this theory is that individual feature dimensions (again, color or motion) are computed within their own 'feature maps', which are thought to be implemented in specific brain regions. However, whether and how specific brain regions contribute to these feature maps remains unknown.

The goal of this study is to determine how brain regions that respond strongly to different feature types (color and motion) and which encode spatial locations of visual stimuli transform 'feature dimension maps' based on stimulus properties as a function of task instructions. The investigators hypothesize that feature-selective brain regions act as neural feature dimension maps, and thus encode representations of relevant location(s) based on their preferred feature dimension, such that the stimulus representation in the most relevant feature map is up-regulated to support adaptive behavior. The investigators will scan healthy human participants using functional MRI (fMRI) in a repeated-measures design while they view visual stimuli made relevant based on a cued feature dimension (e.g., color or motion). The investigators will employ state-of-the-art multivariate analysis techniques that allow them to reconstruct an 'image' of the stimulus representation encoded by each brain region to dissect how neural tissue identifies salient locations. Each participant will perform a challenging discrimination task based on the cued feature (report motion direction or color of stimulus dots) of a stimulus presented in the periphery, which are identical across trial types. Across trials the investigators will manipulate the attended feature value (color, motion, or fixation point). This manipulation will help the investigators fully understand these critical relevance computations in the healthy human visual system. conditions: Basic Science: Visual Attention in Healthy Participants conditions: Basic Science: Neural Representations of Location studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a basic science study in which all participants will participate in all task conditions within each experiment (repeated-measures design). primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Participants will typically be unaware of the conditions presented, though because these involve manipulations of stimuli or task demands, they may be aware of the manipulation. This is not expected to impact the primary outcome measures (e.g., BOLD signal activation patterns). count: 10 type: ESTIMATED name: Stimulus properties: task-defining feature measure: Blood Oxygenation Level Dependent (BOLD) fMRI signal measure: Gaze position measure: Behavioral response (button press) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: University of California, Santa Barbara status: RECRUITING city: Santa Barbara state: California zip: 93117 country: United States name: Melodie Blakemore role: CONTACT phone: 805-893-4286 email: blakemore@research.ucsb.edu name: Tommy C Sprague, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.42083 lon: -119.69819 hasResults: False

 nctId: NCT06281444 id: i07-453-23 briefTitle: Effectiveness of Radial Extracorporeal Shock Wave Therapy in Patients With Knee Osteoarthritis overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-31 date: 2025-07-31 date: 2024-02-28 date: 2024-02-28 name: Ankara University class: OTHER briefSummary: Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty walking. The diagnosis of knee osteoarthritis can be easily made with a detailed history and a comprehensive physical examination. Radiographic examinations are used to support clinical findings and exclude other possible pathologies. The main purpose of treating knee osteoarthritis is to reduce pain and make daily life easier. Since there is no standard treatment method, the patient's treatment must be individualized by taking into account age, comorbidity, severity of the clinical picture, patient preferences and cost of treatment. Conservative treatment includes pharmacological and non-pharmacological treatment, and the optimal treatment should be applied as a combination of these two methods. Patient education, lifestyle modification, exercise, different physical therapy modalities (TENS, Interferential current, ESWT...), acupuncture are some non-pharmacological methods.

Extracorporeal shock wave therapy (ESWT), which is considered within the scope of conservative treatment, started in the seventies with the practice of breaking ureteric stones and has become one of the physical therapy modalities used in the treatment of various musculoskeletal diseases. Considering the historical development of ESWT, it has started to be used as a therapeutic modality in the treatment of knee osteoarthritis in recent years. The process, which started with animal experiments, continued with human studies, and evidence is presented that ESWT reduces knee pain and contributes to functionality. It is noteworthy that there are few studies and their short follow-up periods. In the light of these studies, it was planned to investigate the effectiveness of ESWT treatment, which will be applied together with exercise, on pain, functionality and walking distance in individuals diagnosed with knee osteoarthritis, in comparison with the control group receiving sham ESWT. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise. primaryPurpose: TREATMENT masking: NONE maskingDescription: Patients who meet the study conditions and agree to participate in this study will not know whether they are in the first group or the second group. count: 72 type: ESTIMATED name: ESWT name: Sham-ESWT measure: Change in pain [by using the Visual Analogue Scale(VAS)] measure: Change from baseline in functionality and walking distance measure: Change from baseline in walking distance sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara University status: RECRUITING city: Ankara state: Altındağ zip: 06230 country: Turkey name: Birkan Sonel Tur, Prof. Dr. role: CONTACT phone: +903125956331 email: sonelb@medicine.ankara.edu.tr name: Taha Can Başar, Dr. role: CONTACT phone: +90312595 6331/2822 email: tahacan06@outlook.com name: Birkan Sonel Tur, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Taha Can Başar, Dr. role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06281431 id: CPSP briefTitle: A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain overallStatus: RECRUITING date: 2023-06-12 date: 2025-09-30 date: 2025-09-30 date: 2024-02-28 date: 2024-02-28 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. \>20% of patients suffer from chronic postoperative pain. China has \>70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management. conditions: Chronic Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 1000 type: ESTIMATED name: Echogenic nerve block needle name: Non-echogenic nerve block needle measure: Chronic postoperative pain measure: Moderate to severe pain measure: Acute postoperative pain measure: Acute postoperative pain measure: Acute postoperative pain measure: Puncture operation time measure: Number of needle passes sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: He Huang status: RECRUITING city: Chongqing state: Chongqing zip: 4000000 country: China name: He Huang, ph.D role: CONTACT phone: 13708385559 email: huanghe@cqmu.edu.cn lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06281418 id: 5-24 briefTitle: Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy overallStatus: RECRUITING date: 2024-02-29 date: 2024-10 date: 2024-10 date: 2024-02-28 date: 2024-04-17 name: Future University in Egypt class: OTHER briefSummary: Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC. conditions: Post Operative Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Granisetron 1 Mg/mL Intravenous Solution name: Normal saline measure: VAS score measure: Time to analgesic request measure: Quality of life (QoL) after laparoscopic cholecystectomy (LC) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Hepatology and Tropical Research Institute status: RECRUITING city: Cairo zip: 11617 country: Egypt name: Hoda Mohamed Bayoumi, Bachelor's role: CONTACT phone: 01126143971 email: hoda.bayoumy@fue.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06281405 id: FDRT-2023-290-3409 briefTitle: CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer acronym: TORCH-iTNT overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2028-12-31 date: 2024-02-28 date: 2024-02-28 name: Fudan University class: OTHER briefSummary: TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc. conditions: Locally Advanced Rectal Cancer conditions: Neoadjuvant Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 198 type: ESTIMATED name: PD-1 antibody name: Capecitabine name: Short-course radiotherapy measure: Complete response (CR) rate measure: Grade 3-4 adverse effects rate measure: 3 year anal preservation rate measure: 3 year disease free survival rate measure: 3 year local recurrence free survival rate measure: 3 year overall survival rate measure: Rate of surgical complications sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06281392 id: CEIm: 106/23 briefTitle: Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study) overallStatus: RECRUITING date: 2023-11-15 date: 2026-11-15 date: 2026-11-15 date: 2024-02-28 date: 2024-02-28 name: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana class: OTHER name: University of Valencia briefSummary: Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD). conditions: Inflammatory Bowel Diseases conditions: Dysplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ESTIMATED name: CADe system name: NBI measure: "Per lesion" dysplasia detection rate (DDR) measure: "Per patient" dysplasia detection rate (DDR) measure: Duration of endoscopic examination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antonio López-Serrano status: RECRUITING city: Valencia zip: 46017 country: Spain name: Antonio López-Serrano, Ph.D. role: CONTACT phone: 0034656495490 email: anlopezs@comv.es lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06281379 id: Basaksehir City Hospital briefTitle: Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer: overallStatus: COMPLETED date: 2023-04-01 date: 2023-12-31 date: 2024-01-01 date: 2024-02-28 date: 2024-02-28 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.

Study design:Randomised-controlled study

Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.

Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.

Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization. conditions: Gastric Cancer conditions: Gastric Neoplasm conditions: Gastric Cancer Stage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study group participants: total gastrectomy+mesogastrectomy Control group: Standard total gastrectomy + D2 lymph node dissection primaryPurpose: TREATMENT masking: NONE count: 37 type: ACTUAL name: Total mesogastrectomy measure: Postoperative outcome sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yigit Duzkoylu city: Istanbul zip: 34480 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06281366 id: PR(AMI)470-2023 briefTitle: Diamine Oxidase and Adverse Pregnancy Outcomes overallStatus: RECRUITING date: 2024-02-16 date: 2025-12-31 date: 2025-12-31 date: 2024-02-28 date: 2024-03-20 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER name: DR Healthcare briefSummary: In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies.

First-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity. conditions: Pregnancy Complications studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 75 type: ESTIMATED measure: Diamine oxidase activity first trimester measure: Diamine oxidase gene polymorphisms measure: Blood Diamine oxidase activity at delivery measure: Placental Diamine oxidase activity at delivery measure: Blood histamine levels at delivery measure: Placental histamine levels at delivery measure: Urine histamine levels at delivery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manel Mendoza status: RECRUITING city: Barcelona zip: 08035 country: Spain name: Manel Mendoza, PhD role: CONTACT phone: +34934893085 email: manel.mendoza@vallhebron.cat name: Erika Bonacina, PhD role: CONTACT phone: +34934893264 email: erika.bonacina@vallhebron.cat name: Erika Bonacina, PhD role: SUB_INVESTIGATOR name: Manel Mendoza, PhD role: PRINCIPAL_INVESTIGATOR name: Mireia Armengol, MD role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06281353 id: 22-07-0754 briefTitle: The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue overallStatus: COMPLETED date: 2022-08-16 date: 2023-09-06 date: 2023-09-06 date: 2024-02-28 date: 2024-02-28 name: Indonesia University class: OTHER briefSummary: The goal of this clinical trial is to demonstrate the adjuvant administration of oral nanocurcumin in 90% TCA therapy that increases the proportion of clinical improvement in patients with Anogenital Warts (AGW), mediated by NFĸB, IFN-γ, and FOXP3+Treg. Specific objectives of this clinical trial include:

* To prove that the oral administration of nanocurcumin decreases the levels of IFN-γ, FOXP3+Treg, and NFĸB in lesions of AGW patients, and
* To demonstrate that the reduction in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions is associated with the proportion of clinical improvement in AGW patients undergoing TCA 90% therapy with adjuvant of oral nanocurcumin.

The main questions it aims to answer are:

* Does adjuvant oral nanocurcumin administration in 90% TCA therapy increase the proportion of clinical improvement in patients with AGW compared to controls (90% TCA therapy alone)?
* Is there a greater decrease in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions of patients with AGW given adjuvant oral nanocurcumin compared to controls?
* Is the decrease in IFN-γ, FOXP3+TReg, and NFĸB levels in lesions of patients with AGW, with adjunctive oral nanocurcumin administration in 90% TCA therapy, associated with the degree of clinical improvement in patients with AGW?

Participants will be divided into 2 groups. The first one was given capsules without active ingredients/nanocurcumin (control group), and the second one was given capsules with nanocurcumin (experimental group), both group received a dosage of 200mg capsules per day after breakfast, for 8 weeks. The researchers conducted a comparison between those 2 groups to assess whether the adjuvant administration of oral nanocurcumin in 90% TCA therapy enhances the proportion of clinical improvement in patients with AGW. conditions: Anogenital Wart 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: 78 type: ACTUAL name: Curcumin Oral Capsule name: Trichloroacetic acid name: Blood sample collection name: Cotton swab measure: Clinical improvement in patients with AGW measure: Level of IFN-γ in lesions of AGW patients measure: Level of FOXP3+Treg in lesions of AGW patients measure: Level of NFĸB in lesions of AGW patients sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cipto Mangunkusumo Hospital city: Jakarta Pusat state: DKI Jakarta zip: 10430 country: Indonesia lat: -6.1818 lon: 106.8223 hasResults: False

 nctId: NCT06281340 id: He-ankle US briefTitle: Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2024-04-10 date: 2024-04-21 date: 2024-02-28 date: 2024-02-28 name: Investigación en Hemofilia y Fisioterapia class: NETWORK briefSummary: Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.

Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.

Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.

Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.

Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).

Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage. conditions: Hemophilia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE maskingDescription: Randomization will be performed using a computerized randomization procedure by permuted blocks of 4 subjects in each recruitment center. The 6 possible sequence alternatives will be modified in each block. This task will be carried out by a person who is not involved in the study and who will not know the identity of the subjects. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 20 type: ESTIMATED name: Manual therapy name: Placebo therapy measure: Change from baseline sonographic changes after 4 hours measure: Change from baseline joint pain after 4 hours measure: Change from baseline joint damage after 4 hours measure: Change from baseline degree of joint inflammation after 4 hours sex: MALE minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT facility: University of Oviedo city: Oviedo state: Asturias zip: 33006 country: Spain lat: 43.36029 lon: -5.84476 hasResults: False

 nctId: NCT06281327 id: TX-ITP-001 briefTitle: Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia overallStatus: RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER name: Henan Cancer Hospital name: Tianjin Medical University Second Hospital name: Tianjin Children's Hospital name: The Second Affiliated Hospital of Kunming Medical University briefSummary: To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons. conditions: Immune Thrombocytopenia conditions: Treatment studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Avatrombopag measure: Overall efficacy response after AVA treatment within 12 weeks measure: Treatment response-1 measure: Treatment response-2 measure: Time to Response measure: Persistent response measure: Emergency treatment measure: Reduction of concomitant drug measure: Number of participants with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale. measure: Number of participants with clinically significant bleeding as assessed using the bleeding scale for pediatric patients with ITP. measure: Health-related quality of life survey of subjects(HRQoL)-1 measure: Health-related quality of life survey of subjects(HRQoL)-2 measure: Health-related quality of life survey of subjects(HRQoL)-3 measure: Health-related quality of life survey of subjects(HRQoL)-4 sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Tianjin country: China name: Lei Zhang, MD role: CONTACT phone: +8602223909009 email: zhanglei1@ihcams.ac.cn name: Ting Sun, MD role: CONTACT phone: +8602223909009 email: sunting@ihcams.ac.cn lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06281314 id: VESPA 2.0 briefTitle: The Efficacy of VESPA 2.0 for Cognitive Rehabilitation in Patients With Mild Cognitive Impairment overallStatus: COMPLETED date: 2021-03-01 date: 2022-12-27 date: 2023-12-31 date: 2024-02-28 date: 2024-03-08 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: VESPA 2.0 is based on an integrative and ecological approach used for the treatment of cognitive dysfunction in patients with MCI or other neurodegenerative disorders. conditions: Neurodegenerative Diseases conditions: Cognitive Decline conditions: Parkinson Disease Dementia conditions: Alzheimer Disease conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Vespa software measure: Montreal cognitive assessment (MoCA) sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Centro Neurolesi Bonino Pulejo city: Messina state: Sicily zip: 98124 country: Italy lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06281301 id: HSC-MS-23-1023 briefTitle: Improving Patient Understanding of Macrosomia overallStatus: RECRUITING date: 2024-01-30 date: 2024-04-30 date: 2024-09-01 date: 2024-02-28 date: 2024-02-28 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of this study is to evaluate the effectiveness of a graphic based education tool on patient knowledge of macrosomia through the use of a survey and to evaluate knowledge at 1-2 weeks after initial review of the education tool. conditions: Macrosomia, Fetal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 176 type: ESTIMATED name: education tool name: no additional information measure: Number of participants that showed Macrosomia knowledge greater than 50 percent as assessed by the score on a survey sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The University of Texas Health Science Center at Houston status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Kristen Cagino, MD role: CONTACT phone: 713-500-6412 email: Kristen.A.Cagino@uth.tmc.edu name: Suneet Chauhan role: CONTACT email: mfmchauhan@gmail.com lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06281288 id: P.T.REC/012/004754 briefTitle: Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms overallStatus: ENROLLING_BY_INVITATION date: 2023-12-25 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-03-19 name: Doaa Tammam Atia class: OTHER briefSummary: PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptoms

BACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers"

RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Cognitive-Behavioral Therapy name: Exercise Training measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC), sex: FEMALE minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: doaa Tammam Atia city: Suez country: Egypt lat: 29.97371 lon: 32.52627 hasResults: False

 nctId: NCT06281275 id: TJ-IRB202402008 briefTitle: A Study of the Association Between Frailty and Acute Postoperative Pain in Elderly Thoracoscopic Surgery Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2024-09-30 date: 2024-10-30 date: 2024-02-28 date: 2024-04-12 name: Huazhong University of Science and Technology class: OTHER briefSummary: To gain a clearer understanding of the association between frailty and postoperative acute pain in elderly thoracoscopic surgery patients and its underlying mechanisms, to provide new solution ideas to reduce the level of postoperative acute pain and improve the debilitating state of elderly thoracoscopic surgery patients, and consequently improve their quality of life and mental status. conditions: Frailty conditions: Acute Postoperative Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 78 type: ESTIMATED measure: All patients' Numerical Rating Scale （NRS） scores for most significant pain at rest in the 48h postoperative period measure: Numerical Rating Scale （NRS） scores for the most pronounced pain in the patient's coughing state in the 48h postoperative period measure: PCA pump consumption measure: Number of PCA pump presses sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, 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: NCT06281262 id: GIP-23-L-04-223 briefTitle: Selected Immunological Indicators and Microbiota in Patients With Premature Birth and Preeclampsia acronym: PRIME overallStatus: RECRUITING date: 2023-06-30 date: 2025-03-30 date: 2025-03-30 date: 2024-02-28 date: 2024-03-01 name: General University Hospital, Prague class: OTHER name: Charles University, Czech Republic name: Institute of Hematology and Blood Transfusion, Czech Republic briefSummary: The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota. conditions: Preterm Birth conditions: Preeclampsia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Peripheral blood collection name: Swab sample collection measure: Changes in selected T cell subpopulations in the first trimester associated with subsequent spontaneous preterm birth measure: Changes in selected T cell subpopulations in the first trimester associated with subsequent pre-eclampsia measure: Association of maternal microbiota and maternal T regulatory cell populations. sex: FEMALE minimumAge: 19 Years maximumAge: 40 Years stdAges: ADULT facility: Department of Gynaecology, Obstetrics and Neonatology of the First Faculty of Medicine of the Charles University and General University Hospital in Prague status: RECRUITING city: Prague zip: 128 08 country: Czechia name: Zdeněk Laštůvka, MUDr., Ph.D. role: CONTACT phone: +420777724640 email: zdenek.lastuvka@vfn.cz name: Michal Koucký, Doc., MUDr., Ph.D. role: CONTACT phone: +420603219916 email: michal.koucky@vfn.cz lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06281249 id: 73172 briefTitle: Neuraxial Ultrasound Device Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03 date: 2025-03 date: 2024-02-28 date: 2024-03-15 name: Stanford University class: OTHER name: Rivanna Medical, Inc. briefSummary: The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method. conditions: Labor Pain conditions: Cesarean Delivery Regional Anesthesia Induction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Ultrasound placement device measure: Incidence of difficult block placement measure: Incidence of failed block measure: Incidence of post-dural puncture headache sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06281236 id: SPI-62-CL-1002 briefTitle: A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-28 date: 2024-02-28 name: Sparrow Pharmaceuticals class: INDUSTRY briefSummary: This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited. conditions: Polymyalgia Rheumatica studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Prednisolone name: SPI-62 measure: Erythrocyte sedimentation rate measure: C-reactive protein measure: Plasma fibrinogen sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emovis Gmbh city: Berlin country: Germany name: Anna Wieczorek role: CONTACT phone: +49 30 439741221 email: anna.wieczorek@futuremeds.com name: Frank Zollmann role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: Klinische Forschung Hannover Mitte GmbH/Pratia city: Hannover zip: 30159 country: Germany name: Matilde Planer role: CONTACT phone: +49 511 169 7650 email: matilde.planer@pratia.com name: Jan Wagner role: PRINCIPAL_INVESTIGATOR lat: 52.37052 lon: 9.73322 facility: Klinische Forschung Schwerin GmbH/Pratia city: Schwerin zip: 19055 country: Germany name: Julia Grindel role: CONTACT phone: +49 385 557 740 email: julia.grindel@pratia.com name: Charlotte von Engelhardt role: PRINCIPAL_INVESTIGATOR lat: 53.62937 lon: 11.41316 hasResults: False

 nctId: NCT06281223 id: JBR_2023_9 briefTitle: Study of Brain-spinal Cord Neural Connectivity in Spasticity acronym: MOVE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-05 date: 2026-05 date: 2024-02-28 date: 2024-02-28 name: Fondation Ophtalmologique Adolphe de Rothschild class: NETWORK briefSummary: Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic. conditions: Spasticity, Muscle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: intraoperative neuroelectrophysiological monitoring measure: variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06281210 id: IEO 2034 briefTitle: Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery acronym: BETTY-CRASY overallStatus: RECRUITING date: 2023-12-11 date: 2028-12-31 date: 2028-12-31 date: 2024-02-28 date: 2024-02-28 name: European Institute of Oncology class: OTHER briefSummary: This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT. conditions: Breast Cancer conditions: Triple Negative Breast Cancer conditions: HER2-positive Breast Cancer conditions: Neoadjuvant Chemotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 77 type: ESTIMATED name: Omission of surgical treatment measure: Event-free survival measure: Positive predictive value of MRI measure: Contrast-Enhanced Mammography (CEM) positive predictive value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto di Candiolo IRCCS status: NOT_YET_RECRUITING city: Candiolo state: Turin zip: 10060 country: Italy name: Antonio Toesca, MD role: CONTACT lat: 44.95858 lon: 7.59812 facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Elisabetta Rossi, MD role: CONTACT phone: +390294372191 email: ElisabettaMariaCristina.Rossi@ieo.it name: Mara Negri role: CONTACT email: mara.negri@ieo.it name: Elisabetta Rossi, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06281197 id: 2021/48 briefTitle: Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume overallStatus: COMPLETED date: 2021-01-15 date: 2021-08-15 date: 2022-05-15 date: 2024-02-28 date: 2024-02-28 name: TC Erciyes University class: OTHER briefSummary: After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation. conditions: Maxillofacial Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double blind primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double blind whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 47 type: ACTUAL name: Conventional name: Subspinal measure: Evaluation of Septum Deviation measure: Evaluation of Nasal Airway measure: nasal obstruction scale evaluation sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selin Çelebi city: Kayseri state: Meligazi zip: 38320 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06281184 id: DIA2024.1 id: 715758 type: REGISTRY domain: Regional committee for medical and health research ethics briefTitle: A Post-trial Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate Treatment in Adults With Erosive Hand OA. acronym: MERINO:2 overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-02-01 date: 2027-02-01 date: 2024-02-28 date: 2024-02-28 name: Diakonhjemmet Hospital class: OTHER briefSummary: In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there\&amp;#39;s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression. conditions: Hand Osteoarthritis conditions: Erosive Osteoarthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 108 type: ESTIMATED name: Methotrexate name: No treatment measure: Effect of MTX on radiographic progression of erosive hand OA. measure: Effect of MTX on pain, function and life quality measure: Effect of MTX on radiographic progression of hand OA. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diakonhjemmet Hospital city: Oslo zip: 0319 country: Norway name: Ida Løchting role: CONTACT phone: +4722451500 email: Ida.Lochting@diakonsyk.no name: Alexander Mathiessen, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06281171 id: 90BISB0022 briefTitle: Evaluation of SkillTalk for Autistic Young Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-08-31 date: 2024-02-28 date: 2024-04-17 name: dfusion Inc class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships.

The main questions it aims to answer are:

* Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)?
* Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills?
* Does using SkillTalk increase interpersonal competence?
* Does using SkillTalk increase ability to cope with rejection?
* Does using SkillTalk improve mental health and wellbeing?

Participants will be asked to:

* Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up
* Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up
* Watch a minimum of 85% of the 60 minutes of video assigned conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 110 type: ESTIMATED name: SkillTalk for Autistic Young Adults name: Flyer Library measure: Demonstrated Skill Score in communication skills. measure: Participant Confidence & Satisfaction in their communication skills measure: Interpersonal Competence Score measure: Coping with Rejection, Jealousy and Relationship Anxiety measure: Mental Health and Wellbeing sex: ALL minimumAge: 18 Years maximumAge: 28 Years stdAges: ADULT facility: Virtual Study city: Santa Cruz state: California zip: 95060 country: United States lat: 36.97412 lon: -122.0308 hasResults: False

 nctId: NCT06281158 id: DNLI-F-0009 briefTitle: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants overallStatus: RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-03-01 name: Denali Therapeutics Inc. class: INDUSTRY briefSummary: This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 7 type: ESTIMATED name: [14C]-DNL343 measure: PK Parameter: AUC0-∞ measure: PK Parameter: AUC0-tlast measure: PK Parameter: Cmax measure: PK Parameter: Tmax measure: PK Parameter: t1/2 measure: Total radioactivity in plasma and whole blood measure: Total radioactivity in blood-to-plasma ratio measure: Extent and rate of recovery of total radioactivity in urine and feces measure: PK Parameter: AUC0-∞ measure: PK Parameter: AUC0-tlast measure: PK Parameter: Cmax measure: PK Parameter: Tmax measure: PK Parameter: t1/2 measure: DNL343 and a DNL343 metabolite recoveries in urine measure: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Site status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06281145 id: RSV-SK001/UC-SK004/OUSA briefTitle: Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer acronym: SRI-BrCa_CRC overallStatus: RECRUITING date: 2024-03-15 date: 2027-03-15 date: 2029-03-15 date: 2024-02-28 date: 2024-02-28 name: Comenius University class: OTHER briefSummary: The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC). conditions: Breast Cancer conditions: Colon Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Heart-rate variability biofeedback intervention measure: Primary endpoint - inflammation measure: Primary endpoint - QoL measure: Primary endpoint - executive functions measure: Primary endpoint- salivary cortisol slopes measure: Primary endpoint- sleep quality measure: Primary endpoint - heart rate variability (HRV) measure: Primary endpoint - Working memory measure: Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A measure: Secondary endpoint - Relapse-free Survival (RFS) measure: Secondary endpoint - Overall survival (OS) measure: Secondary endpoint - Serious Adverse Events (SAE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Elizabeth Cancer Institute status: RECRUITING city: Bratislava zip: 81250 country: Slovakia name: Bela Mrinakova, MD role: CONTACT phone: 00421232249111 email: bela.mrinakova@ousa.sk name: Miriam Hancinova, MD role: CONTACT phone: 00421232249111 email: miriam.hancinova@ousa.sk name: Bela Mrinakova role: PRINCIPAL_INVESTIGATOR name: Miriam Hancinova role: SUB_INVESTIGATOR lat: 48.14816 lon: 17.10674 hasResults: False

 nctId: NCT06281132 id: A126_03BE2316 briefTitle: Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D956 in Healthy Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-22 date: 2024-05-07 date: 2024-05-14 date: 2024-02-28 date: 2024-04-02 name: Chong Kun Dang Pharmaceutical class: INDUSTRY briefSummary: The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults. conditions: Hypertension studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 48 type: ACTUAL name: CKD-341, D956 measure: area under curve(AUC) of CKD-341, D956 measure: Cmax of CKD-341, D956 sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Jeonbuk National University Hospital city: Jeonju country: Korea, Republic of lat: 35.82194 lon: 127.14889 hasResults: False

 nctId: NCT06281119 id: SII-qHPV/MC-03 briefTitle: Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-05 date: 2024-02-28 date: 2024-02-28 name: Serum Institute of India Pvt. Ltd. class: INDUSTRY name: Bill and Melinda Gates Foundation briefSummary: Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years. conditions: Human Papillomavirus Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Cervavac as three dose regimen name: Cervavac as two dose regimen name: Gardasil as three dose regimen measure: Geometric mean titers of anti HPV 16 and 18 IgG antibodies measure: Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion measure: Adverse Events measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage measure: CD4+ cell count, HIV viral load, and HIV clinical staging sex: FEMALE minimumAge: 15 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Centre For Clinical Research, Kemri city: Nairobi zip: 54840-00200 country: Kenya name: Nelly Mugo role: CONTACT phone: +254733629665 email: rwamba@uw.edu lat: -1.28333 lon: 36.81667 facility: Partners in Health and Research Development (Phrd) city: Thika zip: 19865-00202 country: Kenya name: Nelly Mugo role: CONTACT phone: +254733629665 email: rwamba@uw.edu lat: -1.03326 lon: 37.06933 facility: Manhiça Health Research Center - Manhiça Foundation (CISM-FM) city: Manhiça zip: 1929 country: Mozambique name: Tacilta Nhampossa role: CONTACT phone: +258 21 810 181 email: tacilta.nhampossa@manhica.net facility: Clinical HIV Research Unit (CHRU), Helen Joseph Hospital city: Johannesburg zip: 2092 country: South Africa name: Carla Chibwesha role: CONTACT phone: +27 072 744 7899 email: carla_chibwesha@med.unc.edu lat: -26.20227 lon: 28.04363 hasResults: False

 nctId: NCT06281106 id: IM011-1118 id: KOFAM 2023-01731 type: OTHER domain: CER-VD briefTitle: TYK2 Inhibition in Paradoxical Psoriasis acronym: TYPP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2025-08 date: 2024-02-28 date: 2024-02-28 name: Prof Curdin Conrad class: OTHER name: Centre Hospitalier Universitaire Vaudois briefSummary: Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists.

This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis. conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: During 4 weeks the patients of the 2 arms receive either Deucravacitinib 6mg 1x/day or an identically looking placebo.

At Week 4, Patients with underlying disease of Crohn's disease, colitis ulcerosa, uveitis will stop the study, to avoid that they are too long without efficient treatment for their underlying disease.

Patients with underlying disease of psoriasis or psoriatic arthritis will have the possiblity to continue in Part 2, where they all will receive Deucravacitinib 6mg 1x/day, open label for 3 months primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Lab personnel whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Deucravacitinib measure: Paradoxical Psoriasis Investigator Global Assessment measure: Paradoxical Psoriasis Body Surface Area measure: Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index measure: Paradoxical Psoriasis Scalp Investigator General Assessment measure: Psoriasis Area and Severity Index (PASI) measure: American College of Rheumatology (ACR) Score measure: Nanostring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre hospitalier universitaire vaudois (CHUV) city: Lausanne state: VD zip: 1011 country: Switzerland name: Franziska Stuber, RN role: CONTACT phone: +41 21 3143427 email: franziska.stuber@chuv.ch name: Curdin Conrad, Professor role: PRINCIPAL_INVESTIGATOR lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06281093 id: PI2022_843_0089 briefTitle: Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System acronym: CHARLINE overallStatus: RECRUITING date: 2024-02-20 date: 2026-09 date: 2026-10 date: 2024-02-28 date: 2024-03-13 name: Centre Hospitalier Universitaire, Amiens class: OTHER name: University Hospital, Brest name: CHU LYON name: University Hospital, Strasbourg, France name: University Hospital, Toulouse briefSummary: Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.

This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase. conditions: Preterm Newborn studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: questionary name: Daily continuous recording of radiofrequency exposure levels name: Follow-up of daily infants clinical parameters name: recording of cerebral (EEG) name: autonomic nervous (ECG) activity measure: Variation of the spectral power in the α band (8-12 Hz) of the EEG measure: variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG sex: ALL minimumAge: 1 Day maximumAge: 1 Month stdAges: CHILD facility: Amiens University Hospital status: RECRUITING city: Amiens state: Picardie zip: 80054 country: France name: Pierre Tourneux, MD role: CONTACT phone: +33 3 22 66 82 86 email: tourneux.pierre@chu-amiens.fr name: Erwan STÉPHAN-BLANCHARD, Dr role: PRINCIPAL_INVESTIGATOR name: Stéphane DELANAUD, PhD role: SUB_INVESTIGATOR name: Frédéric TELLIEZ, Pr role: SUB_INVESTIGATOR name: Karen CHARDON, Pr role: SUB_INVESTIGATOR name: Brahim SELMAOUI, Dr role: SUB_INVESTIGATOR name: Débora TUKA role: SUB_INVESTIGATOR name: Jean-Michel ROUÉ, Pr role: PRINCIPAL_INVESTIGATOR name: Marine BUTIN, Pr role: PRINCIPAL_INVESTIGATOR name: Pierre KUHN, Pr role: PRINCIPAL_INVESTIGATOR name: Géraldine GASCOIN, Pr role: PRINCIPAL_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06281080 id: CRE2023.589-T briefTitle: First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-09-30 date: 2024-02-28 date: 2024-02-28 name: Chinese University of Hong Kong class: OTHER name: Agilis Robotics Limited briefSummary: This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: En-Bloc Resection of Bladder Tumours measure: Successful en-bloc tumour resection by the robotic system measure: Dissection time and speed measure: Total procedure time measure: Surgeon Console time measure: Presence of detrusor muscle in specimen measure: Resection Margin measure: Intra-operative bladder perforation event measure: Post-operative complications measure: Need of bladder irrigation measure: Residual tumour or upstaging of tumour after second look TURBT sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06281067 id: 271.673 briefTitle: Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine acronym: RIALTO PRO overallStatus: RECRUITING date: 2023-12-15 date: 2026-01-01 date: 2026-01-01 date: 2024-02-28 date: 2024-02-28 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER name: Università degli Studi del Piemonte Orientale "Amedeo Avogadro" briefSummary: The "RIALTO-PRO" study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge (MB) patients, testing the diagnostic value of a full invasive diagnostic procedure, and, consequently, the prognostic value of a tailored approach. the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB.

The "RIALTO PRO" study is a randomized, multicentre, prospective, open-label, superiority trial comparing a personalised versus standard management in patients with MB. Consenting and eligible patients will be randomised 1:1 to either a "full-physiology approach", consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment, or a "standard approach", consisting of angiographic evaluation of the tunnelled segment. conditions: Myocardial Bridge studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 500 type: ESTIMATED name: "full-physiology approach" arm name: "standard approach" arm measure: The composite of significant angina and MACE measure: Rate of patients with significant angina (SAQ Angina Summary Score ≤ 70) measure: Incidence of MACE measure: Rate of cardiac death measure: Rate of MI measure: Rate of cardiac hospitalization measure: Rate of TLR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Generale Regionale F. Miulli status: NOT_YET_RECRUITING city: Acquaviva Delle Fonti country: Italy lat: 40.89704 lon: 16.8433 facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo status: NOT_YET_RECRUITING city: Alessandria country: Italy lat: 44.90924 lon: 8.61007 facility: Ospedale San Donato status: NOT_YET_RECRUITING city: Arezzo country: Italy lat: 43.46276 lon: 11.88068 facility: ASST Papa Giovanni XXIII status: NOT_YET_RECRUITING city: Bergamo country: Italy lat: 45.69601 lon: 9.66721 facility: Ospedale degli Infermi di Biella status: NOT_YET_RECRUITING city: Biella country: Italy lat: 45.56304 lon: 8.05796 facility: Policlinico S. Orsola IRCCS Azienda Ospedaliero Universitaria status: NOT_YET_RECRUITING city: Bologna country: Italy lat: 44.49381 lon: 11.33875 facility: Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano status: NOT_YET_RECRUITING city: Caserta country: Italy lat: 41.07262 lon: 14.33231 facility: Villa Maria Cecilia Hospital status: NOT_YET_RECRUITING city: Cotignola country: Italy lat: 44.38572 lon: 11.93852 facility: Azienda Ospedaliero Universitaria di Ferrara status: NOT_YET_RECRUITING city: Ferrara country: Italy lat: 44.83804 lon: 11.62057 facility: Azienda Ospedaliero Universitaria Careggi status: NOT_YET_RECRUITING city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliera Universitaria Policlinico San Martino status: NOT_YET_RECRUITING city: Genova country: Italy lat: 44.40478 lon: 8.94438 facility: Ospedale Della Misericordia status: NOT_YET_RECRUITING city: Grosseto country: Italy lat: 42.76296 lon: 11.10941 facility: Centro Cardiologico Monzino IRCCS status: NOT_YET_RECRUITING city: Milano country: Italy lat: 45.46427 lon: 9.18951 facility: IRCCS Ospedale Galeazzi status: NOT_YET_RECRUITING city: Milano country: Italy lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS San Gerardo dei Tintori status: NOT_YET_RECRUITING city: Monza country: Italy lat: 45.58005 lon: 9.27246 facility: AOU Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Domenico D'Amario, Prof role: CONTACT phone: 0039 0321 3733141 email: domenico.damario@uniupo.it name: Domenico D'Amario, Prof role: PRINCIPAL_INVESTIGATOR name: Giuseppe Patti, Prof role: PRINCIPAL_INVESTIGATOR lat: 45.44694 lon: 8.62118 facility: Azienda Ospedaliero Universitaria di Parma status: NOT_YET_RECRUITING city: Parma country: Italy lat: 44.79935 lon: 10.32618 facility: Azienda Ospedaliera di Perugia status: NOT_YET_RECRUITING city: Perugia country: Italy lat: 43.1122 lon: 12.38878 facility: Azienda Ospedaliero Universitaria Pisana status: NOT_YET_RECRUITING city: Pisa country: Italy lat: 43.70853 lon: 10.4036 facility: Ospedale San Jacopo status: NOT_YET_RECRUITING city: Pistoia country: Italy lat: 43.93064 lon: 10.92365 facility: Ospedali Riuniti di Rivoli status: NOT_YET_RECRUITING city: Rivoli country: Italy lat: 45.07073 lon: 7.51465 facility: Aurelia Hospital status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliera San Camillo-Forlanini status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero Universitaria Sant'Andrea status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale Sandro Pertini status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale Santo Spirito status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Policlinico Universitario Tor Vergata Fondazione PTV status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale Civile Santissima Annunziata status: NOT_YET_RECRUITING city: Sassari country: Italy lat: 40.72586 lon: 8.55552 facility: Azienda Sanitaria Provinciale di Siracusa status: NOT_YET_RECRUITING city: Siracusa country: Italy lat: 37.08415 lon: 15.27628 facility: Azienda Ospedaliera Ordine Mauriziano status: NOT_YET_RECRUITING city: Torino country: Italy lat: 45.07049 lon: 7.68682 facility: Azienda Ospedaliero Universitaria Città Della Salute E Scienza status: NOT_YET_RECRUITING city: Torino country: Italy lat: 45.07049 lon: 7.68682 facility: Presidio Ospedaliero Sant'Andrea status: NOT_YET_RECRUITING city: Vercelli country: Italy lat: 45.32163 lon: 8.41989 facility: Azienda Ospedaliera Universitaria Integrata, Ospedale Borgo Trento status: NOT_YET_RECRUITING city: Verona country: Italy lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06281054 id: SMC2023-12-027 briefTitle: Acute Myocardial Infarction in Cancer Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2002-01-01 date: 2021-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Samsung Medical Center class: OTHER name: Chonnam National University briefSummary: Using national health insurance service database, current study aim to evaluate the risk and prognosis of acute myocardial infarction in cancer patients and to find the optimal treatment strategy for acute myocardial infarction that can improve long-term prognosis. conditions: Acute Myocardial Infarction conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 4500000 type: ESTIMATED name: Revascularization measure: All-cause death measure: Myocardial infarction measure: Revascularization measure: Hospitalization for heart failure measure: Stroke measure: Clinically relevant bleeding sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chonnam National University Hospital, Chonnam National University Medical School city: Gwangju country: Korea, Republic of lat: 35.15472 lon: 126.91556 hasResults: False

 nctId: NCT06281041 id: NHIS20240220 briefTitle: Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention acronym: NHIS overallStatus: ACTIVE_NOT_RECRUITING date: 2013-01-01 date: 2020-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Samsung Medical Center class: OTHER name: Chonnam National University briefSummary: There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR).

Current nationwide cohort study conducted using Korean National Health Insurance Service database evaluated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis with deferred revascularization based on negative FFR (FFR\>0.80). conditions: Coronary Artery Disease conditions: Coronary Artery Stenosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4657 type: ACTUAL name: Antiplatelet Agents measure: Major adverse cardiac and cerebrovascular events measure: Gastrointestinal bleeding measure: All-cause death measure: Myocardial infarction measure: Unplanned revascularization measure: Stroke measure: Major bleeding measure: Gastrointestinal bleeding necessitated hospitalization without documented transfusion measure: Intracranial hemorrhage sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chonnam National University Medical School city: Gwangju country: Korea, Republic of lat: 35.15472 lon: 126.91556 hasResults: False

 nctId: NCT06281028 id: 2023-A02280-45 briefTitle: SOLACEA-H in Heparin-sparing Haemodialysis acronym: SOLHEPA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: The aim of the study is to evaluate the efficacy of the SOLACEA-H dialyser, particularly in patients at high risk of haemorrhage, during post-dilution haemodiafiltration sessions with complete or partial heparin sparing. It will be compared with another dialyser (HYDROLINK-NVU) conditions: Dialysis Membrane Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective, multicenter, randomized primaryPurpose: TREATMENT masking: NONE count: 19 type: ESTIMATED name: SOLACEA-H/HYDROLINK-NVU name: HYDROLINK-NVU/SOLACEA-H measure: SOLACEA-H vs HYDROLINK-NVU efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Privé La Louvière city: Lille zip: 59800 country: France name: Maxime HOFFMANN, MD role: CONTACT phone: 6 86 70 91 23 phoneExt: +33 email: maxime.hoffmann@gmail.com lat: 50.63297 lon: 3.05858 hasResults: False

 nctId: NCT06281015 id: 2023PI095-407 briefTitle: Artificial Intelligence and Bone Tomoscintigraphies Achieved With CZT Camera acronym: IATOS overallStatus: COMPLETED date: 2023-08-30 date: 2023-09-10 date: 2023-10-30 date: 2024-02-28 date: 2024-02-28 name: Central Hospital, Nancy, France class: OTHER briefSummary: This study aimed to determine whether the whole-body bone Single Photon Emission Computed Tomography (SPECT) recording times of around 10 minutes, routinely provided by a high-sensitivity 360 degrees cadmium and zinc telluride (CZT) camera, can be further reduced by a deep learning noise reduction (DLNR) algorithm. conditions: Bone Lesion studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 19 type: ACTUAL name: Whole-body bone single photon emission tomography (SPECT) for detection or follow-up of bone metastasis measure: Assess a dedicated deep learning noise reduction algorithm sex: ALL minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU Nancy city: Vandoeuvre les Nancy cedex zip: 54511 country: France lat: 48.65 lon: 6.18333 hasResults: False

 nctId: NCT06281002 id: FDASU-RecIM112323 briefTitle: Trueness of Full Arch Scans and Generated Digital Implant Models overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-12 date: 2024-02-28 date: 2024-03-06 name: Ain Shams University class: OTHER briefSummary: The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible. conditions: Denture conditions: Complete Edentulism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 9 type: ESTIMATED name: conventional impression stone casts digitization name: digital scanning with coupled scanning aiding device name: Digital Implant Model assessment of accuracy measure: Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies. measure: Trueness of the generated 3D-printed digital implant models. sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06280989 id: P.T.REC/012/004768 briefTitle: Effect of Kinesio Taping Versus Myofascial Release on Menstrual Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-07 date: 2024-08 date: 2024-02-28 date: 2024-02-29 name: Cairo University class: OTHER briefSummary: the aim of this study is to investigate the efficacy of kinesio taping versus myofascial release technique on menstrual low back pain in young females conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: kinesio taping and myofascial release technique primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: kinesio taping name: myofascial release technique measure: pain intensity measure: pain pressure threshold measure: severity of dysmenorrhea measure: Assess the function disability level sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Hala mohamed ahmed morsy city: Giza zip: 12511 country: Egypt name: hala ma morsy, Bachelor role: CONTACT phone: 00201028616865 email: halamohamed8.11.2018@gmail.com lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06280976 id: 23.0001 briefTitle: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) acronym: ARTCAP overallStatus: RECRUITING date: 2024-03-01 date: 2029-01-31 date: 2029-01-31 date: 2024-02-28 date: 2024-04-25 name: University of Louisville class: OTHER briefSummary: The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat. conditions: Coronary Artery Disease conditions: Atherosclerosis conditions: Heart Attack studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PROBE design: Prospective Randomized Open Label Blinded End-point primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Statin name: Aspirin tablet name: Nexlizet name: LEQVIO name: Vascepa name: Jardiance name: Colchicine measure: Plaque quantification measure: Characterization of plaque to evaluate for high-risk features - positive remodeling measure: Quantification of stenosis measure: Quantification of pericoronary fat attenuation. measure: Characterization of plaque to evaluate for high-risk features - low CT attenuation measure: Characterization of plaque to evaluate for high-risk features - napkin-ring sign measure: Quantification of epicardial fat attenuation. measure: Major adverse cardiac and cardiovascular events (MACCE) measure: Polygenic risk score (PRS) measure: Next generation sequencing (NGS) measure: Change in Lipoprotein (a) measure: Change in myeloperoxidase (MPO) activity measure: Change in trimethylamine-N-oxide (TMAO) levels measure: Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels measure: Change in interleukin-6 (IL-6) levels measure: Change in high sensitivity C-creative protein (HS-CRP) levels measure: Buffy coat for chromatin immunoprecipitation (ChIP) measure: Change in high sensitivity Troponin (HS-Tn) measure: Change in natriuretic peptide (BNP, NT-pro BNP measure: Change in levels of open reading frame 1 protein (ORF1p) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases status: RECRUITING 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: Muhammad Umer, MD role: CONTACT phone: 502-588-7010 email: muhammad.umer.1@louisville.edu lat: 38.25424 lon: -85.75941 hasResults: False

 nctId: NCT06280963 id: 012/005532 briefTitle: Posterior Innominate Mobilization Versus Muscle Energy Technique on Lumbopelvic Angles in Sacroiliac Joint Dysfunction acronym: MET overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-01 date: 2024-08-03 date: 2024-02-28 date: 2024-02-28 name: Mahmoud Yousry Rashwan Hefny class: OTHER briefSummary: the goal of this clinical trial study is to compare between posterior innominate mobilization and muscle energy techniqueon lumbopelvic angles in sacroiliac joint dysfunction patients.

the main questions they aim to answer are

1. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on lumbopelvic angles in sacroiliac joint dysfunction patients ?
2. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on pain intensity level in sacroiliac joint dysfunction patients ?

   * purpose of the study is to measure the effect of muscle energy technique versus posterior innominate mobilization on lumbopelvic angles in sacroiliac joint dysfunction conditions: Sacroiliac Joint Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: group one will receive muscle energy technique group two will receive posterior innominate mobilization group three will receive conventional treatment ( TENS , US , stertching exercises and strenghening exercises ) primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: muscle energy technique name: posterior innominate mobilization name: conventional treatment measure: lumbopelvic angles measure: pain intensity sex: ALL minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Dokki state: Giza zip: 12612 country: Egypt name: Haytham M Elhafez, PhD role: CONTACT phone: +201001909630 email: elhafez@yahoo.com lat: 30.03823 lon: 31.2113 hasResults: False

 nctId: NCT06280950 id: DAIT CTOT-43 briefTitle: Expanding Liver Transplant Immunosuppression Minimization Via Everolimus acronym: ELIMINATE overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2027-06-01 date: 2029-06-01 date: 2024-02-28 date: 2024-02-28 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months. conditions: Liver Transplant studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 340 type: ESTIMATED name: Everolimus name: Tacrolimus (continued reduction) name: Tacrolimus (maintain 50% reduction) name: Everolimus measure: Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2 measure: Proportion of subjects with treated Biopsy Proven Acute Rejection (tBPAR) per local pathology. Between cohorts INT-1 and INT-2 measure: Percent change in Estimated Glomerular Filtration Rate (eGFR) in Renal function measure: Percentage of subjects with treated Biopsy Proven Acute Rejection (tBPAR) in Liver Function measure: Changes in liver graft function: Total bilirubin measure: Changes in liver graft function: Direct bilirubin measure: Changes in liver graft function: Alanine Aminotransaminase (ALT) measure: Changes in liver graft function: Aspartate Aminotransferase (AST) measure: Changes in liver graft function: Alkaline Phosphatase measure: Time to graft failure in liver function defined as relisting for transplantation, re-transplantation itself or death with failed graft measure: Time to all-cause mortality measure: Proportion of subjects experiencing a Major Adverse Cardiac Event (MACE) measure: Proportion of subjects experiencing infection requiring hospitalization measure: Proportion of subjects experiencing any malignancy measure: Proportion of subjects developing severe Estimated Glomerular Filtration Rate (eGFR) deterioration >40 percent from baseline using the CKD-EPI 2021 equation measure: Proportion of subjects developing any major immunosuppressive therapy complications measure: Proportion of subjects developing new onset peripheral edema measure: Proportion of subjects developing new onset cytopenia deemed WBC <3.0x10^9 /L, Hb <8.0 g/dL, or platelets <50 x 10^9/L. measure: Proportion of subjects developing new onset oral/gastrointestinal ulcerations measure: Proportion of subjects developing new onset gastrointestinal symptoms (nausea, vomiting, abdominal pain, or diarrhea) related to everolimus therapy. measure: Proportion of subjects developing new onset pneumonitis measure: Proportion of subjects developing new onset hepatic artery thrombosis measure: Proportion of subjects developing other adverse events deemed measure: Proportion of subjects developing any adverse events related to everolimus therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Hospital Arizona (Site #: 71144) city: Phoenix state: Arizona zip: 85054 country: United States name: Hugo Vargas, MD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: University of California, San Francisco (Site #: 71108) city: San Francisco state: California zip: 94143 country: United States name: Joanna Kwan role: CONTACT phone: 415-476-2574 email: joanne.kwan@ucsf.edu name: Sandy Feng, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Northwestern University (Site #: 71110) city: Chicago state: Illinois zip: 60611 country: United States name: Dania Jahangir role: CONTACT email: dania.jahangir@northwestern.edu name: Justin Boike, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Icahn School of Medicine at Mount Sinai (Site #: 71115) city: New York state: New York zip: 10029 country: United States name: Bharathi Ramesh role: CONTACT email: Bharathi.ramesh@mountsinai.org name: Thomas Schiano, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Duke University Medical Center (Site #: 71139) city: Durham state: North Carolina zip: 27710 country: United States name: Linda Perry role: CONTACT email: linda.perry@duke.edu name: Carl Berg, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 facility: University of Pennsylvania (Site #: 71111) city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Lexi Tumblety role: CONTACT phone: 267-441-1800 email: lexi.tumblety@pennmedicine.upenn.edu name: Abraham Shaked, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: University of Pittsburgh Medical Center (Site #: 71162) city: Pittsburgh state: Pennsylvania zip: 15260 country: United States name: Lois Kipling role: CONTACT email: kniplingle@upmc.edu name: Scott Biggins, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: Baylor Medical Center (Site #: 71153) city: Dallas state: Texas zip: 75246 country: United States name: Angela Roy role: CONTACT email: angela.roy@baylorhealth.edu name: Sumeet Asrani, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06280937 id: BEUFTR-2 briefTitle: Short Term Effect of Wearing a Tie overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-10-01 date: 2024-02-28 date: 2024-02-28 name: Bitlis Eren University class: OTHER briefSummary: The goal of this randomized controlled study is to assess the short term effect of wearing a ties on musculoskeletal system. In this scope viscoelastic properties and the mechanosensitivity of the muscles, and cervical range of motion will be measured. In addition to these measurements activity limitation due to wearing a tie and trunk mobility will be assessed. conditions: Musculoskeletal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control group will go on their routine daily activities. Study group will wear a tie during one office working day. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Interventions and assessment will be performed by separate researchers. whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Wearing a tie measure: The Change in the Viscoelastic Properties of the Muscles measure: The Change in the Pressure Pain Threshold of the Spine and Upper Trapezius measure: Cervical Range of Motion measure: Activity Limitation measure: Global Rating of Change measure: Trunk Forward Bending Mobility measure: Trunk Lateral Bending Mobility measure: Neck Circumference sex: MALE 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: NCT06280924 id: HREBA.CC-23-0220 briefTitle: Prehab Prior to Stem Cell Transplantation in Multiple Myeloma acronym: MOTIVATE overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-31 date: 2026-06-30 date: 2024-02-28 date: 2024-02-28 name: University of Alberta class: OTHER briefSummary: The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy. conditions: Multiple Myeloma conditions: Exercise conditions: Prehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: An independent assessor will conduct the post-intervention assessment. The independent assessor will be blinded to group assignment. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Supported Exercise name: Standard Care measure: Study completion rate measure: Recruitment rate measure: Attendance rate measure: Edmonton Symptom Assessment System measure: Functional Assessment of Cancer Therapy Multiple Myeloma measure: Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item) measure: Body weight measure: Body height measure: Grip Strength measure: Calf muscle size measure: Thigh muscle thickness measure: Short Physical Performance Battery measure: Six-minute walk test measure: One leg stance balance measure: Shoulder flexion range of motion measure: Sit and reach test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alberta/ Cross Cancer Institute city: Edmonton state: Alberta zip: T6G 2G4 country: Canada lat: 53.55014 lon: -113.46871 hasResults: False

 nctId: NCT06280911 id: 098 briefTitle: The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy overallStatus: COMPLETED date: 2013-10-10 date: 2014-06-30 date: 2017-12-30 date: 2024-02-28 date: 2024-03-04 name: Selcuk University class: OTHER briefSummary: The study was conducted to determine the effect of consumption of date fruit and nipple stimulation on labor.

The samples were applied to pregnant women satisfying the research criteria in a state hospital in Istanbul between October 2013 and June 2014. conditions: Augmentation conditions: Induction conditions: Labor conditions: Stimulation, Self studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was designed to be randomly controlled. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 198 type: ACTUAL name: Date Fruit group name: Nipple group measure: The spontaneous onset of labor measure: Induction and augmentation of labor measure: Mode of delivery sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Zeynep Kamil Women's and Children's Diseases Training and Research Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06280898 id: KC22RISI0395 briefTitle: Perioperative Factors and Early Postoperative Kidney Graft Function Recovery overallStatus: COMPLETED date: 2020-05-01 date: 2022-03-14 date: 2022-03-14 date: 2024-02-28 date: 2024-02-29 name: Seoul St. Mary's Hospital class: OTHER briefSummary: Divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. Acute kidney injury group, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), or Kidney Disease: Improving Global Outcomes (KDIGO) I would like to divide it according to the definition. After testing the normal distribution of patients, donors, grafts, types of immunosuppressants, surgery/anesthesia factors, and blood test findings between the two groups through the Shapiro-Wilk test, continuous data was tested using the student t-test or Mann-Whitney U test. Sizes are compared using , and categorical data is compared with proportions using the χ2 test or Fisher's exact test. Analysis of factors related to acute kidney injury will be performed through univariate and multivariate logistic regression analysis. conditions: Heart Injuries conditions: Kidney Transplant; Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 539 type: ACTUAL name: Remote ischemic conditioning measure: Troponin I measure: Troponin T measure: QTc interval sex: ALL minimumAge: 19 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul St. Mary's hospital city: Seoul zip: 06591 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06280885 id: FIERCE briefTitle: A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy acronym: FIERCE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2026-03-31 date: 2024-02-28 date: 2024-02-28 name: University of Dublin, Trinity College class: OTHER name: St. James's Hospital, Ireland briefSummary: The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Feasibility randomised controlled trial using a 2:1 randomisation primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Not indicated for this feasibility study. count: 50 type: ESTIMATED name: Exercise name: Health Behaviour Change (Pedometer) measure: Feasibility: Recruitment rates measure: Feasibility: Adherence rates measure: Feasibility: Attendance rates measure: Feasibility: Retention Rates measure: Feasibility: Reason for drop0out measure: Cardiorespiratory Fitness measure: Muscular Strength measure: Body Mass Index measure: Mid-arm circumference measure: Waist Circumference measure: Bioimpedance Analysis measure: Health Related Quality of Life measure: Fatigue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St James's Hospital city: Dublin zip: 8 country: Ireland lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06280872 id: P2023/Neonat/PhyCordPrem briefTitle: Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns acronym: PhyCordPrem overallStatus: RECRUITING date: 2024-02-19 date: 2026-01 date: 2026-07 date: 2024-02-28 date: 2024-03-05 name: Queen Fabiola Children's University Hospital class: OTHER name: The Belgian Kids Fund name: Fonds IRIS-Recherche name: Ars Statistica briefSummary: Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way.

A baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother. conditions: Premature Birth conditions: Respiratory Distress Syndrome in Premature Infant conditions: Sepsis conditions: Intraventricular Hemorrhage of Prematurity conditions: Bronchodysplasia conditions: Jaundice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Physiological Based Cord Clamping name: Differed Cord Clamping measure: Duration of non-invasive or invasive respiratory support. measure: Rate of neonatal mortality measure: Rate of neonatal resuscitation measure: Rate of neonatal respiratory morbidity measure: Number of admission to the NICU or special care baby unit measure: Length of hospitalization measure: Gestational age corrected at discharge measure: Changes in physiological variables during neonatal transition measure: Early neonatal parameters measure: Hemoglobin level measure: Bilirubin level measure: Occurrence of Neonatal adverse events measure: Biological markers of oxidative stress measure: Maternal perioperative parameters measure: Maternal postoperative hemoglobin level measure: Number of maternal adverse events measure: Maternal-infant bonding measure: Maternal-infant bonding measure: Maternal-infant bonding measure: Rate of Maternal-infant bonding measure: Rate of Maternal-infant bonding measure: Rate of Maternal-infant bonding measure: Maternal-infant bonding measure: Parental satisfaction survey measure: Child development assessment measure: Success of PBCC sex: ALL minimumAge: 32 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: CHU Brugmann status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Andrew CARLIN role: CONTACT phone: +3224773295 email: andrew.carlin@chu-brugmann.be name: Andrew CARLIN, MD role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Hôpital Universitaire Des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Anna AMORUSO, MD role: CONTACT phone: +3224773250 email: anna.amoruso@hubruxelles.be name: Anna AMORUSO role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06280859 id: 18784 briefTitle: Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-20 date: 2024-05-30 date: 2024-06-10 date: 2024-02-28 date: 2024-03-15 name: Indiana University class: OTHER name: United States Department of Agriculture (USDA) briefSummary: The clinical trial aims to develop and pilot test a multilevel physical activity (PA) intervention called the Hoosier Sport program. The study follows a participatory co-design protocol involving youth, parents, and community leaders to provide direct input into the intervention's design. The ultimate goal is to contribute to health equity in the community by promoting sustainable physical activity. Hoosier Sport involves delivering enhanced physical education classes, teaching about nutrition and exercise, as well as developing leadership skills in middle school rural students.The intervention will last for 8-weeks with PE classes occur twice a week. Additionally, Hoosier Sport will create more opportunities for students to be active at school (e.g., in home room) through providing virtual classes and other activities. conditions: Cardiovascular Diseases conditions: Sedentary Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Students enrolled in physical education (PE) class will be eligible to enroll in the study, and serve as the intervention group. Those not enrolled in PE that semester will be recruited as the control group. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 34 type: ACTUAL name: Hoosier Sport measure: Feasibility of Intervention Measure (FIM) measure: Acceptability of Intervention Measure (IAM) measure: Intervention Appropriateness Measure (AIM) measure: Daily Steps of Participants measure: Daily Moderate to Vigorous Physical Activity of Participants measure: Heart Rate of Participants measure: Blood Pressure of Participants measure: Basic Psychological Needs of Participants in Intervention Environment measure: Physical Literacy of Participants measure: Cardiovascular Fitness Levels of Participants measure: Muscular Endurance Levels of Participants measure: Self-Reported Weekly Moderate to Vigorous Physical Activity of Participants measure: Nutrition Knowledge of Participants measure: Policy, Systems, and Environmental Factors Influencing Participant Physical Activity and Nutrition Behavior. sex: ALL minimumAge: 9 Years maximumAge: 15 Years stdAges: CHILD facility: Indiana University city: Bloomington state: Indiana zip: 47405 country: United States lat: 39.16533 lon: -86.52639 hasResults: False

 nctId: NCT06280846 id: P.T.REC/012/004878 briefTitle: High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain overallStatus: RECRUITING date: 2024-03-15 date: 2024-10-30 date: 2024-10-30 date: 2024-02-28 date: 2024-04-26 name: Cairo University class: OTHER name: King Khalid University briefSummary: The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture versus low intensity laser acupuncture on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and function in patients with chronic nonspecific low back pain (CNLBP). conditions: Chronic Nonspecific Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: high-intensity laser acupuncture, low-intensity laser acupuncture and exercise therapy program primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: random generator whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: high-intensity laser acupuncture and Exercise therapy program name: low-intensity laser acupuncture and Exercise therapy program name: Sham laser acupuncture measure: peak torque measure: peak torque measure: Fatigue measure: Fatigue measure: Pain Intensity measure: Pain Intensity measure: lumbar flexion ROM assessment measure: lumbar flexion ROM assessment measure: Disability measure: Disability sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Doaa Ayoub Elimy status: RECRUITING city: Giza zip: 11251 country: Egypt name: Doaa A Elimy, lecturer role: CONTACT phone: 00201066474654 email: do3aayoub25@gmail.com lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06280833 id: 10001884 id: 001884-HG briefTitle: Care Choreographies and the Making of the Psychosocial in Genetic Counseling overallStatus: RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-28 date: 2024-04-26 name: National Human Genome Research Institute (NHGRI) class: NIH briefSummary: Background:

Genetic counselors play a new and evolving role in medical care. Recent advances in genetic testing are changing many health care treatments, and genetic counselors play a key role in teaching people how their genes may affect both health and treatments. Genetic counselors may also help guide people through complex talks about their treatment risks; their chances for recovery; and their social and emotional health and wellbeing. Researchers want to learn more about the role genetic counselors play in health care.

Objective:

To observe how genetic counselors at NIH manage the social and psychological aspects of patient care.

Eligibility:

Genetic counselors who work at NIH. People aged 18 years or older who are scheduled to meet with one of these counselors are also needed.

Design:

An investigator will sit in on the session between the counselor and the participant. The investigator will take notes. The session will not be recorded. The investigator will leave at any point if asked.

The investigator will focus on talk about social and psychological care. That person will also listen to talk about risk; diagnosis; odds of recovery; and hope, grief, and loss. That person will note strategies that help the participant manage their emotions and how they perceive their risks.

Counselors may later have a 1-hour interview with the investigator. They will answer questions about their experiences as a care provider at NIH.

Participants will have only 1 session with the investigator. Counselors may have 4 to 10 sessions with an investigator over 8 months. conditions: Genetic Counselor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED measure: Care sex: ALL minimumAge: 18 Years maximumAge: 115 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Human Genome Research Institute (NHGRI) status: RECRUITING city: Bethesda state: Maryland zip: 20892 country: United States name: Sara Hull, Ph.D. role: CONTACT phone: 301-435-8712 email: shull@nhgri.nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06280820 id: 10001889 id: 001889-H briefTitle: Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-04-30 date: 2034-04-30 date: 2024-02-28 date: 2024-04-26 name: National Heart, Lung, and Blood Institute (NHLBI) class: NIH briefSummary: Background:

More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF.

Objective:

To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time.

Eligibility:

People aged 18 years and older with heart failure.

Design:

Participants will be asked to join the study based on a review of their medical records.

They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein.

Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA.

Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation.

Researchers will follow the participants health by monitoring their medical records for up to 5 years. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: To study the association between multi-omics signatures with all-cause mortality measure: Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50)NYHA (3-4 vs. 1-2) measure: To study the cross-sectional association between multi-omics signatures with clinical sub-phenotypes of heart failure sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Heart, Lung and Blood Institute (NHLBI) city: Bethesda state: Maryland zip: 20892 country: United States name: Veronique Roger, M.D. role: CONTACT phone: 301-402-1715 email: veronique.roger@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06280807 id: 10001617 id: 001617-E briefTitle: Observation of Environment and Reproductive-Endocrine Effects overallStatus: RECRUITING date: 2024-05-01 date: 2039-03-28 date: 2039-03-31 date: 2024-02-28 date: 2024-04-26 name: National Institute of Environmental Health Sciences (NIEHS) class: NIH briefSummary: Background:

Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems.

Objective:

To learn how environmental factors may affect the endocrine and reproductive systems.

Eligibility:

Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders.

Design:

Adult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours.

Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis.

Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include:

Body composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume.

Resting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest.

... conditions: Hypogonadism conditions: Hypergonadism conditions: Precocious Puberty conditions: Late Puberty conditions: Amenorrhea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology. measure: the relationship between nutrition, diet and reproduction measure: the impact of stress on reproductive dysfunction measure: the influence of behavioral and psychological factors on reproductive function sex: ALL minimumAge: 8 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: NIEHS Clinical Research Unit (CRU) status: RECRUITING city: Research Triangle Park state: North Carolina zip: 27709 country: United States name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: 800-411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov name: NIEHS Join A Study Recruitment Group role: CONTACT phone: (855) 696-4347 email: myniehs@nih.gov lat: 35.90567 lon: -78.90497 hasResults: False

 nctId: NCT06280794 id: Laser-Bell-2024 briefTitle: Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy overallStatus: COMPLETED date: 2022-03-01 date: 2024-01-01 date: 2024-02-01 date: 2024-02-28 date: 2024-03-29 name: Beijing Tongren Hospital class: OTHER briefSummary: Objective:

Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy in 8 weeks.

Methods:

This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Betahistine Mesylate tablet, Vitamin B1 tablet and Prednisolone.

Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).

Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24. conditions: Bell's Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 336 type: ACTUAL name: Laser acupuncture name: Steroids measure: House Brackmann Grading System (HB) measure: Sunnybrook Facial Grading Scale (SB Grading) measure: Facial Disability Index (FDI) measure: Facial Clinimetric Evaluation Scale (FaCE Scale) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing TongRen Hospital, Capital Medical University city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06280781 id: 22CX7971 id: NIHR152027 type: OTHER_GRANT domain: National Institute of Health Research - Health Technology Assessment briefTitle: Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance) acronym: IP9-ATLAS overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2029-06 date: 2032-06 date: 2024-02-28 date: 2024-02-28 name: Imperial College Healthcare NHS Trust class: OTHER name: East London NHS Foundation Trust name: King's College name: University College, London name: University of York name: University College London Hospitals briefSummary: The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.

Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?

Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories \[ no visible lesion, diffuse changes, discrete visible lesion\]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Current (NICE defined active surveillance):

PSA 3 monthly in year 1 and then 6 monthly with rectal exam annually. MRI will be carried out at 12 months (if not had one at diagnosis). A biopsy will be required if indicated due to changes in rectal exam or PSA.

Planned (Regular MRI based active surveillance):

Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI annually. All other patients will undergo PSA 6 monthly and MRI in years 1, 3 and 5. In all patients, a targeted biopsy will be carried out if the MRI PRECISE score is \>/=4. primaryPurpose: OTHER masking: NONE count: 1263 type: ESTIMATED name: MRI Scans measure: Biopsy measure: Staging measure: Cost-effectiveness measure: Biopsy Measurement measure: MRI & biopsy-related adverse events measure: Treatment measure: Compliance measure: EPIC Questionnaires measure: HADS Questionnaires measure: EQ-5D-5L Questionnaires sex: MALE 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: 2023-12-07 uploadDate: 2024-01-24T08:54 filename: Prot_SAP_000.pdf size: 1231033 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-07 uploadDate: 2024-01-24T09:01 filename: ICF_001.pdf size: 286927 hasResults: False

 nctId: NCT06280768 id: SHR-2004-102 briefTitle: Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Beijing Suncadia Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: SHR-2004 injection measure: Incidence and severity of adverse events (including bleeding events) measure: Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax) measure: Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC) measure: Pharmacokinetics of Dupilumab: Elimination half life (t1/2) measure: PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity measure: PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT) measure: Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004 sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280755 id: ICO-S-002 briefTitle: Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study. acronym: RECLAIM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-04 date: 2027-04 date: 2024-02-28 date: 2024-02-28 name: icometrix class: INDUSTRY name: Charite University, Berlin, Germany name: Ruhr University of Bochum name: Technische Universität Dresden name: University Hospital, Lille name: Casa di Cura IGEA name: General University Hospital, Prague name: Hoffmann-La Roche name: Bristol-Myers Squibb name: Imcyse SA name: AB Science name: Nocturne UG name: Aalto University briefSummary: The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression. conditions: Multiple Sclerosis conditions: NMO Spectrum Disorder conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease conditions: Radiologically Isolated Syndrome conditions: Clinically Isolated Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 7000 type: ESTIMATED measure: The number of patients from each institution who have contributed data to the database. measure: The number of patients from each institution whose data was mapped to the common data model of the harmonised database. measure: The number of patients from the control arms of clinical trials who have contributed data to the database. measure: The data completeness of each variable in the harmonised database. measure: The representativeness of the harmonised dataset for the MS patient population as evaluated by age range, gender balance, the distribution of country of residence, the distribution of race/ethnicity and the distribution of educational level measure: The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable. measure: The temporal uniformity of each institution's data over time as assessed by the number of changes to variables over time (addition of new variables or variables no longer being captured, alterations to how variables are captured). measure: The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable. measure: The presence of contextual information on standard data gathering and analysis processes of each institution measure: The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient. measure: The temporal uniformity of MRI data over time as assessed by the comparability of MRI scans and the average time between subsequent MRI assessments for each patient. measure: The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines. measure: The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis. measure: The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day. measure: The percentage of patients with a complete disease history available, from the date of diagnosis to the current day. measure: The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280742 id: APHP221366 briefTitle: Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study (INFLANET) acronym: INFLANET overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-03-01 date: 2026-03-01 date: 2024-02-28 date: 2024-04-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The Service Hospitalier Frédéric-Joliot (SHFJ) and Paris Brain Institute (ICM) groups have identified \[18F\]-DPA-714 as a promising second-generation TSPO tracer, a macromolecule overexpressed in neuroinflammatory conditions, for PET imaging. They have also developed a non-invasive quantification methodology, enabling the generation of individual neuroinflammation maps in MS patients. Recent findings from \[18F\]-DPA-714 PET imaging in MS patients revealed that most of the white matter lesions contained a smoldering component, even when considered inactive on MRI, and that their neuroinflammatory profiles were associated with longitudinal disability worsening. The Inflanet project aims to leverage a unique consortium comprising French radiochemists, radiopharmacists, nuclear medicine/neuroimaging experts, and MS neurologists to establish the first national network dedicated to \[18F\]-DPA-714 PET imaging in MS, so far limited to monocentric studies.

The objectives of the INFLANET project are (1) to conduct the first multicenter study assessing neuroinflammation in patients with active MS using \[18F\]DPA-714 PET tracer, and (2) to establish a methodology suitable for the quantification of multicenter PET data obtained with \[18F\]DPA-714. The INFLANET initiative aims to disseminate TSPO PET within the French MS research community, thereby opening the unique perspective of future large-scale, multicenter studies. These endeavors are expected to enhance our capacity to predict diseases, stratify patients, and assess new therapeutic interventions. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 41 type: ESTIMATED name: PET-MRI with [18F]-DPA-714 measure: To quantify the smoldering component of white matter lesions in people with MS, as compared with [18F]-DPA-714 binding in the white matter of HC who underwent a PET a acquisition with the same camera camera than patients in each center. measure: To quantify for each patient the regional neuroinflammatory load, measured as [18F]-DPA-714 DVR, in specific regions of interest: total brain, normal appearing white matter, cortex, thalami, deep grey matter. measure: The MRI signatures of each lesional subtypes, and correlation between MRI metrics and [18F]-DPA-714 DVR in each region of interest. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Département de Neurologie,Pierre Wertheimer Neurological Hospital city: Lyon zip: 69500 country: France name: Françoise DURAND-DUBIEF, MD role: CONTACT phone: 04 72 35 75 22 phoneExt: +33 email: francoise.durand-dubief@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: CERMEP city: Lyon zip: 69677 country: France name: Françoise DURAND-DUBIEF, MD role: CONTACT phone: 04 72 35 75 22 phoneExt: +33 email: francoise.durand-dubief@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: CIC Neurosciences, GH Pitié-Salpêtrière city: Paris zip: 75013 country: France name: Bruno Stankoff, MD role: CONTACT phone: 0171970659 phoneExt: +33 email: bruno.stankoff@aphp.fr lat: 48.85341 lon: 2.3488 facility: Centre Eugène Marquis city: Rennes zip: 35000 country: France name: Xavier Palard, MD role: CONTACT phone: 02 99 25 30 83 phoneExt: +33 email: x.palard@rennes.unicancer.fr lat: 48.11198 lon: -1.67429 facility: Service de Neurologie, CHU Pontchaillou city: Rennes zip: 35000 country: France name: Anne Kerbrat, MD role: CONTACT phone: 02 99 28 42 94 phoneExt: +33 email: anne.kerbrat@chu-rennes.fr lat: 48.11198 lon: -1.67429 hasResults: False

 nctId: NCT06280729 id: AI-TRYDIA briefTitle: AI-Predicted Disease Trajectories in Diabetes: A Retrospective Study acronym: AI-TRYDIA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-01 date: 2024-02-28 date: 2024-02-28 name: IRCCS San Raffaele class: OTHER briefSummary: The study explores the utilization of artificial intelligence (AI) to predict disease progression trajectories in patients with diabetes. By analyzing historical data from a retrospective cohort, we aim to identify patterns and predictors of disease evolution. The approach seeks to enhance personalized treatment strategies and improve outcomes by foreseeing potential complications and disease milestones. The findings could pave the way for more targeted and effective management of diabetes through AI-driven insights. conditions: Diabetes Mellitus, Type 1 conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED name: AI-Analyis measure: Primary Endpoint measure: Primary Endpoint measure: Primary Endpoint measure: Exploratory Objectives sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Diabetes Research Institute-IRCCS Ospedale San Raffaele city: Milan state: Lombardy zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06280716 id: 18817 id: J2T-MC-KGBW type: OTHER domain: Eli Lilly and Company briefTitle: A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-12-17 date: 2026-11-04 date: 2024-02-28 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 430 type: ESTIMATED name: Placebo name: Lebrikizumab name: Topical Corticosteroid measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) at Week 16 for Mono Cohort measure: Percentage of Participants Achieving EASI-75 at Week 16 for Combo Cohort measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 for Combo Cohort measure: Percentage of Participants With a Itch Numerical Rating Scale (NRS) Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Combo Cohort measure: Percentage Change From Baseline in EASI Score at Week 16 for Combo Cohort measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort measure: Percentage of Participants Achieving EASI-90 at Week 16 for Mono Cohort measure: Percentage of Participants With a Itch NRS Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Mono Cohort measure: Percentage Change From Baseline in EASI Score at Week 16 for Mono Cohort sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Wannan Medical College Yijishan Hospital city: Wuhu state: Anhui zip: 241001 country: China name: Chao Ci role: PRINCIPAL_INVESTIGATOR lat: 31.33728 lon: 118.37351 facility: China-Japan Friendship Hospital city: Beijing state: Beijing zip: 100029 country: China name: Yong Cui role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100034 country: China name: Jianzhong Zhang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Children's hospital, Capital Medical University city: Beijing state: Beijing zip: 100045 country: China name: Zigang Xu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China name: Linfeng Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100091 country: China name: Wenhui Wang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Tongren Hospital affiliated to Capital Medical University city: Beijing state: Beijing zip: 100730 country: China name: Aihua Wei role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Tsinghua Changgung Hospital city: Beijing state: Beijing zip: 102202 country: China name: Yi Zhao role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: The Children's Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400065 country: China name: Hua Wang role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: Zhongshan Hospital Fudan University (Xiamen Branch) city: Xiamen state: Fujian zip: 361015 country: China name: Yi Wei role: PRINCIPAL_INVESTIGATOR lat: 24.47979 lon: 118.08187 facility: Guangdong Province Dermatology Hospital city: Guangzhou state: Guangdong zip: 510018 country: China name: Yunsheng Liang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital, Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510180 country: China name: Jiande han role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Shenzhen Children's Hospital city: Shenzhen state: Guangdong zip: 518026 country: China name: Ping Li role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: Peking University Shenzhen Hospital city: Shenzhen state: Guangdong zip: 518036 country: China name: Xia Dou role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: The University of Hong Kong-Shenzhen Hospital city: Shenzhen state: Guangdong zip: 518053 country: China name: zhenying zhang role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: Hainan General Hospital city: Haikou state: Hainan zip: 570311 country: China name: Ke Han role: PRINCIPAL_INVESTIGATOR lat: 20.04583 lon: 110.34167 facility: The First Hospital of Wuhan city: Wuhan state: Hubei zip: 430022 country: China name: Liuqing Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Wuhan Union Hospital city: Wuhan state: Hubei zip: 430022 country: China name: Nengxing Lin role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Renmin Hospital of Wuhan University city: Wuhan state: Hubei zip: 430060 country: China name: Tiechi Lei role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Hunan Children's Hospital city: Changsha state: Hunan zip: 410007 country: China name: Zhu Wei role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Su Juan role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: The Second Xiangya Hospital of Central South University city: Changsha state: Hunan zip: 410011 country: China name: Hai Long role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: Wuxi No.2 People's Hospital city: Wuxi state: Jiangsu zip: 214000 country: China name: Xunyi Dai role: PRINCIPAL_INVESTIGATOR lat: 31.56887 lon: 120.28857 facility: Affiliated Hospital of Jiangsu University city: Zhenjiang state: Jiangsu zip: 212000 country: China name: Yumei Li role: PRINCIPAL_INVESTIGATOR lat: 32.21086 lon: 119.45508 facility: The Second Hospital of Jilin University city: Changchun state: Jilin zip: 130000 country: China name: Fuqiu Li role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: The First Hospital of Jilin University city: Changchun state: Jilin zip: 130021 country: China name: Shanshan Li role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'An state: Shaanxi zip: 710004 country: China name: Songmei Geng role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 facility: Huashan Hospital Affiliated Fudan University city: Shanghai state: Shanghai zip: 200040 country: China name: Chaoying Gu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Shanghai Tenth People's Hospital city: Shanghai state: Shanghai zip: 200072 country: China name: Jun Gu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Children's Hospital of Shanxi city: Taiyuan state: Shanxi zip: 030013 country: China name: Xinglian Zhang role: PRINCIPAL_INVESTIGATOR lat: 37.86944 lon: 112.56028 facility: West China Hospital, Sichuan University city: Cheng Du state: Sichuan zip: 610041 country: China name: Xian Jiang role: PRINCIPAL_INVESTIGATOR facility: Kunming Children's hospital city: Kunming state: Yunnan zip: 650034 country: China name: Hong Shu role: PRINCIPAL_INVESTIGATOR lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital, Zhejiang University city: Hangzhou state: Zhejiang zip: 310003 country: China name: Jianjun Qiao role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Hangzhou Third People's Hospital city: Hangzhou state: Zhejiang zip: 310009 country: China name: Aie Xu role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital city: Hangzhou state: Zhejiang zip: 310016 country: China name: Hao Cheng role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Zhejiang University School of Medicine - The Fourth Affiliated Hospital city: Yiwu state: Zhejiang zip: 322000 country: China name: Lunfei Liu role: PRINCIPAL_INVESTIGATOR lat: 29.31506 lon: 120.07676 facility: The First Affiliated Hospital Of Fujian Medical University city: Fuzhou zip: 350005 country: China name: Chao JI role: PRINCIPAL_INVESTIGATOR lat: 26.06139 lon: 119.30611 facility: Shanghai Skin Disease Hospital city: Shanghai zip: 200071 country: China name: Yuling Shi role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: The First Hospital of Hebei Medical University city: Shijiazhuang zip: 050031 country: China name: Guoqiang Zhang role: PRINCIPAL_INVESTIGATOR lat: 38.04139 lon: 114.47861 facility: The Catholic University of Korea, Incheon St. Mary's Hospital city: Bupyeong-gu state: Incheon-gwangyeoksi [Incheon] zip: 21431 country: Korea, Republic of name: Sang-Hyun Cho role: PRINCIPAL_INVESTIGATOR facility: Korea University Ansan Hospital city: Ansan-si state: Kyǒnggi-do zip: 15355 country: Korea, Republic of name: Sang Wook Son role: PRINCIPAL_INVESTIGATOR lat: 37.32361 lon: 126.82194 facility: National Medical Center city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 01812 country: Korea, Republic of name: JiYoung Ahn role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Asan Medical Center city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 05505 country: Korea, Republic of name: Chong Hyun Won role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06280703 id: 18792 id: J4P-MC-IYAB type: OTHER domain: Eli Lilly and Company id: U1111-1301-8386 type: OTHER domain: Universal Trial Number id: 2023-510365-10-00 type: OTHER domain: EU Trial Number briefTitle: A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-02-17 date: 2025-02-17 date: 2024-02-28 date: 2024-03-06 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec.

The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected.

The study will be conducted in three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Deglude given via intravenous (IV) infusion.

The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period. conditions: Healthy conditions: Type 1 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Parallel (Part A) and Crossover design (Part B and Part C) primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Double-Blind (Part A) and Open-Label (Part B and Part C) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: LY3938577 name: Placebo name: Insulin Degludec name: Insulin Lispro measure: Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. measure: Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. measure: Part A: Number of Participants With Clinically Significant Changes in Vital Signs measure: Part B: Number of Participants With Clinically Significant Changes in Vital Signs measure: Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters measure: Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters measure: Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 measure: Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 measure: Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577 measure: Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577 measure: Part C: PK: Concentration of LY3938577 measure: Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577 measure: Part C: PD: Glucose infusion rate (GIR) of LY3938577 sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Profil Institut für Stoffwechselforschung city: Neuss state: Nordrhein-Westfalen zip: 41460 country: Germany role: CONTACT phone: +49 (0) 2131 4018 450 name: Oliver Klein role: PRINCIPAL_INVESTIGATOR lat: 51.19807 lon: 6.68504 hasResults: False

 nctId: NCT06280690 id: NL83765.058.23 briefTitle: SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia acronym: SGM-T1 overallStatus: RECRUITING date: 2024-01-31 date: 2025-04-30 date: 2025-07-30 date: 2024-02-28 date: 2024-02-29 name: Leiden University Medical Center class: OTHER briefSummary: This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101. conditions: Colorectal Cancer conditions: Image conditions: Low Grade Dysplasia of Colon studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a single center prospective, non-randomized phase 2 proof of concept study, on the performance of SGM-101 to discriminate T1RC/HGD from LGD in patients that will be scheduled for endoscopic local en-bloc resection in the Leiden University Medical Centre (LUMC). primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: SGM-101 measure: The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic). measure: - Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective) measure: - In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope. measure: - The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo measure: -The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo measure: - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3) measure: - The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leiden University Medical Center status: RECRUITING city: Leiden zip: 2333ZA country: Netherlands name: Mats Warmerdam, Msc role: CONTACT phone: +31715298420 email: m.i.warmerdam@lumc.nl lat: 52.15833 lon: 4.49306 hasResults: False

 nctId: NCT06280677 id: 2023.Aurora-Donor briefTitle: Aurora Test for ART Donor Patients (AURORA-Donor) overallStatus: RECRUITING date: 2024-02-16 date: 2025-04 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: Fertiga, Belgium class: INDUSTRY name: Fertilab name: Ferring Pharmaceuticals briefSummary: This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger. conditions: Infertility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: AURORA-Donor measure: Basic clinical donor patient and stimulation characteristics: P4 measure: Basic clinical donor patient and stimulation characteristics: E2 measure: Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose measure: Clinical evaluation: number of Follicles measure: Clinical evaluation: number of cumulus-oocyte complex measure: Clinical evaluation: Meiosis II oocytes measure: Clinical evaluation: Abnormal fertilization measure: Clinical evaluation: Normal Fertilization measure: Clinical evaluation: Day 3 embryo evaluation measure: Clinical evaluation: Day 5/6 embryo evaluation measure: Clinical evaluation: Day5/6 good quality blastocyst rate measure: Clinical evaluation: Embryo utilization measure: Expression profile: blastocyst formation measure: Biochemical pregnancy measure: Clinical pregnancy with positive fetal heartbeat measure: Expression profile: pregnancy prediction measure: Normalized messenger ribonucleic acid (mRNA) expression measure: Ongoing pregnancy rate measure: Live birth measure: Cumulative pregnancy measure: Cumulative live birth measure: Miscarriage rate sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fertilab status: RECRUITING city: Barcelona zip: 08017 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06280664 id: IRB20-1151 briefTitle: Efficacy Of Hiatal Closure For GERD overallStatus: RECRUITING date: 2020-10-02 date: 2024-10 date: 2024-10 date: 2024-02-28 date: 2024-02-28 name: University of Chicago class: OTHER briefSummary: The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD. conditions: Gastro Esophageal Reflux studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Concentration of pH testing sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Carlisa Dixon role: CONTACT phone: 773-834-4337 email: cdixon520@bsd.uchicago.edu name: Leila Yazdanbakhsh role: CONTACT phone: 773-834-5087 email: leila.yazdanbakhsh@bsd.uchicago.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06280651 id: RGP 2/348/44 id: RGP 2/348/44 type: OTHER_GRANT domain: kING kHALID UNIVERSITY briefTitle: Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis acronym: OHIDPAP-CS overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-04-30 date: 2024-05-15 date: 2024-02-28 date: 2024-03-15 name: King Khalid University class: OTHER briefSummary: The study aims to explore how dietary habits affect oral health in children with autism. By examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. This observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for children with autism. conditions: Dental Caries in Children conditions: Autistic Disorder conditions: Dietary Habits studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: dietary preferences and their implications for oral health in children with Autism Spectrum Disorder measure: Assess the association between oral hygiene and periodontal disease severity to identify potential implications of dietary preferences for oral health status sex: ALL minimumAge: 2 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06280638 id: 2023-2095 briefTitle: CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS) acronym: CT-COMPASS overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: China National Center for Cardiovascular Diseases class: OTHER_GOV briefSummary: A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique.

Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.

However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90). conditions: Percutaneous Coronary Intervention conditions: Coronary Physiology conditions: Computed Tomography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 280 type: ESTIMATED name: Virtual stent-guided incremental optimization strategy (VIOS) name: Standard angiographic strategy measure: The proportion of patients with a final post-PCI FFR result ≥0.90 measure: The proportion of patients with final post-PCI FFR ≤0.80 measure: The rate of target vessel failure (TVF) and its component features at 6 months. measure: The rate of target vessel failure (TVF) and its component features at 1 year. measure: Change from baseline in self-reported Health-related quality of life evaluation at 6 months. measure: Change from baseline in self-reported Health-related quality of life evaluation at 1 year. measure: Change from baseline in self-reported Angina status evaluation at 6 months. measure: Change from baseline in self-reported Angina status evaluation at 1 year. measure: Procedure Duration measure: Fluoroscopy Dose measure: Contrast Material Dose sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College city: Beijing state: Beijing zip: 100037 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06280625 id: 24388 briefTitle: The Effect of the Inclusion of Soybean Flour on Glycemic Responses overallStatus: RECRUITING date: 2024-03-01 date: 2025-02-28 date: 2025-03-25 date: 2024-02-28 date: 2024-02-28 name: University of Illinois at Urbana-Champaign class: OTHER name: Kenneth Dallmier Consulting, LLC briefSummary: Foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. High glycemic index foods are also linked to an increased risk of developing diabetes. The partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety.

In many regions of Latin America, as well as in the Middle East and North Africa (MENA) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. Bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. The results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: People will be evaluated with a food product prepared with different % of replacement of wheat flour for soy flour. Each person will be their own control. In other words, in randomized order, they will all be assessed with the food product prepared with the regular wheat flour (either bread, tortillas or arepas) and on two other visits with different percentages of soy flour. primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will be given the food product without information on whether it is prepared 100% with wheat flour or with different soy flour %. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Replacement of wheat flour by soyflour measure: Plasma glucose measure: Plasma insulin measure: Hunger-Satiety sex: ALL minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT facility: University of Illinois at Urbana Champaign status: RECRUITING city: Champaign state: Illinois zip: 61820 country: United States name: Marta Y Pepino, MSc, RD role: CONTACT phone: 217-300-2374 email: ypepino@illinois.edu name: Stephanie Okoye, Pharm D role: CONTACT phone: 2173004709 email: siokoye2@illinois.edu lat: 40.11642 lon: -88.24338 hasResults: False

 nctId: NCT06280612 id: RCS10042023 briefTitle: The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients overallStatus: COMPLETED date: 2023-06-01 date: 2023-07-15 date: 2023-09-01 date: 2024-02-28 date: 2024-03-01 name: Karadeniz Technical University class: OTHER briefSummary: It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined. conditions: Therapy-Associated Cancer conditions: Cancer Patient conditions: Happiness conditions: Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The sample number of the research was calculated in the G\*Power 3.1.9.6 program. While α=0.05 was the error amount, 0.628 was the effect size, and 0.90 (90%) was the targeted test power, it was calculated as 36 patients for three groups (living cat group, robotic cat group, control group). Since there was no previous study on the subject, a study examining happiness levels in a different sample group was used as a reference. Considering situations such as wanting to leave the study or death during the research, each group was increased by 25%, and a total of 45 patients, 15 patients for each group, were included in the study. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Since the possibility of patients being affected by each other was minimal, the study was continued with only one of the live cat groups, the simulation cat group, and the control group. For example, only the live cat group and those who received chemotherapy treatment were studied before Monday afternoon. whoMasked: PARTICIPANT count: 45 type: ACTUAL name: Pet therapy measure: Edmonton Symptom Diagnostic Scale measure: Oxford Happiness Scale Short Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gümüşhane University city: Gümüşhane zip: 29600 country: Turkey lat: 40.46001 lon: 39.47176 hasResults: False

 nctId: NCT06280599 id: SON KMU briefTitle: Transitional Care Model for Patients With Stroke overallStatus: RECRUITING date: 2023-09-01 date: 2024-04-01 date: 2024-04-29 date: 2024-02-28 date: 2024-04-03 name: Kaohsiung Medical University class: OTHER briefSummary: Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients were divided into two groups: intervention (n=40) and contrast (n=40). Both groups received post-stroke usual care. The intervention group received an 8-week transitional care model for stroke patients, which included comprehensive discharge planning and home follow-up primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Transitional care model measure: Self-efficacy measure: Activities of daily living measure: Instrumental activities of daily living measure: Depression symptoms measure: Quality of life in stroke patients sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RSUD Prof. Dr. W Z Johannes Kupang status: RECRUITING city: Kupang zip: 308 country: Indonesia name: Sakti Oktaria Batubara role: CONTACT email: oktariabatubara@gmail.com role: CONTACT phoneExt: Saragih email: itadaryanti05@gmail.com name: Ita Daryanti Saragih, Doctoral role: SUB_INVESTIGATOR lat: -10.17083 lon: 123.60694 hasResults: False

 nctId: NCT06280586 id: 44/21 briefTitle: Effectiveness of Intervention in Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Community Elderly acronym: ESPAI-F overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-15 date: 2023-10-30 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Consorci Sanitari del Maresme class: OTHER briefSummary: Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.

The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.

These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.

In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in. conditions: Muscle Strengh conditions: Frailty conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 232 type: ACTUAL name: Multidisciplinary intervention measure: Muscle Mass measure: Muscle strength and/or Muscle function measure: Sarcopenia measure: Frailty measure: Functional Capacity 1 measure: Functional Capacity 2 measure: Functional Capacity 3 measure: Functional Capacity 4 measure: Functional Capacity 5 measure: Functional Capacity 6 sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Consorci Sanitari del Maresme city: Mataró state: Barcelona zip: 08304 country: Spain lat: 41.54211 lon: 2.4445 facility: Mateu Serra-Prat city: Mataró state: Barcelona zip: 08304 country: Spain lat: 41.54211 lon: 2.4445 hasResults: False

 nctId: NCT06280573 id: MS1 briefTitle: COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS) acronym: COBRAMS overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-01 date: 2025-12-01 date: 2025-12-01 date: 2024-02-28 date: 2024-03-19 name: Comenius University class: OTHER briefSummary: The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.

Researchers will compare the effect to control groups of MS patients without intervention. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Wim Hoff method measure: concentration of pro-inflammatory cytokines measure: concentration of markers of oxidative stress measure: concentration of NfL measure: concentration of GFAP measure: concentration of ecDNA measure: Expanded Disability Status Scale measure: Timed 25-Foot Walk measure: Nine-Hole Peg Test measure: Symbol Digit Modalities Test measure: Fatigue Scale for Motor and Cognitive Functions measure: General Anxiety Disorder-7 measure: Patient Health Questionnaire-9 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Derer's University Hospital city: Bratislava zip: 83305 country: Slovakia lat: 48.14816 lon: 17.10674 hasResults: False

 nctId: NCT06280560 id: 2109-FIVI-087-FD id: PI23/00860 type: OTHER_GRANT domain: Instituto de Salud Carlos III, co-funded by European Union briefTitle: Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation acronym: HormoSenoRec overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-06-30 date: 2024-02-28 date: 2024-02-28 name: Fundación IVI class: OTHER name: Instituto Valenciano de Infertilidad, IVI VALENCIA briefSummary: Both controlled ovarian stimulation (COS) and frozen embryo transfer has become an integral part of in vitro fertilization (IVF) treatment. Fresh embryo transfer is usually performed by providing Luteal Phase Support (LPS) with progesterone after COS. Frozen embryo transfer (FET) is usually performed in artificial cycles with hormone replacement treatment (HRT), in which exogenous progesterone is administered, although it can also be performed in a Natural Cycle (without hormone supplementation) (NC). There is evidence that the supraphysiologic levels of estradiol and progesterone during COS+LPS and HRT could lead to morphologic and biochemical endometrial modifications, altering endometrial receptivity and lowering implantation and pregnancy rates.

We hypothesize that the supraphysiologic hormone levels required for both COS+LPS, and HRT may be inducing alterations in endometrial composition and function, specifically the chronic accumulation of senescent cells; either due to an excessive hormonal induction, a lack of clearance due to a deficit of uNKs, or a combination of both, ultimately affecting both endometrial receptivity and decidualization, worsening IVF outcomes.

The in vitro clearance of endometrial senescent cells by selective induction of apoptosis has been found to enhance the decidualization capacity of the rest of Endometrial Stromal Cells (EnSC), which could represent in a future adjuvant strategy to reduce the potentially deleterious effects of supraphysiologic hormone levels and improve reproductive outcomes in IVF patients.

The results derived from this project would have a direct impact on clinical practice. First, the results would allow us to evaluate, based on experimental data, potential endometrial side effects of stimulation protocols commonly used in IVF treatments. In addition, in the case of finding a pathological accumulation of senescent cells affecting endometrial receptivity, we will be able to in vitro evaluate the effectiveness of adjuvant senolytic (drugs designed to specifically remove senescent cells) compounds to in vitro improve the expression of endometrial receptivity markers, as a first step to demonstrate the effectiveness of their use in improving the reproductive outcomes of IVF patients. conditions: Endometrial Receptivity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Controlled Ovarian Stimulation + Luteal Phase Support name: Hormonal Replacement Therapy programmed artificial cycle name: Natural Cycle (NC) name: Endometrial receptivity reference group measure: Endometrial receptivity measure: Senescent Cell Pathological Accumulation sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: IVI-RMA Valencia Clinic status: RECRUITING city: Valencia zip: 46015 country: Spain name: Laura Caracena, PhD role: CONTACT phone: 651791000 email: Laura.Caracena@ivirma.com lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06280547 id: CUP 13-2 id: Cairo university type: OTHER domain: Cairo University briefTitle: The Effect of Oral Health Education on Knowledge, Attitude, Practice and Dental Caries Among Egyptian School Children acronym: KAP overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-03-02 date: 2024-04-02 date: 2024-02-28 date: 2024-02-28 name: Cairo University class: OTHER briefSummary: Aim of the study Assessing the effect of an oral health education program on knowledge, attitude, practice, and dental caries among a group of school children in a governmental school in Fayoum, Egypt. conditions: Dental Caries in Children conditions: Knowledge, Attitudes, Practice studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 115 type: ESTIMATED name: Oral health education measure: Oral health related attitude measure: Change in oral health related Knowledge, attitude and practice measure: Caries experience sex: ALL minimumAge: 6 Years maximumAge: 15 Years stdAges: CHILD hasResults: False

 nctId: NCT06280534 id: XT1061-2022-01 briefTitle: Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects acronym: XT1061 overallStatus: RECRUITING date: 2023-07-18 date: 2024-02-29 date: 2024-03-31 date: 2024-02-28 date: 2024-02-28 name: Xi'an Xintong Pharmaceutical Research Co.,Ltd. class: OTHER briefSummary: A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects. conditions: Chronic Hepatitis b studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: Test drug XT1061 capsules and placebo,Single dose group name: Test drug XT1061 capsules and placebo，Multiple dosing group name: Test drug XT1061 capsules and placebo，Food Impact Group measure: Treatment-related adverse events measure: Cmax measure: Tmax measure: t1/2 measure: AUC measure: CL/F measure: Vz/F measure: CLr/F measure: Ae0-72 h measure: Fe0-72 h measure: bioavailability sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Hospital of Jilin University status: RECRUITING city: Jilin state: Changchun country: China name: Ding Yanhua, master role: CONTACT phone: 18743062721 email: 1023307193@qq.com lat: 43.85083 lon: 126.56028 hasResults: False

 nctId: NCT06280521 id: 38RC23.0331 briefTitle: Validation of the Girls Questionnaire for Autism Spectrum Condition in French Langage acronym: fGQ-ASC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-05 date: 2024-02-28 date: 2024-02-28 name: University Hospital, Grenoble class: OTHER briefSummary: Autism spectrum disorders (ASD) are currently diagnosed at a rate of approximately 3 males per 1 female, while evidence suggests the rate may be 1.8 males per 1.2 females. It has been shown that affected women receive an autism diagnosis on average 5 years later than men. This delay is associated with deleterious consequences on the educational, psychological and physical health levels in these women. Currently, there are a number of obstacles that delay or prevent women with ASD from accessing diagnosis and specialized support. These include, in particular, gendered assumptions about how ASD manifests depending on the gender of the person concerned, a tendency for clinicians to attribute female autistic traits to causes other than ASD, measures of standardized ASD assessments that may not be sensitive enough to identify ASD females, and finally a demonstrated greater tendency among ASD females to camouflage or mask autistic traits in order to blend in in social situations. It is in this context that the Girl Questionnaire for Autism Spectrum Conditions (GQ-ASC) was developped and validated to address these fundamental gaps in the early identification and measurement of female ASD symptoms.

The GQ-ASC is presented as a self-questionnaire with 29 items which assess clinical characteristics specific to the adult female presentation of ASD in the dimensions (five) of imagination and play, camouflage, sensoriality, social situations and interests. To date, several studies have relevantly used the GQ-ASC in populations of adult ASD women, but none in French.

The main objective of this online study is therefore to measure the predictive validity of the French version of the Girl Questionnaire for Autism Spectrum Conditions (fGQ-ASC) for the diagnosis of ASD in adult women over 18 years of age and speaking French kindergarten. Subjects included in this online study will complete the protocol using any computer, tablet, or cell phone. We will include 400 participants (100 females-ASD, 100 females-nonASD, 100 males-ASD, 100 males-nonASD). This study will validate for the first time a screening tool for the diagnosis of ASD in women of French mother tongue over 18 years of age (the Girls Questionnaire for Autism Spectrum Condition French version - fGQ-ASC). This tool will have particularly significant benefits since it will help reduce the diagnostic delay among adult women with ASD in France and accelerate their access to specialized support. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 400 type: ESTIMATED name: fGQ-ASC measure: VP fGQ-ASC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280508 id: SYSKY-2024-082-01 briefTitle: Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-31 date: 2028-03-31 date: 2024-02-28 date: 2024-04-23 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer. conditions: Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Adebrelimab, Apatinib, Gemcitabine, cisplatin measure: 1-year EFS rate measure: R0 Resection rate measure: EFS measure: RFS measure: OS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University status: RECRUITING city: Guangzhou state: China/Guangdong country: China name: Yajin Chen role: CONTACT phone: 13719006202 email: cyj0509@126.com name: Changzhen Shang role: CONTACT phone: 13711279678 email: shangchangzhen@139.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06280495 id: INTENSIFY-CRC briefTitle: Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-31 date: 2028-12-31 date: 2024-02-28 date: 2024-03-04 name: Sun Yat-sen University class: OTHER briefSummary: The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone. conditions: Colorectal Cancer conditions: Liver Metastases studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized, multicenter clinical trial. Stratified randomization based on liver metastasis characteristics, including timing, number, and size, will be conducted in eligible patients. primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Oxaliplatin name: Fluorouracil name: Serplulimab name: Bevacizumab measure: 3-year Progression-Free Survival Rate measure: Median Overall Survival measure: Major Pathological Response (MPR) measure: Pathologic complete response (pCR) measure: Pathological Partial Response measure: Disease Free Survival measure: Treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Yu-hong Li, MD, Ph D role: CONTACT email: liyh@sysucc.org.cn name: Yu-hong Li, MD, Ph D role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06280482 id: HSC-MS-23-0332 briefTitle: Nicotinamide Riboside (NR) to Treat Moyamoya-like Cerebrovascular Disease in Smooth Muscle Dysfunction Syndrome (SMDS) overallStatus: RECRUITING date: 2024-03-06 date: 2025-07-25 date: 2025-07-25 date: 2024-02-28 date: 2024-04-05 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients. conditions: Smooth Muscle Dysfunction Syndrome (SMDS) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Nicotinamide riboside (NR) measure: Change in Fluoro-18-Deoxyglucose (18F-FDG ) uptake in aortic wall as measured by positron emission tomography (PET)/computerized tomography (CT) imaging measure: Change in Levels of Nicotinamide adenine dinucleotide (NAD+) in whole blood as measured by high-performance liquid chromatography (HPLC) measure: Change in Levels of NR in whole blood as measured by high-performance liquid chromatography (HPLC) measure: Change in aortic measurements as assessed by echocardiography measure: Safety as assessed by number of participants that show drug toxicity as shown in bloodwork measure: Safety as assessed by number of participants that show drug toxicity as shown in bloodwork measure: Tolerability as assessed by the number of patients who complete study sex: ALL minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: The University of Texas Health Science Center at Houston status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: David Murdock, MD role: CONTACT phone: 713-500-6735 email: David.R.Murdock@uth.tmc.edu name: Dianna Milewicz, MD, PhD role: CONTACT phone: (713) 500-6725 email: Dianna.M.Milewicz@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06280469 id: KY20232298-C-1 briefTitle: Single-operator Versus Double-operator in Single-Balloon Enteroscopy acronym: SBE overallStatus: RECRUITING date: 2024-01-01 date: 2025-12 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: Shuhui Liang class: OTHER briefSummary: Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy. conditions: Single-balloon Enteroscopy conditions: Operation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Single-Balloon Enteroscopy measure: Maximum insertion depth measure: Total enteroscopy rate measure: Positive findings measure: Advent events measure: procedural time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital of Digestive Diseases status: RECRUITING city: Xi'an country: China name: Shuhui Liang role: CONTACT phone: +862084771536 email: liangsh@fmmu.edu.cn lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06280456 id: 2023-09-017A briefTitle: Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction overallStatus: COMPLETED date: 2022-09-05 date: 2023-01-05 date: 2023-02-05 date: 2024-02-28 date: 2024-02-28 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis and a functional deficit. Many antifibrinolytic agents, including tranexamic acid (TXA), have been used in orthopedic surgeries to reduce postoperative bleeding. Moreover, TXA was proved effective to reduced the events of hemarthrosis and increased the post-operative functional outcomes of the patients in several studies. The purpose of this study is to evaluate the efficacy of intra-articular injection of TXA with different drainage clamping time in patients receiving arthroscopic ACLRs. Patients were randomized into four groups. An intra-articular suction drain was placed recorded 24 h postoperatively. Group 1 patients(TXA 4hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 4 hours. Group 2 patients(TXA 8hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 8 hours. Clinical evaluations using an IKDC functional score and a Visual Analogue Scale (VAS) pain score were performed during admission, at postoperative day 3 and week 4. conditions: Anterior Cruciate Ligament Reconstruction conditions: Tranexamic Acid conditions: Hemarthrosis, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ACTUAL name: Tranexamic Acid Powder measure: The volume of drainage measure: Visual analog scale (VAS) measure: International Knee Documentation Committee (IKDC) functional score sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06280443 id: CE22407B briefTitle: Sarcopenia in Chronic Lung Diseases overallStatus: RECRUITING date: 2022-11-25 date: 2024-10-13 date: 2032-09-30 date: 2024-02-28 date: 2024-04-04 name: Taichung Veterans General Hospital class: OTHER briefSummary: Inclusion criteria A)Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.

B) Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources conditions: Sarcopenia conditions: COPD conditions: Asthma conditions: ILD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: sarcopenia rate sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital status: RECRUITING city: Taichung zip: 40705 country: Taiwan name: Pin-Kuei Fu, MD, PhD role: CONTACT phone: 886-4-23592525 phoneExt: 3213 email: yetquen@gmail.com lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06280430 id: Vascular affection in behcet briefTitle: Vascular Affection in Behcet Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: To measure the level of serum elafin in patients with behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity conditions: Behcet Disease and Vascular Involvement studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED measure: To measure the level of serum elafin in behcet patients and compare it with control group sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06280417 id: Unreamed IMN In IIIa tibia briefTitle: Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-08-01 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome . conditions: Tibia Fracture studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Unreamed intramedullary tibial nail measure: Incidence of non union measure: Incidince of fracture related infection measure: The rate of reoperation for delayed union or non-union , infection and fasciotomy measure: functional evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280404 id: Body first in lap chole briefTitle: Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-08-08 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: The aim of this study is to evaluate the body first approach on the rate of conversion to open technique \& VBI in patients with obscure calot's triangle. conditions: Cholecystitis, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Lap cholecystectomy measure: Safe laparoscopic cholecystectomy. measure: Evaluation of the body first approach technique sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280391 id: ACT18018 id: U1111-1295-3237 type: REGISTRY domain: ICTRP id: 2023-508663-70 type: REGISTRY domain: CTIS briefTitle: A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis overallStatus: RECRUITING date: 2024-02-20 date: 2026-03-24 date: 2026-08-11 date: 2024-02-28 date: 2024-04-12 name: Sanofi class: INDUSTRY name: Regeneron Pharmaceuticals briefSummary: ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive).

Study details include:

* The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks.
* The treatment duration will be up to 24-52 weeks.
* The follow-up duration will be 20 weeks.
* Site/phone visits are at a monthly interval. conditions: Bronchiectasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Itepekimab (SAR440340) name: Placebo measure: Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period measure: Time to first moderate or severe PE over the treatment period measure: Percentage of participants who are PE free over the treatment period measure: Annualized rate of severe PEs over the treatment period measure: Percentage of participants who are severe PE free over the treatment period measure: Time to first severe PE over the treatment period measure: Change From Baseline in FEV1 at Week 8 and Week 24 measure: Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use measure: Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24 measure: Change from baseline in SGRQ total score at Week 24 measure: Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24 measure: Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period measure: Serum concentrations of itepekimab from baseline to end of study measure: Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Allianz Research Institute Site Number : 8400013 status: RECRUITING city: Westminster state: California zip: 92683 country: United States lat: 33.75918 lon: -118.00673 facility: Southeastern Research Center Site Number : 8400008 status: RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States lat: 36.09986 lon: -80.24422 facility: Investigational Site Number : 8260008 status: RECRUITING city: Norwich state: Norfolk zip: NR4 7UY country: United Kingdom lat: 52.62783 lon: 1.29834 facility: Investigational Site Number : 8260003 status: RECRUITING city: Tyne And Wear state: North Tyneside zip: NE29 8NH country: United Kingdom facility: Investigational Site Number : 8260001 status: RECRUITING city: Newcastle upon Tyne zip: NE7 7DN country: United Kingdom lat: 54.97328 lon: -1.61396 facility: Investigational Site Number : 8260005 status: RECRUITING city: Reading zip: RG1 5AN country: United Kingdom lat: 51.45625 lon: -0.97113 hasResults: False

 nctId: NCT06280378 id: CP-KL003-003/01 briefTitle: A Phase I/II Clinical Study of the KL003 Cell Injection in β-Thalassemia Major Participants overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-05 date: 2027-05 date: 2024-02-28 date: 2024-02-28 name: Kanglin Biotechnology (Hangzhou) Co., Ltd. class: INDUSTRY briefSummary: This is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. The goal of this clinical trial is to evaluate the safety and efficacy of KL003 cell injection in subjects with β-thalassemia major. conditions: Transfusion-dependent Beta-Thalassemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 41 type: ESTIMATED name: KL003 Cell Injection Drug Product measure: KL003 engraftment measure: Engraftment time of neutrophil and platelet measure: Overall Survival measure: The number, frequency and severity of adverse events (AE) within 1 year after infusion of KL003 drug products measure: Clonal dominance or secondary tumors caused by lentiviral vector insertional-mutation measure: Numbers of Participants With Vector-Derived Replication-Competent Lentivirus (RCL) measure: The proportion of participants achieved Transfusion Independence (TI)for at least 6 months measure: The proportion of participants achieved TI 12 measure: The start time of Transfusion Independence (TI) after KL003 infusion measure: Total Hb and the vector-derived HbA^T87Q sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai country: China name: Wei Tang, PhD role: CONTACT phone: +86 13472889588 name: Saijuan Chen, PhD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Institute of Hematology & Blood Diseases Hospital city: Tianjin state: Tianjin country: China name: Zhen Gao, Master role: CONTACT phone: +86 15522360862 email: Gaozhen@ihcams.ac.cn name: Jun Shi, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06280365 id: 012 briefTitle: MWM Technique in Patients With Knee OA overallStatus: COMPLETED date: 2024-02-19 date: 2024-03-15 date: 2024-03-15 date: 2024-02-28 date: 2024-04-03 name: Okan University class: OTHER briefSummary: The aim of this study is to investigate the effect of the MWM technique on pain, normal joint movement, proprioception and quality of life in patients with knee osteoarthritis (OA). conditions: Mobilization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Mulligan Mobilization with Movement Technique measure: Visual Analog Scale (VAS) measure: Short form-36 (SF-36) measure: Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) measure: Evaluation of proprioception measure: The range of motion sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emine Atıcı city: Tuzla state: İstanbul country: Turkey hasResults: False

 nctId: NCT06280352 id: AUVA_Knieathlon_2024 briefTitle: Robotic Assisted vs Custom Made Total Knee Arthroplasty acronym: Knieathlon overallStatus: RECRUITING date: 2024-03-01 date: 2024-12 date: 2026-12 date: 2024-02-28 date: 2024-03-12 name: Austrian Workers Compensation Board Styria class: OTHER briefSummary: The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:

* Which implant/philosophy yields better clinical outcomes?
* Which implant/philosophy yields better satisfaction?
* Which system is more OR efficient? Participants will be followed for 2 years postoperatively. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Custom made Total Knee Arthroplasty name: Functionally aligned robotically assisted total knee arthroplasty measure: Clinical Outcome using the Forgotten Joint Score measure: Clinical outcomes using the Kujala anterior knee pain Score measure: Patient satisfaction measure: Visual analog pain (VAS) scale measure: Surgical and total theatre time measure: Opioid use measure: Number of physiotherapy sessions measure: Range of motion measurements (in degrees) measure: Radiographic data including radiolucent lines measure: Revision rate sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AUVA UKH Steiermark Standort Graz status: RECRUITING city: Graz state: Styria zip: 8020 country: Austria name: Antonio Klasan, MD, PHD, EMBA role: CONTACT lat: 47.06667 lon: 15.45 facility: AUVA UKH Steiermark Standort Kalwang status: RECRUITING city: Kalwang state: Styria zip: 8775 country: Austria name: Antonio Klasan, MD, PhD, EMBA role: CONTACT lat: 47.42172 lon: 14.75221 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-27 uploadDate: 2024-02-05T09:59 filename: Prot_SAP_000.pdf size: 156436 hasResults: False

 nctId: NCT06280339 id: IRB23-0190 briefTitle: Food Cravings Strategies During Dietary Weight Loss overallStatus: RECRUITING date: 2024-01-29 date: 2024-06-01 date: 2024-08-01 date: 2024-02-28 date: 2024-02-28 name: University of Illinois at Urbana-Champaign class: OTHER briefSummary: The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management.

The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings. conditions: Obesity conditions: Food Cravings conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be enrolled in dietary weight loss program. Before the first meeting they will be randomized to one of the two study groups that focus on teaching participants different strategies to cope with food cravings (Inclusion vs. Avoidance).. To ensure balanced representation and meaningful study results, the randomization process will consider specific characteristics, including BMI category, sex, and age. This stratified randomization method helps us compare the effects of the intervention between different groups of participants. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Test two food cravings strategies during dietary weight loss name: Dietary weight loss program +Food cravings strategies measure: Body weight measure: Food Craving Strategies Compliance measure: Food Cravings measure: Food Cravings measure: Dietary intake sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bevier HAll UIUC status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Nouf Alfouzan role: CONTACT phone: 217-898-5480 email: noufa2@illinois.edu lat: 40.11059 lon: -88.20727 facility: Bevier HAll UIUC status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Nouf Alfouzan role: CONTACT phone: 217-898-5480 email: noufa2@illinois.edu name: Manabu Nakamura role: PRINCIPAL_INVESTIGATOR lat: 40.11059 lon: -88.20727 hasResults: False

 nctId: NCT06280326 id: Orogastric Tube Removal briefTitle: Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-05 date: 2024-06-05 date: 2024-08-05 date: 2024-02-28 date: 2024-02-28 name: Ondokuz Mayıs University class: OTHER briefSummary: While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage. conditions: Neonatal Skin Conditions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled experimental trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 86 type: ACTUAL name: Sunflower oil name: Slicone based spray measure: Neonatal Skin Condition Score sex: ALL minimumAge: 32 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Hatice Uzşen city: Samsun state: Atakum zip: 55100 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06280313 id: uHCC-STI-TJ01 briefTitle: Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension overallStatus: RECRUITING date: 2024-03-15 date: 2027-03-15 date: 2028-03-15 date: 2024-02-28 date: 2024-04-10 name: Zhiyong Huang class: OTHER name: Wuhan Union Hospital, China name: Wuhan University name: Renmin Hospital of Wuhan University name: Taihe Hospital name: Hubei Cancer Hospital name: Xiangyang Central Hospital name: Wuhan Central Hospital name: Yichang Third Renmin Hospital briefSummary: Currently, the combination of targeted therapy and immunotherapy is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, a subset of HCC patients with severe splenomegaly, splenic hyperfunction, and esophagogastric varices due to liver cirrhosis and portal hypertension may be unable to undergo or sustain the combination therapy, ultimately missing the optimal treatment window. Prior studies have indicated that splenectomy can significantly improve liver function and hepatic reserve in cirrhotic patients. It also addresses splenic hyperfunction and reduces the risk of bleeding from esophagogastric varices by combining splenectomy with devascularization around the cardia. Additionally, splenectomy contributes to the improvement of liver fibrosis and restoration of immune function in cirrhotic patients. This study aims to elucidate the impact of splenectomy on the efficacy of combination targeted and immunotherapy in unresectable HCC patients with cirrhotic portal hypertension, particularly those with poor liver function, significant splenic hyperfunction, and severe esophagogastric varices. The research also seeks to explore whether changes in the tumor immune microenvironment before and after splenectomy can influence the effectiveness of immunotherapy. Ultimately, the goal is to provide therapeutic opportunities for this specific patient population. conditions: Unresectable Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Splenectomy+Targeted therapy+ Immunotherapy measure: Objective Response Rate (ORR) measure: Overall Survival (OS) measure: Progression Free Survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Zhiyong Huang role: CONTACT phone: 86-13995507729 email: Zyhuang126@126.com name: Erlei Zhang role: CONTACT email: baiyu19861104@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06280300 id: UVMMC2203 briefTitle: Multi-disciplinary Care for Brain Metastases overallStatus: RECRUITING date: 2023-11-16 date: 2024-11-01 date: 2025-11-01 date: 2024-02-28 date: 2024-02-28 name: University of Vermont Medical Center class: OTHER briefSummary: This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases. conditions: Brain Metastases, Adult studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: cohort study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 40 type: ESTIMATED name: health services intervention measure: Patient reported outcomes measure: Feasibility measure: Patient understanding of prognosis measure: survival measure: Exploratory survival outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vermont Medical Center status: RECRUITING city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 hasResults: False

 nctId: NCT06280287 id: FAPI-PLAQUE briefTitle: PET Imaging of Fibroblast Activation in Atherosclerosis overallStatus: RECRUITING date: 2021-08-01 date: 2024-12-31 date: 2025-12-31 date: 2024-02-28 date: 2024-02-28 name: Peking Union Medical College Hospital class: OTHER briefSummary: Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome. conditions: Atherosclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: FAPI PET measure: SUVmax of atherosclerotic plaque in carotid or coronary arteries measure: TBR of atherosclerotic plaque in carotid or coronary arteries sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Li Huo role: CONTACT phone: 86-13910801986 email: huoli@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06280274 id: STUDY00025798 briefTitle: Metformin Use in Patients Undergoing Total Joint Replacement Surgery overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2025-05-30 date: 2025-05-30 date: 2024-02-28 date: 2024-03-01 name: Oregon Health and Science University class: OTHER briefSummary: The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.

The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.

Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial. conditions: Hyperglycemia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Metformin name: Placebo measure: Rate of participant enrollment measure: Rate of appropriate study drug administration measure: Rate of participant adherence to trial intervention per protocol measure: Rate of participant retention to 90-day follow up measure: Perioperative glycemic variability measure: Sliding scale insulin utilization measure: Hospital length of stay measure: 90-day Rate of surgical site infection measure: 90-day Rate of periprosthetic joint infection measure: 90-day Rate of mortality measure: 90-day rate of readmission sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Health & Science University city: Portland state: Oregon zip: 97239 country: United States name: Ryland Kagan role: CONTACT phone: 503-494-5649 email: kagan@ohsu.edu lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06280261 id: GO20/296 briefTitle: The Struggle That Is Phenylketonuria : What Do The Patients and Caregivers Suffer From overallStatus: COMPLETED date: 2020-05-27 date: 2020-09-01 date: 2020-09-01 date: 2024-02-28 date: 2024-02-28 name: Hacettepe University class: OTHER briefSummary: Objective: To assess the stress levels and life hardships of phenylketonuria patients and their parents. conditions: Psychological Well-Being conditions: Caregiver Burden conditions: Life Stress studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: PROSPECTIVE count: 156 type: ACTUAL name: parenting stress index, Zarit burden scale, Rosenberg self esteem scale, stait trait anxiety inventory, struggles and difficulties questionnaire measure: Rosenberg Self-Esteem Scale measure: Stait trait anxiety inventory measure: Strenghts and difficulties questionnaire measure: Zarit burden scale measure: Parenting stress index sex: ALL minimumAge: 6 Months maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Hacettepe University city: Ankara state: Sihhiye zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2020-10-20 uploadDate: 2024-02-19T08:48 filename: Prot_SAP_000.pdf size: 288978 hasResults: False

 nctId: NCT06280248 id: EUS in pancreatic fluid briefTitle: EUS Guided Drainage of Post Pancreatitis Pancreatic Fluid Collection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-06 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: The number as well as the caliber of plastic stents used for EUS-guided PFC drainage are controversial in current practice \[Lin et al., 2014\]. The timing of necrosectomy in WOPN drainage continues to be debated. To date, no comparative studies have been conducted to investigate the ideal timing for stent removal. Thus, the aim of our study is to:

* Assess the technical success rates, clinical success rates and potential complications of the different techniques for the best drainage of PFCs as regard type, caliber and number of plastic stents and ideal timing for stent removal.
* Compare between early vs late intervention for complete endoscopic necrosectomy of WOPN as regard technical success rates, clinical success rates, potential complications and number of sessions needed. conditions: Pancreas Pseudocyst studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst measure: Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280235 id: 1447-0005 id: U1111-1297-3126 type: REGISTRY domain: WHO International Clinical Trials Registry Platform (ICTRP) id: 2023-507942-10-00 type: REGISTRY domain: CTIS briefTitle: A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine overallStatus: RECRUITING date: 2024-03-07 date: 2025-08-12 date: 2025-10-03 date: 2024-02-28 date: 2024-04-16 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.

Participants continue their standard therapy throughout the study.

Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.

Participants are in the study for about 2 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms.

The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants. conditions: Depressive Disorder, Major studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 204 type: ESTIMATED name: BI 1569912 name: Placebo measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 8 measure: Change from baseline in MADRS total score at Week 6 measure: Response defined as ≥50% MADRS reduction from baseline at Day 8 measure: Response defined as ≥50% MADRS reduction from baseline at Week 6 measure: Remission defined as MADRS total score ≤10 at Week 6 measure: Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8 measure: Change from baseline in SMDDS total score at Week 4 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hassman Research Institute status: RECRUITING city: Marlton state: New Jersey zip: 08053 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 39.89122 lon: -74.92183 facility: Neurobehavioral Research, Inc. status: RECRUITING city: Cedarhurst state: New York zip: 11516 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 40.62288 lon: -73.7243 facility: Sooner Clinical Research status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 35.46756 lon: -97.51643 facility: Grayline Research Center status: RECRUITING city: Wichita Falls state: Texas zip: 76309 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 33.91371 lon: -98.49339 hasResults: False

 nctId: NCT06280222 id: VR FOR ANXIETY-HMO-CTIL briefTitle: The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation. acronym: VRFORANXIETY overallStatus: RECRUITING date: 2023-11-15 date: 2024-11-15 date: 2025-02-01 date: 2024-02-28 date: 2024-02-28 name: Hadassah Medical Organization class: OTHER briefSummary: A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level . conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: The VR instrument - Oculus Quest 2 measure: Vital signs measure: Vital signs measure: VAS (visual-analogue scale) measure: State and Trait Anxiety (STAI) Score sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hadassah mound scopus IVF unit status: RECRUITING city: Jerusalem country: Israel name: Anat Hershko-Klement, M.D role: CONTACT phone: +972549170084 email: anat.klement@gmail.com lat: 31.76904 lon: 35.21633 hasResults: False

 nctId: NCT06280209 id: 351-201 id: 2023-506737-30-00 type: OTHER domain: EU CT briefTitle: A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy overallStatus: RECRUITING date: 2024-01-03 date: 2025-12 date: 2025-12 date: 2024-02-28 date: 2024-04-16 name: BioMarin Pharmaceutical class: INDUSTRY briefSummary: The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping. conditions: Duchenne Muscular Dystrophy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: BMN 351 measure: To evaluate and safety and tolerability of single and multiple doses of BMN 351 (incidence, severity, and dose-relationship of adverse effects and changes in laboratory parameters). measure: Pharmacokinetics (PK) concentration of BMN 351 in plasma, urine and muscle approximately every 8 weeks for up to 48 weeks. measure: To evaluate the immune response to BMN 351. measure: To evaluate the effect of BMN 351 on physical function. measure: To evaluate the effect of BMN 351 on physical function. measure: Change from baseline in dystrophin expression measured by Liquid chromatography-mass spectrometry (LC-MS). sex: MALE minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Hospital Sant Joan de Deu status: RECRUITING city: Barcelona zip: 08950 country: Spain name: Soraya Peralta role: CONTACT phone: +34 673200068 email: soraya.peralta@sjd.es name: Andres Nascimento role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Viamed Santa Angela De la Cruz status: RECRUITING city: Sevilla zip: 41013 country: Spain name: Carmen Silva role: CONTACT phone: +34 669393637 email: tuautorapreferida@gmail.com name: Marcos Madruga-Garrido role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: Great Ormond Street Hospital NHS Foundation Trust status: RECRUITING city: London zip: WC1N 3JH country: United Kingdom name: Marta Zancolli role: CONTACT phone: +44 (0)20 7905 2188 email: marta.zancolli@gosh.nhs.uk name: Giovanni Baranello role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06280196 id: BAT-3306-002-CR briefTitle: A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC overallStatus: NOT_YET_RECRUITING date: 2024-08-15 date: 2027-07-30 date: 2028-10-30 date: 2024-02-28 date: 2024-03-25 name: Bio-Thera Solutions class: INDUSTRY briefSummary: To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin. conditions: Carcinoma, Non-Small-Cell Lung studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double-blind, randomized primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 676 type: ESTIMATED name: BAT3306 name: EU-Keytruda® name: US-Keytruda® name: Pemetrexed name: Carboplatin measure: clinical equivalence measure: safety of BAT3306-AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280183 id: 323132 briefTitle: Functional Inspiratory Muscle Training in Obese Individuals overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2025-06-30 date: 2025-06-30 date: 2024-02-28 date: 2024-02-28 name: Biruni University class: OTHER name: Istanbul Galata University briefSummary: In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals.

This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, single-blind study three arm study. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The assessor will be blind to the group allocation, and participants will be blind to group allocation whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Functional Inspiratory Muscle Training name: Aerobic+Resistive Exercise Traning measure: Respiratory Muscle Strength measure: Incremental load test (Respiratory Muscle Endurance) measure: Forced expiratory volume 1st second (Respiratory Function) measure: Forced vital capacity (Respiratory Function) measure: Comorbidity Assessment measure: Physical Activity Assessment measure: Edmonton Obesity Staging System (EOSS) measure: Functional Capacity measure: Peripheral Muscle Strength measure: Waist circumference measure: Hip circumference measure: Body fat-muscle ratios measure: Glucose profile measure: Lipid profile sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06280170 id: ST11480 briefTitle: AI to Support Mental Health Case Management Providers overallStatus: ENROLLING_BY_INVITATION date: 2024-02-19 date: 2025-06-30 date: 2025-12-31 date: 2024-02-28 date: 2024-02-28 name: Eleos Health class: INDUSTRY name: Centerstone Research Institute briefSummary: The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are:

1. Is the AI platform acceptable and feasible for case managers?
2. Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation. conditions: Depressive Disorder conditions: Anxiety Disorders conditions: Substance Use Disorders conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This study will follow a stepped-wedge, randomized controlled design, where each provider team will undergo two phases: SAU and the AI platform phase. All teams will initially start with SAU, and the AI platform will be sequentially introduced to teams over time. Teams will be randomly assigned to different time periods for the AI platform phase using simple randomization. The order of implementation will be determined by randomly selecting the number of the team from sealed envelopes every two months. In both phases, the study will enroll new and existing clients. At the end of the trial all teams would have used Eleos for a few months primaryPurpose: OTHER masking: NONE maskingDescription: The masking in this study involves a differential approach between providers and clients. Providers will be aware of whether they are in the Services-As-Usual (SAU) or Artificial Intelligence (AI) phase. However, participating clients will not be informed about the platform their provider is using to document their therapy sessions. count: 280 type: ESTIMATED name: Artificial Intelligence platform for case managers measure: Case manager satisfaction measure: Case manager productivity measure: Case manager note completion time measure: Clients' crisis services utilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centerstone city: Alton state: Illinois zip: 62002 country: United States lat: 38.8906 lon: -90.18428 hasResults: False

 nctId: NCT06280157 id: MVX0007 id: 332126 type: OTHER domain: IRAS briefTitle: A Follow up Study of Group B Streptococcus Vaccine (GBS-NN/NN2 Vaccine) in Healthy Volunteers overallStatus: ENROLLING_BY_INVITATION date: 2024-01-18 date: 2028-01 date: 2028-01 date: 2024-02-28 date: 2024-02-28 name: Minervax ApS class: OTHER name: Simbec-Orion Group briefSummary: The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations.

Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination. conditions: Group B Streptococcus Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 55 type: ESTIMATED name: GBS-NN/NN2 measure: Antibody Concentration Specific for GBS-NN and GBS-NN2 measure: Antibody Responses Specific to AlpCN, RibN, Alp1N and Alp2-3N sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Simbec-Orion Clinical Pharmacology city: Merthyr Tydfil state: Pentrebach Merthyr Tydfil CF48 4DR country: United Kingdom lat: 51.74794 lon: -3.37779 hasResults: False

 nctId: NCT06280144 id: PF20230428 briefTitle: Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine overallStatus: RECRUITING date: 2023-09-22 date: 2024-06-30 date: 2024-10-30 date: 2024-02-28 date: 2024-02-28 name: Changchun BCHT Biotechnology Co. class: INDUSTRY name: Hu Bei province Center for Disease control and prevention name: The Inner Mongolia Autonomous Region Center for Disease Control and Prevention briefSummary: To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.

To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine. conditions: Influenza Prevention studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 6080 type: ESTIMATED name: Influenza Vaccine, Live, Nasal, Freeze-dried name: Sterile water for inhalation measure: Primary influenza protective effect endpoint measure: Primary influenza protective effect endpoint measure: Secondary protective efficacy endpoint measure: Secondary protective efficacy endpoint measure: Secondary protective efficacy endpoint measure: Safety measure: Study on detoxification measure: Protective effect of COVID-19 cases. sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD status: RECRUITING city: Chi Feng state: Inner Mongolia Autonomous Region zip: 024000 country: China name: Xiaoling Tian role: CONTACT phone: 13848710296 email: txlingok@126.com hasResults: False

 nctId: NCT06280131 id: multiple sclerosis and pulse briefTitle: The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients: overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: This work is aimed to assess the short term effect of pulse therapy on clinical and neurophysiological course before and after pulse therapy in order to understand the possible mechanism of action of steroid therapy on RRMS patients low-dose oral treatment should also be retained for patients in whom this approach seems appropriate conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: to evaluate efficacy of a pulse therapy on clinical outcome measure: clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional measure: clinical correlation between clinical scales scores and neurophysiological changes( cortical exitability parameters) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280118 id: EFCPR008 briefTitle: The Effect of Fatigue on CPR overallStatus: COMPLETED date: 2023-04-20 date: 2023-06-20 date: 2023-10-25 date: 2024-02-28 date: 2024-02-28 name: Artvin Coruh University class: OTHER briefSummary: Background: This study, in contrast to the previous studies, generated a scenario of fatigue in an earthquake scenario and aimed to measure the effect of fatigue on the quality of cardiopulmonary resuscitation (CPR) performed by paramedics in a debris course.

Methods: The study was designed as a randomized controlled trial. The sample, consisting of 84 paramedic students, was randomly assigned as 42 control and 42 experimental groups. Fatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track. A personal information form and a CPR measurement form were used to obtain the data. The simulator was used to evaluate the accuracy of CPR. The collected data were analysed with the statistical program. conditions: Resuscitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: SCREENING masking: NONE count: 84 type: ACTUAL name: Fatigue measure: Correct number of ventilations measure: Correct number of compression measure: CPR duration sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: Resuscitation simulation laboratory of Artvin Çoruh University Health Services Vocational School city: Artvin zip: 08000 country: Turkey lat: 41.18161 lon: 41.82172 hasResults: False

 nctId: NCT06280105 id: 2023_148_01 briefTitle: A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2026-03-31 date: 2027-03-31 date: 2024-02-28 date: 2024-02-28 name: Meng Chao Hepatobiliary Hospital of Fujian Medical University class: OTHER briefSummary: To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Cadonilimab+regorafenib measure: objective response rate (ORR) per RECIST1.1 measure: Progression-free survival（PFS） measure: Overall survival（OS） measure: Duration of response (DOR) measure: Occurence of AE and SAE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mengchao Hepatobiliary Hospital, Fujian Medical University city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06280092 id: 23-009133 briefTitle: Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-03 date: 2025-03 date: 2024-02-28 date: 2024-04-08 name: Sanjeet S. Grewal class: OTHER briefSummary: This study is a non-randomized, open label, phase 1 clinical trial to evaluate the fesibility and safety of intrathalamic delivery of MSCs during standard of care DBS surgery for epilepsy.

Subjects will be screened at our outpatient clinic and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients will undergo a standard preoperative evaluation which includes baseline laboratory values and a high-definition MRI. Patients will then undergo a stereotactic procedure for bilateral thalamic implantation of DBS leads through the ClearPoint® system. After the thalamic target for DBS is identified, cells will be infused directly into the anterior nucleus of the thalamus previous to lead implantation.

Patients will be followed in the outpatient setting for up to a year after therapy application.

Surgical, clinical, and radiographic data will be obtained during these visits conditions: Epilepsy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A single dose of 5x10\^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery primaryPurpose: OTHER masking: NONE maskingDescription: This is an unmasked study count: 5 type: ESTIMATED name: AMSCs measure: Primary Objective measure: Secondary Objective sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280079 id: LIPCAL-ALS II 1.1 briefTitle: Ultra-high-caloric, Fatty Diet in ALS acronym: LIPCAL-ALS II overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-02-28 date: 2024-03-01 name: University of Ulm class: OTHER briefSummary: This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS). conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 392 type: ESTIMATED name: Ultra-high-caloric fatty diet name: Placebo measure: Survival measure: Amyotrophic Lateral Sclerosis Functional Rating Scale Revised measure: Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale measure: Individual Quality of Life measure: Slow vital capacity measure: Survival measure: Survival measure: Time to death measure: Time to tracheostomy measure: Time to permanent continous ventilator dependence measure: Ventilation assistance-free survival measure: Body Mass Index measure: Council of Nutrition Appetite Questionnaire measure: Eating Habits measure: Neurofilament light chain measure: Amyotrophic Lateral Sclerosis Functional Rating Scale Revised Prediction Model measure: Neurofilament Assess Score measure: Microtubule-associated protein 2 in serum measure: Microtubule-associated protein 2 in cerebrospinal fluid measure: Ubiquitin carboxy-terminal hydrolase L1 in serum measure: Ubiquitin carboxy-terminal hydrolase L1 in cerebrospinal fluid measure: Transmembrane glycoprotein NMB in serum measure: Transmembrane glycoprotein NMB in cerebrospinal fluid measure: Human cartilage glycoprotein 39 in serum measure: Human cartilage glycoprotein 39 in cerebrospinal fluid measure: SNAP-25 in serum measure: SNAP-25 in cerebrospinal fluid measure: Beta-synuclein in serum measure: Beta-synuclein in cerebrospinal fluid measure: Aquaporin-4 in serum measure: Aquaporin-4 in cerebrospinal fluid measure: Glial fibrillary acidic protein in serum measure: Glial fibrillary acidic protein in cerebrospinal fluid measure: Soluble triggering receptor expressed on myeloid cell-1 in serum measure: Soluble triggering receptor expressed on myeloid cell-1 in cerebrospinal fluid measure: CC-chemokine ligand 2 in serum measure: CC-chemokine ligand 2 in cerebrospinal fluid measure: interleukin-1b in serum measure: interleukin-1b in cerebrospinal fluid measure: interleukin-2 in serum measure: interleukin-2 in cerebrospinal fluid measure: interleukin-4 in serum measure: interleukin-4 in cerebrospinal fluid measure: interleukin-6 in serum measure: interleukin-6 in cerebrospinal fluid measure: interleukin-10 in serum measure: interleukin-10 in cerebrospinal fluid measure: interleukin-12p70 in serum measure: interleukin-12p70 in cerebrospinal fluid measure: interleukin-17 in serum measure: interleukin-17 in cerebrospinal fluid measure: Tumor necrosis factor alpha in serum measure: Tumor necrosis factor alpha in cerebrospinal fluid sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RWTH Aachen city: Aachen country: Germany lat: 50.77664 lon: 6.08342 facility: Charité Universitätsmedizin Berlin city: Berlin country: Germany name: André Maier, Dr. role: CONTACT lat: 52.52437 lon: 13.41053 facility: University Clinic Bochum city: Bochum country: Germany lat: 51.48165 lon: 7.21648 facility: University Clinic Bonn city: Bonn country: Germany name: Patrick Weydt, Dr. role: CONTACT lat: 50.73438 lon: 7.09549 facility: Technical University Dresden city: Dresden country: Germany name: René Günther, Dr. role: CONTACT lat: 51.05089 lon: 13.73832 facility: University Clinic Erlangen city: Erlangen country: Germany name: Jürgen Winkler, Prof. Dr. role: CONTACT lat: 49.59099 lon: 11.00783 facility: Alfried Krupp Krankenhaus Essen city: Essen country: Germany name: Torsten Grehl, Dr. role: CONTACT lat: 51.45657 lon: 7.01228 facility: University Clinic Göttingen city: Göttingen country: Germany name: Jan C Koch, Dr. role: CONTACT lat: 51.53443 lon: 9.93228 facility: University Clinic Halle city: Halle country: Germany name: Elena Schlapakow, Dr. role: CONTACT lat: 51.48159 lon: 11.97948 facility: Hannover Medical School city: Hannover country: Germany name: Susanne Petri, Prof. Dr. role: CONTACT lat: 52.37052 lon: 9.73322 facility: University Clinic Jena city: Jena country: Germany name: Annekathrin Rödiger, Dr. role: CONTACT lat: 50.92878 lon: 11.5899 facility: DRK Clinic Kassel city: Kassel country: Germany name: Clemens Eickhoff, Dr. role: CONTACT lat: 51.31667 lon: 9.5 facility: Klinikum Kempten city: Kempten country: Germany name: Elmar Pinkhardt, Dr. role: CONTACT lat: 47.72674 lon: 10.31389 facility: University Clinic Leipzig city: Leipzig country: Germany name: Moritz Metelmann, Dr. role: CONTACT lat: 51.33962 lon: 12.37129 facility: University Clinic Lübeck city: Lübeck country: Germany name: Julian Großkreutz, Prof. Dr. role: CONTACT lat: 53.86893 lon: 10.68729 facility: University Clinic Mannheim city: Mannheim country: Germany name: Joachim Wolf, Dr. role: CONTACT lat: 49.4891 lon: 8.46694 facility: Technical University Munich city: Munich country: Germany name: Paul Lingor, Prof. Dr. role: CONTACT lat: 48.13743 lon: 11.57549 facility: University Clinic Münster city: Münster country: Germany name: Matthias Böntert, Dr. role: CONTACT lat: 51.96236 lon: 7.62571 facility: University Clinic Regensburg city: Regensburg country: Germany name: Zacharias Kohl, Dr. role: CONTACT lat: 49.01513 lon: 12.10161 facility: University Clinic Rostock city: Rostock country: Germany name: Johannes Prudlo, Prof. Dr. role: CONTACT name: Andreas Herrmann role: PRINCIPAL_INVESTIGATOR lat: 54.0887 lon: 12.14049 facility: University of Ulm city: Ulm country: Germany name: Johannes Dorst, Prof. Dr. role: CONTACT lat: 48.39841 lon: 9.99155 facility: DKD HELIOS Clinic Wiesbaden city: Wiesbaden country: Germany name: Bertold Schrank, Dr. role: CONTACT lat: 50.08258 lon: 8.24932 facility: University Clinic Würzburg city: Würzburg country: Germany name: Daniel Zeller, Dr. role: CONTACT lat: 49.79391 lon: 9.95121 hasResults: False

 nctId: NCT06280066 id: 2023/607 briefTitle: An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-09 date: 2024-02-28 date: 2024-04-17 name: Kirsehir Ahi Evran Universitesi class: OTHER name: TC Erciyes University briefSummary: Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, prepared for children with CF (8-12 years old) and their mothers.In the first stage, the CF experiences of children with cystic fibrosis and how they perceive these experiences will be examined with visual phenomenology, and their mothers' CF experiences and perceptions will be examined with phenomenology. In this regard, 10 children will be asked to draw pictures and their pictures will be analyzed. In-depth individual interviews will be held with mothers.In the 2nd stage, the effectiveness of the Intervention Program Based on Strengthening Psychological Resilience for Children Diagnosed with Cystic Fibrosis and Their Mothers will be determined with a pre-test-post-test randomized controlled experimental design.In the literature review, Gpower analysis was performed (α: 0.05, β: 0.99, d: 1.88) based on the results of studies conducted with children diagnosed with CF and their parents, similar to this study, and 15 samples were used for each group. It is planned to recruit people. Considering the possibility of data loss in the study, it was always deemed appropriate to include 22 people for the group. It was planned to sample a total of 88 children with CF and their mothers, 44 in the intervention group and 44 in the control group. In the 3rd stage, after the experiment, the participants' experiences regarding the intervention program will be examined through interviews and qualitative research method. Thus, qualitative interviews will be conducted before and after the experiment. Data will be collected using these tools: Children; Child and Mother Descriptive Characteristics Form, Semi-Structured Interview Form,Respiratory Function Test, Reorganized Cystic Fibrosis Questionnaire, Psychological Resilience Attitude and Skills Scale and Functional Disability Inventory; Mothers; The Revised Cystic Fibrosis Questionnaire, The Depression Anxiety and Stress Scale, Post-Traumatic Growth Scale and Brief Psychological Resilience Scale. Measurements will be taken before the intervention, after the intervention, at the 1st and 3rd months. conditions: Cystic Fibrosis conditions: Children conditions: Resilience,Psychological conditions: Laughter Yoga conditions: Laughter Therapy conditions: Mothers conditions: Psychological Health conditions: Lung Functions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ESTIMATED name: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers measure: The Respiratory Function Test measure: The Revised Cystic Fibrosis Questionnaire Child Form measure: Psychological Resilience Attitude and Skills Scale Child Form measure: Functional Disability Inventory Child measure: The Revised Cystic Fibrosis Questionnaire Parent Form measure: Depression Anxiety and Stress Scale measure: Post-Traumatic Growth Scale measure: Brief Psychological Resilience Scale sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Erciyes University city: Kayseri zip: 38000 country: Turkey name: Selin Söyünmez role: CONTACT phone: +905319762180 email: selinsoyunmez@gmail.com name: Yağmur Sezer Efe, PhD role: PRINCIPAL_INVESTIGATOR name: Selin Söyünmez, PhD Student role: PRINCIPAL_INVESTIGATOR name: Mehmet Köse, MD role: PRINCIPAL_INVESTIGATOR lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06280053 id: 103-3024A3 briefTitle: HealiAid in the Treatment of Different Wounds overallStatus: COMPLETED date: 2016-03-02 date: 2018-04-11 date: 2018-10-26 date: 2024-02-28 date: 2024-02-28 name: Maxigen Biotech Inc. class: INDUSTRY briefSummary: The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds.

The main questions it aims to answer are:

1. The wound healing which was defined as the percentage of area change.
2. The duration of wound healing.
3. The granulation tissue growth of the wound.
4. The wound exudate.
5. Safety Indicators of which incidences after treatment.

HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks. conditions: Venous Ulcers conditions: Bedsores conditions: Diabetic Foot Wound conditions: Burn Wound studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The patients' wound conditions were divided into four types: venous ulcers, bedsores, diabetic foot wounds and burn wounds. primaryPurpose: OTHER masking: NONE count: 18 type: ACTUAL name: HealiAid Collagen Wound Dressing measure: Wound Healing measure: Wound Healing measure: Duration of Wound Healing measure: Granulation Tissue Growth measure: Wound Exudate measure: Incidence of Safety Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06280040 id: UM Longitudinal 1942/2022 briefTitle: Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma overallStatus: RECRUITING date: 2023-11-23 date: 2025-06-30 date: 2025-06-30 date: 2024-02-28 date: 2024-03-06 name: Medical University of Vienna class: OTHER briefSummary: The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry. conditions: Uveal Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Clinical examination and multimodal ocular imaging measure: Incidence and Severity of Retinopathy measure: Incidence and Severity of Opticopathy measure: Functional Outcome measure: Incidence and Severity of Retinopathy and Opticopathy in oximeter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology and Optometry, Medical University Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Judith Kreminger, MD role: CONTACT phone: 0043 1 40400 48470 email: judith.kreminger@meduniwien.ac.at name: Reinhard Told, MD, PhD, Priv.-Doz. role: CONTACT phone: 0043 1 40400 48470 email: reinhard.told@meduniwien.ac.at name: Adrian Reumueller, MD, Priv.-Doz role: SUB_INVESTIGATOR name: Roman Dunavoelgyi, MD, Assoc.-Prof. role: SUB_INVESTIGATOR lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06280027 id: MUDHF_BK1 briefTitle: Effect of Midline Discrepancy and Crown Width Disporportion on Esthetics overallStatus: COMPLETED date: 2023-06-05 date: 2023-06-12 date: 2023-12-22 date: 2024-02-28 date: 2024-02-28 name: Marmara University class: OTHER briefSummary: In the web-based cross-sectional study 180 participants were included. Half of them (n = 90) were patients (laypeople) of the university clinic and the remaining half were restorative dentists and prosthodontists with similar levels of clinical experience (at least 3 years of academic training).

A frontal view full-face portrait image of a 25-year-old female was selected as a model for the study, with a smile exhibiting good dental alignment, a quite good midline position, and tooth size symmetry.

The original image was digitally modified by a single restorative instructor using Photoshop CC (Adobe, USA) software program. The modifications were divided into three parts. The first part was the generation of midline discrepancy at different levels. The midline was digitally moved to the right side of the patient 1 - 4 millimeters, gradually. The midline movement was performed together with the whole maxillary arch.

The second part was the generation of individual crown width disproportions. Accordingly, the mesiodistal width of the left central, lateral, and canine was digitally decreased one by one, gradually, while the width of the symmetrical teeth on the right side was simultaneously increased.

The third part was the generation of distributed crown width disproportions. Accordingly, the total mesiodistal width of the left central, lateral, and canine was equally decreased, gradually, while the total width of the symmetrical teeth on the right side was simultaneously increased.

In total, 15 images were displayed in random order to the participants including the original image. An online survey was generated to quantitatively evaluate the level of esthetic perception. Subsequently, the participants were asked to evaluate the level of smile esthetics of the presented random images, without being informed about the digital manipulations of the images. The participants were even not informed about the original image. They were expected to answer the question "How esthetic do you consider this smile?" The evaluation of each image was performed via a Visual analog scale VAS, ranging from point 0 (extremely not esthetic) to point 100 (extremely esthetic). conditions: Esthetics, Dental studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 180 type: ACTUAL name: survey measure: survey on midline discrepancy at different levels measure: survey on individual crown width disproportions measure: survey on distributed crown width disproportions sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University Faculty of Dentistry city: İstanbul zip: 34854 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06280014 id: YYU-09/15.12.2021 briefTitle: Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Wisdom Dental Surgery overallStatus: COMPLETED date: 2022-01-20 date: 2022-02-20 date: 2023-09-25 date: 2024-02-28 date: 2024-02-28 name: Yuzuncu Yıl University class: OTHER briefSummary: This study was administered to 22 female and 8 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After impacted tooth extraction, the patient used mefenamic acid on one side and dexketoprofen on the other side for postoperative pain relief. The effects of these two materials on patient comfort were investigated. conditions: Tooth, Impacted conditions: Tooth Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Surgery of impacted mandibular wisdom teeth name: Surgery of impacted mandibular wisdom teeth measure: Mouth opening measurements measure: Facial edema measure: Visual Analog Scale sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Serap Keskin Tunc city: Van zip: 65100 country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False

 nctId: NCT06280001 id: 2023YFC2308802-04 briefTitle: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-02-28 date: 2024-03-04 name: Zhejiang University class: OTHER name: Beijing Ditan Hospital name: Beijing YouAn Hospital name: Huashan Hospital name: Qilu Hospital of Shandong University briefSummary: The goal of this observational study is to determine the incidence and spectrum of opportunistic infections among Chinese HIV/AIDS patients at this stage, to find intervention targets, to construct an early warning prediction model, and to give an individualized program with integrated immune function to obtain salvage opportunities for patients.The main questions it aims to answer are:

* Describe the populations and characteristics of pathogenic microorganisms involved in HIV co-infection, map the spatial and temporal changes in the infection system of pathogenic microorganisms, and evaluate their impact on disease regression.
* Explore the mechanism of interaction between pathogenic microorganisms and host autoimmune deficiencies.
* Discover early warning and predictive markers and immunological indicators of pathogenic microorganisms, and explore new technologies and programs to reduce the mortality rate of infection. conditions: Acquired Immunodeficiency Syndrome conditions: HIV Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Secondary infections in patients with HIV/AIDS at 4 weeks measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks measure: Survival rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279988 id: K24 briefTitle: BRING-UP 3 Heart Failure acronym: BRING-UP3HF overallStatus: RECRUITING date: 2023-09-15 date: 2026-06-30 date: 2026-07-30 date: 2024-02-28 date: 2024-02-28 name: Heart Care Foundation class: OTHER briefSummary: The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF). conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Rate of adherence to Guideline-Directed Medical Therapy (GDMTs) in HFrEF measure: Rate of patient achieving appropriate dosages of GDMTs measure: Treatment patterns of patients with Heart failure with mildly reduced ejection fraction (HFmrEF) and Heart failure with preserved ejection fraction (HFpEF) measure: Treatment patterns of patients with Acute Heart Failure (AHF) irrespective of the level of EF measure: All cause and specific causes of death and hospitalization (Exploratory endpoint) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Santo Spirito - Sc Cardiologia status: RECRUITING city: Casale Monferrato state: AL zip: 15033 country: Italy name: FEDERICO NARDI, MD role: CONTACT lat: 45.13338 lon: 8.4525 facility: Ospedale San Giacomo - Sc Cardiologia status: RECRUITING city: Novi Ligure state: AL zip: 15067 country: Italy name: MARIA E ROVERE, MD role: CONTACT lat: 44.76246 lon: 8.787 facility: Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic status: RECRUITING city: Ancona state: AN zip: 60122 country: Italy name: ILARIA BATTISTONI, MD role: CONTACT lat: 43.5942 lon: 13.50337 facility: Irccs Inrca - Uo Cardiologia/Utic/Telecardiologia status: RECRUITING city: Ancona state: AN zip: 60131 country: Italy name: PAOLA TAMBURRINI, MD role: CONTACT lat: 43.5942 lon: 13.50337 facility: Ospedale San Donato - U.O.C Cardiologia status: RECRUITING city: Arezzo state: AR zip: 52100 country: Italy name: MATTEO ROCCO RECCIA, MD role: CONTACT lat: 43.46276 lon: 11.88068 facility: Ospedale Valdichiana Santa Margherita - Uosd Cardiologia S.O. Cortona status: RECRUITING city: Cortona state: AR zip: 52044 country: Italy name: SIMONA D'ORAZIO, MD role: CONTACT lat: 43.27467 lon: 11.98533 facility: Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti' status: RECRUITING city: Avellino state: AV zip: 83100 country: Italy name: EMILIO DI LORENZO, MD role: CONTACT lat: 40.91494 lon: 14.79103 facility: Ospedale Miulli - U.O.C. Cardiologia - Utic status: RECRUITING city: Acquaviva Delle Fonti state: BA zip: 70021 country: Italy name: NICOLA VITULANO, MD role: CONTACT lat: 40.89704 lon: 16.8433 facility: Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic status: RECRUITING city: Altamura state: BA zip: 70022 country: Italy name: PIETRO SCICCHITANO, MD role: CONTACT lat: 40.82664 lon: 16.54952 facility: Ospedale San Paolo - Cardiologia-Utic status: RECRUITING city: Bari state: BA zip: 70123 country: Italy name: PASQUALE CALDAROLA, MD role: CONTACT lat: 41.11148 lon: 16.8554 facility: Ics Maugeri Spa Societa' Benefit Irccs Bari - Cardiologia Riabilitativa status: RECRUITING city: Bari state: BA zip: 70124 country: Italy name: ANDREA PASSANTINO, MD role: CONTACT lat: 41.11148 lon: 16.8554 facility: Mater Dei Hospital - Riabilitazione Cardiologica status: RECRUITING city: Bari state: BA zip: 70124 country: Italy name: ROCCO LAGIOIA, MD role: CONTACT lat: 41.11148 lon: 16.8554 facility: Ospedale Di Venere - U.O.C. Di Cardiologia status: RECRUITING city: Carbonara Di Bari state: BA zip: 70012 country: Italy name: MASSIMO V BONFANTINO, MD role: CONTACT lat: 41.06667 lon: 16.86667 facility: Ospedale San Giacomo - Uoc Cardiologia status: RECRUITING city: Monopoli state: BA zip: 70043 country: Italy name: ONOFRIO ROSSI, MD role: CONTACT lat: 40.94918 lon: 17.29717 facility: Ospedale Degli Infermi - Sc Di Cardiologia status: RECRUITING city: Ponderano state: BI zip: 13875 country: Italy name: ANDREA ROGNONI, MD role: CONTACT lat: 45.53846 lon: 8.05592 facility: Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic status: RECRUITING city: Feltre state: BL zip: 32032 country: Italy name: FRANCESCA DE CIAN, MD role: CONTACT lat: 46.02085 lon: 11.90031 facility: Ospedale Di Bentivoglio - U.O. Cardiologia Pianura status: RECRUITING city: Bentivoglio state: BO zip: 40010 country: Italy name: GIANFRANCO TORTORICI, MD role: CONTACT lat: 44.6369 lon: 11.41737 facility: Ospedale Maggiore - U.O.C. Di Cardiologia status: RECRUITING city: Bologna state: BO zip: 40133 country: Italy name: GIULIA BUGANI, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: Ospedale Policlinico S. Orsola-Malpighi - Medicina Interna - Borghi status: RECRUITING city: Bologna state: BO zip: 40138 country: Italy name: CLAUDIO BORGHI, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: Ospedale Perrino - U.O.C. Di Cardiologia status: RECRUITING city: Brindisi state: BR zip: 72100 country: Italy name: GIAN PAOLO GIORDA, MD role: CONTACT lat: 40.63215 lon: 17.93607 facility: Istituto Ospedaliero Fondazione Poliambulanza - Unita Operativa Di Cardiologia E Utic status: RECRUITING city: Brescia state: BS zip: 25124 country: Italy name: LORENZO CAPRINI, MD role: CONTACT lat: 45.53558 lon: 10.21472 facility: Ospedale Di Desenzano Del Garda - Divisione Di Cardiologia - U.C.C. status: RECRUITING city: Desenzano Del Garda state: BS zip: 25015 country: Italy name: GIOSUE' MASCIOLI, MD role: CONTACT lat: 45.47127 lon: 10.53559 facility: Ospedale Civile 'La Memoria' - U.O. Di Cardiologia status: RECRUITING city: Gavardo state: BS zip: 25085 country: Italy name: MARCO TRIGGIANI, MD role: CONTACT lat: 45.58939 lon: 10.44257 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Lumezzane - U.O. Di Cardiologia Riabilitativa status: RECRUITING city: Lumezzane state: BS zip: 25065 country: Italy name: EMANUELA ZANELLI, MD role: CONTACT lat: 45.64789 lon: 10.26487 facility: Ospedale Monsignor Angelo R. Di Miccoli - Uoc Cardiologia/Utic status: ACTIVE_NOT_RECRUITING city: Barletta state: BT zip: 76121 country: Italy lat: 41.31429 lon: 16.28165 facility: Ospedale Caduti in Guerra - U.O.S.V.D Di Riabilitazione Cardiologica status: RECRUITING city: Canosa Di Puglia state: BT zip: 76012 country: Italy name: FRANCESCO BARTOLOMUCCI, MD role: CONTACT lat: 41.21954 lon: 16.06768 facility: Ospedale Centrale Bolzano - Cardiologia E Prove Funzionali status: RECRUITING city: Bolzano state: BZ zip: 39100 country: Italy name: PRISCILLA MILEWSKI, MD role: CONTACT lat: 46.49067 lon: 11.33982 facility: Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic status: RECRUITING city: Caserta state: CE zip: 81100 country: Italy name: PAOLO CALABRO', MD role: CONTACT lat: 41.07262 lon: 14.33231 facility: Villa Delle Magnolie - Riabilitazione Cardiologica status: RECRUITING city: Castel Morrone state: CE zip: 81020 country: Italy name: FRANCESO PERONE, MD role: CONTACT lat: 41.12102 lon: 14.35473 facility: Casa Di Cura San Michele - Uo Cardiologia status: RECRUITING city: Maddaloni state: CE zip: 81024 country: Italy name: MARCO PEPE, MD role: CONTACT lat: 41.03578 lon: 14.3823 facility: Ospedale Policlinico Ss. Annunziata - Uoc Cardiologia-Utic status: RECRUITING city: Chieti state: CH zip: 66013 country: Italy name: MARCO ZIMARINO, MD role: CONTACT lat: 42.34827 lon: 14.16494 facility: Azienda Ospedaliera Santa Croce E Carle - Sc Cardiologia status: RECRUITING city: Cuneo state: CN zip: 12100 country: Italy name: ROBERTA ROSSINI, MD role: CONTACT lat: 44.39071 lon: 7.54828 facility: Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic status: RECRUITING city: Mondovì state: CN zip: 12084 country: Italy name: MAURO FEOLA, MD role: CONTACT lat: 44.39603 lon: 7.81764 facility: Ospedale Maggiore Ss. Annunziata - Sc Cardiologia status: RECRUITING city: Savigliano state: CN zip: 12038 country: Italy name: MICHELE DE BENEDICTIS, MD role: CONTACT lat: 44.64808 lon: 7.65677 facility: Ospedale Pietro E Michele Ferrero - Cardiologia E Utic status: RECRUITING city: Verduno state: CN zip: 12060 country: Italy name: VIRGINIA BOVOLO, MD role: CONTACT lat: 44.66614 lon: 7.93074 facility: Ospedale S. Anna - U.O.C. Di Cardiologia status: RECRUITING city: San Fermo Della Battaglia state: CO zip: 22020 country: Italy lat: 45.80868 lon: 9.04744 facility: Ospedale Oglio Po - U.O. Di Cardiologia-Utic status: RECRUITING city: Casalmaggiore state: CR zip: 26041 country: Italy name: CARLO PISCICELLI, MD role: CONTACT lat: 44.98981 lon: 10.42055 facility: Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic status: RECRUITING city: Castrovillari state: CS zip: 87012 country: Italy name: ANDREA MADEO, MD role: CONTACT lat: 39.81632 lon: 16.20183 facility: Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia status: RECRUITING city: Paola state: CS zip: 87027 country: Italy name: MARIA T MANES, MD role: CONTACT lat: 39.36313 lon: 16.03691 facility: P.O. Garibaldi-Nesima - Arnas Garibaldi - U.O.C. Di Cardiologia Con Utic status: RECRUITING city: Catania state: CT zip: 95122 country: Italy name: MICHELE M GULIZIA, MD role: CONTACT lat: 37.49223 lon: 15.07041 facility: Policlinico Catania Po G. Rodolico - Cardiologia Utic status: RECRUITING city: Catania state: CT zip: 95125 country: Italy name: GIUSEPPE LEONARDI, MD role: CONTACT lat: 37.49223 lon: 15.07041 facility: Azienda Ospedaliera Cannizzaro - Uoc Cardiologia status: RECRUITING city: Catania state: CT zip: 95126 country: Italy name: FRANCESCO AMICO, MD role: CONTACT lat: 37.49223 lon: 15.07041 facility: P.O. "Materdomini" - A.O.U. "Renato Dulbecco" - Ssd Cardiologia Riabilitativa status: RECRUITING city: Catanzaro state: CZ zip: 88100 country: Italy name: DOMENICO ZUCCO, MD role: CONTACT lat: 38.88247 lon: 16.60086 facility: P.O. "Pugliese" - A.O.U. "Renato Dulbecco" - Utic-Emodinamica E Cardiologia Interventistica status: RECRUITING city: Catanzaro state: CZ zip: 88100 country: Italy name: FRANCESCO CASSADONTE, MD role: CONTACT lat: 38.88247 lon: 16.60086 facility: Presidio Ospedaliero Umberto I - Cardiologia - Utic- Riabilitazione status: RECRUITING city: Enna state: EN zip: 94100 country: Italy name: RAFFAELLA IUDICELLO, MD role: CONTACT lat: 37.5655 lon: 14.27433 facility: Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia status: RECRUITING city: Forli' state: FC zip: 47121 country: Italy name: ELISA GARDINI, MD role: CONTACT lat: 44.22177 lon: 12.04144 facility: Ospedale Ss. Annunziata - U.O. Di Cardiologia Provinciale status: RECRUITING city: Cento state: FE zip: 44042 country: Italy name: BIAGIO SASSONE, MD role: CONTACT lat: 44.73099 lon: 11.28716 facility: Arcispedale Sant'Anna - U.O. Cardiologia status: RECRUITING city: Ferrara state: FE zip: 44124 country: Italy name: ALESSANDRO FUCILI, MD role: CONTACT lat: 44.83804 lon: 11.62057 facility: Ospedale Del Delta - U.O. Cardiologia status: RECRUITING city: Lagosanto state: FE zip: 44023 country: Italy name: BIAGIO SASSONE, MD role: CONTACT lat: 44.76282 lon: 12.14005 facility: Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic status: RECRUITING city: Foggia state: FG zip: 71100 country: Italy name: NATALE D BRUNETTI, MD role: CONTACT lat: 41.45845 lon: 15.55188 facility: Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica status: ACTIVE_NOT_RECRUITING city: San Giovanni Rotondo state: FG zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: Ospedale San Giuseppe - Cardiologia status: RECRUITING city: Empoli state: FI zip: 50053 country: Italy name: FLAVIO VENTURI, MD role: CONTACT lat: 43.71795 lon: 10.94758 facility: Ospedale Santa Maria Nuova - Cardiologia status: RECRUITING city: Firenze state: FI zip: 50122 country: Italy name: MASSIMO MILLI, MD role: CONTACT lat: 43.77925 lon: 11.24626 facility: Ospedale San Giovanni Di Dio - Sos Cardiologia status: RECRUITING city: Firenze state: FI zip: 50124 country: Italy name: MASSIMO MILLI, MD role: CONTACT lat: 43.77925 lon: 11.24626 facility: Aou Careggi - Geriatria - Utig status: RECRUITING city: Firenze state: FI zip: 50141 country: Italy name: ANDREA UNGAR, MD role: CONTACT lat: 43.77925 lon: 11.24626 facility: Ospedale Padre Antero Micone - Sc Cardiologia - Utic status: RECRUITING city: Genova state: GE zip: 16100 country: Italy name: SILVIA COSTA, MD role: CONTACT lat: 44.40478 lon: 8.94438 facility: Irccs Ospedale Policlinico San Martino - Clinica Malattie Apparato Cardiovascolare status: RECRUITING city: Genova state: GE zip: 16132 country: Italy name: MARCO CANEPA, MD role: CONTACT lat: 44.40478 lon: 8.94438 facility: Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic status: RECRUITING city: Lavagna state: GE zip: 16033 country: Italy name: GUIDO PARODI, MD role: CONTACT lat: 44.3062 lon: 9.35383 facility: Ospedale San Giovanni Di Dio - Sc Cardiologia (Gorizia-Monfalcone) status: RECRUITING city: Gorizia state: GO zip: 34170 country: Italy name: GERARDINA LARDIERI, MD role: CONTACT lat: 45.94088 lon: 13.62167 facility: Ospedale Civile San Polo - Sc Cardiologia (Gorizia-Monfalcone) status: RECRUITING city: Monfalcone state: GO zip: 34074 country: Italy name: GERARDINA LARDIERI, MD role: CONTACT lat: 45.80463 lon: 13.53292 facility: Ospedale S. Andrea - Alta Maremma - Uosd Cardiologia status: RECRUITING city: Massa Marittima state: GR zip: 58024 country: Italy name: NICOLA D'APRILE, MD role: CONTACT lat: 43.04779 lon: 10.89293 facility: Ospedale Alessandro Manzoni - S.C. Di Cardiologia status: RECRUITING city: Lecco state: LC zip: 23900 country: Italy name: ROBERTO SPOLADORE, MD role: CONTACT lat: 45.85589 lon: 9.39704 facility: Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia status: ACTIVE_NOT_RECRUITING city: Copertino state: LE zip: 73043 country: Italy lat: 40.26821 lon: 18.0543 facility: Ospedale Vito Fazzi - Uoc Cardiologia-Utic Ed Emodinamica status: RECRUITING city: Lecce state: LE zip: 73100 country: Italy name: STEFANIA MARAZIA, MD role: CONTACT lat: 40.35481 lon: 18.17244 facility: Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic "E. Vilei" status: RECRUITING city: Scorrano state: LE zip: 73020 country: Italy name: COSIMO A GRECO, MD role: CONTACT lat: 40.09018 lon: 18.29993 facility: Ospedali Riuniti - U.O.C. Cardiologia E Utic status: RECRUITING city: Livorno state: LI zip: 57124 country: Italy name: EMILIO M PASANISI, MD role: CONTACT lat: 43.54427 lon: 10.32615 facility: Ospedale Villamarina - Cardiologia E Utic Piombino Elba status: RECRUITING city: Piombino state: LI zip: 57025 country: Italy name: LARA FREDIANI, MD role: CONTACT lat: 42.92554 lon: 10.52585 facility: Nuovo Ospedale Versilia - Sc Cardiologia status: RECRUITING city: Camaiore state: LU zip: 55041 country: Italy name: GIANCARLO CASOLO, MD role: CONTACT lat: 43.94265 lon: 10.29754 facility: Ospedale Santa Croce - Uosd Cardiologia E Di Continuita Assist. status: ACTIVE_NOT_RECRUITING city: Castelnuovo Di Garfagnana state: LU zip: 55032 country: Italy lat: 44.1126 lon: 10.40518 facility: Ospedale Pio Xi - U.O.C. Di Cardiologia status: RECRUITING city: Desio state: MB zip: 20832 country: Italy name: FELICE ACHILLI, MD role: CONTACT lat: 45.61831 lon: 9.20249 facility: Policlinico Di Monza - Cardiologia Clinica E Utic status: RECRUITING city: Monza state: MB zip: 20900 country: Italy name: MATTEO OLDANI, MD role: CONTACT lat: 45.58005 lon: 9.27246 facility: Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic status: RECRUITING city: Vimercate state: MB zip: 20871 country: Italy name: ANTONIO CIRO', MD role: CONTACT lat: 45.61545 lon: 9.36801 facility: Ospedale Generale Provinciale - U.O. Cardiologia status: RECRUITING city: Macerata state: MC zip: 62100 country: Italy name: DANIELE CONTADINI, MD role: CONTACT lat: 43.29789 lon: 13.45293 facility: Irccs Centro Neurolesi Bonino Pulejo - P.O Piemonte - Cardiologia E Utic status: RECRUITING city: Messina state: ME zip: 98124 country: Italy name: MYRIAM D'ANGELO, MD role: CONTACT lat: 38.19394 lon: 15.55256 facility: Azienda Ospedaliera Papardo - U.O. Cardiologia Con Utic - Emodinamica status: RECRUITING city: Messina state: ME zip: 98158 country: Italy name: MARIA C TODARO, MD role: CONTACT lat: 38.19394 lon: 15.55256 facility: Asst Papa Giovanni Xxiii - Sc Cardiologia 1 status: RECRUITING city: Bergamo state: MI zip: 24127 country: Italy name: EMILIA D'ELIA, MD role: CONTACT lat: 45.69601 lon: 9.66721 facility: Ospedale Di Cernusco Sul Naviglio - U. O. Di Cardiologia E Ucc status: RECRUITING city: Cernusco Sul Naviglio state: MI zip: 20063 country: Italy name: SERGIO SALA, MD role: CONTACT lat: 45.52526 lon: 9.33297 facility: Ospedale Edoardo Bassini - Sc Cardiologia-Ucc Asst Nord Milano (Bassini-Ssg) status: RECRUITING city: Cinisello Balsamo state: MI zip: 20092 country: Italy name: GRAZIA M CASTELLI, MD role: CONTACT lat: 45.55823 lon: 9.21495 facility: Asst Ovest Milanese - Po Di Legnano - Cardiologia E Unita' Coronarica status: RECRUITING city: Legnano state: MI zip: 20025 country: Italy name: CORINNA A INSERRA, MD role: CONTACT lat: 45.59788 lon: 8.91506 facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari status: RECRUITING city: Milano state: MI zip: 20122 country: Italy name: STEFANO CARUGO, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Ospedale Fatebenefratelli E Oftalmico - Cardiologia E U.C.C. status: RECRUITING city: Milano state: MI zip: 20122 country: Italy name: ADA F GIGLIO, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Centro Cardiologico Monzino Irccs - Scompenso,Cardiologia Clinica status: RECRUITING city: Milano state: MI zip: 20138 country: Italy name: PIETRO PALERMO, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Riabilitazione Cardiologica status: RECRUITING city: Milano state: MI zip: 20138 country: Italy name: MAURO MONELLI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Uo Cure Subacute status: RECRUITING city: Milano state: MI zip: 20138 country: Italy name: MAURO PROIETTI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: ASST SANTI PAOLO E CARLO - PO San Carlo - CARDIOLOGIA-UCC status: RECRUITING city: Milano state: MI zip: 20153 country: Italy name: STEFANO LUCREZIOTTI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Irccs Ospedale Galeazzi - Sant'Ambrogio - Cardiologia Universitaria Ed Imaging Cardiaco status: RECRUITING city: Milano state: MI zip: 20157 country: Italy name: EDOARDO CONTE, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 2 - Insufficienza Cardiaca E Trapianto status: RECRUITING city: Milano state: MI zip: 20162 country: Italy name: ANDREA GARASCIA, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Clinica San Carlo - U.O. Cardiologia-Unita'Cure Coronariche status: RECRUITING city: Paderno Dugnano state: MI zip: 20037 country: Italy name: ALESSIO CAPPELLERI, MD role: CONTACT lat: 45.56899 lon: 9.16483 facility: Presidio Ospedaliero Di Passirana - Cardiologia Riabilitativa status: RECRUITING city: Passirana state: MI zip: 20017 country: Italy name: ANNA FRISINGHELLI, MD role: CONTACT lat: 45.54792 lon: 9.04412 facility: Istituto Clinico Humanitas - Irccs - Cardiologia Clinica, Interventistica E Ucc status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: GIUSEPPE PINTO, MD role: CONTACT lat: 45.38193 lon: 9.1559 facility: Irccs Policlinico San Donato - U.O. Cardiologia Con Utic status: RECRUITING city: San Donato Milanese state: MI zip: 20097 country: Italy name: MASSIMO PIEPOLI, MD role: CONTACT lat: 45.41047 lon: 9.26838 facility: Irccs Policlinico Multimedica - Uo Di Cardiologia status: RECRUITING city: Sesto San Giovanni state: MI zip: 20099 country: Italy name: GIUSEPPE GALATI, MD role: CONTACT lat: 45.53329 lon: 9.22585 facility: Ospedale Madonna Delle Grazie - Ssd Utic status: ACTIVE_NOT_RECRUITING city: Matera state: Mount zip: 75100 country: Italy lat: 40.66599 lon: 16.60463 facility: Ospedale Giovanni Paolo Ii - Uosd Utic status: RECRUITING city: Policoro state: Mount zip: 75025 country: Italy name: ANDREA ANDRIANI, MD role: CONTACT lat: 40.2128 lon: 16.67795 facility: Ospedale Santa Maria Bianca - U.O. Di Cardiologia status: RECRUITING city: Mirandola state: MO zip: 41037 country: Italy name: BENEDETTA VERONESI, MD role: CONTACT lat: 44.88515 lon: 11.06902 facility: Ospedale Di Sassuolo - Cardiologia status: RECRUITING city: Sassuolo state: MO zip: 41049 country: Italy name: ANNA MARTELLI, MD role: CONTACT lat: 44.5432 lon: 10.7848 facility: Ospedale Giovanni Paolo Ii - Utic - Cardiologia status: RECRUITING city: Olbia state: OT zip: 07026 country: Italy name: MARIA ELENA L PICOI, MD role: CONTACT lat: 40.92337 lon: 9.49802 facility: Fondazione G. Giglio - U.O. Di Cardiologia status: RECRUITING city: Cefalu' state: PA zip: 90015 country: Italy name: TOMMASO A CIPOLLA, MD role: CONTACT lat: 38.03856 lon: 14.02285 facility: Ospedale Buccheri La Ferla Fatebenefratelli - Ssd Riabilitazione Cardiovascolare status: RECRUITING city: Palermo state: PA zip: 90123 country: Italy name: FILIPPO M SARULLO, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Arnas P.O. Civico E Benfratelli - Uoc Utic status: RECRUITING city: Palermo state: PA zip: 90127 country: Italy name: IGNAZIO M SMECCA, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Arnas P.O. Civico E Benfratelli - Uosd Cardiologia Clinica Trattam. Scompenso Card. status: RECRUITING city: Palermo state: PA zip: 90127 country: Italy name: EGLE INCALCATERRA, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Maria Eleonora Hospital - Cardiologia status: RECRUITING city: Palermo state: PA zip: 90135 country: Italy name: VINCENZO PERNICE, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello status: RECRUITING city: Palermo state: PA zip: 90146 country: Italy name: VINCENZO POLIZZI, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia status: RECRUITING city: Palermo state: PA zip: 90146 country: Italy name: AGATA M FLORESTA, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Ospedale Unico Della Val Tidone - Cardiologia E Riabilitazione status: RECRUITING city: Castel San Giovanni state: PC zip: 29015 country: Italy name: GIANLUCA LANATI, MD role: CONTACT lat: 45.06014 lon: 9.43784 facility: Ospedale Civile 'Guglielmo Da Saliceto' - Uoc Cardiologia E Utic status: RECRUITING city: Piacenza state: PC zip: 29100 country: Italy name: DANIELA ASCHIERI, MD role: CONTACT lat: 45.05242 lon: 9.69342 facility: Ospedali Riuniti Padova Sud - U.O.C. Cardiologia status: RECRUITING city: Monselice state: PD zip: 35043 country: Italy name: FRANCESCA E BOVOLATO, MD role: CONTACT lat: 45.239 lon: 11.74984 facility: Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic status: RECRUITING city: Pescara state: PE zip: 65124 country: Italy name: MASSIMO DI MARCO, MD role: CONTACT lat: 42.4584 lon: 14.20283 facility: Presidio Ospedaliero Citta' Di Castello - U.O. Cardiologia/Utic status: RECRUITING city: Citta' Di Castello state: PG zip: 06012 country: Italy name: KWAME MBOUMI, MD role: CONTACT lat: 43.46556 lon: 12.2375 facility: Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia status: RECRUITING city: Foligno state: PG zip: 06034 country: Italy name: EMILIA BISCOTTINI, MD role: CONTACT lat: 42.95488 lon: 12.70268 facility: Ospedale Gubbio-Gualdo Tadino - U.O. Di Utic E Cardiologia status: RECRUITING city: Gubbio state: PG zip: 06024 country: Italy name: DEBORAH COSMI, MD role: CONTACT lat: 43.34996 lon: 12.57309 facility: Centro Servizi Grocco - Cardiologia Riabilitativa E Prevenzione status: RECRUITING city: Perugia state: PG zip: 06123 country: Italy name: LUCIA FILIPPUCCI, MD role: CONTACT lat: 43.1122 lon: 12.38878 facility: Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare status: RECRUITING city: Pisa state: PI zip: 56124 country: Italy name: MICHELE EMDIN, MD role: CONTACT lat: 43.70853 lon: 10.4036 facility: Ospedale Generale Provinciale Lotti - U.O. Malattie Cardiovascolari Vde E Avc status: ACTIVE_NOT_RECRUITING city: Pontedera state: PI zip: 56025 country: Italy lat: 43.66141 lon: 10.63067 facility: Ospedale Di S. Vito Al Tagliamento - Ssd Cardiologia San Vito - Spilimbergo status: RECRUITING city: San Vito Al Tagliamento state: PN zip: 33078 country: Italy name: ARIANNA GARDIN, MD role: CONTACT lat: 45.9168 lon: 12.85945 facility: Ospedale San Jacopo - Soc Cardiologia status: RECRUITING city: Pistoia state: Point zip: 51100 country: Italy name: MICHELA TAGLIOLI, MD role: CONTACT lat: 43.93064 lon: 10.92365 facility: Ospedale Civile - U.O.C. Cardiologia - Utic status: RECRUITING city: Fidenza state: PR zip: 43036 country: Italy name: GIOVANNI TORTORELLA, MD role: CONTACT lat: 44.86694 lon: 10.06039 facility: Fondazione Irccs Policlinico San Matteo - Uoc Cardiologia 1 status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: ANNALISA TURCO, MD role: CONTACT lat: 45.19205 lon: 9.15917 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Pavia - U.O. Di Riabilitazione Cardiologica status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: GIOVANNI FORNI, MD role: CONTACT lat: 45.19205 lon: 9.15917 facility: Ospedale Civile - U.O. Di Cardiologia status: RECRUITING city: Voghera state: PV zip: 27058 country: Italy name: MICHELA G COCCIA, MD role: CONTACT lat: 44.99151 lon: 9.01175 facility: Ospedale Civile - Uo Servizio Cardiologia status: RECRUITING city: Lugo state: RA zip: 48022 country: Italy name: GIULIA RICCI LUCCHI, MD role: CONTACT lat: 44.42137 lon: 11.91094 facility: Ospedale Civile Santa Maria Delle Croci - Uoc Cardiologia status: RECRUITING city: Ravenna state: RA zip: 48121 country: Italy name: ANDREA RUBBOLI, MD role: CONTACT lat: 44.41344 lon: 12.20121 facility: Ospedale Civile Di Guastalla - Sos Cardiologia E Riabilitazione Card Area Nord status: RECRUITING city: Guastalla state: RE zip: 42016 country: Italy name: ALESSANDRO NAVAZIO, MD role: CONTACT lat: 44.91172 lon: 10.66186 facility: Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera status: RECRUITING city: Reggio Emilia state: RE zip: 42100 country: Italy name: ALESSANDRO NAVAZIO, MD role: CONTACT lat: 44.69825 lon: 10.63125 facility: Ospedale Riccardo Guzzardi - U.O.C. Di Cardiologia-Utic status: RECRUITING city: Vittoria state: RG zip: 97019 country: Italy name: GIUSEPPE DI STABILE, MD role: CONTACT lat: 36.95151 lon: 14.52788 facility: P.O. San Camillo de Lellis - U.O.C. Cardiologia status: RECRUITING city: Rieti state: RI zip: 02100 country: Italy name: AMIR KOL, MD role: CONTACT lat: 42.40476 lon: 12.85735 facility: Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic status: RECRUITING city: Ariccia state: RM zip: 00072 country: Italy name: ANNA R FELICI, MD role: CONTACT lat: 41.72063 lon: 12.6723 facility: Ospedale Civile San Paolo - U.O.C. Cardiologia - Utic status: RECRUITING city: Civitavecchia state: RM zip: 00053 country: Italy name: SERGIO CALCAGNO, MD role: CONTACT lat: 42.09325 lon: 11.79674 facility: Campus Biomedico - Cardiologia status: RECRUITING city: Roma state: RM zip: 00128 country: Italy name: FRANCESCA GRIGIONI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Clinica E Riabilitativa status: RECRUITING city: Roma state: RM zip: 00135 country: Italy name: FURIO COLIVICCHI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Inmi Lazzaro Spallanzani Irccs - Servizio Di Cardiologia Del Dipartimento Clinico status: RECRUITING city: Roma state: RM zip: 00149 country: Italy name: MARIA C GATTO, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Camillo - Uoc Cardiologia status: RECRUITING city: Roma state: RM zip: 00152 country: Italy name: GIOVANNI PULIGNANO, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale Sandro Pertini - Uoc Cardiologia status: RECRUITING city: Roma state: RM zip: 00157 country: Italy name: ANTONINO GRANATELLI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Policlinico Casilino - U.O.C. Cardiologia status: RECRUITING city: Roma state: RM zip: 00169 country: Italy name: LEONARDO CALO', MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ao San Giovanni Addolorata - Uoc Cardiologia D'Urgenza E Utic status: RECRUITING city: Roma state: RM zip: 00184 country: Italy name: VITTORIA RIZZELLO, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale Isola Tiberina - Uoc Cardiologia Diagnostica Interventistica-Utic status: RECRUITING city: Roma state: RM zip: 00188 country: Italy name: MATTEO RUZZOLINI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia status: RECRUITING city: Roma state: RM zip: 00189 country: Italy name: EMANUELE BARBATO, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale Santo Spirito - Uoc Cardiologia status: RECRUITING city: Roma state: RM zip: 00193 country: Italy name: ANGELA B SCARDOVI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic status: RECRUITING city: Tivoli state: RM zip: 00019 country: Italy name: ALFREDO POSTERARO, MD role: CONTACT lat: 41.95952 lon: 12.8016 facility: Ospedale Infermi - U.O. Cardiologia status: RECRUITING city: Rimini state: RN zip: 47900 country: Italy name: SAMUELA CARIGI, MD role: CONTACT lat: 44.05755 lon: 12.56528 facility: Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic status: RECRUITING city: Eboli state: SA zip: 84025 country: Italy name: ELISA DI IACONI, MD role: CONTACT lat: 40.61747 lon: 15.05693 facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva Ospedaliera status: RECRUITING city: Salerno state: SA zip: 84131 country: Italy name: MICHELE R DI MURO, MD role: CONTACT lat: 40.67545 lon: 14.79328 facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Ssd Utic status: RECRUITING city: Salerno state: SA zip: 84131 country: Italy name: AMELIA RAVERA, MD role: CONTACT lat: 40.67545 lon: 14.79328 facility: Ospedale San Luca - U.O. Utic - Cardiologia status: RECRUITING city: Vallo Della Lucania state: SA zip: 84078 country: Italy name: ANTONIO ALOIA, MD role: CONTACT lat: 40.22786 lon: 15.26635 facility: Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic status: RECRUITING city: Poggibonsi state: SI zip: 53036 country: Italy name: VALERIO ZACA', MD role: CONTACT lat: 43.47064 lon: 11.14804 facility: Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia status: RECRUITING city: Siena state: SI zip: 53100 country: Italy name: SERAFINA VALENTE, MD role: CONTACT lat: 43.31822 lon: 11.33064 facility: Ospedale San Bartolomeo - Sc Riabilitazione Cardiologica status: RECRUITING city: Sarzana state: SP zip: 19038 country: Italy name: DANIELE BERTOLI, MD role: CONTACT lat: 44.11178 lon: 9.9622 facility: Ospedale E. Muscatello - U.O. Di Cardiologia - Utic status: RECRUITING city: Augusta state: SR zip: 96011 country: Italy name: GIOVANNI LICCIARDELLO, MD role: CONTACT lat: 37.24065 lon: 15.22121 facility: Ospedale G. Di Maria - Cardiologia Utic status: RECRUITING city: Avola state: SR zip: 96012 country: Italy name: PAOLO COSTA, MD role: CONTACT lat: 36.9084 lon: 15.13937 facility: Ospedale Ss. Annunziata - Cardiologia Clinica Ed Interventistica status: RECRUITING city: Sassari state: SS zip: 07100 country: Italy name: GAVINO CASU, MD role: CONTACT lat: 40.72586 lon: 8.55552 facility: Ospedale Nostra Signora Di Bonaria - U.O.C. Cardiologia E Utic status: RECRUITING city: San Gavino Monreale state: SU zip: 09037 country: Italy name: MARGHERITA CASULA, MD role: CONTACT lat: 39.55008 lon: 8.79065 facility: Po Ponente - Ospedale Santa Corona - Sc Cardiologia Ponente status: RECRUITING city: Pietra Ligure state: SV zip: 17027 country: Italy name: CHIARA BERNELLI, MD role: CONTACT lat: 44.1492 lon: 8.28206 facility: P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante status: RECRUITING city: Savona state: SV zip: 17100 country: Italy name: ALBERTO SOMASCHINI, MD role: CONTACT lat: 44.30905 lon: 8.47715 facility: Casa Di Cura Villa Verde - Cardiologia status: RECRUITING city: Taranto state: TA zip: 74100 country: Italy name: ANGELO ALOISIO, MD role: CONTACT lat: 40.46435 lon: 17.24707 facility: Ospedale Santa Chiara - Divisione Di Cardiologia status: RECRUITING city: Trento state: TN zip: 38122 country: Italy name: MICHELE MORETTI, MD role: CONTACT lat: 46.06787 lon: 11.12108 facility: Ospedale Civico - Sc Cardiologia status: RECRUITING city: Chivasso state: TO zip: 10034 country: Italy name: CLAUDIO MORETTI, MD role: CONTACT lat: 45.19093 lon: 7.88981 facility: Por Cirié- Lanzo Presidio Cirié - S.C. Cardiologia status: RECRUITING city: Cirié state: TO zip: 10073 country: Italy name: MICHELE CAPRIOLO, MD role: CONTACT lat: 45.23486 lon: 7.60125 facility: Ospedale Civile - S.C. Cardiologia status: RECRUITING city: Ivrea state: TO zip: 10015 country: Italy name: MARCO M CINGOLANI, MD role: CONTACT lat: 45.46723 lon: 7.87617 facility: Aou San Luigi Gonzaga - S.C.D.O. Cardiologia status: RECRUITING city: Orbassano state: TO zip: 10043 country: Italy name: CARLOALBERTO BIOLÉ, MD role: CONTACT lat: 45.00547 lon: 7.53813 facility: Aou Citta' Della Salute E Della Scienza - S.C. Cardiologia U status: RECRUITING city: Torino state: TO zip: 10126 country: Italy name: Gaetano M De Ferrari, MD role: CONTACT lat: 45.07049 lon: 7.68682 facility: Ospedale Martini - Cardiologia (Mrt-Mv) status: RECRUITING city: Torino state: TO zip: 10142 country: Italy name: MASSIMO GIAMMARIA, MD role: CONTACT lat: 45.07049 lon: 7.68682 facility: Ospedale Maria Vittoria - Cardiologia (Mrt-Mv) status: ACTIVE_NOT_RECRUITING city: Torino state: To zip: 10149 country: Italy lat: 45.07049 lon: 7.68682 facility: Ospedale San Giovanni Bosco - Sc Cardiologia status: RECRUITING city: Torino state: TO zip: 10154 country: Italy name: PIERLUIGI SBARRA, MD role: CONTACT lat: 45.07049 lon: 7.68682 facility: Ospedale Santa Maria Del Carmine - Cardiologia status: RECRUITING city: Rovereto state: Trento zip: 38068 country: Italy name: ANNA MANICA, MD role: CONTACT lat: 45.8904 lon: 11.04053 facility: Asugi Trieste - Sc Patologie Cardiovascolari status: RECRUITING city: Trieste state: TS zip: 34125 country: Italy name: GIULIA RUSSO, MD role: CONTACT lat: 45.64953 lon: 13.77679 facility: Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia status: RECRUITING city: Udine state: UD zip: 33100 country: Italy name: MARZIA DE BIASIO, MD role: CONTACT lat: 46.0693 lon: 13.23715 facility: Ospedale Multimedica Castellanza - Cardiologia status: RECRUITING city: Castellanza state: VA zip: 21053 country: Italy name: LUCIA SAPORITI, MD role: CONTACT lat: 45.61079 lon: 8.89616 facility: Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia status: RECRUITING city: Saronno state: VA zip: 21047 country: Italy name: DANIELE NASSIACOS, MD role: CONTACT lat: 45.62513 lon: 9.03517 facility: Ospedale Di Circolo Galmarini - Cardiologia status: RECRUITING city: Tradate state: VA zip: 21049 country: Italy name: PAOLA ANTOGNAZZA, MD role: CONTACT lat: 45.70843 lon: 8.90763 facility: Ospedale Sant'Andrea - Sc Cardiologia status: RECRUITING city: Vercelli state: VC zip: 13100 country: Italy name: ELISA RONDANO, MD role: CONTACT lat: 45.32163 lon: 8.41989 facility: Ospedale Dell'Angelo - U.O.C. Cardiologia status: RECRUITING city: Mestre state: VE zip: 30171 country: Italy name: SAKIS THEMISTOCLAKIS, MD role: CONTACT lat: 45.49167 lon: 12.24538 facility: Ospedale P.F. Calvi - Uos Di Cardiologia Riabilitativa status: RECRUITING city: Noale state: VE zip: 30033 country: Italy name: VALENTINA PESCATORE, MD role: CONTACT lat: 45.54596 lon: 12.06445 facility: Ospedale Civile - U.O.C. Di Cardiologia status: RECRUITING city: Arzignano state: VI zip: 36071 country: Italy name: CLAUDIO BILATO, MD role: CONTACT lat: 45.52027 lon: 11.33446 facility: Ospedale Alto Vicentino - U.O.C. Cardiologia - Ucic status: RECRUITING city: Santorso state: VI zip: 36014 country: Italy name: GIOVANNI MORANI, MD role: CONTACT lat: 45.73383 lon: 11.38785 facility: Ospedale G. Fracastoro - U.O.C. Di Cardiologia status: RECRUITING city: San Bonifacio state: VR zip: 37047 country: Italy name: MAURIZIO ANSELMI, MD role: CONTACT lat: 45.39595 lon: 11.27352 facility: Ospedale Civita Castellana - Ssd Cardiologia status: ACTIVE_NOT_RECRUITING city: Civita Castellana state: VT zip: 01033 country: Italy lat: 42.29304 lon: 12.40885 facility: Ospedale Belcolle - Uoc Cardiologia Ed Emodinamica status: RECRUITING city: Viterbo state: VT zip: 01100 country: Italy name: LUIGI SOMMARIVA, MD role: CONTACT lat: 42.41937 lon: 12.1056 facility: Ospedale Ss. Trinita' - S.C. Di Cardiologia status: RECRUITING city: Borgomanero zip: 28021 country: Italy name: PIERFRANCO S DELLAVESA, MD role: CONTACT lat: 45.69873 lon: 8.4623 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Veruno - Uo Cardiologia Riabilitativa status: RECRUITING city: Gattico zip: 28013 country: Italy name: MASSIMO PISTONO, MD role: CONTACT lat: 45.70717 lon: 8.52003 facility: Ospedale Anna Rizzoli - Cardiologia-Utic status: ACTIVE_NOT_RECRUITING city: Lacco Ameno zip: 80076 country: Italy lat: 40.74901 lon: 13.88718 facility: Ospedale Buon Consiglio Fatebenefratelli - U.O.Complessa Di Cardiologia E Utic status: RECRUITING city: Napoli zip: 80123 country: Italy name: GAETANO M RUOCCO, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Aorn Cardarelli - U.O. Cardiologia Con Utic status: RECRUITING city: Napoli zip: 80131 country: Italy name: CIRO MAURO, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Aorn Ospedale Dei Colli - P.O. Monaldi - Uosd Card. Riabilitativa Intensiva E Scompenso status: RECRUITING city: Napoli zip: 80131 country: Italy name: GIUSEPPE PACILEO, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Aorn Ospedale Dei Colli - P.O. Monaldi - Uosd Malattie Cardiologiche Congenite Adulti-Guch status: RECRUITING city: Napoli zip: 80131 country: Italy name: BERARDO SARUBBI, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Ospedale S. Giovanni Bosco - Sc Cardiologia - Utic status: RECRUITING city: Napoli zip: 80134 country: Italy name: PAOLO TAMMARO, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Aou Maggiore Della Carita' - Scdo Cardiologia Ii status: RECRUITING city: Novara zip: 28100 country: Italy name: LIDIA ROSSI, MD role: CONTACT lat: 45.44694 lon: 8.62118 facility: Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic Con Emodinamica status: RECRUITING city: Pozzuoli zip: 80078 country: Italy name: MARIANO AVERSA, MD role: CONTACT lat: 40.84394 lon: 14.0952 hasResults: False

 nctId: NCT06279975 id: Req-2023-01275; am23Sutter2 briefTitle: Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study acronym: INSPECT overallStatus: RECRUITING date: 2023-12-18 date: 2029-12 date: 2030-12 date: 2024-02-28 date: 2024-02-28 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination. conditions: Brain Death conditions: Adults studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: non-invasive device-supported, automated pupillometry measure: Reliability of clinical examination of pupils in patients with suspected brain death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Intensive care unit at the University Hospital Basel status: RECRUITING city: Basel state: Basel-Stadt zip: 4031 country: Switzerland name: Raoul Sutter, Prof. role: CONTACT phone: +41 61 328 7928 email: raoul.sutter@usb.ch name: Raoul Sutter, Prof. role: PRINCIPAL_INVESTIGATOR name: Pascale Grzonka, MD role: SUB_INVESTIGATOR lat: 47.55839 lon: 7.57327 facility: University Hospital Basel status: RECRUITING city: Basel country: Switzerland name: Raoul Sutter, Prof. role: CONTACT email: raoul.sutter@usb.ch name: Pascale Grzonka, MD role: CONTACT email: PascaleSusanne.Grzonka@usb.ch lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06279962 id: 2000034620 briefTitle: Survey Experiment to Estimate Level of Mental Illness Stigma Based on Condition and Gender overallStatus: COMPLETED date: 2023-06-15 date: 2023-09-15 date: 2023-09-15 date: 2024-02-28 date: 2024-02-28 name: Yale University class: OTHER name: Empower Through Health briefSummary: This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness. conditions: Mental Illness conditions: Stigma, Social studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 379 type: ACTUAL name: Survey questionnaire measure: Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE measure: Level of acceptance for the individual depicted in the vignette as measured by BROAD ACCEPTANCE SCALE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Empowerment to Heal - Uganda city: Iganga country: Uganda lat: 0.60917 lon: 33.46861 hasResults: False

 nctId: NCT06279949 id: 2000036999 id: 1K01MH136929-01 type: OTHER domain: NIMH *ID not yet added briefTitle: Confidential Care and Adolescent HIV Testing overallStatus: NOT_YET_RECRUITING date: 2026-04 date: 2027-10 date: 2027-10 date: 2024-02-28 date: 2024-02-28 name: Yale University class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The purpose of this study is to assess the feasibility and acceptability of structural intervention components to increase adolescent HIV testing uptake by improving the implementation of confidential care as standard practice in pediatric primary care. conditions: Hiv studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 4 type: ESTIMATED name: Provider training name: Clinic protocols measure: Feasibility, defined as the extent to which structural intervention components to improve confidential care implementation can be successfully carried out in pediatric primary care settings measure: Acceptability, defined as the perception among pediatric primary care clinic leadership and providers that structural intervention components to improve confidential care implementation are agreeable or satisfactory measure: Change in HIV testing uptake measure: Reach, defined as the number of adolescent patients who receive confidential care measure: Adoption, defined as the proportion of pediatric primary care providers who have time alone with and/or provide confidentiality assurances to adolescent patients measure: Implementation, defined as pediatric primary care provider fidelity to confidential care provision measure: Maintenance, defined as the extent to which confidential care is provided and adolescent patients are screened for, accept, and receive results of HIV testing 6-months post-intervention sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06279936 id: B3002021000171 briefTitle: Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID acronym: Cov-N-Psy overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-01 date: 2023-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Universiteit Antwerpen class: OTHER name: UZA Foundation briefSummary: Objectives:

To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between immunological measures and long COVID symptoms.

Study design:

Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021 until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb). The total sample size is estimated on 130. Four visits are organized: at baseline, three, six and twelve months.

The study is organized in three work packages (WP). WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients. conditions: Long COVID studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ACTUAL name: Neuropsychological battery name: Surveys and symptom severity questionnaires name: Blood withdrawal name: Saliva swabs measure: Concentration of immunological and HPA-axis markers measure: Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints measure: Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SINAPS city: Duffel state: Antwerp zip: 2570 country: Belgium lat: 51.09554 lon: 4.50903 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-10-01 uploadDate: 2024-02-08T04:56 filename: Prot_SAP_000.pdf size: 1140716 hasResults: False

 nctId: NCT06279923 id: TXB2023023 briefTitle: CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases overallStatus: RECRUITING date: 2024-04-15 date: 2027-02-01 date: 2027-02-01 date: 2024-02-28 date: 2024-04-09 name: Zhejiang University class: OTHER name: Shanghai YaKe Biotechnology Ltd. briefSummary: Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases. conditions: Autoimmune Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: CD19-BAFF Targeted CAR T-cells measure: Dose-limiting toxicity (DLT) measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Multiple Myeloma (MM), Overall response rate (ORR) measure: Progression-free survival (PFS) measure: Duration of remission,DOR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first affiliated hospital of medical college of zhejiang university status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: He Huang, MD role: CONTACT phone: 86-13605714822 email: hehuangyu@126.com name: Yongxian Hu, MD role: CONTACT phone: +8615957162012 email: huyongxian2000@aliyun.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06279910 id: 2021 36 (EOm) briefTitle: Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19). acronym: COVIDIOL overallStatus: RECRUITING date: 2024-02-21 date: 2024-03-21 date: 2024-04-25 date: 2024-02-28 date: 2024-02-28 name: Complejo Hospitalario Universitario de Albacete class: OTHER briefSummary: Descriptive, retrospective, observational, anonymous, study to evaluate the potential effect of incorporating calcifediol into the therapeutic protocol of patients hospitalized for COVID-19 on mortality and other outcome variables, such as admission to the Intensive Care Unit (ICU), to "Gerencia de Atención Integrada (GAI) de Albacete". "Complejo Hospitalario Universitario de Albacete". Albacete (Spain)", based on the files of the MXXI medical records, Information System of the Laboratory (ISL) and Pharmacy. conditions: SARS-CoV 2 Pneumonia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 275 type: ESTIMATED name: Calcifediol measure: Measure mortality by differentiating groups: calcifediol yes/no. measure: Measure the need for ICU admission by differentiating the groups calcifediol yes/no. measure: Measure mortality in relation to baseline 25(OH)D levels measure: To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency measure: Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Complejo Hospitalario Universitario de la Gerencia de Atención Integrada (GAI) de Albacete status: RECRUITING city: Albacete zip: 02008 country: Spain name: Jose A Blazquez, MD role: CONTACT phone: +34967597100 phoneExt: 37214 email: jblazquez@sescam.jccm.es name: Laura Navarro, MD role: CONTACT phone: +34967597460 email: lnavarro@sescam.jccm.es name: Javier Torres, PhD. role: SUB_INVESTIGATOR lat: 38.99424 lon: -1.85643 facility: Maimónides Biomedical Research Institute of Córdoba (IMIBIC). status: WITHDRAWN city: Cordoba zip: 14004 country: Spain lat: 37.89155 lon: -4.77275 hasResults: False

 nctId: NCT06279897 id: 2023-068 briefTitle: LBNP Tolerance With Skin Warming After Exercise Cold Stress overallStatus: RECRUITING date: 2022-01-24 date: 2025-09-30 date: 2025-09-30 date: 2024-02-28 date: 2024-02-28 name: University of Colorado, Colorado Springs class: OTHER briefSummary: Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold. conditions: Blood Pressure conditions: Blood Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will complete trial 1 at the beginning of the study. Participants will then complete trials 2 through 5 in a random, counterbalanced order. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Participants are blinded to the skin temperature control. count: 10 type: ESTIMATED name: Skin Surface Rewarming name: Skin Surface Warming name: Skin Surface Heating name: Skin Surface Cooling measure: Arterial blood pressure measure: Tolerance to simulated blood loss measure: Core temperature measure: Cutaneous Vascular Conductance sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Colorado Colorado Springs status: RECRUITING city: Colorado Springs state: Colorado zip: 80918 country: United States name: James Pearson, PhD role: CONTACT phone: 719-255-3806 email: jpearso5@uccs.edu lat: 38.83388 lon: -104.82136 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-01-03 uploadDate: 2024-02-22T15:33 filename: Prot_ICF_000.pdf size: 315418 hasResults: False

 nctId: NCT06279884 id: 2023YFC2308802-03 briefTitle: A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-02-28 date: 2024-03-04 name: Zhejiang University class: OTHER name: Beijing Ditan Hospital name: Beijing YouAn Hospital name: Huashan Hospital name: Qilu Hospital of Shandong University briefSummary: The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are:

* Characterize the distribution of pathogenic bacteria infecting liver transplant recipients.
* Establish a monitoring and early warning system for secondary infections. conditions: Liver Transplantation conditions: Transplant Recipients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Secondary Infections in liver transplant recipients at 4 weeks measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks measure: Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection measure: Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection measure: qSOFA score at 8 weeks measure: qSOFA score at 12 weeks sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279871 id: ARCT-2303-01 briefTitle: Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2024-12 date: 2024-02-28 date: 2024-02-28 name: Arcturus Therapeutics, Inc. class: INDUSTRY name: Seqirus name: Novotech (Australia) Pty Limited briefSummary: This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine. conditions: COVID-19 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1680 type: ESTIMATED name: ARCT-2303 name: Influenza vaccine name: Influenza vaccine, adjuvanted name: Placebo measure: SARS-CoV-2 neutralizing antibody titers measure: SARS-CoV-2 neutralizing antibody seroconversion rates measure: Hemagglutination Inhibition (HI) titers measure: SARS-CoV-2 neutralizing antibody titers measure: SARS-CoV-2 neutralizing antibody titers measure: SARS-CoV-2 neutralizing antibody seroconversion rates measure: SARS-CoV-2 neutralizing antibody response (Group 1a; Group 2a) measure: Hemagglutination Inhibition (HI) titers measure: SARS-CoV-2 neutralizing antibody responses measure: Hemagglutination Inhibition (HI) assay titers measure: Local and systemic adverse events (AEs) measure: Unsolicited AEs measure: SAE, Medically Attended Adverse Events (MAAE), Adverse Events of Special Interest (AESI), and AE leading to early termination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279858 id: 1-2024 briefTitle: Probiotic Intervention for Microbiome Modifications and Clinical Improvements in Fragile X Syndrome overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Specila hospital for cerebral palsy and developmental neurology class: OTHER name: FRAXA Research Foundation briefSummary: The primary objective of this clinical trial is to evaluate efficacy of probiotic mixture which contains Lactobacillus casei, Lactobacillus salivarius and Bifidobacterium breve, in children with Fragile X aged 3-18 years. Specifically, links between microbiome modifications by probiotic mixture and behavioral manifestations and brain processing (eye tracker, EEG analysis) will be assessed. Exploratory objects of this trial are analyses of microbiome composition and assessment of its alterations and modifications (by probiotic mixture) that may lead to clinical improvement and prediction which patients with FXS may be likely to benefit from probiotics treatment.

This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. The study plans to enroll 15 participants with FXS, aged 3-18 years, both sexes, during 1-year period and complete all study-related activities by January 2025. During the 3-month study period, subjects will attend three visits (screening/baseline, 6-week, and 3-month visits) to the Fragile X Clinic at the Special Hospital for Cerebral Palsy and Developmental Neurology, Belgrade, Serbia. The primary outcome measureswill be Vineland Adaptive Behavior Scales-Third Edition (VABS-III) and eye tracking measures (social gaze and pupillometry). Exploratory endpoint will be microbiome analyses. Secondary outcome measures will be: CGI-S and CGI-I scores, ABC-CFX score, quality of life, sleep habits and EEG analyses. conditions: Fragile X Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. In this approach, participants act as their own controls by measuring the microbiome and other parameters before and after taking the probiotics. This design was chosen because individual's microbiome is highly personalized. Even within a family, individuals can have distinct microbiomes. The unique composition of an individual's microbiome can have implications for the effectiveness of probiotics. Thus, changes in analyses and scores between baseline and 3-month study period will be assessed for everyone. Specifically, microbiome modifications that may be associated with changes in behavior and brain processing will be examined. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Probiotics measure: 1. Vineland Adaptive Behavior Scales-Third Edition (VABS-III) measure: Eye tracking measure: Clinical Global Impression Scales of Severity (CGI-S) and Improvement (CGI-I) - measure: The Aberrant Behavior Checklist - Community Edition (ABC-C), scored using the FXS-specific factoring system (ABC-CFX) measure: Pediatric Quality of Life Questionnaire (PedsQL) Parent Proxy measure: Child Sleep Habits Questionnaire (CSHQ) measure: EEG analyses measure: Microbiome analyses sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Special Hospital for Cerebral Palsy and Developmental Neurology status: RECRUITING city: Belgrade zip: 11000 country: Serbia name: Dragana Protic, Prof. role: CONTACT phone: +381640667466 email: dragana.protic@sbcprn.com name: Sanja Dimitrijevic, PhD role: CONTACT phone: +381640667466 email: sanja.dimitrijevic@sbcprn.com lat: 44.80401 lon: 20.46513 hasResults: False

 nctId: NCT06279845 id: 2023YFC2308802-02 briefTitle: A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-02-28 date: 2024-03-04 name: Zhejiang University class: OTHER name: Beijing Ditan Hospital name: Beijing YouAn Hospital name: Huashan Hospital name: Qilu Hospital of Shandong University briefSummary: The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are:

* Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis.
* Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression. conditions: Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Secondary infection in patients at 4 weeks measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks measure: Survival rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279832 id: 3994 briefTitle: Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer. acronym: Romantic overallStatus: RECRUITING date: 2023-11-01 date: 2024-10-31 date: 2025-10-31 date: 2024-02-28 date: 2024-02-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).

These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: As far as the sample size concerns, the number of images required for the analysis are a figure of at least 100 positive cases (15). We considered as positive patients with a favorable prognostic profile according to PORTEC-4a and also low and intermediate risk class according to ESGO/ESTRO/ESP 2020 recommendations.Therefore, we estimate to enroll at least 1000 patients in order to reach the 100 positive cases. primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: trascriptomic profiling measure: Predictive value of the model measure: Validity of the model sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Agostino Gemelli IRCSS status: RECRUITING city: Rome state: Lazio zip: 00118 country: Italy name: francesco fanfani role: CONTACT phone: 0630151 email: francesco.fanfani@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06279819 id: 2024-008 briefTitle: Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Fudan University class: OTHER briefSummary: The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:

* Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.
* Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.
* Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.

Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months. conditions: Hiv conditions: Cardiovascular Diseases conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: gut microbiota-targeted dietary intervention measure: ASCVD risk estimated by the PCE measure: The composition of gut microbiota measure: fasting blood lipids measure: blood pressure measure: BMI measure: ASCVD symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University city: Shanghai state: Shanghai zip: 200032 country: China name: Junwen Yu role: CONTACT phone: 13320178333 email: 13320178333@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06279806 id: SerapAlkas briefTitle: The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2024-06-30 date: 2024-10-30 date: 2024-02-28 date: 2024-02-28 name: Gazi University class: OTHER briefSummary: Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Treatments are aimed at prolonging survival from breast cancer and enabling patients to live better. Women repeatedly experience many vital crises such as the diagnosis of cancer, the difficulties of the treatment process and the fear of recurrence in the post-treatment period. In the face of these crises, post-traumatic growth occurs when the individual's efforts to cope are transformed into positive psychological experiences. Positive experiences lead to improvement in women's life, while negative experiences make it difficult to cope and adapt. In order for post-traumatic growth to take place, women should be supported to cope with these negative emotions. The care given to patients during cancer treatment should be such as to support the change process that will help individuals adapt to the new lifestyle.This information and supportive care content should include the topics that women will need in the long term after the treatment, in addition to the diagnosis and treatment process. Generally, the education and counseling given to the patient at the last treatment appointment may be limited. Due to the long period from the last treatment appointment to the control appointment, patients cannot interact with healthcare professionals for a long time. Long-term side effects and needs of people may differ after breast cancer treatment. For this reason, the need for information and consultancy services of healthcare professionals continues in this process as well.Today, the use of remotely accessible mechanisms in the treatment of breast cancer and in the follow-up of women after treatment is increasing. It is thought that the mobile application to be developed within the scope of the project will increase the quality and efficiency of health services with an R\&D and innovative approach and make these services accessible to everyone through digital technologies. In addition, our study will set an example for nursing care to be presented in one of the priority areas of health, such as cancer, through digital technologies. In our study, it is aimed to evaluate the effect of mobile health application based on Mezirow's Transformational Learning Theory on post-traumatic development in women with breast cancer. The research is a single center, parallel group, stratified block randomized controlled experimental study. It is planned to be conducted with 56 (intervention: 28, control: 28) women at Gazi University Health Research and Practice Center. The training content to be included in the mobile application has been determined by considering the results of the studies in the literature and the recommendations of international guides to determine the problems experienced by women with breast cancer during the post-treatment period. After receiving expert opinions on the subject content, the development process of the mobile application will be started. In the implementation phase of the study, the women in the intervention group will start using the mobile application 1 week after completing the active treatment chemotherapy and radiotherapy) process.The implementation of the study will last 8 weeks. At the end of eight weeks, data collection tools will be applied to the women. The final tests will be repeated 4 weeks after the end of the application. Starting from this period, women in the control group who want to use the application will also be included in the mobile application system. After completing the data collection tools, the analysis and reporting part will be started. Statistical analyzes will be made using SPSS Package Program (IBM SPSS Statistics 27). Student t test, Pearson Chi-square test, Independent Sample t test, Mann Whitney U test, One-Way Analysis of Variance or Friedman test will be used in the analyses. conditions: Posttraumatic Growth conditions: Grief studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In order to ensure similarity between the groups, stratified block randomization will be used to assign the women in the sample group to the experimental and control groups. In this method, after stratification according to risk factors, block randomization is performed within each stratum. Since the type of treatment applied in breast cancer and marital status will significantly affect posttraumatic development, stratification was made in terms of these parameters. Stratum 1 in terms of treatment type: Mastectomy, 2nd stratum: Breast conserving surgery or reconstructive surgery during mastectomy; Stratum 1 in terms of partner presence: Has a partner, Stratum 2: No partner. In order to determine which stratum group the women who were found to meet the research criteria and who agreed to participate in the study were in, blocks will be formed with a combination of 4 and the assignment list will be determined through the www.randomizer.org website. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The data obtained from the research will be coded as A and B by an independent researcher and transferred to the SPSS program. The data will also be analyzed by an independent statistician. whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Mobile health application use name: Information of the breast cancer survivor period booklet measure: Women's progression through the stages of grief measure: Women's increased level of posttraumatic development sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279793 id: MODIFYCSX briefTitle: Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients. acronym: MODIFYCSX overallStatus: RECRUITING date: 2024-02-15 date: 2024-12-01 date: 2025-12-01 date: 2024-02-28 date: 2024-02-28 name: GCP-Service International West GmbH class: INDUSTRY name: Charite University, Berlin, Germany name: Wuerzburg University Hospital briefSummary: The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only.