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protocolSection identificationModule nctId: NCT06336759, orgStudyIdInfo id: 2021-10-GAL-JWL, briefTitle: Safety and Efficacy of Fillers for Contouring the Jawline, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-11, primaryCompletionDateStruct date: 2022-12-14, completionDateStruct date: 2023-11-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Erevna Innovations Inc., class: OTHER, descriptionModule briefSummary: The study aims to evaluate the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, addressing concerns about contour deficits in patients seeking aesthetic treatments., conditionsModule conditions: Jawline Contour Deficit, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Restylane Defyne, interventions name: Restylane Lyft, outcomesModule primaryOutcomes measure: Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS), primaryOutcomes measure: Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale, secondaryOutcomes measure: Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS), secondaryOutcomes measure: Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erevna Innovations Inc., city: Montréal, state: Quebec, zip: H3R3A1, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06336746, orgStudyIdInfo id: RHenningsson, briefTitle: Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Karlstad Central Hospital, class: OTHER, descriptionModule briefSummary: The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent.The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions.In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioningDuring surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery., conditionsModule conditions: Heart Failure, Systolic, conditions: Robotic Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Esophageal Doppler, outcomesModule primaryOutcomes measure: Change of Stroke Volume during Trendelenburg position and pneumoperitoneum., secondaryOutcomes measure: % Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected, secondaryOutcomes measure: % change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dpt of Anesthesiology&Intensive Care; Central Hospital of Karlstad, city: Karlstad, state: Värmland, zip: 65230, country: Sweden, contacts name: Ragnar N Henningsson, Associate Professor, role: CONTACT, phone: +461083317434, email: ragnar.henningsson@regionvarmland.se, geoPoint lat: 59.3793, lon: 13.50357, hasResults: False
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protocolSection identificationModule nctId: NCT06336733, orgStudyIdInfo id: APHP220828, briefTitle: Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy, acronym: KIN-ATTACK-FMF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03-03, completionDateStruct date: 2026-09-15, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of* on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine.* compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment., conditionsModule conditions: FMF, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ANAKINRA, outcomesModule primaryOutcomes measure: Mean number of FMF-attacks per month at 6 months of treatment., secondaryOutcomes measure: Cumulative days of FMF attack treatment, secondaryOutcomes measure: AIDAI (Auto-inflammatory Diseases activity index) score, secondaryOutcomes measure: Number of painful days and severity of FMF attacks occurring between randomization and M6, secondaryOutcomes measure: Quality of life score measured by EuroQOL questionnaire (EQ-5D5L), secondaryOutcomes measure: Number of local cutaneous reactions at 6 months (erythema and oedema involving the injection sites) in the anakinra arm, secondaryOutcomes measure: Proportion of Adverse events, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Médecine interne Hopital Tenon, city: Paris, zip: 75020, country: France, contacts name: Léa SAVEY, role: CONTACT, phone: 00 33 1 56 01 60 77, email: lea.savey@aphp.fr, contacts name: Sophie Georgin-Lavialle, MD,PHD, role: CONTACT, phone: 0 33 1 56 01 74 31, email: sophie.georgin-lavialle@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06336720, orgStudyIdInfo id: HMI-SA-PoNS-STK001, briefTitle: PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Helius Medical Inc, class: INDUSTRY, descriptionModule briefSummary: Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors.Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization.Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up., conditionsModule conditions: Chronic Stroke Survivors, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Portable Neuromodulation Stimulator (PoNS), outcomesModule primaryOutcomes measure: Primary safety endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brooks Rehabilitation, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32216, country: United States, contacts name: Mark Bowden, PhD. PT, role: CONTACT, phone: 904-345-6626, email: Mark.Bowden@Brooksrehab.org, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Shepherd Center, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30309, country: United States, contacts name: Cathy Furbish, PT, DPT, CCRP, role: CONTACT, phone: 404-350-7591, email: cathy.furbish@shepherd.org, geoPoint lat: 33.749, lon: -84.38798, locations facility: Neurology Center of New England, P.C., status: RECRUITING, city: Foxboro, state: Massachusetts, zip: 02035, country: United States, contacts name: Rachel O'Donnell, role: CONTACT, phone: 781-551-5812, phoneExt: 101, email: rodonnell@myneurodr.com, contacts name: MD, role: CONTACT, geoPoint lat: 42.06538, lon: -71.24783, locations facility: Rehabologym Corp, status: RECRUITING, city: Tarrytown, state: New York, zip: 10591, country: United States, contacts name: Avrielle Peltz, MA OTR/L, role: CONTACT, phone: 914-603-8600, email: avrielle.peltz@rehabologym.com, geoPoint lat: 41.07621, lon: -73.85875, hasResults: False
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protocolSection identificationModule nctId: NCT06336707, orgStudyIdInfo id: HS-20089-103, briefTitle: HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2026-04-08, completionDateStruct date: 2028-04-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Hansoh BioMedical R&D Company, class: INDUSTRY, descriptionModule briefSummary: HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1048, type: ESTIMATED, armsInterventionsModule interventions name: HS-20089, interventions name: Adebrelimab, interventions name: Bevacizumab, interventions name: Cisplatin / carboplatin, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20089 in combination therapy, secondaryOutcomes measure: Incidence and severity of adverse events (AEs), secondaryOutcomes measure: Observed maximum plasma concentration (Cmax) of HS-20089, secondaryOutcomes measure: Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose, secondaryOutcomes measure: Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089, secondaryOutcomes measure: Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089, secondaryOutcomes measure: Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, secondaryOutcomes measure: Duration of response (DoR) assessed by investigators according to RECIST 1.1, secondaryOutcomes measure: Disease control rate (DCR) assessed by investigators according to RECIST 1.1, secondaryOutcomes measure: Progression-free survival (PFS) assessed by investigators according to RECIST 1.1, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Percentage of participants with antibodies to HS-20089 in serum, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06336694, orgStudyIdInfo id: SYSUFAH2021-025, briefTitle: A Deep Learning Radiomics Model for Predicting Occult Peritoneal Metastases of Pancreatic Adenocarcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2022-10-31, completionDateStruct date: 2023-07-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital, Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Occult peritoneal metastases (OPM) in patients with pancreatic ductal adenocarcinoma (PDAC) are frequently overlooked during imaging. We aimed to develop and validate a CT-based deep learning-based radiomics (DLR) model with clinical-radiological characteristics to identify OPM in patients with PDAC before treatment., conditionsModule conditions: Pancreatic Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 302, type: ACTUAL, armsInterventionsModule interventions name: surgery or diagnostic staging laparoscopy, outcomesModule primaryOutcomes measure: diagnosed with peritoneal metastases, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shi Siya, city: Guangzhou, state: Guangdong, zip: 510000, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06336681, orgStudyIdInfo id: #12966, briefTitle: Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB), acronym: IMT_EIB, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-10, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, descriptionModule briefSummary: Due to the lack of studies examining the impact of inspiratory muscle training (IMT) on the severity of exercise-induced bronchoconstriction (EIB) and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, short-acting beta-2-agonist medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, exertional dyspnea, and cycling time-trial performance., conditionsModule conditions: Exercise Induced Bronchospasm, conditions: Exercise Induced Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: PrO2Fit Device, outcomesModule primaryOutcomes measure: Exercise-Induced Bronchoconstriction (EIB) Severity, primaryOutcomes measure: Maximum Inspiratory Pressure and Sustained Maximum Inspiratory Pressure, primaryOutcomes measure: 16-km Cycling Time-Trial Time to Completion, primaryOutcomes measure: 16-km Cycling Time-Trial Power Output, primaryOutcomes measure: Constant Load Performance, secondaryOutcomes measure: Perception of Breathing Intensity and Unpleasantness and Leg Fatigue, secondaryOutcomes measure: Deoxygenation of the respiratory and limb locomotor muscles by near-infrared spectroscopy, secondaryOutcomes measure: Femoral blood flow (FBF) of the limb locomotor muscles by ultrasound, secondaryOutcomes measure: Lung Volumes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: School of Public Health-Bloomington, status: RECRUITING, city: Bloomington, state: Indiana, zip: 47405, country: United States, contacts name: Tim Mickleborough, Ph.D., role: CONTACT, phone: 812-855-0753, email: tmickleb@indiana.edu, geoPoint lat: 39.16533, lon: -86.52639, hasResults: False
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protocolSection identificationModule nctId: NCT06336668, orgStudyIdInfo id: REB23-1283, briefTitle: Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks., conditionsModule conditions: Feeding; Difficult, Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Prospective randomized-controlled crossover trial comparing 2 different HMFs and 2 intestinal rSO2S periods in random order: 6 hours while on B-HMF and 6 hours on H-HMF with at least 6 hours washing period, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Randomizing the participants to either Bovine-HMF or Human Milk based-HMF will mask the Investigator, whoMasked: INVESTIGATOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Human milk-based HMF, outcomesModule primaryOutcomes measure: Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy, secondaryOutcomes measure: Changes in SMA doppler peak flow velocity (PSV), secondaryOutcomes measure: Changes in SMA doppler end-diastolic velocity (EDV), secondaryOutcomes measure: Changes in SMA doppler Porcelout's resistance index (RI), eligibilityModule sex: ALL, maximumAge: 30 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336655, orgStudyIdInfo id: 153309, briefTitle: Physiology of Unloading VA ECMO Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, collaborators name: University of Minnesota, descriptionModule briefSummary: The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for non-postoperative cardiogenic shock (CS). The main aims of the study are:1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO2. To determine the effects on myocardial function of adding LV unloading to ECMO3. To test the effects on myocardial recovery of adding LV unloading to VA ECMOParticipants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups., conditionsModule conditions: Cardiogenic Shock, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: IABP, outcomesModule primaryOutcomes measure: Change in pulmonary capillary wedge pressure, secondaryOutcomes measure: Change in pulmonary artery diastolic pressure, secondaryOutcomes measure: Change in left ventricular end diastolic diameter, secondaryOutcomes measure: Change in N-terminal pro b-type natriuretic peptide, secondaryOutcomes measure: Hemodynamic stability, secondaryOutcomes measure: Global cardiovascular function, secondaryOutcomes measure: Difference in partial pressure of carbon dioxide (pCO2), secondaryOutcomes measure: Lactate, secondaryOutcomes measure: Cardiac BIN1, secondaryOutcomes measure: Troponin I, secondaryOutcomes measure: Tumor necrosis factor alpha, secondaryOutcomes measure: Ejection fraction percentage, secondaryOutcomes measure: Interferon gamma, secondaryOutcomes measure: Limb ischemia, secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84132, country: United States, contacts name: Joseph E. Tonna, MD, FAAEM, role: CONTACT, phone: 801-587-9373, email: joseph.tonna@hsc.utah.edu, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06336642, orgStudyIdInfo id: 2023-0933, secondaryIdInfos id: NCI-2024-02452, type: OTHER, domain: NCI-CTRP Clinical Trials Registry, briefTitle: Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2030-03-31, completionDateStruct date: 2032-03-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer., conditionsModule conditions: Dyspnea, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: SPOT-ON Early Start, interventions name: SPOT-ON Delayed Start, outcomesModule primaryOutcomes measure: Primary Outcome Measure: 1.Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: David Hui, MD, role: CONTACT, phone: 713-792-6258, email: dhui@mdanderson.org, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06336629, orgStudyIdInfo id: WIN2023, briefTitle: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Sun Pharmaceutical Industries Limited, class: INDUSTRY, descriptionModule briefSummary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice., conditionsModule conditions: Acne Vulgaris, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Winlevi (clascoterone) 1% & Duac gel, outcomesModule primaryOutcomes measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16., secondaryOutcomes measure: Percent of total lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Percent of inflammatory lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline., secondaryOutcomes measure: Tolerability measures of erythema based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of dryness based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of peeling based on 5-point severity scale, secondaryOutcomes measure: Assessment of skin oiliness based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of burning/stinging based on 6-point severity scale, secondaryOutcomes measure: Tolerability measures of pruritus based on 6-point severity scale, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skin Sciences, PLLC, city: Louisville, state: Kentucky, zip: 40217, country: United States, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False
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protocolSection identificationModule nctId: NCT06336616, orgStudyIdInfo id: 31164, briefTitle: Getting Out of the House: Using Behavioral Activation to Increase Community Participation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Temple University, class: OTHER, collaborators name: National Institute on Disability, Independent Living, and Rehabilitation Research, descriptionModule briefSummary: The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness.The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows:1. To determine if the intervention leads to increases the frequency and variety of activities.2. To determine if the intervention leads to increases in community mobility.3. To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.4. To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period.For data collection, participants will also be asked to:1. Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;2. Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and3. Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group., conditionsModule conditions: Major Depressive Disorder, conditions: Schizo Affective Disorder, conditions: Schizophrenia, conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Behavior Activation, outcomesModule primaryOutcomes measure: Activity Logs, primaryOutcomes measure: Participation Checklist, primaryOutcomes measure: Behavior Activation for Depression Scale, primaryOutcomes measure: Temple University Community Participation Measure, primaryOutcomes measure: Community Mobility (Global Positioning System; GPS), primaryOutcomes measure: Community Mobility (Global Positioning System; GPS), secondaryOutcomes measure: Lerman Quality of Life Interview, secondaryOutcomes measure: New General Self-Efficacy Scale (adapted to participation), secondaryOutcomes measure: Recovery Assessment Scale (RAS), secondaryOutcomes measure: Activity Assessment Scale, secondaryOutcomes measure: Capabilities and Opportunities for Participation Questionnaire, secondaryOutcomes measure: Self-Control and Self-Management Scale, secondaryOutcomes measure: Habit Strength Scale, secondaryOutcomes measure: University of California Los Angeles Loneliness Scale, secondaryOutcomes measure: Lehman Quality of LIfe (QOL) Interview Social Relations sub scale, secondaryOutcomes measure: Hopkins Symptoms Checklist, secondaryOutcomes measure: The Life Engagement Test, secondaryOutcomes measure: The University of Rhode Island Change Assessment Measure (URICA), secondaryOutcomes measure: Reward Probability Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Temple University, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19120, country: United States, contacts name: Crystal Slanzi, role: CONTACT, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06336603, orgStudyIdInfo id: WIN2022, briefTitle: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Sun Pharmaceutical Industries Limited, class: INDUSTRY, descriptionModule briefSummary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in combination to emulate real life practice., conditionsModule conditions: Acne Vulgaris, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Winlevi (clascoterone) 1% & Adapalene 0.3% gel, outcomesModule primaryOutcomes measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16., secondaryOutcomes measure: Percent of total lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Percent of inflammatory lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Tolerability measures of erythema based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of dryness based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of peeling based on 5-point severity scale, secondaryOutcomes measure: Assessment of skin oiliness based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of burning/stinging based on 6-point severity scale, secondaryOutcomes measure: Tolerability measures of pruritus based on 6-point severity scale, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skin Sciences, PLLC, city: Louisville, state: Kentucky, zip: 40217, country: United States, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False
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protocolSection identificationModule nctId: NCT06336590, orgStudyIdInfo id: Pro2024000249, briefTitle: Student Exercise and Sleep Timing Study - Part 2, acronym: SiESTa 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-16, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, descriptionModule briefSummary: The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality.Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration.Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger).Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity., conditionsModule conditions: Sleep, conditions: Mood, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Morning Exercise, outcomesModule primaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Mood, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Productivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 23 Years, stdAges: ADULT, contactsLocationsModule locations facility: College Avenue Gym, city: New Brunswick, state: New Jersey, zip: 08901, country: United States, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Cook/Douglass Rec Center, city: New Brunswick, state: New Jersey, zip: 08901, country: United States, contacts name: Assistant Director of Operations, role: CONTACT, phone: 848-932-8063, email: samantha.plum@rutgers.edu, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Rutgers Fitness Center, city: New Brunswick, state: New Jersey, zip: 08901, country: United States, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Rutgers Sleep Lab, city: New Brunswick, state: New Jersey, zip: 08901, country: United States, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Livingston Rec Center, city: Piscataway, state: New Jersey, zip: 08854, country: United States, contacts name: Assistant Director of Operations, role: CONTACT, phone: 848-932-8063, email: samantha.plum@rutgers.edu, geoPoint lat: 40.49927, lon: -74.39904, locations facility: Werblin Rec Center, city: Piscataway, state: New Jersey, zip: 08854, country: United States, contacts name: Assistant Director of Operations, role: CONTACT, phone: 848-932-8063, email: samantha.plum@rutgers.edu, geoPoint lat: 40.49927, lon: -74.39904, hasResults: False
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protocolSection identificationModule nctId: NCT06336577, orgStudyIdInfo id: 2024/0003, briefTitle: Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France, acronym: ARBT21, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Sud Francilien, class: OTHER, descriptionModule briefSummary: The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France., conditionsModule conditions: Down Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: lower respiratory tract disease, outcomesModule primaryOutcomes measure: distribution of lower respiratory tract diseases, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre Hospitalier Sud Francilien, city: Corbeil-Essonnes, zip: 91106, country: France, contacts name: Yousra MESBAHI, role: CONTACT, phone: 0161697760, email: yousra.mesbahi@chsf.fr, geoPoint lat: 48.60603, lon: 2.48757, hasResults: False
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protocolSection identificationModule nctId: NCT06336564, orgStudyIdInfo id: 71168623.6.0000.5544, briefTitle: Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Centro de Atenção ao Assoalho Pélvico, class: OTHER, descriptionModule briefSummary: Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM., conditionsModule conditions: Menopause, conditions: Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic floor muscle training, interventions name: Microablative Radiofrequency, outcomesModule primaryOutcomes measure: Resolution or improvement of episodes of urinary loss assessed by pad test, primaryOutcomes measure: Resolution or improvement of episodes of urinary loss assessed by urinary diary, primaryOutcomes measure: Number of patients with tolerability related to treatment assessed by Likert Scale., primaryOutcomes measure: Number of patients with adverse effects related to treatment assessed by histopathology., primaryOutcomes measure: Resolution or improvement of episodes of urinary loss assessed by questionnaire., secondaryOutcomes measure: Recovery of vaginal health assessed by Vaginal Index Maturation, secondaryOutcomes measure: Recovery of vaginal health assessed by vaginal pH, secondaryOutcomes measure: Improvement of Sexual Function assessed by Female Sexual Function Index, secondaryOutcomes measure: Improvement of quality of life assessed by Short-Form Health Survey (SF-36), secondaryOutcomes measure: Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire., secondaryOutcomes measure: Degree of patient satisfaction using a five-point Likert scale., secondaryOutcomes measure: Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS), eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Atenção ao Assoalho Pelvico, city: Salvador, state: Ba, zip: 40.290-000, country: Brazil, geoPoint lat: -12.97111, lon: -38.51083, hasResults: False
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protocolSection identificationModule nctId: NCT06336551, orgStudyIdInfo id: UniversityAmsterdam, briefTitle: Acceptance and Commitment Therapy for Insomnia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-26, completionDateStruct date: 2026-01-26, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Amsterdam, class: OTHER, descriptionModule briefSummary: Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for insomnia. However, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown.The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia, compared to a waitlist control group. The second goal is to explore the potential working mechanisms of ACT-I, using network intervention analysis.Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I group.The main questions this RCT aims to answer are:* Is ACT-I superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)?* How do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following ACT-I?, conditionsModule conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance and Commitment Therapy for insomnia (ACT-I), outcomesModule primaryOutcomes measure: Insomnia severity, secondaryOutcomes measure: Insomnia severity, secondaryOutcomes measure: Insomnia severity, secondaryOutcomes measure: Insomnia severity, secondaryOutcomes measure: General well-being, secondaryOutcomes measure: General well-being, secondaryOutcomes measure: General well-being, secondaryOutcomes measure: General well-being, secondaryOutcomes measure: Sleep-related quality of life, secondaryOutcomes measure: Sleep-related quality of life, secondaryOutcomes measure: Sleep-related quality of life, secondaryOutcomes measure: Sleep-related quality of life, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Sleep diary: total sleep time, secondaryOutcomes measure: Sleep diary: total sleep time, secondaryOutcomes measure: Sleep diary: total sleep time, secondaryOutcomes measure: Sleep diary: total sleep time, secondaryOutcomes measure: Sleep diary: sleep onset latency, secondaryOutcomes measure: Sleep diary: sleep onset latency, secondaryOutcomes measure: Sleep diary: sleep onset latency, secondaryOutcomes measure: Sleep diary: sleep onset latency, secondaryOutcomes measure: Sleep diary: wake after sleep onset, secondaryOutcomes measure: Sleep diary: wake after sleep onset, secondaryOutcomes measure: Sleep diary: wake after sleep onset, secondaryOutcomes measure: Sleep diary: wake after sleep onset, secondaryOutcomes measure: Sleep diary: sleep efficiency, secondaryOutcomes measure: Sleep diary: sleep efficiency, secondaryOutcomes measure: Sleep diary: sleep efficiency, secondaryOutcomes measure: Sleep diary: sleep efficiency, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Psychological inflexibility, secondaryOutcomes measure: Psychological inflexibility, secondaryOutcomes measure: Psychological inflexibility, secondaryOutcomes measure: Psychological inflexibility, secondaryOutcomes measure: Sleep-related arousal, secondaryOutcomes measure: Sleep-related arousal, secondaryOutcomes measure: Sleep-related arousal, secondaryOutcomes measure: Sleep-related arousal, secondaryOutcomes measure: Dysfunctional sleep-related cognitions, secondaryOutcomes measure: Dysfunctional sleep-related cognitions, secondaryOutcomes measure: Dysfunctional sleep-related cognitions, secondaryOutcomes measure: Dysfunctional sleep-related cognitions, secondaryOutcomes measure: Sleep-related safety behaviors, secondaryOutcomes measure: Sleep-related safety behaviors, secondaryOutcomes measure: Sleep-related safety behaviors, secondaryOutcomes measure: Sleep-related safety behaviors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Amsterdam, city: Amsterdam, state: Noord-Holland, zip: 1018 WS, country: Netherlands, contacts name: Mathilde I Looman, MSc, role: CONTACT, phone: (0)20 525 6810, phoneExt: +31, email: m.i.looman@uva.nl, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
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protocolSection identificationModule nctId: NCT06336538, orgStudyIdInfo id: CASE1124, briefTitle: Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression., conditionsModule conditions: Breast Cancer, conditions: Breast Cancer Female, conditions: Breast Cancer Stage I, conditions: Breast Cancer Stage II, conditions: Breast Cancer Stage III, conditions: Mild Depression, conditions: Moderate Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Investigator will first conduct focus groups with older (≥65 years old) African American/Black (AA/B) breast cancer survivors (BCS) with elevated depressive symptoms. They will collect participant perspectives on barriers and facilitators to participation in MBI clinical trials, as well as how to adapt this intervention, called Mindfulness-Based Cognitive Therapy-Brief (MBCT-Brief), to increase cultural relevancy for older AA/B BCS with elevated depressive symptoms. They will then conduct a single arm clinical trial that incorporates the results of the qualitative data analysis to establish feasibility and acceptability of MBCT-Brief., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: MBCT, outcomesModule primaryOutcomes measure: Mean participant attendance rate, secondaryOutcomes measure: Acceptability rate using CSQ(Client Satisfaction Questionnaire-8), otherOutcomes measure: Change in fear of recurrence as assessed using FCRI(Fear of Cancer Recurrence Inventory) scores, otherOutcomes measure: Change in trait mindfulness as assessed using FFMQ-15(Five Facet of Mindfulness Scale Short Form) scores, otherOutcomes measure: Change in Quality of life as assessed using ICS-2(Impact of Cancer Scale version 2) scores, otherOutcomes measure: Change in depressive symptoms as assessed using PROMIS-D(Patient Reported Outcomes Measurement Information System-Depression) scores, eligibilityModule sex: FEMALE, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic Department of Wellness and Preventive Medicine, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Jacob Hill, ND, role: CONTACT, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06336525, orgStudyIdInfo id: 2023P001895, secondaryIdInfos id: R01HL164462, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL164462, briefTitle: Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: University of Alabama at Birmingham, collaborators name: Emory University, collaborators name: University of Pennsylvania, collaborators name: University of Massachusetts, Worcester, collaborators name: The University of Texas Health Science Center at San Antonio, collaborators name: Beth Israel Deaconess Medical Center, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health., conditionsModule conditions: Sleep Apnea, conditions: Insomnia, conditions: Sleep Deprivation, conditions: Sleep Disorders, Circadian Rhythm, conditions: Sleepiness, Excessive Daytime, conditions: Fatigue, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 3680, type: ESTIMATED, outcomesModule primaryOutcomes measure: Oxygen desaturation index, primaryOutcomes measure: Insomnia Severity Index, primaryOutcomes measure: Sleep Duration, primaryOutcomes measure: Sleep Duration Regularity, primaryOutcomes measure: Sleep Timing, primaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment Short Form 8a, secondaryOutcomes measure: Restless Legs Syndrome (RLS), secondaryOutcomes measure: Chronotype, secondaryOutcomes measure: Sleep Timing Regularity, secondaryOutcomes measure: Global Sleep Quality, secondaryOutcomes measure: Oxygen desaturation index, 3%, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06336512, orgStudyIdInfo id: RC.28.1.2024, briefTitle: Trimester Sequential Estimation of Serum Zonulin as a Predictor of Gestational Diabetes Mellitus, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-15, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2023-10-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics., conditionsModule conditions: Gestational Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Newly Pregnant Women with singleton fetus, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: ELISA, outcomesModule primaryOutcomes measure: Estimation of Gestational DM, eligibilityModule sex: FEMALE, minimumAge: 22 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Benha university, city: Banhā, state: El- Qalyobia, zip: 13511, country: Egypt, geoPoint lat: 30.45906, lon: 31.17858, hasResults: False
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protocolSection identificationModule nctId: NCT06336499, orgStudyIdInfo id: TREC2023-KY107, briefTitle: Risk Stratification of Orbital Tumors Based on MRl and Artificial Intelligence, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-01, primaryCompletionDateStruct date: 2022-10-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Beijing Tongren Hospital, class: OTHER, descriptionModule briefSummary: Orbital tumors can be categorized into benign and malignant tumors, and there are significant variations in their biological behavior, treatment, and prognosis. This study aims to enhance the accurate diagnosis and risk stratification of orbital tumors using artificial intelligence (AI) technology and multiparameter magnetic resonance imaging (MRI) data. It further explores the intrinsic relationship between MRI and the differential diagnosis of benign and malignant orbital tumors, as well as the pathological subtypes of malignant tumors and Ki-67 expression levels. This research aims to aid in guiding personalized diagnosis and treatment decision-making for patients with orbital tumors while promoting the practical application and incorporation of AI technology., conditionsModule conditions: Orbital Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ACTUAL, armsInterventionsModule interventions name: Multi-parametric MRI and image analysis by deep learning or machine learning algorithms, outcomesModule primaryOutcomes measure: The area under the curve of Receiver Operating Characteristic of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and levels of Ki-67 expression in malignant ones., secondaryOutcomes measure: The area under the Precision-Recall curve of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors., secondaryOutcomes measure: Sensitivity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors., secondaryOutcomes measure: Specificity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors., secondaryOutcomes measure: Accuracy of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336486, orgStudyIdInfo id: BalikesirU-FTR-BG-01, briefTitle: the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-04, primaryCompletionDateStruct date: 2020-02-01, completionDateStruct date: 2020-02-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Busra Gunes, class: OTHER, descriptionModule briefSummary: In this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated, conditionsModule conditions: Diabetic Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups with a conventional therapy control group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: intermittent pneumatic compression +pregabalin group, interventions name: pregabalin group, outcomesModule primaryOutcomes measure: The Leeds assessment of neuropathic symptoms and signs(LANSS), primaryOutcomes measure: Pain quality rating scale(PQAS), primaryOutcomes measure: Visual Analog Scale(VAS), secondaryOutcomes measure: 36-Item Short Form Health Survey(SF-36), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Balıkesir University, city: Balıkesir, state: Merkez, zip: 10050, country: Turkey, geoPoint lat: 39.64917, lon: 27.88611, hasResults: False
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protocolSection identificationModule nctId: NCT06336473, orgStudyIdInfo id: 2023-A02097-38, briefTitle: Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome, acronym: SEDSKIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: GCS Ramsay Santé pour l'Enseignement et la Recherche, class: OTHER, descriptionModule briefSummary: The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS)., conditionsModule conditions: Ehlers-Danlos Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-center study performed on biopsied skin samples, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: skin biopsy, outcomesModule primaryOutcomes measure: Young's modulus quantification, secondaryOutcomes measure: Collagen fibril diameter measurement, secondaryOutcomes measure: Collagen fibril D-period length measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique Maussins-Nollet, city: Paris, zip: 75019, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06336460, orgStudyIdInfo id: 2023-537, briefTitle: PENG vs. FIC Blocks in Hip Fractures in the ED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Orange Park Medical Center, class: OTHER, descriptionModule briefSummary: This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture., conditionsModule conditions: Hip Fractures, conditions: Nerve Block, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The research associate/outcome assessor will not have access to group assignment and will therefore be blinded to the type of block. Although the patient, their caregiver(s), and the clinician caring for the patient will not be directly informed of the group assignment, a note will be logged in the clinical record by the physician placing the block indicating the details of the block after this procedure has been completed., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pericapsular Nerve Group (PENG) Block, interventions name: Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures, outcomesModule primaryOutcomes measure: Numeric pain score at 30 minutes, primaryOutcomes measure: Numeric pain score at 60 minutes, secondaryOutcomes measure: Cumulative Morphine Milligram Equivalents in 24 hours after enrollment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336447, orgStudyIdInfo id: STU00220295, briefTitle: VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures., conditionsModule conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trail., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessor will be blinded to study randomization, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Group #1: Virtual Reality Headset, interventions name: Group 2 No Virtual Reality Headset, outcomesModule primaryOutcomes measure: Procedural related pain, secondaryOutcomes measure: Procedure related satisfaction, secondaryOutcomes measure: Post procedure anxiety, secondaryOutcomes measure: Mean reduction in pain 1 month after procedure, secondaryOutcomes measure: Midazolam administered, secondaryOutcomes measure: Fentanyl administered, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern Medicine Pain Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Paul Fitzgerald, role: CONTACT, phone: 312-695-1064, email: p-fitzgerald2@northwestern.edu, contacts name: Jason Ross, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06336434, orgStudyIdInfo id: IMPAACT 2040, briefTitle: CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-24, primaryCompletionDateStruct date: 2026-12-24, completionDateStruct date: 2026-12-24, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants., conditionsModule conditions: HIV-1-infection, conditions: Pregnancy, conditions: Postpartum, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: CAB LA 600mg, interventions name: RPV LA 900mg, interventions name: CAB LA 400mg, interventions name: RPV LA 600mg, outcomesModule primaryOutcomes measure: PK trough of CAB LA measured in plasma in pregnancy and postpartum, primaryOutcomes measure: Percentage of adults with at least one Grade 3 or higher adverse event in pregnancy and through 18 weeks postpartum, primaryOutcomes measure: Percentage of adults with at least one serious adverse event in pregnancy and through 18 weeks postpartum, secondaryOutcomes measure: PK trough measured in plasma in pregnancy and postpartum, secondaryOutcomes measure: Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery, secondaryOutcomes measure: Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery using the standardized FDA snapshot algorithm, secondaryOutcomes measure: Percentage of adults with virologic escape (single measurement of greater than or equal to 200 copies/mL) from study entry through pregnancy and through 18 weeks postpartum, secondaryOutcomes measure: Percentage of adults with confirmed virologic failure through 18 weeks postpartum, secondaryOutcomes measure: Number of adults with HIV-1 resistance to CAB and/or RPV using IAS-USA in participants who experience confirmed virologic failure, assessed at entry and time of failure, secondaryOutcomes measure: Number of infants with HIV-1 infection, secondaryOutcomes measure: Percentage of infants at least one Grade 3 or higher adverse event through 18 weeks post-birth, secondaryOutcomes measure: Percentage of infants at least one serious adverse event through 18 weeks post-birth, secondaryOutcomes measure: Percentage of infants with a congenital anomaly consistent with the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect, secondaryOutcomes measure: Percentage of deaths among infants, secondaryOutcomes measure: Percentage of adults with a spontaneous abortion (less than 20 weeks gestation), secondaryOutcomes measure: Percentage of adults with a fetal demise/stillbirth (greater than or equal to 20 weeks gestation), secondaryOutcomes measure: Percentage of neonatal deaths (within 28 days of life) among infants, secondaryOutcomes measure: Percentage of infants born small for gestational age (SGA) at < 10th percentile, secondaryOutcomes measure: Percentage of infants born with low birth weight < 2500 g, secondaryOutcomes measure: Percentage of infants born preterm < 37 weeks gestation, secondaryOutcomes measure: Percentage of adult-infant participant pairs with any adverse pregnancy outcome of spontaneous abortion, fetal demise/stillbirth, neonatal death, SGA, or preterm delivery, secondaryOutcomes measure: CAB and RPV plasma concentrations in infants exposed to CAB LA + RPV LA during pregnancy and via chest/breastfeeding, secondaryOutcomes measure: Percentage of adults who discontinued injections prior to receiving the full course of injections due to intolerability of injection, secondaryOutcomes measure: Frequency of CAB LA + RPV LA injections received, secondaryOutcomes measure: Percentage of adults willing to continue CAB LA + RPV LA postpartum and/or in future pregnancies, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 4601, University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, city: La Jolla, state: California, zip: 92093-0672, country: United States, contacts name: Megan Loughran, BA, role: CONTACT, phone: 858-534-9218, email: meloughran@health.ucsd.edu, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Site 5048, University of Southern California LA, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Lourdes Topete, role: CONTACT, phone: 323-865-1585, email: ltopete@usc.edu, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Site 5092, Johns Hopkins University, Baltimore, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Amanda Haines, role: CONTACT, phone: 443-287-8950, email: ahaines8@jhmi.edu, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Site 5013, Jacobi Medical Center Bronx, city: Bronx, state: New York, zip: 10461, country: United States, contacts name: Marlene Burey, NP, role: CONTACT, phone: 718-918-4783, email: marlene.burey@nychhc.org, geoPoint lat: 40.84985, lon: -73.86641, locations facility: Site 8051 - Wits RHI Shandukani Research Centre, city: Johannesburg, zip: 2001, country: South Africa, contacts name: Rorisang Komane, BNS, role: CONTACT, phone: +27-72-933-4002, email: rkomane@wrhi.ac.za, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Site 8052, Soweto, city: Johannesburg, country: South Africa, contacts name: Ntatule Ndiweni, role: CONTACT, phone: +27-11-989-9748, email: ndiwenih@phru.co.za, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Site 8950, FAMCRU CRS, city: Parow, zip: 7505, country: South Africa, contacts name: Jeanne de Jager, MSc, role: CONTACT, phone: +27-21-938-4290, email: jeannes@sun.ac.za, geoPoint lat: -33.89723, lon: 18.59992, locations facility: Site 30300, Umlazi Clinical Research Site, city: Umlazi, zip: 4066, country: South Africa, contacts name: Zukiswa Godlwana, role: CONTACT, phone: +27-31-2601998, email: zukiswa.godlwana@caprisa.org, geoPoint lat: -29.96572, lon: 30.88639, hasResults: False
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protocolSection identificationModule nctId: NCT06336421, orgStudyIdInfo id: Şuletuvanç, briefTitle: The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2024-03-22, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section indication in the Ataturk University Health Research and Application Center Gynecology Clinic Operating Room., conditionsModule conditions: Cesarean Section Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: statistics expert, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Virtual Reality, outcomesModule primaryOutcomes measure: Personal Information Form, primaryOutcomes measure: State Anxiety Scale, primaryOutcomes measure: Pregnant follow-up form, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ayse Aydin, city: Yakutiye, state: Erzurum, zip: 25000, country: Turkey, geoPoint lat: 39.89821, lon: 41.26916, hasResults: False
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protocolSection identificationModule nctId: NCT06336408, orgStudyIdInfo id: B2023-370R, briefTitle: The SLEEP-CARE Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: Sleep disorder is common in ICU patients, such as reduced sleep time, fragmentation, and abnormal sleep rhythm. In 2023, American Thoracic Society released a research statement on sleep and circadian disruption(SCD) in ICU, which considered SCD is an important potential target for improving critical illness outcomes. Although polysomnography(PSG) is the gold standard of sleep measurement, subjective sleep evaluation tools are still used in most clinical studies related to sleep in ICU. This makes the sleep quality of ICU patients overestimated and difficult to reflect their true sleep conditions. And the answers to how and which outcomes different levels of sleep deprivation affect patient outcomes are still unclear and need to be further explored., conditionsModule conditions: Sleep Disturbance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: Compound outcome index, secondaryOutcomes measure: LOS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital, Fudan University, status: RECRUITING, city: Shanghai, country: China, contacts name: Jingjing Li, Master, role: CONTACT, phone: 13512106878, email: li.jingjing@zs-hospital.sh.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06336395, orgStudyIdInfo id: 2019/00888, briefTitle: Ma-Spore ALL 2020 Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-03-04, primaryCompletionDateStruct date: 2030-03, completionDateStruct date: 2030-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: National University Hospital, Singapore, class: OTHER, descriptionModule briefSummary: The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy., conditionsModule conditions: B Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Prednisolone, interventions name: Dexamethasone, interventions name: Vincristine, interventions name: Methotrexate, interventions name: L-Asparaginase, interventions name: Pegylated asparaginase, interventions name: Erwinase, interventions name: Dasatinib, interventions name: Imatinib, interventions name: Cyclophosphamide, interventions name: Cytarabine, interventions name: Mercaptopurine, interventions name: Thioguanine, interventions name: Rituximab, interventions name: Doxorubicin, interventions name: Fludarabine, outcomesModule primaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Event free survival (EFS), otherOutcomes measure: Cumulative incidence (CI) of relapse for all treated cohorts, otherOutcomes measure: Cumulative incidence (CI) of therapy-related mortality (TRM) for all treated subjects, eligibilityModule sex: ALL, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Subang Jaya Medical Centre, status: RECRUITING, city: Kuala Lumpur, zip: 47500, country: Malaysia, contacts name: Hai Peng Lin, role: CONTACT, phone: +603 56391621, email: flslhp@gmail.com, contacts name: Lee Lee Chan, MBBS, role: SUB_INVESTIGATOR, geoPoint lat: 3.1412, lon: 101.68653, locations facility: University Malaya Medical Centre, status: RECRUITING, city: Kuala Lumpur, zip: 59100, country: Malaysia, contacts name: Hany Arrifin, MBBS, role: CONTACT, phone: +603 79492065, email: hany@ummc.edu.my, geoPoint lat: 3.1412, lon: 101.68653, locations facility: KK Women's and Children's Hospital, status: RECRUITING, city: Singapore, zip: 229899, country: Singapore, contacts name: Ah Moy Tan, MBBS, role: CONTACT, phone: +65 63941039, email: tan.ah.moy01@singhealth.com.sg, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06336382, orgStudyIdInfo id: 23-0874, secondaryIdInfos id: 1R21MH135148, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21MH135148, briefTitle: Tau Biomarkers in Late-onset Psychosis (LOP), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Jeremy Koppel, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing., conditionsModule conditions: Late Onset Schizophrenia, conditions: Delusional Disorder (Late Onset), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Tau PET imaging scan, outcomesModule primaryOutcomes measure: Quantification of neurofibrillary tangle pathology in subjects via PET [18F]PI-2620 radiotracer uptake., secondaryOutcomes measure: Measurement of peripheral soluble tau pathology with tau plasma immunoassays., otherOutcomes measure: Evaluation of sensorimotor gating integrity and it's association to tau PET ligand uptake., eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Feinstein Institutes for Medical Research, status: RECRUITING, city: Manhasset, state: New York, zip: 11030, country: United States, contacts name: Erica Christen, MS, role: CONTACT, phone: 516-562-3492, email: EChriste@northwell.edu, contacts name: Michelle Gong, AS, role: CONTACT, phone: 516-562-3492, email: MGong@northwell.edu, geoPoint lat: 40.79788, lon: -73.69957, hasResults: False
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protocolSection identificationModule nctId: NCT06336369, orgStudyIdInfo id: 1713/2023, briefTitle: Brown Adipose Tissue Activity in Gilbert's Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2027-01-15, completionDateStruct date: 2027-01-15, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, collaborators name: University of Vienna, collaborators name: Griffith University, descriptionModule briefSummary: The goal of this case-control study is to investigate energy metabolism and brown adipose tissue (BAT) activity in individuals with Gilbert's syndrome (GS) and controls. The main focus of the study is to analyze:1. the link between bilirubin metabolism and metabolic health.2. energy metabolism and body composition in individuals with Gilbert's syndrome and control subjects3. brown adipose tissue activity in Gilbert's syndrome and healthy controls.Participants will undergo the following investigations:1. cold exposure2. PET-CT imaging with 18-F-FDG3. MRI imaging of liver, abdominal fat and muscle4. blood sampling5. indirect calorimetry6. bioelectrical impedance analysis7. infrared thermographyResearchers will compare individuals with GS and control subjects in terms of metabolic health, body composition and BAT activity., conditionsModule conditions: Gilbert Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: analyzing brown adipose tissue, body composition and metabolic health, outcomesModule primaryOutcomes measure: cold-induced brown adipose tissue (BAT) activation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Florian Kiefer, MD, PhD, role: CONTACT, phone: +43140400, phoneExt: 43120, email: florian.kiefer@meduniwien.ac.at, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
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protocolSection identificationModule nctId: NCT06336356, orgStudyIdInfo id: D6970C00011, briefTitle: A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2024-11-05, completionDateStruct date: 2024-11-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension., conditionsModule conditions: Uncontrolled Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Baxdrostat, interventions name: Placebo, outcomesModule primaryOutcomes measure: Individual Cortisol Level, secondaryOutcomes measure: Number of Participants with Abnormal Stimulated Cortisol, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336343, orgStudyIdInfo id: STUDY-23-01698, briefTitle: Bimekizumab in Plaque Psoriasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, collaborators name: UCB Pharma, collaborators name: Psoriasis Treatment Center of Central New Jersey, descriptionModule briefSummary: The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and 17F), which are known to increase inflammation. This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23., conditionsModule conditions: Plaque Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bimekizumab, outcomesModule primaryOutcomes measure: Body Surface Area (BSA) of < 1, secondaryOutcomes measure: Psoriasis and Severity Index Score (PASI) of < 1, secondaryOutcomes measure: Physician Global Assessment (PGA) of < 1, secondaryOutcomes measure: Psoriasis and Severity Index Score (PASI) of < 2, secondaryOutcomes measure: Physician Global Assessment (PGA) of < 2, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey, status: RECRUITING, city: East Windsor, state: New Jersey, zip: 08520, country: United States, contacts name: Elise Nelson, role: CONTACT, phone: 609-443-4500, contacts name: Jerry Bagel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.268, lon: -74.54043, locations facility: Icahn School of Medicine at Mount Sinai, status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Giselle Singer, role: CONTACT, phone: 212-241-3288, contacts name: Mark Lebwohl, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06336330, orgStudyIdInfo id: D1699R00050, briefTitle: Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany, acronym: EvolutionHF-DE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany., conditionsModule conditions: Heart Diseases, conditions: Cardiovascular Diseases, conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Time to discontinuation of dapagliflozin, primaryOutcomes measure: Reasons for discontinuation of dapagliflozin, primaryOutcomes measure: Dose changes of dapagliflozin, primaryOutcomes measure: Number of patients with dapagliflozin treatment interruptions, primaryOutcomes measure: Treatment switches from dapagliflozin to other SGLT2i, primaryOutcomes measure: Time to other heart failure treatment discontinuation, primaryOutcomes measure: Number of other heart failure treatment initiation, primaryOutcomes measure: Number of other heart failure treatment dosage changes, primaryOutcomes measure: Number of other heart failure treatment discontinuation, primaryOutcomes measure: Number of glucose lowering medication initiation, primaryOutcomes measure: Number of glucose lowering medication dosage changes, primaryOutcomes measure: Number of glucose lowering medication discontinuation, secondaryOutcomes measure: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score, secondaryOutcomes measure: Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire, secondaryOutcomes measure: Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score, otherOutcomes measure: The absolute change from baseline in occurrence of depressions in patients initiated on dapagliflozin for HF as captured by the Patient Health Questionnaire-9 (PHQ-9), otherOutcomes measure: Healthcare resource utilisation - Number of hospitalisations since dapagliflozin initiation, otherOutcomes measure: Healthcare resource utilisation - Length of HF-related hospital stay since dapagliflozin initiation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336317, orgStudyIdInfo id: ELIMINATE-2024, briefTitle: Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE, acronym: ELIMINATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Region Örebro County, class: OTHER, collaborators name: The Swedish Heart and Lung Association, collaborators name: Örebro University, Sweden, collaborators name: University of Cambridge, descriptionModule briefSummary: The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are:Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo., conditionsModule conditions: Acute Myocardial Infarction, conditions: Cardiovascular Diseases, conditions: Inflammatory Response, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Influenza vaccine, interventions name: Placebo, outcomesModule primaryOutcomes measure: The right coronary artery, secondaryOutcomes measure: The whole coronary tree, secondaryOutcomes measure: Ascending aorta, secondaryOutcomes measure: Interleukin 1 beta (IL-1β), secondaryOutcomes measure: Tumor necrosis factor alpha (TNF-α), secondaryOutcomes measure: Interleukin-2 receptor (IL-2r), secondaryOutcomes measure: Interleukin Interleukin-6 (IL-6 ), secondaryOutcomes measure: Ferritin, secondaryOutcomes measure: Troponin-I, secondaryOutcomes measure: N-terminal pro-B-type natriuretic peptide, otherOutcomes measure: Explorative endpoints, otherOutcomes measure: Explorative endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336304, orgStudyIdInfo id: NXTPMCF-01, briefTitle: NXT Post-Market Clinical Follow-up, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Laborie Medical Technologies Inc., class: INDUSTRY, descriptionModule briefSummary: NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations, conditionsModule conditions: Urinary Incontinence, conditions: Urinary Obstruction, conditions: Urinary Bladder, Overactive, conditions: Urinary Bladder, Neurogenic, conditions: Urinary Incontinence, Urge, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assess NXT system performance, primaryOutcomes measure: Assess NXT system safety, secondaryOutcomes measure: Assess NXT system performance, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336291, orgStudyIdInfo id: PH-L19TNFLOM-01/23, briefTitle: A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence, acronym: GLIOSTELLA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Philogen S.p.A., class: INDUSTRY, descriptionModule briefSummary: The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence, conditionsModule conditions: Glioblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: L19TNF, interventions name: L19TNF, interventions name: L19TNF, interventions name: Lomustine, interventions name: Lomustine, outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Serious Adverse Events, primaryOutcomes measure: Unacceptable Toxicity, primaryOutcomes measure: DILI assessment, primaryOutcomes measure: Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Time to reach maximum drug concentration [Tmax], secondaryOutcomes measure: Terminal half-life [t1/2], secondaryOutcomes measure: Area under the drug concentration-time curve, extrapolated to infinity [AUC], secondaryOutcomes measure: Maximum drug concentration [Cmax], secondaryOutcomes measure: Human anti-fusion protein antibodies (HAFA) levels against L19TNF, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336278, orgStudyIdInfo id: 19/03/2024, briefTitle: Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2023-10-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Selda Sarıkaya, class: OTHER, descriptionModule briefSummary: Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. It is also known that fear of movement, known as kinesiophobia, develops in patients with chronic pain. The aim of this study is to investigate CS and kinesiophobia in patients with knee OA, their relationships with each other, and their effects on pain intensity, functional status, pain catastrophizing and depression.Materials and Methods: Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms., conditionsModule conditions: Knee Osteoarthritis, conditions: Central Sensitisation, conditions: Kinesiophobia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 84, type: ACTUAL, armsInterventionsModule interventions name: Pressure Algometer, outcomesModule primaryOutcomes measure: Pain Pressure Treshold, primaryOutcomes measure: Central Sensitization, primaryOutcomes measure: Kinesiophobia, secondaryOutcomes measure: Pain Catastrophizing, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Visuel Analog Scala, secondaryOutcomes measure: Western Ontario and McMaster Universitesies Osteoarthritis Index, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zonguldak Bulent Ecevit Universitiy, city: Zonguldak, zip: 67100, country: Turkey, geoPoint lat: 41.45139, lon: 31.79305, hasResults: False
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protocolSection identificationModule nctId: NCT06336265, orgStudyIdInfo id: Diaphragm ultrasound, briefTitle: Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Xingui Dai, class: OTHER, descriptionModule briefSummary: Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis., conditionsModule conditions: Hypoxic Respiratory Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 269, type: ESTIMATED, armsInterventionsModule interventions name: Diaphragm ultrasound, outcomesModule primaryOutcomes measure: Thickness and thickening fraction of Diaphragm, primaryOutcomes measure: Diaphragmatic excursion, primaryOutcomes measure: Respiratory rate, primaryOutcomes measure: Incidence of tracheal intubation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336252, orgStudyIdInfo id: F-23059441, briefTitle: Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients, acronym: SENS4ME, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12-20, completionDateStruct date: 2026-06-20, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Bispebjerg Hospital, class: OTHER, collaborators name: AAL, collaborators name: Innovationsfonden, descriptionModule briefSummary: Primary Objective To investigate if patients hospitalised for older adults with a decreased level of physical function, either related to a chronic condition e.g., COPD, Congestive heart failure, renal failure; infections; frailty and tendency of falling; orthopaedic surgery - after hip fracture will increase their time spent out of bed during hospitalisation and 3 months after discharge through visual feedback and motivational intervention about physical activities from a new mobile technology.Hypothesis Patients hospitalised for medical disease will increase their physical activity level during hospitalisation and 3 months after discharge through visual feedback and motivational intervention from a new mobile technology., conditionsModule conditions: COPD, conditions: Heart Failure, conditions: Parkinson Disease, conditions: Arthritis, conditions: Old Age; Cachexia, conditions: Stroke Sequelae, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1/1 allocation, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Primary outcome (accelerometer data) blinded for the investigator and assesor., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: Digital nudging intervention target to change behavior, outcomesModule primaryOutcomes measure: Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes), secondaryOutcomes measure: Readmission within 90 days, secondaryOutcomes measure: Length of stay (days), secondaryOutcomes measure: Time spent lying down, sitting, standing, and walking measured in minutes related to the total accelerometer wear time (minutes), secondaryOutcomes measure: Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes), secondaryOutcomes measure: Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes), secondaryOutcomes measure: Quality of life (EQ5D-5L), secondaryOutcomes measure: - In-hospital fall incidents, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Christian Dall, status: RECRUITING, city: Copenhagen, zip: 2400, country: Denmark, contacts name: Christian H Dall, PhD, role: CONTACT, phone: 00 45 28604402, email: christian.have.dall@regionh.dk, contacts name: Morten T Kristensen, Professor, role: CONTACT, phone: 0045 38635000, email: morten.tange.kristensen@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06336239, orgStudyIdInfo id: KS2023097, briefTitle: PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study, acronym: PLACARD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Beijing Anzhen Hospital, class: OTHER, descriptionModule briefSummary: The association between Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD) is well established. Traditional risk factors for CVD and CKD are similar, with type 2 diabetes mellitus (T2DM) being the most prevalent risk factor. However, CKD is underdiagnosed and undertreated in patients with CVD. Further understanding of the combination of CKD in CVD patients is important to formulate prevention and treatment strategies for CVD patients and high-risk groups, reduce adverse events in CVD patients, and prevent progression of CKD to End Stage Renal Disease (ESRD)., conditionsModule conditions: Cardiovascular Disease, conditions: Type 2 Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: The prevalence of albuminuria, secondaryOutcomes measure: Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria, secondaryOutcomes measure: The prevalence of microalbuminuria and macroalbuminuria, secondaryOutcomes measure: To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments;, secondaryOutcomes measure: Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals., otherOutcomes measure: Exploratory Objective, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Sixth Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Lei Dong, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Fangshan District First Hospital, status: COMPLETED, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, status: COMPLETED, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chinese PLA Army Characteristic Medical Center, status: COMPLETED, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Haidong City Second People's Hospital, status: NOT_YET_RECRUITING, city: Haidong, state: Gansu, country: China, contacts name: Haiyan Xu, role: CONTACT, locations facility: The First Affiliated Hospital of Sun Yat-sen University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Chen Liu, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: First Hospital of Hebei Medical University, status: RECRUITING, city: Shijia Zhuang, state: Hebei, country: China, contacts name: Le Wang, role: CONTACT, phone: 18633889597, email: coronary2012@163.com, geoPoint lat: 34.17775, lon: 109.84894, locations facility: Ruyang County People's Hospita, status: RECRUITING, city: Luoyang, state: Henan, zip: 471201, country: China, contacts name: Yanna Song, role: CONTACT, contacts name: Litao Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Luoyang Sixth People's Hospita, status: COMPLETED, city: Luoyang, state: Henan, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Yongcheng People's Hospital, status: COMPLETED, city: Yongcheng, state: Henan, country: China, locations facility: The First Affiliated Hospital of Zhengzhou University, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, country: China, contacts name: Zhanying Han, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Zhangjiagang Sixth People's Hospital, status: COMPLETED, city: Zhangjiagang, state: Jiangsu, country: China, geoPoint lat: 31.865, lon: 120.53889, locations facility: Shenyang Ninth People's Hospital, status: RECRUITING, city: Shenyang, state: Liaoning, country: China, contacts name: Peng Gao, role: CONTACT, phone: 18940223349, email: 35095369@qq.com, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shenyang Tenth People's Hospital, status: ACTIVE_NOT_RECRUITING, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Jining First People's Hospital, status: NOT_YET_RECRUITING, city: Jining, state: Shandong, country: China, contacts name: Changjie Ren, role: CONTACT, geoPoint lat: 35.405, lon: 116.58139, locations facility: Tai'an First People's Hospital, status: COMPLETED, city: Tai'an, state: Shandong, country: China, geoPoint lat: 36.18528, lon: 117.12, locations facility: Weihai Central Hospital, status: NOT_YET_RECRUITING, city: Weihai, state: Shandong, country: China, contacts name: Yufeng Wang, role: CONTACT, geoPoint lat: 37.50914, lon: 122.11356, locations facility: Jing'an District Central Hospital of Shanghai, status: COMPLETED, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Xin Chen, Phd, role: CONTACT, email: heartmedi@163.com, contacts name: Xin Chen, Phd, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Zhongshan Hospital Fudan University Qingpu Branch, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Zilong Wang, role: CONTACT, phone: 18116016189, email: qy1499@126.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Qinyuan County People's Hospital, status: COMPLETED, city: Changzhi, state: Shanxi, country: China, geoPoint lat: 35.20889, lon: 111.73861, locations facility: Shanxi Bethune Hospital, status: RECRUITING, city: Taiyuan, state: Shanxi, country: China, contacts name: Yue Song, role: CONTACT, phone: 13657218603, email: song_yu_e@163.com, geoPoint lat: 37.86944, lon: 112.56028, locations facility: The First Affiliated Hospital of Xi'an Jiaotong University, status: NOT_YET_RECRUITING, city: XI Ail, state: Shanxi, country: China, contacts name: Zuyi Yuan, role: CONTACT, geoPoint lat: 44.9, lon: 122.8, locations facility: The Fifth People's Hospital of Sichuan Province, status: NOT_YET_RECRUITING, city: Chendu, state: Sichuan, country: China, contacts name: Xiaojuan Zhang, role: CONTACT, locations facility: West China Hospital of Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Yong Peng, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The First Affiliated Hospital of Xinjiang Medical University, status: NOT_YET_RECRUITING, city: Ürümqi, state: Xinjiang, country: China, contacts name: Xiang Ma, role: CONTACT, geoPoint lat: 43.80096, lon: 87.60046, locations facility: Taizhou Central Hospital, status: RECRUITING, city: Taizhou, state: Zhejiang, country: China, contacts name: Haipeng Cai, role: CONTACT, phone: 13867622455, email: 1917483306@qq.com, geoPoint lat: 32.49069, lon: 119.90812, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-26, uploadDate: 2024-02-29T04:49, filename: Prot_000.pdf, size: 711941, hasResults: False
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protocolSection identificationModule nctId: NCT06336226, orgStudyIdInfo id: BB AVF one stage vs two stage, briefTitle: Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques ., conditionsModule conditions: Arterio-venous Fistula, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Brachio basilic arterio venous fistula one stage versus two stage, outcomesModule primaryOutcomes measure: Comparative study between one stage brachio basilic arterio venous fistula versus two stage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336213, orgStudyIdInfo id: 20240306, briefTitle: Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Petrovsky National Research Centre of Surgery, class: OTHER, descriptionModule briefSummary: According to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis., conditionsModule conditions: Aortic Aneurysm and Dissection, conditions: Cardiac Valve Disease, conditions: Thoracic Aortic Aneurysm, conditions: Thoracic Aortic Dissection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ampicillin-sulbactam, outcomesModule primaryOutcomes measure: Infectious complications rate, secondaryOutcomes measure: Total amount of complicated patients, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Length of ICU stay, secondaryOutcomes measure: Multiorgan failure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Petrovsky Research National Centre of Surgery (Petrovsky NRCS), status: RECRUITING, city: Moscow, zip: 119991, country: Russian Federation, contacts name: Artem Gubko, Ph.D., role: CONTACT, phone: +79684241490, email: gubko@artvig.ru, contacts name: Denis Guskov, Ph.D, role: SUB_INVESTIGATOR, contacts name: Boris Akselrod, Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
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protocolSection identificationModule nctId: NCT06336200, orgStudyIdInfo id: Karabuk-006, briefTitle: Knee Osteoarthritis and Kinesiophobia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Karabuk University, class: OTHER, descriptionModule briefSummary: Kinesiophobia after total knee arthroplasty is an important parameter affecting recovery. However, the relationship between kinesiophobia and the factors it may cause is not clear. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after total knee arthroplasty., conditionsModule conditions: Knee Osteoarthritis, conditions: Kinesiophobia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Kinesiophobia, primaryOutcomes measure: Severity of pain, primaryOutcomes measure: Functional mobility, primaryOutcomes measure: Proprioception, primaryOutcomes measure: Fear of falling, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Pursaklar Public Hospital, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Musa Gunes, Msc, role: CONTACT, phone: 0 (370) 418 9081, email: musagunes@karabuk.edu.tr, contacts name: Fidan Yılmaz, Msc, role: PRINCIPAL_INVESTIGATOR, contacts name: Emime Emirmahmutoğlu, Bachelors, role: PRINCIPAL_INVESTIGATOR, contacts name: Buğrahan Şahin, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06336187, orgStudyIdInfo id: UPO 2020 02, briefTitle: European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study), acronym: EASE, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-06-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, collaborators name: Università degli Studi del Piemonte Orientale "Amedeo Avogadro", descriptionModule briefSummary: The goal of this observational, prospective, multi-national clinical study is to assess overall survival of patients who are diagnosed with incidental, histologically (biopsy) confirmed, \<4 cm Renal Cell Carcinoma (RCC) and are managed conservatively with active surveillance.The primary endpoint is overall survival. The Secondary endpoints are tumor growth rate, progression rate, cancer-specific survival, progression-free survival, identification of clinical and pathological variables and molecular and genetic markers that correlate with growth rate and progression.The main question it aims to answer is: patients with RCC (less than 4 cm) diagnosis can be managed with active surveillance instead treated with invasive curative procedure? For all participants a percutaneous biopsy of the renal mass will be arranged in all cases to histologically confirm the diagnosis of RCC (unless a diagnostic biopsy has been acquired in the previous 6 months). As a minimum, two samples will be used for diagnostic purposes while remaining core(s) will be preserved for molecular studies.Then, all patients will be under active surveillance, which is defined as the initial monitoring of tumor size by serial abdominal imaging (US, CT, or MRI) Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter. A follow-up visit will also be carried out at the time of progression when it occurs. Follow-up visits will include medical history and physical examination (optional), and assessment of concurrent medications, blood and urine collection and storage if participating in translational activities, cross-sectional abdominal and chest imaging exams.Follow-up percutaneous biopsies of the renal tumor are not mandatory, but can be performed when considered clinically important., conditionsModule conditions: Renal Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: active surveillance, interventions name: molecular investigation, outcomesModule primaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Disease progression, secondaryOutcomes measure: Molecular pattern, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Alessandro Volpe, MD, role: CONTACT, geoPoint lat: 45.44694, lon: 8.62118, hasResults: False
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protocolSection identificationModule nctId: NCT06336174, orgStudyIdInfo id: Anhui-SIA-cohort, briefTitle: Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Anhui Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients., conditionsModule conditions: Intracranial Atherosclerosis, conditions: Cognitive Impairment, conditions: Cerebrovascular Event, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin, interventions name: Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin, outcomesModule primaryOutcomes measure: The changes in Memory, primaryOutcomes measure: Occurrence of ischemic cerebrovascular events, secondaryOutcomes measure: MoCA (Montreal Cognitive Assessment), secondaryOutcomes measure: MMSE (Mini Mental State Examination), secondaryOutcomes measure: DST (Digital Span Test; Forward and Backward), secondaryOutcomes measure: The Stroop Color Test, secondaryOutcomes measure: CTT (Color Trail Test), secondaryOutcomes measure: CDT (Clock drawing test), secondaryOutcomes measure: VFT (Verbal Fluency Test), secondaryOutcomes measure: HAMD (Hamilton Depression Scale), secondaryOutcomes measure: HAMA (Hamilton Anxiety Scale), secondaryOutcomes measure: MRI measure- resting state MRI images, secondaryOutcomes measure: MRI measures-structural phase MRI images, secondaryOutcomes measure: MRI measures-3D pCASL images, secondaryOutcomes measure: Ultrasound measures-MCA-PI (middle cerebral artery-pulsatility index), secondaryOutcomes measure: Ultrasound measures-IMT (intima-media thickness), secondaryOutcomes measure: Blood Metabolomics measures-CRP (C-reactive protiein), secondaryOutcomes measure: Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein), secondaryOutcomes measure: Blood Metabolomics measures-miRNA/microRNA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Medical University, status: RECRUITING, city: Hefei, state: Anhui, zip: 230032, country: China, contacts name: Qiang Wei, PhD, role: CONTACT, phone: +8618788836237, email: qiangwei_914@126.com, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06336161, orgStudyIdInfo id: ESPB versus CEI, briefTitle: Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques, conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Fentanyl, outcomesModule primaryOutcomes measure: Measurement of Post-operative Pain, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Al-Azhar University hospitals, city: Cairo, country: Egypt, contacts name: Mohamed Khalil, Resident, role: CONTACT, phone: +201001297071, email: khalil.mohamed24mkh@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06336148, orgStudyIdInfo id: ACTM-838-01, briefTitle: A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Actym Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an Open label Single dose study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open label, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: ACTM-838, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b, primaryOutcomes measure: Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b, primaryOutcomes measure: Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b, primaryOutcomes measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b, primaryOutcomes measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b, primaryOutcomes measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b, primaryOutcomes measure: Progression free survival (PFS) - Part 1b, primaryOutcomes measure: Change in tumor markers - Part 1b, primaryOutcomes measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b, secondaryOutcomes measure: Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a, secondaryOutcomes measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a, secondaryOutcomes measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a, secondaryOutcomes measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a, secondaryOutcomes measure: Progression free survival (PFS) - Part 1a, secondaryOutcomes measure: Change in tumor markers - Part 1a, secondaryOutcomes measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a, secondaryOutcomes measure: Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200, city: Westmead, state: New South Wales, zip: 2145, country: Australia, contacts name: Mark Wong, Dr, role: CONTACT, phone: +61 2 9845 5200, email: mark.wong@sydney.edu.au, geoPoint lat: -33.80383, lon: 150.98768, locations facility: Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202, city: Bedford Park, state: South Australia, zip: 5042, country: Australia, contacts name: Ganessan Kichenadasse, Dr, role: CONTACT, phone: +61 491 670 039, email: clinicaltrials@socru.org.au, geoPoint lat: -35.03333, lon: 138.56667, locations facility: Alfred Hospital, 55 Commercial Road, Site No: 201, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Andrew Haydon, Dr, role: CONTACT, phone: +61 3 9076 3129, email: andrew.haydon@monash.edu.au, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
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protocolSection identificationModule nctId: NCT06336135, orgStudyIdInfo id: 23-001, briefTitle: Reduction in Symptoms After Laser Therapy With Acorn aHFS, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Acorn Biolabs Inc., class: INDUSTRY, descriptionModule briefSummary: This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily., conditionsModule conditions: Skin Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: autologous hair follicle derived secretome, outcomesModule primaryOutcomes measure: Reduction in severity and duration of symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rejuuv Medi Spa, city: Markham, state: Ontario, zip: L3R0M3, country: Canada, geoPoint lat: 43.86682, lon: -79.2663, hasResults: False
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protocolSection identificationModule nctId: NCT06336122, orgStudyIdInfo id: 83904_1, secondaryIdInfos id: R01DK135885-01, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK135885-01, briefTitle: OASIS: Peer Support for T2DM in Appalachia (Peer Participant), acronym: OASIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Kentucky, class: OTHER, collaborators name: Department of Health and Human Services, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management?If effective, which facets of the peer model are most effective? Peer coaches will Undergo peer coach training.Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting.Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Peer Coach Training - Weekly, interventions name: Peer Coach Training - Biweekly, outcomesModule primaryOutcomes measure: Number of participants with change in A1c, secondaryOutcomes measure: Diabetes Empowerment, secondaryOutcomes measure: Quality of Life Index, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Depression Scale, secondaryOutcomes measure: Problem Areas in Diabetes, secondaryOutcomes measure: Diabetes Self-Management, secondaryOutcomes measure: Acts of Daily Living, secondaryOutcomes measure: Social Network Scale, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barren River Area Development District, status: RECRUITING, city: Bowling Green, state: Kentucky, zip: 42101, country: United States, contacts name: Michelle Hines, role: CONTACT, phone: 270-306-4036, email: michelle@bradd.org, geoPoint lat: 36.99032, lon: -86.4436, locations facility: UK HealthCare, status: RECRUITING, city: Hazard, state: Kentucky, zip: 41701, country: United States, contacts name: Kay Douthitt, MD, role: CONTACT, email: key.douthitt@uky.edu, geoPoint lat: 37.24954, lon: -83.19323, hasResults: False
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protocolSection identificationModule nctId: NCT06336109, orgStudyIdInfo id: N-20220063-3, briefTitle: Fragmented Sleep, Pain, and Biomechanics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Aalborg University, class: OTHER, descriptionModule briefSummary: This interventional study aims to test the effects of sleep disruption on pain sensitivity and biomechanics in healthy individuals during experimental knee and shoulder pain. The main question the study aims to answer is:1) Does sleep fragmentation increase experimental knee and shoulder pain and what are the underlying mechanisms?Participants will receive two injections a) Hypertonic saline (painful) in the knee and b) hypertonic saline (painful) in the upper arm., conditionsModule conditions: Pain, conditions: Healthy, conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Hypertonic saline knee and shoulder injection, outcomesModule primaryOutcomes measure: Knee Pain intensity (NRS 0-10), primaryOutcomes measure: Shoulder Pain intensity (NRS 0-10), secondaryOutcomes measure: Pain sensitivity, secondaryOutcomes measure: The Pittsburgh Sleep Quality Index score, secondaryOutcomes measure: The Pain catastrophizing Scale score, secondaryOutcomes measure: The Hospital Anxiety and Depression Scale score, secondaryOutcomes measure: The Knee injury and Osteoarthritis Outcome Score, secondaryOutcomes measure: Rapid Assessment of Physical Activity score, secondaryOutcomes measure: Pain distribution by number of pixels marked on a body chart, secondaryOutcomes measure: Video-based motion capture, otherOutcomes measure: Quality of sleep (NRS 0-100), otherOutcomes measure: Level of rest (NRS 0-100), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aalborg University, status: RECRUITING, city: Aalborg, state: Nordjylland, zip: 9000, country: Denmark, contacts name: Kristian K Petersen, Dr. Med, role: CONTACT, phone: (+45) 31697510, email: kkp@hst.aau.dk, contacts name: Emma Hertel, M. Sc., role: CONTACT, phone: (+45) 60887473, email: eh@hst.aau.dk, geoPoint lat: 57.048, lon: 9.9187, hasResults: False
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protocolSection identificationModule nctId: NCT06336096, orgStudyIdInfo id: VX23-548-017, briefTitle: A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Vertex Pharmaceuticals Incorporated, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Suzetrigine, interventions name: Suzetrigine, outcomesModule primaryOutcomes measure: Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ, primaryOutcomes measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ, primaryOutcomes measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ, primaryOutcomes measure: Part B: Cmax of SUZ, primaryOutcomes measure: Part B: AUC0-tlast of SUZ, primaryOutcomes measure: Part B: AUC0-inf of SUZ, secondaryOutcomes measure: Part A: Cmax of SUZ Metabolite, secondaryOutcomes measure: Part A: AUC0-tlast of SUZ Metabolite, secondaryOutcomes measure: Part A: AUC0-inf of SUZ Metabolite, secondaryOutcomes measure: Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Part B: Cmax of SUZ Metabolite, secondaryOutcomes measure: Part B: AUC0-tlast of SUZ Metabolite, secondaryOutcomes measure: Part B: AUC0-inf of SUZ Metabolite, secondaryOutcomes measure: Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs, secondaryOutcomes measure: Part C: Cmax of SUZ and its Metabolite, secondaryOutcomes measure: Part C: AUC0-tlast of SUZ and its Metabolite, secondaryOutcomes measure: Part C: AUC0-inf of SUZ and its Metabolite, secondaryOutcomes measure: Part C: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion - Tempe, status: RECRUITING, city: Tempe, state: Arizona, zip: 85283, country: United States, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False
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protocolSection identificationModule nctId: NCT06336083, orgStudyIdInfo id: RC31/23/0618, briefTitle: Familial Form of Carotid Web: a Doppler Ultrasound Study, acronym: Family-WEB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: There is no evidence of familial forms of carotid web. The aim of this study is to determine the prevalence of carotid web among relatives of patient with carotid web using carotid doppler ultrasound., conditionsModule conditions: Carotid Web, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Doppler ultrasound, outcomesModule primaryOutcomes measure: Evaluation of the prevalence of carotid web by doppler ultrasound in first-degree relatives of patients with carotid web., secondaryOutcomes measure: Description of the clinical characteristics of relatives with carotid web and their index case., secondaryOutcomes measure: Description of the morphological characteristics of relatives with carotid web and their index case., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Toulouse, Purpan, city: Toulouse, zip: 31059, country: France, contacts name: Louis FONTAINE, MD, role: CONTACT, phone: 05 61 77 93 67, phoneExt: +33, email: fontaine.l@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
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protocolSection identificationModule nctId: NCT06336070, orgStudyIdInfo id: 2024-FIS-3251696, secondaryIdInfos id: CIACIF/2022/368, type: OTHER_GRANT, domain: Regional Ministry of Education, Universities and Employment - Generalitat Valenciana, briefTitle: Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study, acronym: POWER Health, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, collaborators name: Generalitat Valenciana, descriptionModule briefSummary: POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations., conditionsModule conditions: Breast Cancer Female, conditions: Cardiometabolic Syndrome, conditions: Metabolism Disorder, Lipid, conditions: Autonomic Dysfunction, conditions: Cardiovascular Diseases in Old Age, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: HIIT program (8 weeks), interventions name: MPI program (8 weeks), outcomesModule primaryOutcomes measure: Fat oxidation during incremental test, primaryOutcomes measure: Detrended Fluctuation Analysis, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Calf, waist and hip circumferences., secondaryOutcomes measure: Lean mass, secondaryOutcomes measure: Fat-free mass, secondaryOutcomes measure: Visceral adipose tissue, secondaryOutcomes measure: Bone Mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Blood Pressure, secondaryOutcomes measure: Oxygen Saturation, secondaryOutcomes measure: Sarcopenia, secondaryOutcomes measure: Physical activity and sedentariness, secondaryOutcomes measure: Lactate, secondaryOutcomes measure: Rating Perceived Exertion, secondaryOutcomes measure: Visual Analogue Scale of Pain, secondaryOutcomes measure: Cadence, secondaryOutcomes measure: Mechanical Power, secondaryOutcomes measure: Muscle Power 5STS, secondaryOutcomes measure: Basal metabolic rate, secondaryOutcomes measure: Respiratory exheange ratio at rest, secondaryOutcomes measure: Fat oxidation at rest, secondaryOutcomes measure: Carbohydrate oxidation at rest, secondaryOutcomes measure: Carbohydrate oxidation during incremental test, secondaryOutcomes measure: Energy expenditure during incremental test, secondaryOutcomes measure: FATmax intensity, secondaryOutcomes measure: VO2peak, secondaryOutcomes measure: Sample Entropy, secondaryOutcomes measure: SD1/SD2 ratio, secondaryOutcomes measure: The root mean square of successive differences between normal heartbeats (RMSSD), eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physical Activity and Sport Sciences, status: RECRUITING, city: Valencia, state: Comunidad Valenciana, zip: 46010, country: Spain, contacts name: Cristina Blasco Lafarga, PhD, role: CONTACT, phone: 64372, phoneExt: 9638, email: m.cristina.blasco@uv.es, contacts name: Jordi Monferrer-Marín, Predoctoral student, role: SUB_INVESTIGATOR, contacts name: Ainoa Roldán, PhD, role: SUB_INVESTIGATOR, contacts name: Jørn Wulff Helge, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06336057, orgStudyIdInfo id: RC31/23/0408, briefTitle: Mentalizating in Adults Suffering From Narcolepsy Type 1., acronym: NARCOMENTAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: The main objective is to examine the potential mentalization impairments affecting a population suffering from narcolepsy type 1. Indeed, the hypothesis of this research is that mentalization could be impaired in narcoleptic patients., conditionsModule conditions: Narcolepsy Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mentalization, outcomesModule primaryOutcomes measure: Comparison of mentalization abilities, in a population of patients with NT1 versus a control group., secondaryOutcomes measure: Comparison and description of mentalization abilities in a population of patients versus controls., secondaryOutcomes measure: Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through., secondaryOutcomes measure: Determination of the existence of a correlation between the time of appearance of the first symptoms and the initiation of treatment and the level of mentalization in NT1 patients, or not., secondaryOutcomes measure: Determination of the existence of a correlation between the age at the first symptoms of NT1 patients and mentalization abilities, or not., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet, city: Toulouse, zip: 31059, country: France, contacts name: Rachel DEBS, Dr, role: CONTACT, phone: 05 61 77 94 88, email: debs.r@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
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protocolSection identificationModule nctId: NCT06336044, orgStudyIdInfo id: Taufiller/22, briefTitle: Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Filler of Hyaluronic Acid Recombinant Collagen, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Taumedika s.r.l., class: INDUSTRY, collaborators name: Nextrasearch S.r.l.s., descriptionModule briefSummary: Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 20 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events, conditionsModule conditions: Wrinkle, conditions: Scar, conditions: Laxity; Skin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 20 patients will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Karisma, outcomesModule primaryOutcomes measure: Safety: no adverse events, primaryOutcomes measure: Efficacy: change of wrinkles and scars, primaryOutcomes measure: Efficacy: change of wrinkles and scars, primaryOutcomes measure: Efficacy: change of wrinkles and scars, primaryOutcomes measure: Efficacy: change of wrinkles and scars, secondaryOutcomes measure: Duration of the efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336031, orgStudyIdInfo id: 30002163, briefTitle: Impact of Blood Phobia on Fainting Susceptibility, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Simon Fraser University, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to characterize cardiovascular autonomic function to emotional stimuli (blood-injection-injury phobia \[needle phobia\]) during an orthostatic (upright) challenge in individuals with and without known needle phobia. It is well established that emotional stress can produce hypotensive (low blood pressure) reactions. Interestingly, these hypotensive reactions to venipuncture (even with minimal blood drawn), insulin injections, finger sticks for blood sugar monitoring, dental care, and vaccinations can affect up to a quarter of adults and appear to be uniquely associated with blood-injection-injury phobia rather than other phobias. These hypotensive reactions can ultimately lead to a vasovagal syncope (fainting) response, and lead to increased avoidance of medical and dental procedures as a result of this phobia. Ultimately, this has severe implications on public health and places additional strain on the Canadian healthcare system. Currently, there is limited understanding surrounding the initiation of this response. Additionally, a comprehensive profile of cardiovascular autonomic function during exposure to provoking stimuli during orthostatic stress has not been captured in the literature. We will test individuals with and without blood-injection-injury phobia using our standard approach while exposing them to emotional stimuli., conditionsModule conditions: Syncope, Vasovagal, conditions: Blood, Injection, Injury Type Phobia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: blood-injection-injury (BII) phobia stimuli, interventions name: neutral stimuli, outcomesModule primaryOutcomes measure: Orthostatic Tolerance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Simon Fraser University, status: RECRUITING, city: Burnaby, state: British Columbia, zip: V5A 1S6, country: Canada, contacts name: Vera E Lucci, PhD, role: CONTACT, phone: 7787828560, email: vlucci@sfu.ca, contacts name: Victoria E Claydon, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.26636, lon: -122.95263, hasResults: False
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protocolSection identificationModule nctId: NCT06336018, orgStudyIdInfo id: NN7535-7703, secondaryIdInfos id: U1111-1289-2466, type: OTHER, domain: World Health Organization (WHO), briefTitle: A Research Study on Etavopivat in Participants With and Without Liver Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-07-04, completionDateStruct date: 2025-07-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days., conditionsModule conditions: Liver Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Etavopivat, outcomesModule primaryOutcomes measure: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat), primaryOutcomes measure: Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat), secondaryOutcomes measure: Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat), secondaryOutcomes measure: Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat), secondaryOutcomes measure: Terminal half-life for etavopivat after a single dose (t1/2, etavopivat), secondaryOutcomes measure: Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat), secondaryOutcomes measure: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat), secondaryOutcomes measure: Number of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Orlando Clinical Research Center, city: Orlando, state: Florida, zip: 32806, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Amer. Rrsch Corp-TX Liver Inst, city: San Antonio, state: Texas, zip: 78215, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
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protocolSection identificationModule nctId: NCT06336005, orgStudyIdInfo id: NN6022-7683, briefTitle: A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-10-17, completionDateStruct date: 2024-10-17, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.The study will last for about 10 months in total., conditionsModule conditions: Healthy Volunteers, conditions: Cardiometabolic Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: NNC6022-0001, interventions name: Placebo (NNC6022-0001), outcomesModule primaryOutcomes measure: Number of treatment emergent adverse events (TEAE), secondaryOutcomes measure: AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose, secondaryOutcomes measure: AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose, secondaryOutcomes measure: Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose, secondaryOutcomes measure: IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON - location Groningen, status: RECRUITING, city: Groningen, zip: 9728 NZ, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False
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protocolSection identificationModule nctId: NCT06335992, orgStudyIdInfo id: Dnr 2022-00831-01, briefTitle: Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention., acronym: T-Rex, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: Lund University, descriptionModule briefSummary: The main objective of this project is to identify mechanisms for lung regeneration in patients with COPD induced by exercise training. The hypothesis is that adjusted exercise training improves disease outcome in these patients by decrease remodelling processes linked to oxidative stress, inflammatory and/or immunological pathways in the lung. Along the way, the investigator also expect to identify (or validate) biomarkers mirroring systemic processes such as reduced inflammation and ameliorating the epithelial barrier in these patients. These events may additionally act as potential targets for interventions.Objectives (i) Evaluate biomarkers for regenerative processes, matrix turnover, stem cell activity and inflammatory patterns in lung tissue biopsies, blood- and urine samples correlated to vital lung parameters and physical capacity, before and after attending an exercise-training program.(ii) Study the effects of exercise training on the pulmonary ventilation/perfusion ratio and quality of life.(iii) Evaluate the relation between pathophysiology in the lung evaluated by CT scan, and systemic response measured by muscle biopsies and biomarkers in blood/urine.(iv) Investigate in vitro cell behaviour and remodelling/regenerative processes altered in COPD patients upon exercise training (aim 1)., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Exercise regime, outcomesModule primaryOutcomes measure: Pulmonary Function, secondaryOutcomes measure: Physical capacity, secondaryOutcomes measure: Inflammation markers, secondaryOutcomes measure: Level of emphysema, secondaryOutcomes measure: Maximal physical capacity ( Wmax), secondaryOutcomes measure: COPD Assessment Test (CAT), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lund University, status: RECRUITING, city: Lund, country: Sweden, contacts name: Gunilla Westergren Thorsson, Phd, role: CONTACT, phone: +4646222 00 00, email: gunilla.westergren-thorsson@med.lu.se, contacts name: Caroline Ms Larsson, Phd, role: CONTACT, phone: +46736673026, email: caroline.larsson@med.lu.se, geoPoint lat: 55.70584, lon: 13.19321, locations facility: Uppsala University, status: RECRUITING, city: Uppsala, country: Sweden, contacts name: Margareta Mrs Emtner, Phd, role: CONTACT, phone: +46737594481, email: margareta.emtner@medsci.uu.se, contacts name: Christer Mr Janson, Phd, role: CONTACT, phone: +46186114115, email: christer.janson@medsci.uu.se, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False
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protocolSection identificationModule nctId: NCT06335979, orgStudyIdInfo id: CPIT565B12101, secondaryIdInfos id: 2023-510025-14-00, type: OTHER, domain: EU CT, briefTitle: An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE)., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-16, primaryCompletionDateStruct date: 2028-08-23, completionDateStruct date: 2028-08-23, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE, conditionsModule conditions: Systemic Lupus Erythematosus, SLE, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: PIT565, outcomesModule primaryOutcomes measure: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs), secondaryOutcomes measure: Maximum Observed Blood Concentrations (Cmax), secondaryOutcomes measure: Time to Reach Maximum Blood Concentrations (Tmax), secondaryOutcomes measure: Presence/absence of Anti-drug Antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335966, orgStudyIdInfo id: STUDY00025975, briefTitle: BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy, acronym: BEST-RPP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: OHSU Knight Cancer Institute, class: OTHER, collaborators name: Kuni Foundation, collaborators name: Oregon Health and Science University, descriptionModule briefSummary: Recent advancements in swallowable esophageal cell-collection devices (SECD) offer a safe, minimally invasive, accurate, and low-cost alternative to esophageal screening without the need for an upper endoscopy. The BEST-RPP study aims to evaluate the acceptability and feasibility of using this novel approach to screen for Barrett's Esophagus (BE) and Esophageal Carcinoma (EAC) in rural primary care clinic settings in Oregon., conditionsModule conditions: Esophageal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Screening with swallowable esophageal cell-collection devices (SECD), outcomesModule primaryOutcomes measure: Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD, primaryOutcomes measure: Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff, primaryOutcomes measure: Feasibility of the use of SECD: Number of referrals, primaryOutcomes measure: Feasibility of the use of SECD: Number enrolled, primaryOutcomes measure: Patient acceptability: Number of interested patients who schedule an appointment to be screened, primaryOutcomes measure: Patient acceptability: Number of patients who come to their appointments, primaryOutcomes measure: Patient acceptability: Number of patients interested in being screened via SECD at other care centers, secondaryOutcomes measure: Access: time to full diagnostic work up for patients with positive SECD results, eligibilityModule sex: MALE, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHSU Knight Cancer Institute, status: RECRUITING, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Laura Ferrara, MA, role: CONTACT, phone: 541-399-1139, contacts name: Fouad Otaki, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06335953, orgStudyIdInfo id: IRB00418404, secondaryIdInfos id: U54AG063546, type: NIH, link: https://reporter.nih.gov/quickSearch/U54AG063546, briefTitle: ALIGN: Aligning Medications With What Matters Most (Demonstration), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners.The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP.The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months., conditionsModule conditions: Polypharmacy, conditions: Alzheimer's Disease and Related Dementias, conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Pharmacist-led deprescribing intervention, outcomesModule primaryOutcomes measure: Proportion of patients who stop one or more medications, secondaryOutcomes measure: Proportion of patients who start one or more new medications, secondaryOutcomes measure: Proportion of patients who stop one or more potentially inappropriate medication (PIM), secondaryOutcomes measure: Total number of medications, otherOutcomes measure: Shared decision-making as assessed by CollaboRATE, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Bayview Medical Center, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Ariel Green, MD, MPH, PhD, role: CONTACT, phone: 410-550-6733, email: ariel@jhmi.edu, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06335940, orgStudyIdInfo id: 38RC23.0376, briefTitle: Admission for Respiratory Disease And VIdeo Regulation System, acronym: ARAVIS-PED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-10-18, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: Pediatric dyspnea is a major health problem, accounting for up to 27% of admissions to emergency departments in winter. It is estimated that a significant number (13%) of patients presenting to emergency departments are outpatients, at a time when emergency departments are having to cope with an ever-increasing flow of patients.Proper referral of patients calling the SAMU Centre-15 takes on its full meaning in this context, but regulating paediatric calls is more difficult. Indeed, the regulating doctor is most often in contact with the parents, who describe what they see and pass on their concerns, and it is difficult to have direct contact with patients who are often very young. Obtaining objective criteria such as saturation and respiratory rate is also a real challenge.To overcome the complexity of medical regulation, a number of tools and aids have been developed, including visio or video-regulation (regulation via the camera on the caller's smartphone).This device has been evaluated in a number of situations, enabling it to take its place in the daily practice of many doctors, but there is very little data concerning pediatric visio-regulation, particularly with regard to dyspnea.To the best of the investigator knowledge, there is no prospective study looking at the impact of Video-Regulation on the outcome of patients requiring the advice of SAMU Centre-15 for pediatric dyspnea., conditionsModule conditions: Pediatric Respiratory Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 588, type: ESTIMATED, armsInterventionsModule interventions name: Videoregulation, outcomesModule primaryOutcomes measure: To determine in children under 10 years of age for whom a call to the SAMU38 for dyspnea is made, whether the use of Visio-Regulation reduces the percentage of emergency room admissions compared with standard telephone medical regulation., secondaryOutcomes measure: Evaluate whether the use of video-regulation has an impact on the dispatcher's referral decision between ambulatory medicine and the emergency department., secondaryOutcomes measure: Determine whether the use of video-regulation leads to an increase in call time with the regulating doctor, secondaryOutcomes measure: Evaluate parents' satisfaction with videoregulation compared with a standard call, secondaryOutcomes measure: Evaluate the number of rescue vectors (fire brigade, private ambulance) triggered but whose decision will ultimately be to "leave on the spot" after the rescue worker's assessment., secondaryOutcomes measure: Evaluate whether the increased use of video-regulation is not associated with a higher rate of hospitalization in a conventional ward or intensive care unit, eligibilityModule sex: ALL, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335927, orgStudyIdInfo id: GWK2023-001, briefTitle: HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-11, primaryCompletionDateStruct date: 2025-05-10, completionDateStruct date: 2026-05-10, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma.The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: HAIC-GEMOX+Cadonilimab+Regorafenib, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Hepatic Objective Response Rate (hORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Safety and tolerability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Li Tan, role: CONTACT, phone: +8615800680751, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06335914, orgStudyIdInfo id: dualPET-mPC, secondaryIdInfos id: CAPCR: 23-5595, type: OTHER, domain: University Health Network, briefTitle: Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-03-04, completionDateStruct date: 2029-09-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future., conditionsModule conditions: Advanced Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ga 68 PSMA-11 PET, interventions name: 18F-DCFPyL PET, interventions name: FDG PET, outcomesModule primaryOutcomes measure: Proportion of patients with high volume mCSPC having PSMA avid disease, secondaryOutcomes measure: Proportion of patients with PSMA-/FDG+ discordant lesions, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Princess Margaret Cancer Centre, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, contacts name: Di (Maria) Jiang, M.D., role: CONTACT, phone: 416-946-4501, phoneExt: 4807, email: di.jiang@uhn.ca, contacts name: Di (Maria) Jiang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06335901, orgStudyIdInfo id: xx20190901, briefTitle: Clinical Characteristics and Outcomes of Coronary Heart Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-02-01, primaryCompletionDateStruct date: 2022-01-31, completionDateStruct date: 2022-04-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Xinjiang Medical University, class: OTHER, descriptionModule briefSummary: This study evaluated and compared the prognostic value of different Baseline data and clinical variables to develop a risk ractor ediction model in patients with CHD., conditionsModule conditions: Coronary Heart Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20000, type: ACTUAL, armsInterventionsModule interventions name: Drug:Standard therapy, outcomesModule primaryOutcomes measure: Death （All-cause mortality、Cardiac mortality ）, secondaryOutcomes measure: Major adverse cardiovascular events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Xinjiang Medical University, city: Ürümqi, state: Xinjiang, zip: 630000, country: China, geoPoint lat: 43.80096, lon: 87.60046, hasResults: False
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protocolSection identificationModule nctId: NCT06335888, orgStudyIdInfo id: CRAFT, briefTitle: A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis, acronym: CRAFT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, collaborators name: Paul Scherrer Institut, Center for Proton Therapy, descriptionModule briefSummary: The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PET/CT in the diagnosis of GCA (giant cell arteritis), to compare AzaFol- with 2-\[18F\]FDG-PET/CT, and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA.Participants will undergo AzaFol-PET/CT imaging at a single timepoint., conditionsModule conditions: Giant Cell Arteritis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Cross-over, randomized, open label, single-centre, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: AzaFol, interventions name: FDG, outcomesModule primaryOutcomes measure: Specificity of the GCA-diagnosis at the patient level, secondaryOutcomes measure: Lesion detection rate (visual analysis), secondaryOutcomes measure: Lesion detection rate (semiquantitative analysis), secondaryOutcomes measure: Sensitivity of the GCA-diagnosis at the patient level, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Rheumatology and Immunology, University Hospital Bern, Inselspital, city: Bern, zip: 3010, country: Switzerland, contacts name: Britta Maurer, role: CONTACT, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False
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protocolSection identificationModule nctId: NCT06335875, orgStudyIdInfo id: HUM00227568, briefTitle: Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones, acronym: BIPO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, descriptionModule briefSummary: Small exploratory open-label pilot study to assess supplementation of a ketone ester (Juvenescence) combined with a 'ketogenic-mimicking diet' as a potential therapy for persons with bipolar disorder., conditionsModule conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Ketone Ester Beverage, interventions name: Low Glycemic Index Diet, outcomesModule primaryOutcomes measure: Change in blood beta-hydroxybutyrate level, secondaryOutcomes measure: Change in blood glucose lability, secondaryOutcomes measure: Change in neural network stability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Domino's Farms, city: Ann Arbor, state: Michigan, zip: 48105, country: United States, geoPoint lat: 42.27756, lon: -83.74088, locations facility: University Hospital, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06335862, orgStudyIdInfo id: NL.84862.041.23, briefTitle: Primary Posterior Tracheopexy Prevents Tracheal Collapse, acronym: PORTRAIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: For Wis(h)dom Foundation, collaborators name: Erasmus Medical Center, collaborators name: Great Ormond Street Hospital for Children NHS Foundation Trust, collaborators name: Karolinska University Hospital, descriptionModule briefSummary: Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT).Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages.Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial., conditionsModule conditions: Oesophageal Atresia With Tracheo-Oesophageal Fistula, conditions: Tracheomalacia, conditions: Oesophageal Atresia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized 1:1 into either the intervention group (PPT-group) or the wait-and-see group (no-PPT). Since the sutures of the PPT remain in place (in the PPT-group), the participants are allocated to one arm for the duration of the study. After the PPT was or was not performed, the participants will follow the same follow-up schedule., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: All participants, parents/caregivers, investigators and treating healthcare personnel, except for the surgical team performing the OA correction, will be blinded to which study arm the participant is assigned. None of the data gathered is affected by the unblinded surgical team since the primary and key secondary outcome measures are evaluated based on pseudonymised video footage. Furthermore, this video footage is assessed by otolaryngologists who are blinded to the patient and study arm. Moreover, the follow-up and documentation of the secondary endpoints are typically performed by the paediatrician and speech- and language therapists (not the paediatric surgeon or otolaryngologist)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Randomisation between the PPT- and no-PPT-group, interventions name: Primary Posterior Tracheopexy, interventions name: Preoperative tracheobronchoscopy, interventions name: Intraoperative tracheobronchoscopy, interventions name: Postoperative tracheobronchoscopy through the endotracheal tube during extubation, interventions name: Postoperative tracheobronchoscopy after 2-6 months, outcomesModule primaryOutcomes measure: Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy, secondaryOutcomes measure: Key secondary outcome: Difference in degree of TM between the PPT-group and no-PPT-group during postoperative tracheobronchoscopy, secondaryOutcomes measure: Difference in symptoms between the PPT-group and no-PPT-group, secondaryOutcomes measure: Degree of preoperative TM compared to postoperative TM, eligibilityModule sex: ALL, minimumAge: 34 Weeks, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335849, orgStudyIdInfo id: LYB004-CT-AUS-101, briefTitle: A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Guangzhou Patronus Biotech Co., Ltd., class: INDUSTRY, collaborators name: Yantai Patronus Biotech Co., Ltd., descriptionModule briefSummary: This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years., conditionsModule conditions: Herpes Zoster, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: LYB004 25µg, interventions name: LYB004 50µg, interventions name: SHINGRIX, outcomesModule primaryOutcomes measure: Evaluate the reactogenicity of LYB004 vaccine, primaryOutcomes measure: Evaluate the safety and reactogenicity of LYB004 vaccine, primaryOutcomes measure: Evaluate the safety of LYB004 vaccine, primaryOutcomes measure: Evaluate the safety and tolerability in laboratory tests of LYB004 vaccine, primaryOutcomes measure: Evaluate the SAEs and AESIs of LYB004 vaccine, secondaryOutcomes measure: Observe the humoral immunity of LYB004 vaccine, secondaryOutcomes measure: Observe the cellular immunity of LYB004 vaccine, secondaryOutcomes measure: Observe the persistence of humoral immunity of LYB004 vaccine, secondaryOutcomes measure: Observe the persistence of cellular immunity of LYB004 vaccine, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nucleus Network Pty Ltd, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Katherine Gunn, role: CONTACT, phone: (07) 3707 2781, email: k.gunn@nucleusnetwork.com.au, contacts name: Kristof Boot, role: CONTACT, phone: (07) 3707 2780, email: k.boot@nucleusnetwork.com.au, contacts name: Christina Chang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
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protocolSection identificationModule nctId: NCT06335836, orgStudyIdInfo id: 2024-SR-127, secondaryIdInfos id: 2024-SR-127, type: OTHER, domain: Ethics Committee of Nanjing Medical University, briefTitle: The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD;2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation;3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions;4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients., conditionsModule conditions: Social Isolation, conditions: SCD, conditions: Subjective Cognitive Decline, conditions: MCI, conditions: Mild Cognitive Impairment, conditions: AD, conditions: Alzheimer Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 209, type: ESTIMATED, armsInterventionsModule interventions name: social isolation, outcomesModule primaryOutcomes measure: Incidence of Mild Cognitive Impairment (MCI), primaryOutcomes measure: Incidence of Alzheimer's disease (AD), secondaryOutcomes measure: AVLT-H, secondaryOutcomes measure: MoCA, secondaryOutcomes measure: WMS-RLM, secondaryOutcomes measure: WDS, secondaryOutcomes measure: VFT, secondaryOutcomes measure: BNT, secondaryOutcomes measure: LSNS-6, secondaryOutcomes measure: UCLA, secondaryOutcomes measure: GDS, secondaryOutcomes measure: PSQI, secondaryOutcomes measure: DTC, secondaryOutcomes measure: fMRI, secondaryOutcomes measure: tau, secondaryOutcomes measure: Aβ, secondaryOutcomes measure: APOE genotyping, secondaryOutcomes measure: TMT-A, TMT-B, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: China, Jiangsu, zip: 210000, country: China, contacts name: Zhu Yi, role: CONTACT, phone: +86 137 0516 4030, email: ZhuYi1981@njmu.edu.cn, contacts name: Shi Chunxu, role: CONTACT, phone: +8618625175592, email: scx_0212@outlook.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06335823, orgStudyIdInfo id: STUDY20231621, briefTitle: Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Jean Marino, class: OTHER, descriptionModule briefSummary: Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement., conditionsModule conditions: IUD Insertion Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous electrical nerve stimulation (TENS), interventions name: Placebo Transcutaneous electrical nerve stimulation (TENS), outcomesModule primaryOutcomes measure: Pain during IUD insertion as measured by the VAS score, secondaryOutcomes measure: Pain during IUD insertion as measured by the VAS score, secondaryOutcomes measure: Pain during IUD insertion as measured by the VAS score, secondaryOutcomes measure: Pain during IUD insertion as measured by the VAS score, secondaryOutcomes measure: Pain during IUD insertion as measured by the VAS score, otherOutcomes measure: Pain during IUD insertion as measured by the VAS score, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Hospitals, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Jean M Marino, APRN-CNP, role: CONTACT, phone: 440-720-3250, email: Jean.Marino@UHhospitals.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06335810, orgStudyIdInfo id: 23-10026599, secondaryIdInfos id: R01DK135949-01, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK135949-01, briefTitle: Reducing Obesity Using Social Ties Program, acronym: ROBUST, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change. Specifically, the study will test if, by including up to two friends, family members, or co-workers in a lifestyle intervention for weight loss, the person enrolled in the study loses more weight than someone whose friends, family members, or co-workers were not invited to participate., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Social Network Intervention, interventions name: Individual Lifestyle Intervention, interventions name: Social Network Member, outcomesModule primaryOutcomes measure: Number of participants who have attended at least 75 percent of the behavioral coaching sessions, primaryOutcomes measure: Number of intervention participants who have at least one social network member engage in the study, primaryOutcomes measure: Number of participants and social network members combined who complete the final study assessment, secondaryOutcomes measure: Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire, secondaryOutcomes measure: Change in weight related social norms, secondaryOutcomes measure: Change in median Fitbit wear time in minutes, secondaryOutcomes measure: Change in total caloric amounts on three-day food record, secondaryOutcomes measure: Change in median number of days that the Fitbit is worn, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Weill Cornell Urology, status: RECRUITING, city: Brooklyn, state: New York, zip: 11217, country: United States, contacts name: Jesabely Solano, BS, role: CONTACT, phone: 646-962-9209, email: jes4037@med.cornell.edu, geoPoint lat: 40.6501, lon: -73.94958, locations facility: Weill Cornell Internal Medicine Associates, status: RECRUITING, city: New York, state: New York, zip: 10021, country: United States, contacts name: Jesabely Solano, BS, role: CONTACT, phone: 646-962-9209, email: jes4037@med.cornell.edu, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Weill Cornell Primary Care at Lower Manhattan, status: RECRUITING, city: New York, state: New York, zip: 10038, country: United States, contacts name: Jesabely Solano, BS, role: CONTACT, phone: 646-962-9209, email: jes4037@med.cornell.edu, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Weill Cornell Urology, status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Jesabely Solano, BS, role: CONTACT, phone: 646-962-9209, email: jes4037@med.cornell.edu, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06335797, orgStudyIdInfo id: IRB00110733, briefTitle: Optimization of Postoperative Bowel Habits, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, descriptionModule briefSummary: Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository., conditionsModule conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Senna Tab, interventions name: Dulcolax Suppositories, outcomesModule primaryOutcomes measure: Time in hours to first bowel movement comparison between the two arms, secondaryOutcomes measure: Change in Overall Satisfaction (TSQM) Scores, secondaryOutcomes measure: Visual Analog Scale (VAS) Pain Scores, secondaryOutcomes measure: Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores, secondaryOutcomes measure: Bristol Stool Form Scale (BSFS) Scores, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wake Forest University Health Sciences, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Christina M Mezes, MD, role: CONTACT, phone: 336-713-4098, email: cmezes@wakehealth.edu, contacts name: Sachin N Vyas, MS, PhD, role: CONTACT, phone: 336.713.4098, email: svyas@wakehealth.edu, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
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protocolSection identificationModule nctId: NCT06335784, orgStudyIdInfo id: 2023-00456, briefTitle: Mental Imagery and Targeted Memory Reactivation in Insomnia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2027-05-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University Hospital, Geneva, class: OTHER, collaborators name: University of Geneva, Switzerland, descriptionModule briefSummary: In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID).Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night.Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure).At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night.The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition., conditionsModule conditions: Insomnia Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Imagery Rescripting (IR), interventions name: Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep, interventions name: Sleep Hygiene, interventions name: Sleep Hygiene + Odor, interventions name: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention, outcomesModule primaryOutcomes measure: Insomnia Severity Index (ISI), secondaryOutcomes measure: Pittsburgh sleep quality index (PSQI), secondaryOutcomes measure: Total Sleep Time (TST), secondaryOutcomes measure: Wake After Sleep Onset (WASO), secondaryOutcomes measure: Beck Depression Inventory II (BDI-II), secondaryOutcomes measure: State Trait Anxiety Inventory (STAI), secondaryOutcomes measure: Sleep efficiency (SE), secondaryOutcomes measure: Micro-arousals, otherOutcomes measure: Temperament and Character Inventory, otherOutcomes measure: Pre-sleep Arousal Scale (PSAS), otherOutcomes measure: Arousal Predisposition Scale (APS), otherOutcomes measure: Digit Span Task, otherOutcomes measure: Psychomotor Vigilance Task (PVT), otherOutcomes measure: Declarative word paired-associate learning task, otherOutcomes measure: Attachment Style Questionnaire (ASQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center for Sleep Medicine, status: RECRUITING, city: Geneva, country: Switzerland, contacts name: Lampros Perogamvros, role: CONTACT, phone: +41223729946, email: Lampros.Perogamvros@hcuge.ch, contacts name: Lampros Perogamvros, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.20222, lon: 6.14569, hasResults: False
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protocolSection identificationModule nctId: NCT06335771, orgStudyIdInfo id: 2098077, secondaryIdInfos id: R01DK131188, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK131188, briefTitle: Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity, acronym: ATM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Bettina Mittendorfer, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.Both groups will have:* screening visit* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans)* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss., conditionsModule conditions: Obesity, conditions: Nonalcoholic Fatty Liver, conditions: Diabetes Type 2, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dietary consultation weight loss intervention, outcomesModule primaryOutcomes measure: Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure., primaryOutcomes measure: 24-hour plasma glucose concentration, primaryOutcomes measure: Macrophage isolation in adipose tissue biopsy, primaryOutcomes measure: Macrophage isolation in skeletal muscle tissue, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Missouri School of Medicine, city: Columbia, state: Missouri, zip: 65212, country: United States, contacts name: Bettina Mittendorfer, role: CONTACT, phone: 573-822-9377, email: b.mittendorfer@missouri.edu, geoPoint lat: 38.95171, lon: -92.33407, hasResults: False
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protocolSection identificationModule nctId: NCT06335758, orgStudyIdInfo id: EXC-039-2023-CLR, briefTitle: Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication., acronym: RegStud, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Dosentrx Ltd., class: INDUSTRY, collaborators name: US Oncology Research, descriptionModule briefSummary: The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.The study will evaluate and monitor use of ReX in respect of:* treatment duration* adverse events* patient adherence and compliance* engagement with ReX via patient-reported outcomesPatients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen., conditionsModule conditions: Any Solid Oral Medication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Use of ReX to dispense and monitor solid oral medication therapy., outcomesModule primaryOutcomes measure: Treatment duration, primaryOutcomes measure: Patient satisfaction, primaryOutcomes measure: Adverse events, primaryOutcomes measure: Patient adherence, primaryOutcomes measure: Patient compliance, primaryOutcomes measure: Patient engagement, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHC, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45242, country: United States, contacts name: Zachary Beck, role: CONTACT, geoPoint lat: 39.12713, lon: -84.51435, hasResults: False
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protocolSection identificationModule nctId: NCT06335745, orgStudyIdInfo id: 24-066, briefTitle: PediCARE Health Equity Intervention in High-Risk Neuroblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, descriptionModule briefSummary: This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.The names of the intervention groups in this research study are:* Usual supportive care* PediCARE + usual supportive care, conditionsModule conditions: Neuroblastoma, conditions: High-risk Neuroblastoma, conditions: Pediatric Cancer, conditions: Disparities, conditions: Financial Stress, conditions: Poverty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: PediCARE Intervention, outcomesModule primaryOutcomes measure: Change in Kessler-6 Psychological Distress Scale Score, secondaryOutcomes measure: Proportion of Enrolled Participants (Feasibility), secondaryOutcomes measure: Change in Mean Household Material Hardship (HMH) Score, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06335732, orgStudyIdInfo id: P.T.REC/012/004394, briefTitle: Prevalenc Of Lumbosacral Radiculopathy Among Physiotherapists Of Pediatric Rehabilitation OF PEDIATRIC REHABILITATION, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-05, primaryCompletionDateStruct date: 2023-06-08, completionDateStruct date: 2023-08-22, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Kerolous Ishak Shehata, class: OTHER, descriptionModule briefSummary: Determine the prevalence of lumbosacral radiculopathy among pediatric physiotherapists in the ministry of health in Cairo, Egypt., conditionsModule conditions: Prevalence, Lumbosacral Radiculopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: Cross section study; single group related measurement design., outcomesModule primaryOutcomes measure: The Roland-Morris disability scale (RMS), primaryOutcomes measure: Straight Leg Raising (SLR), eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kerolous Ishak Shehata, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06335719, orgStudyIdInfo id: IRB #22-926, briefTitle: Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule briefSummary: A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross face nerve graft facial reanimation surgery., conditionsModule conditions: Facial Paralysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will undergo all the standard steps of the facial reanimation procedures. The difference in care is 2/3 participants may receive the brief electrical stimulation therapy.Other 1/3 of study participants will undergo the surgery as they normally would if they had not chosen to participate., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is a randomized, controlled, double-blinded (patient and evaluator) prospective study. Plan is to enroll up to 30 patients, with a minimum of 20 completing full follow-up. Randomization 2:1 treatment to control due to previous peripheral nerve research demonstrating intraoperative stimulation accelerates axonal regeneration, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: BES, interventions name: Standard of Care surgery, outcomesModule primaryOutcomes measure: To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology., secondaryOutcomes measure: To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic Foundation, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Hana Rosen, MD, role: CONTACT, phone: 216-444-7018, email: rosenh@ccf.org, contacts name: John O'Neill, BS, role: CONTACT, phone: 4405062611, email: oneillj2@ccf.org, contacts name: Patrick Byrne, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Michael Fritz, MD, role: SUB_INVESTIGATOR, contacts name: Brandon Hopkins, MD, role: SUB_INVESTIGATOR, contacts name: Peter Ciolek, MD, role: SUB_INVESTIGATOR, contacts name: Dane Genther, MD, role: SUB_INVESTIGATOR, contacts name: Stephen Hadford, MD, role: SUB_INVESTIGATOR, contacts name: Peng Ding, MD, role: SUB_INVESTIGATOR, contacts name: Derek Vos, BS, role: SUB_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06335706, orgStudyIdInfo id: 0596/66, briefTitle: The Influence of Fit of Underpants Worn on Semen Quality, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate the impact of underpants fit among Thai males attending the Infertility Clinic, whether alone or with their spouses. The main questions it aims to answer are:* Assessing the effect of underpants fit on basic semen parameters and sperm DNA integrity.* Determining the prevalence of preferred type of underpants worn by Thai males.The participants will need to provide informed consent, complete a questionnaire consisting of 28 questions, and provide a semen sample., conditionsModule conditions: Infertility, Male, conditions: Semen Analysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Fit of underpants worn, outcomesModule primaryOutcomes measure: Semen Volume, primaryOutcomes measure: Total sperm count, primaryOutcomes measure: Sperm concentration, primaryOutcomes measure: Sperm motility, primaryOutcomes measure: Sperm morphology, secondaryOutcomes measure: Sperm DNA integrity, otherOutcomes measure: Preferred type of underpants, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335693, orgStudyIdInfo id: CHHHospital, briefTitle: Adjuvant Hypofractionated Radiotherapy for Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, outcomesModule primaryOutcomes measure: Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events, secondaryOutcomes measure: progression-free survival (PFS), secondaryOutcomes measure: medical expenses, secondaryOutcomes measure: quality of life(QoL), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: prostate cancer-specific survival (CSS), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Naval Medical University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Huojun Zhang, PhD, role: CONTACT, phone: 021-31162222, email: huojunzh@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06335680, orgStudyIdInfo id: 21-001493, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
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protocolSection identificationModule nctId: NCT06335667, orgStudyIdInfo id: 4565, secondaryIdInfos id: UCI 23-72, type: OTHER, domain: UCI CFCCC, briefTitle: mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer Objectives, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2030-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC)., conditionsModule conditions: Urothelial Bladder Cancer, conditions: Muscle-Invasive Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: mpMRI + Diagnostic TURBT, outcomesModule primaryOutcomes measure: Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT., secondaryOutcomes measure: Progression free survival (PFS) with mpMRI compared to diagnostic TURBT, secondaryOutcomes measure: Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy, secondaryOutcomes measure: Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI)., secondaryOutcomes measure: Incidence of adverse events with mpMRI versus diagnostic TURBT., secondaryOutcomes measure: Patient Quality of Life with mpMRI versus diagnostic TURBT., secondaryOutcomes measure: Incidence of repeat TURBT., secondaryOutcomes measure: Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chao Family Comprehensive Cancer Center University of California, Irvine, city: Orange, state: California, zip: 92868, country: United States, contacts name: Nataliya Mar, MD, role: CONTACT, phone: 877-827-8839, email: ucstudy@uci.edu, geoPoint lat: 33.78779, lon: -117.85311, hasResults: False
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protocolSection identificationModule nctId: NCT06335654, orgStudyIdInfo id: 24K056-001, briefTitle: Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Jilin University, class: OTHER, descriptionModule briefSummary: Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. However, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to distinguish neoplastic from non-neoplastic during colonoscopy. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC can demonstrate the atypical of gland structure and cells after staining and display the super-amplified surface microvessels of the lesion under the EC-NBI mode. However, the judgment of endocytoscopic images needs a lot of experience to improve the diagnostic accuracy. Moreover, endoscopists have certain subjective judgments and errors in endocytoscopic diagnosis. There is an artificial intelligence system which has been developed to identify colorectal neoplasms. However, there is still a lack of prospective clinical verification based on Chinese population. In the study, the investigators performed a prospective clinical study to determine the diagnostic accuracy of artificial intelligence system., conditionsModule conditions: Colorectal Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: artificial intelligence system, outcomesModule primaryOutcomes measure: sensitivity, primaryOutcomes measure: specificity, primaryOutcomes measure: accuracy, primaryOutcomes measure: positive predictive value, primaryOutcomes measure: negative predictive value, primaryOutcomes measure: high confidence diagnosis rate, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First hospital of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, zip: 130021, country: China, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
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protocolSection identificationModule nctId: NCT06335641, orgStudyIdInfo id: COOLHD24-CAN, briefTitle: Head COOLing in iscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety stuDy, acronym: COOLHEAD-2-CAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures., conditionsModule conditions: Stroke, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: External active conductive head cooling, outcomesModule primaryOutcomes measure: Adherence to the intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335628, orgStudyIdInfo id: RCT: CTG-VCMX, briefTitle: Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Bern, class: OTHER, descriptionModule briefSummary: The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed., conditionsModule conditions: Connective Tissue Graft, conditions: Volume Collagen Matrix Xenograft, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Geistlich Fibro-Gide®, outcomesModule primaryOutcomes measure: Volumetric dimensional changes, secondaryOutcomes measure: Clinical: PPD, secondaryOutcomes measure: Clinical BoP, secondaryOutcomes measure: Clinical: Suppuration, secondaryOutcomes measure: Clinical: Mucosa, secondaryOutcomes measure: Clinical: ktw, secondaryOutcomes measure: Clinical: Mobility, secondaryOutcomes measure: Clinical: Thickness, secondaryOutcomes measure: Clinical: Contributing factors, secondaryOutcomes measure: Patient-reported satisfaction, secondaryOutcomes measure: Patient-reported esthetics, secondaryOutcomes measure: Patient-reported discomfort, secondaryOutcomes measure: Patient-reported pain, secondaryOutcomes measure: Prosthetics Survival, secondaryOutcomes measure: Prosthetics Sucess, secondaryOutcomes measure: Prosthetics Complications, secondaryOutcomes measure: Prosthetics PES-WES, secondaryOutcomes measure: Prosthetics: Occlusal, secondaryOutcomes measure: Prosthetics: Interproximal, secondaryOutcomes measure: Radiographics BL, secondaryOutcomes measure: Radiographics PP, secondaryOutcomes measure: Radiographics distance, secondaryOutcomes measure: Radiographics Contacts, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bern, city: Bern, zip: 3010, country: Switzerland, contacts name: Martin Schimmel, Prof., role: CONTACT, phone: +41316840630, email: martin.schimmel@unibe.ch, contacts name: Manrique Fonseca, Dr. med. dent., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False
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protocolSection identificationModule nctId: NCT06335615, orgStudyIdInfo id: FMG-5790_2023, briefTitle: A Brief Acceptance Intervention for Stress to Improve Students' Well-Being, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2023-12-19, completionDateStruct date: 2023-12-19, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: VU University of Amsterdam, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to test a brief psychological intervention that focusses on acceptance of stress in a student population. The main questions it aims to answer are:* Does this brief acceptance intervention increase the well-being of students in the short term?* By which mechanisms does this effect occur?* What are moderating factors of this effect?Half of the participants follow a one-hour intervention, which includes* psychoeducation and metaphors about stress and how acceptance can help to deal with it* experiential exercises* mindfulness meditation* mindfulness homework practiceStudents that receive the intervention will be compared to students that merely received psychoeducation about stress and acceptance to see if the intervention lead to larger increases in well-being., conditionsModule conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 116, type: ACTUAL, armsInterventionsModule interventions name: Brief Acceptance Intervention, interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: Psychological Well-Being, secondaryOutcomes measure: State Anxiety, secondaryOutcomes measure: Study Stress, secondaryOutcomes measure: Interoceptive awareness, secondaryOutcomes measure: Psychological Flexibility, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 29 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Amsterdam, city: Amsterdam, state: Noord-Holland, zip: 1018 WS, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
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protocolSection identificationModule nctId: NCT06335602, orgStudyIdInfo id: 202301283A3, briefTitle: TCM for Post-operative Edema, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: There are loads of research on knee surgery, including surgical methods, rehabilitation strategies, and complication prevention. Whether it is general surgery or endoscopic surgery, there may be postoperative joint swelling, which may last for several weeks depending on the patient's condition. Therefore, reducing swelling as soon as possible is important in post-operative treatment. Swelling of the knee joint may increase soft tissue tension, causing pain and discomfort, and affecting the range of motion and functional recovery of the joint. It may also affect wound healing and increase the risk of complications such as infection and thrombosis. Most clinical research related to traditional Chinese medicine focuses on reducing pain, and little attention is paid to reducing swelling, relatively. Nevertheless most relevant literatures discuss total knee replacement surgery.Cruciate ligament surgery is very common in sports medicine orthopedics. It is expected that ordinary patients get function recovery quickly after surgery, and athletes can return to play as soon as possible. This study is a prospective study, with partially double-blinded, randomized controlled study design. The investigators are aiming to TCM intervention for knee swelling after cruciate ligament surgery, and evaluation of postoperative swelling and functional improvement. TCM intervention methods are laser acupuncture and external application of herbal medicine., conditionsModule conditions: Anterior Cruciate Ligament Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: LASER acupuncture, outcomesModule primaryOutcomes measure: Leg girth measurement, secondaryOutcomes measure: VAS, secondaryOutcomes measure: WOMAC, secondaryOutcomes measure: Tegner score, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06335589, orgStudyIdInfo id: CDX 24-002, briefTitle: Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-17, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment)., conditionsModule conditions: Stress Disorders, Post-Traumatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Massed PTSD treatment (e.g., cognitive processing therapy \[CPT\] or prolonged exposure \[PE\] therapy delivered at least 3 times per week) will be compared to CPT \& PE delivered as usual, which is usually once per week., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Clinical interviewers who assess primary outcomes will not be informed of participant's randomization assignment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: EBP-Massed, interventions name: EBP-TAU, outcomesModule primaryOutcomes measure: Treatment completion, primaryOutcomes measure: Acceptability of Intervention (AIM), primaryOutcomes measure: Client Satisfaction Questionnaire-8 (CSQ-8), primaryOutcomes measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score, primaryOutcomes measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score, secondaryOutcomes measure: Session attendance, secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Brief Inventory of Psychosocial Functioning (BIPF), secondaryOutcomes measure: Brief Inventory of Psychosocial Functioning (BIPF), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Durham VA Medical Center, Durham, NC, city: Durham, state: North Carolina, zip: 27705-3875, country: United States, contacts name: Stephanie Y Wells, PhD MS BA, role: CONTACT, phone: 919-286-0411, phoneExt: 134053, email: stephanie.wells2@va.gov, contacts name: Laurel B Koss, MS OTR, role: CONTACT, phone: (919) 286-0411, phoneExt: 775648, email: laurel.koss@va.gov, contacts name: Stephanie Y Wells, PhD MS BA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06335576, orgStudyIdInfo id: ZSGCproteomics, briefTitle: Establishment of Serum Proteomics Subtypes of Gastric Cancer and Its Clinical Application, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: This study is a prospective, single-center, observational study aimed at detecting the status of serum protein profiles at key time points in gastric cancer patients receiving neoadjuvant therapy for advanced disease, and constructing a serum protein model for evaluating the efficacy of neoadjuvant therapy for gastric cancer. Subjects will receive neoadjuvant therapy (treatment regimen determined by the primary physician, limited to systemic therapy, with options including immune checkpoint inhibitor-based regimens and non-immune checkpoint inhibitor-based regimens). After four cycles of treatment, the efficacy will be assessed. Patients eligible for R0 resection will undergo D2 radical surgery regardless of tumor regression, while those ineligible for R0 resection will enter the palliative treatment phase (Note: Subjects are all patients who require neoadjuvant therapy even if they do not participate in this clinical study). Patients will receive regular follow-up evaluations for metastasis/recurrence and survival until tumor recurrence/progression or the last known date of patient survival (Note: Regular follow-up in this study follows the frequency of routine clinical follow-ups). The primary endpoint is progression-free survival (PFS), and the secondary endpoint is pathological response rate (based on Becker tumor regression grading, with residual tumor less than 50% considered effective preoperative treatment).Peripheral venous blood samples will be collected before the start of neoadjuvant therapy (blood sampling point 1 - baseline) and before surgery after neoadjuvant therapy (blood sampling point 2 - post-treatment). Approximately 3 ml of blood will be collected each time, and about 1.5 ml of serum will be obtained after processing. Serum protein profiling will be conducted to assess the expression of protein profiles at these treatment time points., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 89, type: ESTIMATED, armsInterventionsModule interventions name: This study is a single-arm and observational study with no intervention., outcomesModule primaryOutcomes measure: C-index, secondaryOutcomes measure: Sensitivity and specificity of model, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335563, orgStudyIdInfo id: STAR009, briefTitle: Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Shanghai Pulmonary Hospital, Shanghai, China, class: OTHER, descriptionModule briefSummary: This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules., conditionsModule conditions: Pulmonary Nodule, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: AR glasses-assisted puncture localizing group versus CT-guided conventional pulmonary nodule puncture localizing group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: no masking, enrollmentInfo count: 166, type: ESTIMATED, armsInterventionsModule interventions name: AR glasses-assisted pulmonary nodule puncture localization, interventions name: CT-guided pulmonary nodule puncture localization, outcomesModule primaryOutcomes measure: Accuracy of puncture localization of pulmonary nodules, secondaryOutcomes measure: Success rate of puncture localization of pulmonary nodules, secondaryOutcomes measure: Adjust the number of needle punctures, secondaryOutcomes measure: Operating time, secondaryOutcomes measure: Radiation dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Pulmonary Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Shenghao Huang, role: CONTACT, email: huangshplus5@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06335550, orgStudyIdInfo id: 2021/2680, briefTitle: Surgical and Patient Reported Outcomes in Robotic Mastectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-24, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Changi General Hospital, class: OTHER, descriptionModule briefSummary: Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 29, type: ACTUAL, armsInterventionsModule interventions name: Robotic mastectomy, outcomesModule primaryOutcomes measure: Surgical Outcomes - Operative parameters, primaryOutcomes measure: Surgical Outcomes - Length of stay (days), primaryOutcomes measure: Surgical Outcomes- 30-days morbidity/complications, secondaryOutcomes measure: Oncologic outcomes, secondaryOutcomes measure: Learning curve, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changi General Hospital, city: Singapore, zip: 529889, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-05, uploadDate: 2024-03-08T05:13, filename: Prot_SAP_000.pdf, size: 785756, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-05-03, uploadDate: 2024-03-08T05:19, filename: ICF_001.pdf, size: 704077, hasResults: False
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protocolSection identificationModule nctId: NCT06335537, orgStudyIdInfo id: 2405, briefTitle: Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels., conditionsModule conditions: Uric Acid Stones, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The following study will be a randomized cross-over trial evaluating the effects of baking soda and Urocit-K on 24-hour urinary parameters in hypocitrituric calcium oxalate and uric acid stone formers. All participants that consent to participate in the study will undergo the same tests.Participants will begin a 2-week washout period of Urocit-K as their standard of care. After completion of the washout period subjects will be randomized to take either Urocit-K or Baking Soda for 4 weeks. After participants undergo a secondary 2-week washout period, then they are assigned to medication not taken in the first study period for 4 weeks., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: This is an unblinded study., enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Potassium citrate, interventions name: Sodium bicarbonate, outcomesModule primaryOutcomes measure: Change in 24-hour Urinary pH, primaryOutcomes measure: Change in 24-hour Urinary Citrate, secondaryOutcomes measure: Change in Supersaturation of Calcium Oxalate, secondaryOutcomes measure: Change in Supersaturation of Uric acid, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Irvine Medical Center, city: Orange, state: California, zip: 92868, country: United States, geoPoint lat: 33.78779, lon: -117.85311, hasResults: False
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protocolSection identificationModule nctId: NCT06335524, orgStudyIdInfo id: IRB-300012718, briefTitle: Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants, acronym: IMPACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age., conditionsModule conditions: Child Development, conditions: Infant Development, conditions: Infant, Premature, Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 188, type: ESTIMATED, armsInterventionsModule interventions name: Finger puppet, interventions name: Bookworm reading intervention training and routine EDI care., outcomesModule primaryOutcomes measure: ASQ-3 scores, secondaryOutcomes measure: ASQ-3 scores, secondaryOutcomes measure: ASQ scores below -2SD, secondaryOutcomes measure: ASQ scores below -2SD, secondaryOutcomes measure: ASQ scores below -1SD, secondaryOutcomes measure: ASQ scores below -1SD, secondaryOutcomes measure: ASQ-SE2 scores, secondaryOutcomes measure: ASQ-SE2 scores, secondaryOutcomes measure: Severe neurodevelopmental impairment, secondaryOutcomes measure: Moderate or severe neurodevelopmental impairment, secondaryOutcomes measure: Cognitive Composite Score on BSID-IV, secondaryOutcomes measure: Language Composite Score on BSID-IV, secondaryOutcomes measure: Motor Composite Score on BSID-IV, secondaryOutcomes measure: Edinburgh Postnatal Depression Scale, secondaryOutcomes measure: MCHAT score, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 17 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335511, orgStudyIdInfo id: 631-2021-OSS-AUSLBO, briefTitle: Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study, acronym: ARCHIMEDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-10, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Azienda Usl di Bologna, class: OTHER_GOV, descriptionModule briefSummary: Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis., conditionsModule conditions: Lumbar Spinal Stenosis, conditions: Degenerative Lumbar Spinal Stenosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: microsurgical decompression, interventions name: decompression and instrumented fusion, outcomesModule primaryOutcomes measure: Short Form 12, primaryOutcomes measure: Short Form 12, primaryOutcomes measure: Short Form 12, primaryOutcomes measure: Short Form 12, primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Oswestry Disability Index, primaryOutcomes measure: Oswestry Disability Index, primaryOutcomes measure: Oswestry Disability Index, primaryOutcomes measure: Oswestry Disability Index, primaryOutcomes measure: EuroQol-5D, primaryOutcomes measure: EuroQol-5D, primaryOutcomes measure: EuroQol-5D, primaryOutcomes measure: EuroQol-5D, primaryOutcomes measure: Postural Balance, primaryOutcomes measure: Postural Balance, primaryOutcomes measure: Postural Balance, primaryOutcomes measure: Postural Balance, primaryOutcomes measure: Locomotor performance, primaryOutcomes measure: Locomotor performance, primaryOutcomes measure: Locomotor performance, primaryOutcomes measure: Locomotor performance, primaryOutcomes measure: Spinal mobility, primaryOutcomes measure: Spinal mobility, primaryOutcomes measure: Spinal mobility, primaryOutcomes measure: Spinal mobility, secondaryOutcomes measure: Evaluation of costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Ortopedico Rizzolo, status: RECRUITING, city: Bologna, zip: 40136, country: Italy, contacts name: Giovanni Barbanti Brodano, Dr., role: CONTACT, phone: +390516366971, email: giovanni.barbantibrodano@ior.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: IRCCS Istituto delle Scienze Neurologiche di Bologna, status: RECRUITING, city: Bologna, zip: 40139, country: Italy, contacts name: Alfredo Conti, Prof., role: CONTACT, phone: 3382131017, email: alfredo.conti2@unibo.it, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
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protocolSection identificationModule nctId: NCT06335498, orgStudyIdInfo id: 130-0008P, briefTitle: Further Study of AFGen1 Clinical Performance, acronym: CS3, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-04-12, completionDateStruct date: 2024-04-19, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: TriVirum, Inc., class: INDUSTRY, descriptionModule briefSummary: AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish further evidence for the clinical performance of AFGen1 on human participants., conditionsModule conditions: Atrial Fibrillation, conditions: Afib, conditions: ECG, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: ECG co-measurement, interventions name: Periodic ECG triggered measurement, outcomesModule primaryOutcomes measure: Bland-Altman Comparison, primaryOutcomes measure: Qualitative Evaluation, primaryOutcomes measure: Adhesive performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 1808 49Th St Ct NW, city: Gig Harbor, state: Washington, zip: 98335, country: United States, geoPoint lat: 47.32926, lon: -122.58013, hasResults: False
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protocolSection identificationModule nctId: NCT06335485, orgStudyIdInfo id: 2020- P123456, briefTitle: Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-01, primaryCompletionDateStruct date: 2022-09-29, completionDateStruct date: 2022-09-29, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: This study investigates a Cognitive Behavioral Therapy (CBT) intervention for women who are undergoing elective surgery. The objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery., conditionsModule conditions: Back Pain, conditions: Cognitive Behavioral Therapy, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients are randomized to either the intervention group or general group, for the intervention group patients will be randomly assigned to attend 4 weekly online virtual CBT sessions that will provide information on stress and pain reduction techniques before surgery, and 2 sessions following patient surgery., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Cognitive Behavioral Therapy, outcomesModule primaryOutcomes measure: Numeric Pain Rating, secondaryOutcomes measure: Pain Medication Usage, secondaryOutcomes measure: Activity Tracking (Digital Phenotyping), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06335472, orgStudyIdInfo id: Three nerves radiofrequency, briefTitle: Three Nerves Versus Suprascapular Nerve Radiofrequency Combined With Hydrodissection in Adhesive Capsulitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02-03, completionDateStruct date: 2027-03-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up., conditionsModule conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Ultrasound-guided effect of three nerves pulsed radiofrequency versus supra-scapular nerve pulsed radiofrequency both combined with hydro-dissection in reducing the intensity of pain in adhesive capsulitis, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: pain control and range of motion in adhesive capsulitis, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 3 nerves pulsed radiofrequency with hydrodissection, interventions name: suprascapular nerve pulsed radiofrequency with hydrodissection, outcomesModule primaryOutcomes measure: The most effective modality on pain management of shoulder adhesive capsulitis using visual analog score., eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut university Hospital, city: Assiut, country: Egypt, contacts name: safaa noaman, assistant lecturer, role: CONTACT, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
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