data
stringlengths 358
232k
|
|---|
protocolSection identificationModule nctId: NCT06345859, orgStudyIdInfo id: UP-23-00467, secondaryIdInfos id: R01MH133842, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MH133842, briefTitle: Regulation of Affect and Physiology in Depression, acronym: RAPID, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule interventions name: Heart rate variability biofeedback, outcomesModule primaryOutcomes measure: Physiological regulation success, primaryOutcomes measure: Average level of heart rate variability, secondaryOutcomes measure: Perceived regulation success, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 27 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Southern California, status: RECRUITING, city: Los Angeles, state: California, zip: 90089, country: United States, contacts name: Umiemah Farrukh, role: CONTACT, phone: 213-740-4503, email: carlab@usc.edu, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
|
protocolSection identificationModule nctId: NCT06345846, orgStudyIdInfo id: Secondary IOL, briefTitle: Stability of Secondary Intraocular Lenses With no Capsular Support, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-12-30, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Vienna Institute for Research in Ocular Surgery, class: OTHER, descriptionModule briefSummary: Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: IFIOL, interventions name: SFIOL, outcomesModule primaryOutcomes measure: Centration of the IOL, secondaryOutcomes measure: Tilt of the IOL, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, city: Vienna, zip: 1140, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
|
protocolSection identificationModule nctId: NCT06345833, orgStudyIdInfo id: ENT-2024-32847, briefTitle: Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\[12\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date., conditionsModule conditions: Hemophilia, conditions: Hemorrhage, conditions: Facelift Surgery, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 1%Tranexamic acid with standard local, interventions name: 3% TXA, interventions name: 1% TXA with local plus 3% TXA-soaked pledgets, outcomesModule primaryOutcomes measure: Blood loss, secondaryOutcomes measure: adverse effects of TXA rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06345820, orgStudyIdInfo id: Evolux, briefTitle: Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-28, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Vienna Institute for Research in Ocular Surgery, class: OTHER, descriptionModule briefSummary: Comparison of the clinical performance of two enhanced monofocal IOLs with similar design., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Evolux, interventions name: Tecnis Eyhance, outcomesModule primaryOutcomes measure: Monocular intermediate visual acuity, secondaryOutcomes measure: Monocular distance visual acuity, secondaryOutcomes measure: Monocular near visual acuity, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, status: RECRUITING, city: Vienna, zip: 1140, country: Austria, contacts name: Andreas Rotter, MD, role: CONTACT, phone: 01 91021, phoneExt: 57564, email: office@viros.at, contacts name: Manuel Ruiss, MSc, role: CONTACT, phone: 01 91021, phoneExt: 57564, email: office@viros.at, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
|
protocolSection identificationModule nctId: NCT06345807, orgStudyIdInfo id: 2023-A02617-38, briefTitle: Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation, acronym: APIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Elsan, class: OTHER, descriptionModule briefSummary: The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient., conditionsModule conditions: Individualised Physical Activity Program, conditions: Coronary Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: interventional study, randomized in 3 parallel groups, single center,, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Individuals activity programs, interventions name: activity program, interventions name: no Physical Activity program, outcomesModule primaryOutcomes measure: 6 minutes walk test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06345794, orgStudyIdInfo id: 27111, secondaryIdInfos id: J5C-MC-FOAG, type: OTHER, domain: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, briefTitle: A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-06-17, completionDateStruct date: 2024-06-17, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company, class: INDUSTRY, collaborators name: Eli Lilly and Company, descriptionModule briefSummary: The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: LY4100511 (DC-853), interventions name: Itraconazole, interventions name: Fluconazole, interventions name: Carbamazepine, outcomesModule primaryOutcomes measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853), primaryOutcomes measure: PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853), primaryOutcomes measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON San Antonio Clinical Research Unit, city: San Antonio, state: Texas, zip: 78209, country: United States, contacts role: CONTACT, phone: 210-283-4500, contacts name: Chinonye Ogbonnaya-Odor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
|
protocolSection identificationModule nctId: NCT06345781, orgStudyIdInfo id: 2174433-1, briefTitle: Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Craig Hospital, class: OTHER, collaborators name: Neuroscience Research Australia, descriptionModule briefSummary: The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device., conditionsModule conditions: Spinal Cord Injuries, conditions: Neurogenic Bowel, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Abdominal Functional Electrical Stimulation, outcomesModule primaryOutcomes measure: Bowel Management Time (BMT), secondaryOutcomes measure: Bowel Management Strategy, secondaryOutcomes measure: Stimulation Dose, secondaryOutcomes measure: EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire, secondaryOutcomes measure: International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire, secondaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Neurogenic Bladder Symptom Score (NBSS), secondaryOutcomes measure: Intervention Acceptability, secondaryOutcomes measure: Intervention Safety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Craig Hospital, city: Englewood, state: Colorado, zip: 80113, country: United States, geoPoint lat: 39.64777, lon: -104.98776, hasResults: False
|
protocolSection identificationModule nctId: NCT06345768, orgStudyIdInfo id: 147258369, briefTitle: The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients' Fear, Stress and Comfort., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort., conditionsModule conditions: Cholecystitis, conditions: Stress, conditions: Fear, conditions: Comfort, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Stress Ball, outcomesModule primaryOutcomes measure: Fear of surgery, primaryOutcomes measure: Fear of surgery, primaryOutcomes measure: Comfort, primaryOutcomes measure: Comfort, primaryOutcomes measure: Stress, primaryOutcomes measure: Stress, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06345755, orgStudyIdInfo id: VX23-407-001, briefTitle: A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of VX-407 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Vertex Pharmaceuticals Incorporated, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants., conditionsModule conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: VX-407, interventions name: Placebo, interventions name: Midazolam, outcomesModule primaryOutcomes measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407, primaryOutcomes measure: Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407, secondaryOutcomes measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407, secondaryOutcomes measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407, secondaryOutcomes measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407, secondaryOutcomes measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407, secondaryOutcomes measure: Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON Lenexa, status: RECRUITING, city: Lenexa, state: Kansas, zip: 66219, country: United States, geoPoint lat: 38.95362, lon: -94.73357, hasResults: False
|
protocolSection identificationModule nctId: NCT06345742, orgStudyIdInfo id: ATADEK-2023-10/396, briefTitle: The Effect of Parental Participation on Newborn Comfort During Diaper Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants., conditionsModule conditions: Preterm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: No parental participation, interventions name: Mother participation, interventions name: Father participation, outcomesModule primaryOutcomes measure: Level of Parental Stress, primaryOutcomes measure: Change in Level of Comfort, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Acıbadem University, status: RECRUITING, city: İstanbul, state: Ataşehir, zip: 34750, country: Turkey, contacts name: Tuğba Türker, Nurse, role: CONTACT, email: tugba.turker@live.acibadem.edu.tr, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06345729, orgStudyIdInfo id: 1084-004, secondaryIdInfos id: MK-1084-004, type: OTHER, domain: Merck, secondaryIdInfos id: U1111-1296-8093, type: OTHER, domain: UTN, secondaryIdInfos id: 2023-507776-42, type: REGISTRY, domain: EU CT, briefTitle: A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2029-02-19, completionDateStruct date: 2031-02-18, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS)., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: MK-1084, interventions name: Placebo, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS), primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Number of Participants Who Experience One or More Adverse Event (AEs), secondaryOutcomes measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE), secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score, secondaryOutcomes measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, secondaryOutcomes measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score, secondaryOutcomes measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score, secondaryOutcomes measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score, secondaryOutcomes measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score, secondaryOutcomes measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06345716, orgStudyIdInfo id: renal colic 2024, briefTitle: Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic, acronym: RC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Monastir, class: OTHER, descriptionModule briefSummary: This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group., conditionsModule conditions: Renal Colic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: paracétamol tramadol, interventions name: Paracétamol cafeine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Pain recurrence, secondaryOutcomes measure: Painful recurrence, secondaryOutcomes measure: number of patient who revist the ED for residual pain, otherOutcomes measure: Adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06345703, orgStudyIdInfo id: NeuShen Therapeutics, briefTitle: First-into-human Study of NS-136 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: NeuShen Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?* What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen?, conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The trial consists of three parts: the first part is a single ascending dose (SAD) study, the second part is a multiple ascending dose (MAD) study, and the third part is food effect (FE) study. The first two parts (SAD and MAD) will be randomized, double-blind, single or multiple ascending dose and placebo-controlled study designs. The third part (FE) will be a randomized, open-label, two-period, crossover study design. To evaluate the safety, tolerability, pharmacokinetic profile, and the effect of food on the PK profile of NS-136 in healthy subjects and to determine the maximum tolerated dose (MTD), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: NS-136 tablet, outcomesModule primaryOutcomes measure: Number of Participants with Treatment-Related Adverse Events, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CMAX Clinical Research Pty Ltd, city: Adelaide, state: South Australia, zip: 5000, country: Australia, contacts name: Study Services Director, role: CONTACT, phone: +61 08 7088 7900, email: cmax@cmax.com.au, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
|
protocolSection identificationModule nctId: NCT06345690, orgStudyIdInfo id: VIA-2023-003, briefTitle: VIA Disc NP Registry 3.0, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: VIVEX Biologics, Inc., class: INDUSTRY, collaborators name: Moxie Clinical, descriptionModule briefSummary: Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP., conditionsModule conditions: Discogenic Pain, conditions: Back Pain, conditions: Back Pain, Low, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: VIA Disc NP, outcomesModule primaryOutcomes measure: Numeric Pain Rating Scale (NPRS), primaryOutcomes measure: Oswestry Disability Index (ODI), primaryOutcomes measure: Patient Satisfaction, primaryOutcomes measure: Pain Medication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Denver Spine & Pain Institute, status: RECRUITING, city: Greenwood Village, state: Colorado, zip: 80111, country: United States, contacts name: Josephine Steinbrecher, role: CONTACT, email: josephine@denverpaininstitute.com, contacts name: Scott Bainbridge, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.61721, lon: -104.95081, locations facility: The Orthopedic Institute, status: RECRUITING, city: Gainesville, state: Florida, zip: 32605, country: United States, contacts name: Carole Newell, role: CONTACT, email: cnewell@toi-health.com, contacts name: Ajay Antony, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Interventional Pain Specialists - Pain Clinic, status: RECRUITING, city: Opelousas, state: Louisiana, zip: 70570, country: United States, contacts name: Lisa Briggs, role: CONTACT, email: lisa@ipspain.org, contacts name: Albert Gros, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.53353, lon: -92.08151, locations facility: Premier Pain Solutions, status: RECRUITING, city: Asheville, state: North Carolina, zip: 28803, country: United States, contacts name: Courtney Musser, role: CONTACT, email: courtney@premierpainnc.com, contacts name: Javid Baksh, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.60095, lon: -82.55402, locations facility: Crystal Coast Pain Management, status: RECRUITING, city: New Bern, state: North Carolina, zip: 28560, country: United States, contacts name: Amy Harum, role: CONTACT, email: aharum@crystalcoastpm.com, contacts name: Kirk Harum, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.10849, lon: -77.04411, hasResults: False
|
protocolSection identificationModule nctId: NCT06345677, orgStudyIdInfo id: ViXe-CLP-0002, briefTitle: Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects, acronym: XAVIER, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-09, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Vensica Therapeutics Ltd., class: INDUSTRY, collaborators name: Blueclinical, Ltd., descriptionModule briefSummary: The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question\[s\] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit., conditionsModule conditions: Overactive Bladder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: ViXe Xombination, interventions name: Placebo + Sham, outcomesModule primaryOutcomes measure: Adverse Events Rate, primaryOutcomes measure: Usability and ease-of-use perception by investigator, subject and technician, secondaryOutcomes measure: Daily Urgency Urinary Incontinence, secondaryOutcomes measure: Total Daily Episodes, secondaryOutcomes measure: Urinary Urgency, secondaryOutcomes measure: Voiding Leaks, secondaryOutcomes measure: Quality of Life Queationnsaire, secondaryOutcomes measure: Nocturia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHUC, city: Coimbra, country: Portugal, geoPoint lat: 40.20564, lon: -8.41955, locations facility: HSOG, city: Guimarães, country: Portugal, geoPoint lat: 41.44443, lon: -8.29619, locations facility: CHLN, city: Lisboa, country: Portugal, geoPoint lat: 38.71667, lon: -9.13333, locations facility: CHUSJ, city: Porto, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, locations facility: Hospital Lusíadas, city: Porto, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, locations facility: Hospital Prelada, city: Porto, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, locations facility: Hospital Luz Setúbal, city: Setúbal, country: Portugal, geoPoint lat: 38.5244, lon: -8.8882, locations facility: CHVNG, city: Vila Nova De Gaia, country: Portugal, geoPoint lat: 41.13363, lon: -8.61742, hasResults: False
|
protocolSection identificationModule nctId: NCT06345664, orgStudyIdInfo id: 548/2022BO1, briefTitle: Interdisciplinary E-health Based Follow-up of Preterm Born Children, acronym: NeoUp, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children., conditionsModule conditions: Preterm Birth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostics and intervention recommendations, outcomesModule primaryOutcomes measure: Bayley Scales of Infant and Toddler Development, primaryOutcomes measure: Wechsler Intelligence Scale for Children (WISC-V), primaryOutcomes measure: Children's Sleep Habit Questionnaire (CSHQ-DE 4-10), primaryOutcomes measure: Sleep Self Report (SSR), primaryOutcomes measure: Somatics, primaryOutcomes measure: Child Behavior Checklist (CBCL), primaryOutcomes measure: Youth Self Report (YSR), primaryOutcomes measure: Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB), primaryOutcomes measure: KIDSCREEN-27 (The KIDSCREEN), primaryOutcomes measure: Parent's Stress Inventory (EBI), primaryOutcomes measure: App-questions, primaryOutcomes measure: Postexperimental questionnaire, secondaryOutcomes measure: Demographic data, secondaryOutcomes measure: Actigraphy measurement, secondaryOutcomes measure: Video of a sleeping sequence, secondaryOutcomes measure: Sleep cartoon for children, secondaryOutcomes measure: Kiddie-Sads-Present and Lifetime Version (K-SADS PL), secondaryOutcomes measure: Self efficacy dealing with social situations (WIRKSOZ), secondaryOutcomes measure: Group interviews, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: University Hospital Tuebingen, status: RECRUITING, city: Tuebingen, zip: 72076, country: Germany, contacts name: Annette Conzelmann, Prof. Dr., role: CONTACT, contacts name: Axel Franz, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Mirja Quante, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Andrea Bevot, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Anna Haigis, role: SUB_INVESTIGATOR, contacts name: Dorothee Fütterer, Dr., role: SUB_INVESTIGATOR, contacts name: Annette Conzelmann, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Tobias Renner, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
|
protocolSection identificationModule nctId: NCT06345651, orgStudyIdInfo id: 2023-03, Version 7, briefTitle: Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder, acronym: BOSSFRONT2, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: Major depressive disorder (MDD) is a common severe psychiatric disease with enormous socioeconomic costs for the patient and society alike. Current pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted side effects. Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation to alleviate de-pressive symptomatology in patients with MDD in a double-blind randomized controlled pilot clinical trial., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a single-site randomized standard TMS therapy-controlled double-blind paral-lel-group design clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: In both conditions the identical setup is used consisting of Neuronavigation, EEG and TMS. Only in the experimental condition the treatment will be EEG-informed. In the control condition the treatment will be applied indepentently of the EEG signal., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Magnetic Stimulation, outcomesModule primaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale (MADRS), secondaryOutcomes measure: MADRS (Montgomery-Åsberg Depression Rating Scale) 4 weeks after intervention, secondaryOutcomes measure: HDRS-17 (Hamilton Depression Rating Scale-17), secondaryOutcomes measure: BDI-2 (Beck Depression Inventory-2), secondaryOutcomes measure: IDS-30 (Inventory of depressive symptoms-30), secondaryOutcomes measure: Response Rate, secondaryOutcomes measure: Remission Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Tuebingen, status: RECRUITING, city: Tuebingen, state: Baden-Wuerttemberg, zip: 72076, country: Germany, contacts name: Anne Lieb, Dr., role: CONTACT, phone: +4970712980483, email: anne.lieb@uni-tuebingen.de, contacts name: Andreas J. Fallgatter, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Ulf Ziemann, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Julia Becker-Sadzio, Dr., role: SUB_INVESTIGATOR, contacts name: Anne Lieb, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
|
protocolSection identificationModule nctId: NCT06345638, orgStudyIdInfo id: 854343, briefTitle: Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).* The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD.* The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC.* The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood., conditionsModule conditions: Sickle Cell Disease, conditions: Vaso-occlusive Crisis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: C-reactive protein level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Penn Medicine University City, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Pennsylvania Hospital, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Hospital of the University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19143, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
|
protocolSection identificationModule nctId: NCT06345625, orgStudyIdInfo id: 6012, briefTitle: Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults, acronym: BALANCAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, descriptionModule briefSummary: The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing., conditionsModule conditions: Aged, conditions: Accidental Fall, conditions: Postural Balance, conditions: Gait, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Cognition, interventions name: Sensory function, interventions name: Frailty, interventions name: Biomechanical movement analysis, interventions name: Screening, interventions name: Follow up, outcomesModule primaryOutcomes measure: Spatio-temporal parameters of gait, primaryOutcomes measure: Foot placement estimator, primaryOutcomes measure: Onset latency, primaryOutcomes measure: Peak amplitude, primaryOutcomes measure: Fixation duration, primaryOutcomes measure: Gain, primaryOutcomes measure: Latency, primaryOutcomes measure: Fall characteristics, secondaryOutcomes measure: Multisensory integration, secondaryOutcomes measure: Digit symbol substitution test, secondaryOutcomes measure: Trail making test, secondaryOutcomes measure: Go/No Go test, secondaryOutcomes measure: Head Repositioning Accuracy, secondaryOutcomes measure: Fly test, secondaryOutcomes measure: Fly test, secondaryOutcomes measure: vHIT, secondaryOutcomes measure: fHIT, secondaryOutcomes measure: Frailty, otherOutcomes measure: Age, otherOutcomes measure: Gender, otherOutcomes measure: Medical history, otherOutcomes measure: Fall history, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 100 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Antwerp, status: RECRUITING, city: Antwerp, zip: 2160, country: Belgium, contacts name: Ann Hallemans, PhD, role: CONTACT, phone: +32 3 265 29 12, email: ann.hallemans@uantwerpen.be, contacts name: PhD, role: CONTACT, geoPoint lat: 51.21989, lon: 4.40346, hasResults: False
|
protocolSection identificationModule nctId: NCT06345612, orgStudyIdInfo id: Hypoxia-Exercise-DiabetesT1, briefTitle: Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Silesian Centre for Heart Diseases, class: OTHER, descriptionModule briefSummary: Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters, conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: hypoxia, interventions name: normoxia, interventions name: creatine supplementation, interventions name: no creatine supplementation, outcomesModule primaryOutcomes measure: Metabolic control of diabetes, primaryOutcomes measure: Time in range, primaryOutcomes measure: Time below range, primaryOutcomes measure: Maximum oxygen consumption (VO2max), eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland, status: RECRUITING, city: Zabrze, state: Silesia, zip: 41-800, country: Poland, contacts name: Marta Wróbel, PhD, role: CONTACT, phone: 48606873060, email: mwrobel@sum.edu.pl, geoPoint lat: 50.32492, lon: 18.78576, hasResults: False
|
protocolSection identificationModule nctId: NCT06345599, orgStudyIdInfo id: LK2023100, briefTitle: PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-01-10, completionDateStruct date: 2027-01-10, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, interventions name: Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab, interventions name: Chemotherapy:Albumin-bound paclitaxel、Gemcitabine, outcomesModule primaryOutcomes measure: Adverse events, primaryOutcomes measure: Serious adverse events, primaryOutcomes measure: 1-year overall survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-22, uploadDate: 2024-03-26T10:41, filename: Prot_SAP_000.pdf, size: 1237855, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-27, uploadDate: 2024-03-26T10:44, filename: ICF_001.pdf, size: 376918, hasResults: False
|
protocolSection identificationModule nctId: NCT06345586, orgStudyIdInfo id: 078066, briefTitle: Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery, conditionsModule conditions: Contraception, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants received Drospirenone will be assess for cervical mucus change by modified Insler score, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Drospirenone, outcomesModule primaryOutcomes measure: Cervical mucus by modified Insler score, secondaryOutcomes measure: Estrogen and progesterone levels versus time, secondaryOutcomes measure: Number of Participants With Treatment-Related Adverse Events, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chulalongkorn University, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
|
protocolSection identificationModule nctId: NCT06345573, orgStudyIdInfo id: BASEC 2020-02922, briefTitle: Heart-brain-axis and Psychosocial Stress, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-10-11, primaryCompletionDateStruct date: 2023-11-20, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: The main study objective is to prospectively determine the influence of sex-related risk factors and psychosocial variables on neuronal stress responses and myocardial perfusion in a population of 64 female and male individuals 50-75 years of age and free of cardiovascular disease., conditionsModule conditions: Mental Stress, conditions: Myocardial Ischemia, conditions: Sex Role, conditions: Gender, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: Mental stress, outcomesModule primaryOutcomes measure: Amygdala-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV), primaryOutcomes measure: Difference between the rest and stress amygdala-to-cerebellum perfusion ratios (kBq/kBq), primaryOutcomes measure: Myocardial flow reserve (MFR, no unit), secondaryOutcomes measure: Amygdala-to-vmPFC ratio of glycolytic metabolic activities (SUV/SUV), secondaryOutcomes measure: Difference between the rest and stress amygdala-to-vmPFC perfusion ratios (kBq/kBq), secondaryOutcomes measure: Myocardial blood flow (MBF) at rest (mL/g/min), secondaryOutcomes measure: Myocardial blood flow (MBF) at stress (mL/g/min), secondaryOutcomes measure: Heart-rate response (HRR, no unit), secondaryOutcomes measure: Salivary cortisol (mol/L), secondaryOutcomes measure: Noradrenaline (mL/min), secondaryOutcomes measure: Adrenaline (mL/min), secondaryOutcomes measure: Dopamine (mL/min), secondaryOutcomes measure: Spleen metabolic activity (SUV), secondaryOutcomes measure: Bone marrow metabolic activity (SUV), secondaryOutcomes measure: Aorta metabolic activity (SUV), secondaryOutcomes measure: Left ventricular ejection fraction (LVEF, %), secondaryOutcomes measure: C-reactive protein (CRP, mg/L), secondaryOutcomes measure: Interleukin-2 (IL-2, pg/mL), secondaryOutcomes measure: Interleukin-4 (IL-4, pg/mL), secondaryOutcomes measure: Interleukin-6 (IL-6, pg/mL), secondaryOutcomes measure: Interleukin-8 (IL-8, pg/mL), secondaryOutcomes measure: Interleukin-10 (IL-10, pg/mL), secondaryOutcomes measure: Tumor necrosis factor (TNF, pg/mL), secondaryOutcomes measure: Matrix metalloproteinase-9 (MMP9, pg/mL), secondaryOutcomes measure: Monocyte Chemoattractant Protein-1 (MCP1, pg/mL), secondaryOutcomes measure: Vascular Cell Adhesion Molecule (VCAM), secondaryOutcomes measure: Gender score questionnaire, otherOutcomes measure: Rate-Pressure-Product (RPP, in beats per minute x mmHg), otherOutcomes measure: vmPFC-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV), otherOutcomes measure: Nail cortisol value (pg/mg), otherOutcomes measure: General Anxiety Disorder (GAD-7) Questionnaire, otherOutcomes measure: Patient Health Questionnaire (PHQ-8), otherOutcomes measure: Shortened Maastricht Exhaustion Questionnaire, otherOutcomes measure: Type D Personality (DS14) questionnaire, otherOutcomes measure: Wagnild & Young Score resilience questionnaire, otherOutcomes measure: Perceived Stress Scale (PSS-4) questionnaire, otherOutcomes measure: Jenkins Sleep Scale (JSS-4), otherOutcomes measure: Trier Inventory for Chronic Stress (TICS), otherOutcomes measure: Perceived stress, otherOutcomes measure: Left ventricular stroke volume (LVSV, mL), otherOutcomes measure: Left ventricular end-systolic volume (LVESV, mL), otherOutcomes measure: Left ventricular end-diastolic volume (LVEDV, mL), otherOutcomes measure: Estradiol levels (pmol/L), otherOutcomes measure: Progesterone levels (nmol/L), otherOutcomes measure: Sex Hormone Binding Globulin (SHBG) levels (nmol/L), otherOutcomes measure: Total testosterone levels (nmol/L), otherOutcomes measure: Free testosterone levels (pmol/L), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zurich, city: Zürich, zip: 8091, country: Switzerland, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
|
protocolSection identificationModule nctId: NCT06345560, orgStudyIdInfo id: 077766, briefTitle: Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption, conditionsModule conditions: Contraception, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pre-bariatric surgery pharmacokinetics study of Drospirenone compare with post-bariatric surgery, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Drospirenone, outcomesModule primaryOutcomes measure: Plasma concentration versus Time of Drospirenone, secondaryOutcomes measure: Number of Participants With Treatment-Related Adverse Events, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chulalongkorn University, city: Bangkok, zip: 10330, country: Thailand, contacts name: Punyawee Utaipatanacheep, role: CONTACT, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
|
protocolSection identificationModule nctId: NCT06345547, orgStudyIdInfo id: EDGE 003539, briefTitle: Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE), acronym: MMUSCLE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2026-05-02, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, descriptionModule briefSummary: The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are:* what is the prevalence and development of sarcopenia in cirrhosis?* what is the role of malnutrition? Participants will * undergo a muscle ultrasound of the lower and upper limb muscles * handgrip strength will be measured * malnutrition screening and assessment * complete a questionnaire to assess quality of life, conditionsModule conditions: Sarcopenia, conditions: Cirrhosis, conditions: Malnutrition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: ultrasound, outcomesModule primaryOutcomes measure: Prevalence of sarcopenia: muscle mass, primaryOutcomes measure: Prevalence of sarcopenia: muscle strength, primaryOutcomes measure: Development of sarcopenia: changes in muscle mass, primaryOutcomes measure: Development of sarcopenia: changes in muscle strength, primaryOutcomes measure: Development of sarcopenia: changes in muscle quality, secondaryOutcomes measure: Decompensation events: MELD score • MELD evolution, secondaryOutcomes measure: Decompensation events: mortality • MELD evolution, secondaryOutcomes measure: Decompensation events: transplantation • MELD evolution, secondaryOutcomes measure: Malnutrition, secondaryOutcomes measure: Quality of life in cirrhosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Antwerp, city: Edegem, state: Antwerpen, zip: 2650, country: Belgium, contacts name: Karolien Dams, MD, role: CONTACT, phone: +3238213635, phoneExt: 5175, email: karolien.dams@uza.be, contacts name: Jolien Derdeyn, MD, role: CONTACT, phone: +328213807, phoneExt: 3807, email: jolien.derdeyn@uza.be, contacts name: Jolien Derdeyn, MD, role: SUB_INVESTIGATOR, contacts name: Thomas Vanwolleghem, MD, Phd, role: SUB_INVESTIGATOR, contacts name: Philippe Jorens, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Stany Perkisas, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Karolien Dams, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.15662, lon: 4.44504, hasResults: False
|
protocolSection identificationModule nctId: NCT06345534, orgStudyIdInfo id: ONZ-2023-0255, briefTitle: FAST-FORWARD vs HAI5, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2033-12-31, completionDateStruct date: 2033-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, descriptionModule briefSummary: Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions., conditionsModule conditions: Cancer, Breast, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients participating in the study will be randomized 1:1 between the FAST-FORWARD schedule and the HAI5 schedule. The first group is treated according to the FAST-FORWARD schedule, consisting of 5 radiation sessions on 5 consecutive working days (e.g. Monday to Friday). 2 rest days are allowed in the schedule, so that the treatment lasts a maximum of 7 days. The second group is treated according to the HAI5 schedule, developed by the radiotherapy department of Ghent University Hospital. In this schedule, at least 1 day of rest is scheduled between each treatment session, so the treatment is administered over 10-14 days., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Both healthcare provider and patient know the treatment, enrollmentInfo count: 740, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Early side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitary Hospital, city: Ghent, zip: 9000, country: Belgium, contacts name: Liv Veldeman, MD, PhD, role: CONTACT, phone: 09 332 30 15, email: liv.veldeman@uzgent.be, contacts name: Emma Van Damme, MD, role: CONTACT, phone: 09 332 19 53, email: emma.vandamme@uzgent.be, geoPoint lat: 51.05, lon: 3.71667, hasResults: False
|
protocolSection identificationModule nctId: NCT06345521, orgStudyIdInfo id: 2022-1-4032-3, briefTitle: The Follow-up System of Pediatric Heart Failure and the Establishment of End-stage Heart Failure Registry, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-06-22, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: China National Center for Cardiovascular Diseases, class: OTHER_GOV, collaborators name: Peking University First Hospital, collaborators name: Beijing Children's Hospital, descriptionModule briefSummary: Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure, conditionsModule conditions: Heart Failure, conditions: Congenital, conditions: End-stage Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: the recurrence rate of heart failure, secondaryOutcomes measure: NT-proBNP level, secondaryOutcomes measure: Incidence rate of drug adverse reactions, secondaryOutcomes measure: Readmission rate for heart failure, eligibilityModule sex: ALL, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Fuwai hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Shoujun Li, MD, role: CONTACT, phone: +86 13501071589, email: drlishoujunfw@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06345508, orgStudyIdInfo id: 2024-12161, briefTitle: Early Detection of Liver Cancer by QUS, acronym: QUS in HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-06, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Centre hospitalier de l'Université de Montréal (CHUM), class: OTHER, collaborators name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: Worldwide, liver cancers are the third most common cause of cancer mortality. Even when liver cancer is suspected by blood tests, imaging is required to determine the location, size, and extent of disease. Medical societies therefore recommend surveillance with ultrasound every 6 months in at-risk patients. However, a key challenge to improving the survival is that ultrasound may miss half of early-stage liver cancers, thus diagnosis must rely on additional tests such as computed tomography (CT), magnetic resonance imaging (MRI), or biopsy. Hence, there is a clear need to improve the ability to detect liver cancers, especially with ultrasound. The investigator's team proposes novel ultrasound approaches to detect cancer nodules invisible on conventional ultrasound based on differences in mechanical and structural properties between liver and tumor. Improving detection is critical because liver cancer can be cured only if detected at an early stage, as shown by improvements in survival rates in patients enrolled in surveillance programs. The investigator's multi-disciplinary, national, and international team includes experts in clinical fields (hepatology, oncology, radiology, pathology), basic sciences (engineering, medical physics, machine learning, biostatistics), and patient partnership. The investirgator will apply the methodology of patient partner recruitment and collaborate with the Centre of Excellence on Partnership with Patients and the Public to select potential new collaborators. This will permit this project to be informed at every stage by patient and family perspectives, ensuring that the results of this project will be more robust, impactful, and aligned with the priorities, needs and experiences of those who live with liver cancer. The investigator submits a research proposal focused on advanced imaging techniques because imaging constitutes a foundation for surveillance, diagnosis, staging, treatment selection and assessment of treatment response in patients with liver cancer., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Liver Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 328, type: ESTIMATED, armsInterventionsModule interventions name: Quantitative Ultrasound, interventions name: B-mode Ultrasound, interventions name: Magnetic Resonance Imaging, interventions name: Liver Biopsy, outcomesModule primaryOutcomes measure: Compare the sensitivity of QUS + B-mode US vs B-mode US alone for lesion detection, using MRI as the reference standard for detection, secondaryOutcomes measure: Compare the specificity of QUS + B-mode US vs B-mode US alone for diagnosis of HCC, using MRI or biopsy as the composite reference standard for classification, secondaryOutcomes measure: Determine the lesion-to-liver contrast of investigational QUS techniques for detection of HCC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de l'Université de Montréal (CHUM), city: Montréal, state: Quebec, zip: H2X 0A9, country: Canada, contacts name: An Tang, MD, MSc, role: CONTACT, phone: 514-890-8000, phoneExt: 36400, email: an.tang@umontreal.ca, contacts name: Casey Bourdeau Caporuscio, MSc, role: CONTACT, phone: 514-890-8000, phoneExt: 14756, email: casey.bourdeau-caporuscio.chum@ssss.gouv.qc.ca, contacts name: An Tang, MD, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
|
protocolSection identificationModule nctId: NCT06345495, orgStudyIdInfo id: 2023-0899, secondaryIdInfos id: NCI-2024-02814, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2029-01-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Incyte Corporation, descriptionModule briefSummary: To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed., conditionsModule conditions: Splenomegaly, conditions: Myelofibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ruxolitinib, interventions name: Allogeneic Stem Cell Transplantation, interventions name: Levetiracetam, interventions name: Eltrombopag, interventions name: Busulfan, interventions name: Romiplostim, interventions name: Fludarabine phosphate, interventions name: Cyclophosphamide, interventions name: Mesna, interventions name: Tacrolimus, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
|
protocolSection identificationModule nctId: NCT06345482, orgStudyIdInfo id: MHB039A-A-101, briefTitle: A Study of MHB039A for Advanced Solid Tumor, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2029-06-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Minghui Pharmaceutical (Hangzhou) Ltd, class: INDUSTRY, descriptionModule briefSummary: Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 196, type: ESTIMATED, armsInterventionsModule interventions name: MHB039A, outcomesModule primaryOutcomes measure: Incidence of participants with adverse events (AE), primaryOutcomes measure: Number of participants with dose-limiting toxicity (DLT), secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of MHB039A, secondaryOutcomes measure: The area under the plasma concentration-time curve (AUC) of MHB039A, secondaryOutcomes measure: To detectable anti-drug antibodies with treated subjects, secondaryOutcomes measure: Objective response rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, city: Shanghai, state: Shanghai, zip: 200030, country: China, contacts name: Shun Lu, MD, role: CONTACT, phone: 13601813062, email: shun_lu@hotmail.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06345469, orgStudyIdInfo id: O-PBM2, briefTitle: Cost Analysis of Therapies for Severe Anemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Helios Klinik Gotha/Ohrdruf, class: OTHER, collaborators name: Marisa Eichner, descriptionModule briefSummary: The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses.The main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia?, conditionsModule conditions: Severe Anemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 640, type: ESTIMATED, armsInterventionsModule interventions name: Patient blood management (PBM), interventions name: Allogeneic transfusion, outcomesModule primaryOutcomes measure: cost-effectiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06345456, orgStudyIdInfo id: izmirkatip, briefTitle: The Value of End-tidal Capnography in Gastrointestinal Bleeding, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-06-01, primaryCompletionDateStruct date: 2021-01-01, completionDateStruct date: 2021-01-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Izmir Katip Celebi University, class: OTHER, descriptionModule briefSummary: Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level.In our study, the investigators aimed to determine the severity of gastrointestinal bleeding by using the Glaskow Blachford Score and AIMS65 score in cases presenting with gastrointestinal bleeding, to determine the end tidal carbon dioxide value by capnography in these cases and to determine its effectiveness in evaluating mortality and morbidity in gastrointestinal bleeding., conditionsModule conditions: Gastro Intestinal Bleeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 103, type: ACTUAL, armsInterventionsModule interventions name: End-tidal capnography, outcomesModule primaryOutcomes measure: The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Katip Çelebi Üniversitesi, city: İzmir, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2020-06-01, uploadDate: 2024-04-01T04:48, filename: SAP_000.pdf, size: 281538, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2020-06-01, uploadDate: 2024-04-01T04:35, filename: ICF_001.pdf, size: 418132, hasResults: False
|
protocolSection identificationModule nctId: NCT06345443, orgStudyIdInfo id: 23-005288, briefTitle: NRM on Vascular Perfusion in Heathy Adults, acronym: NRM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to better understand the effects of nicotinamide riboside supplement in overall cardiovascular health in healthy adults., conditionsModule conditions: Vascular Stiffness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: The pharmacy will be responsible for randomization and dispensing appropriate randomized intervention., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Nicotinamide Riboside Malate, interventions name: Placebo, outcomesModule primaryOutcomes measure: Reduction of Endothelial stiffness, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Snigdha Panda, BS, role: CONTACT, phone: 507-538-5827, email: GIMRESEARCHSTUDIES@mayo.edu, contacts name: Jennifer Soderlind, role: CONTACT, phone: 507-284-4799, email: GIMRESEARCHSTUDIES@mayo.edu, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
|
protocolSection identificationModule nctId: NCT06345430, orgStudyIdInfo id: 2023-14, briefTitle: Wearable Technological Device Applied to Patients With Chronic Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-18, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Within the scope of this research, a single session of Wearable Technological Device (Exopulse Molli-Suit) will be applied to patients with chronic back and neck pain. The results will be evaluated acutely, after 24 hours, after 1 week and after 1 month., conditionsModule conditions: Neck Pain, conditions: Low Back Pain, conditions: Chronic Pain, conditions: Musculoskeletal Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Exopulse Molli-Suit (Wearable Technological Device), outcomesModule primaryOutcomes measure: Pain Severity, secondaryOutcomes measure: Sleep Qaulity, secondaryOutcomes measure: Disability Level, secondaryOutcomes measure: Repetitive Reach Test, secondaryOutcomes measure: Body Composition Analysis, secondaryOutcomes measure: Lifting object overhead test, secondaryOutcomes measure: Sustained Overhead Work Test, secondaryOutcomes measure: back performance test, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yasemin Özel Aslıyüce, city: Yeni̇mahalle, state: Ankara, zip: 06100, country: Turkey, hasResults: False
|
protocolSection identificationModule nctId: NCT06345417, orgStudyIdInfo id: O-PBM1, briefTitle: Outcomes of Patient Blood Management in Severely Anemic Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Helios Klinik Gotha/Ohrdruf, class: OTHER, collaborators name: Helios Klinikum Erfurt, descriptionModule briefSummary: The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy. Its main question\[s\] it aims to answer are:* Which group of patients dies more frequent: Patients who receive patient blood management only, patients who receive patient blood management and transfusions or patients who receive only transfusions?* Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patient blood management, which is the management of anemia, bleeding and coagulation problems, will receive transfusions, that is, blood from other people, or a mix of both., conditionsModule conditions: Severe Anemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, armsInterventionsModule interventions name: Patient Blood Management (PBM), interventions name: Allogeneic transfusion, outcomesModule primaryOutcomes measure: Number of dead participants at the end of hospitalization (inhospital mortality), secondaryOutcomes measure: Number of participants with surgical wound complications, secondaryOutcomes measure: Number of participants with a documented acute myocardial infarction, secondaryOutcomes measure: Number of participants suffering renal injury, secondaryOutcomes measure: Number of days spent in hospital (Length of stay in hospital), secondaryOutcomes measure: Number of participants readmitted to the studied hospital, secondaryOutcomes measure: Number of participants with a documented transfusion reaction, secondaryOutcomes measure: Number of participants receiving an allogeneic transfusion, secondaryOutcomes measure: Number of participants treated in an intensive care ward, secondaryOutcomes measure: Number of participants with documented respiratory complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Helios Klinikum, city: Erfurt, state: Thuringia, country: Germany, contacts name: Achim Spenner, role: CONTACT, phone: +49-361-7810, email: Achim.Spenner@helios-gesundheit.de, geoPoint lat: 50.9787, lon: 11.03283, locations facility: Helios Klinikum, city: Gotha, state: Thuringia, zip: 99867, country: Germany, contacts name: Petra See, role: CONTACT, phone: +49-3621-220 0, email: petra.seeber@helios-gesundheit.de, contacts name: Kai D, role: CONTACT, phone: +49-3621-220, phoneExt: 5058, email: Kai-uwe.doebel@helios-gesundheit.de, geoPoint lat: 50.94823, lon: 10.70193, hasResults: False
|
protocolSection identificationModule nctId: NCT06345404, orgStudyIdInfo id: CPI-818-003, briefTitle: Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Corvus Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD, conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Sequential Dose Escalation, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Blinded Placebo-Controlled, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Soquelitinib, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms, secondaryOutcomes measure: To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI), secondaryOutcomes measure: To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Corvus Clinical Trials Information, status: RECRUITING, city: Burlingame, state: California, zip: 94010, country: United States, contacts name: Liza Tom, role: CONTACT, phone: 650-900-4514, email: ltom@corvuspharma.com, contacts name: Gabriel Luciano, role: CONTACT, phone: 6509004548, email: gluciano@corvuspharma.com, geoPoint lat: 37.5841, lon: -122.36608, hasResults: False
|
protocolSection identificationModule nctId: NCT06345391, orgStudyIdInfo id: PANACEA_CO-CREATION_2024, briefTitle: Co-creation of Pain Science Education for Children Living Beyond Cancer, acronym: PANACEA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Vrije Universiteit Brussel, class: OTHER, collaborators name: Universitair Ziekenhuis Brussel, collaborators name: University Ghent, collaborators name: University Hospital, Ghent, collaborators name: University of Calgary, descriptionModule briefSummary: A pain science education (PSE) intervention for children (8-12y) living beyond cancer (CBC) will be developed through a co-creational approach with CBC, their parents and pediatric oncology clinicians. The study will be guided by the Intervention Mapping Protocol., conditionsModule conditions: Children Living Beyond Cancer (i.e. Child Cancer Survivor), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Co-creation, interventions name: Concept Mapping, outcomesModule primaryOutcomes measure: Satisfaction with the co-created intervention, secondaryOutcomes measure: Understandability of the co-created intervention, secondaryOutcomes measure: Empowerment with regard to the co-created intervention, secondaryOutcomes measure: Ownership of the intervention development, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Vrije Universiteit Brussel, city: Jette, state: Brussels, zip: 1090, country: Belgium, contacts name: Emma Rheel, PhD, role: CONTACT, phone: +32496908353, email: emma.rheel@vub.be, contacts name: Kelly Ickmans, PhD, role: CONTACT, phone: +32498483347, email: kelly.ickmans@vub.be, contacts name: Sophie Pleysier, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 50.87309, lon: 4.33419, hasResults: False
|
protocolSection identificationModule nctId: NCT06345378, orgStudyIdInfo id: IRFMN_PapaGio, briefTitle: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (ASST Papa Giovanni XXIII), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-11-25, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, descriptionModule briefSummary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients., conditionsModule conditions: Quality of Care, conditions: Evaluation, conditions: Emergency Departments, conditions: Appropriateness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Algorithm creation, primaryOutcomes measure: Algorithm validation, primaryOutcomes measure: Algorithm application, primaryOutcomes measure: Appropriateness estimation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST Papa Giovanni XXIII, city: Bergamo, state: BG, zip: 24127, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, hasResults: False
|
protocolSection identificationModule nctId: NCT06345365, orgStudyIdInfo id: 09, briefTitle: MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Zhongnan Hospital, class: OTHER, collaborators name: Ruijin Hospital, collaborators name: Shanxi Province Cancer Hospital, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: Jingzhou Central Hospital, collaborators name: Yichang Central People's Hospital, collaborators name: Taihe Hospital, collaborators name: The Central Hospital of Xiaogan, collaborators name: Xianning Central Hospital, collaborators name: The First People's Hospital of Jingzhou, descriptionModule briefSummary: Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine)., conditionsModule conditions: Acute Myeloid Leukaemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: mitoxantrone liposome, Ara-Cytarabine and azacitidine, interventions name: Daunorubicin,Ara-Cytarabine, azacitidine, outcomesModule primaryOutcomes measure: Complete remission rate, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Compound CR rate, secondaryOutcomes measure: Objective remission rate, secondaryOutcomes measure: No remission rate, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Mortality rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Zhengzhou University, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 450052, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The Central Hospital of Huanggang, status: NOT_YET_RECRUITING, city: Huanggang, state: Hubei, zip: 438000, country: China, geoPoint lat: 23.67704, lon: 116.99961, locations facility: The First People's Hospital of Jingzhou, status: NOT_YET_RECRUITING, city: Jingzhou, state: Hubei, zip: 434000, country: China, geoPoint lat: 30.35028, lon: 112.19028, locations facility: Jingzhou Central Hospital, status: NOT_YET_RECRUITING, city: Jingzhou, state: Hubei, zip: 434020, country: China, geoPoint lat: 30.35028, lon: 112.19028, locations facility: Shiyan Taihe Hospital, status: NOT_YET_RECRUITING, city: Shiyan, state: Hubei, zip: 442000, country: China, geoPoint lat: 32.6475, lon: 110.77806, locations facility: Zhongnan Hospital of Wuhan University, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430071, country: China, contacts name: Zhou Fuling, director, role: CONTACT, phone: +86-02767813137, email: zhoufuling@163.com, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Xianning Central Hospital, status: NOT_YET_RECRUITING, city: Xianning, state: Hubei, zip: 437100, country: China, geoPoint lat: 29.84347, lon: 114.32201, locations facility: The Central Hospital of Xiaogan, status: NOT_YET_RECRUITING, city: Xiaogan, state: Hubei, zip: 432100, country: China, geoPoint lat: 30.92689, lon: 113.92221, locations facility: Yichang Central Hospital, status: NOT_YET_RECRUITING, city: Yichang, state: Hubei, zip: 443003, country: China, geoPoint lat: 30.71444, lon: 111.28472, locations facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, status: NOT_YET_RECRUITING, city: Wuxi, state: Jiangsu, zip: 214028, country: China, geoPoint lat: 31.56887, lon: 120.28857, locations facility: Shanxi Cancer Hospital, status: NOT_YET_RECRUITING, city: Taiyuan, state: Shanxi, zip: 030009, country: China, geoPoint lat: 37.86944, lon: 112.56028, hasResults: False
|
protocolSection identificationModule nctId: NCT06345352, orgStudyIdInfo id: IRFMN_7520_PoliMI, briefTitle: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-09-15, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, descriptionModule briefSummary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients., conditionsModule conditions: Quality of Care, conditions: Evaluation, conditions: Emergency Department, conditions: Appropriateness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Algorithm creation, primaryOutcomes measure: Algorithm validation, primaryOutcomes measure: Algorithm application, primaryOutcomes measure: Appropriateness estimation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, city: Milano, state: MI, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06345339, orgStudyIdInfo id: M21-341, briefTitle: A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2028-06-03, completionDateStruct date: 2028-06-03, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy., conditionsModule conditions: Hypothyroidism, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 2800, type: ESTIMATED, armsInterventionsModule interventions name: Armour Thyroid, interventions name: Levothyroxine, outcomesModule primaryOutcomes measure: Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response, primaryOutcomes measure: Number of Participants with Adverse Events (AEs), secondaryOutcomes measure: Percentage of Participants who Achieve TSH Response, secondaryOutcomes measure: Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid, secondaryOutcomes measure: Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diagnamics Inc. /ID# 262680, status: RECRUITING, city: Encinitas, state: California, zip: 92024, country: United States, geoPoint lat: 33.03699, lon: -117.29198, locations facility: NorCal Medical Research /ID# 256512, status: RECRUITING, city: Greenbrae, state: California, zip: 94904, country: United States, geoPoint lat: 37.94854, lon: -122.5247, locations facility: West Orange Endocrinology /ID# 256139, status: RECRUITING, city: Ocoee, state: Florida, zip: 34761-4547, country: United States, geoPoint lat: 28.56917, lon: -81.54396, locations facility: Endocrine Research Solutions /ID# 256784, status: RECRUITING, city: Roswell, state: Georgia, zip: 30076, country: United States, contacts name: Site Coordinator, role: CONTACT, phone: 678-878-4750, geoPoint lat: 34.02316, lon: -84.36159, locations facility: West Broadway Clinic /ID# 256756, status: RECRUITING, city: Council Bluffs, state: Iowa, zip: 51501-3822, country: United States, geoPoint lat: 41.26194, lon: -95.86083, locations facility: L-MARC Research Center /ID# 255733, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40213-1014, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Physician's East Endocrinology /ID# 256491, status: RECRUITING, city: Greenville, state: North Carolina, zip: 27834, country: United States, geoPoint lat: 35.61266, lon: -77.36635, locations facility: Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, geoPoint lat: 40.79895, lon: -81.37845, locations facility: Lynn Institute of Norman /ID# 256785, status: RECRUITING, city: Norman, state: Oklahoma, zip: 73072, country: United States, geoPoint lat: 35.22257, lon: -97.43948, locations facility: Lynn Institute of Oklahoma City /ID# 263141, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73112, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Texas Diabetes and Endocrinology - Central Austin /ID# 255728, status: RECRUITING, city: Austin, state: Texas, zip: 78731, country: United States, contacts name: Site Coordinator, role: CONTACT, phone: 512-334-3505, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Texas Diabetes and Endocrinology - South Austin /ID# 255723, status: RECRUITING, city: Austin, state: Texas, zip: 78749, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: North TX Endocrine Center /ID# 255737, status: RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Diabetes and Thyroid Center of Ft. Worth /ID# 256781, status: RECRUITING, city: Fort Worth, state: Texas, zip: 76132, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Juno Research /ID# 259238, status: RECRUITING, city: Houston, state: Texas, zip: 77040-5059, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Consano Clinical Research, LLC /ID# 256138, status: RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, contacts name: Site Coordinator, role: CONTACT, phone: 210.291.3797, geoPoint lat: 29.58495, lon: -98.55252, locations facility: Texas Valley Clinical Research /ID# 261476, status: RECRUITING, city: Weslaco, state: Texas, zip: 78596, country: United States, geoPoint lat: 26.15952, lon: -97.99084, hasResults: False
|
protocolSection identificationModule nctId: NCT06345326, orgStudyIdInfo id: E1-22-3155, briefTitle: Greater Occipital Nerve Block Versus Pulse Radiofrequency in Migraine, acronym: GON-B/PRF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-15, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Adiyaman University Research Hospital, class: OTHER, collaborators name: Ankara City Hospital Bilkent, descriptionModule briefSummary: The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF), conditionsModule conditions: Migraine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective observational, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Greater occipital nerve block, outcomesModule primaryOutcomes measure: NRS, secondaryOutcomes measure: Complications, secondaryOutcomes measure: the frequency of headhache, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara City Hospital Bilkent, status: RECRUITING, city: Ankara, zip: 06680, country: Turkey, contacts name: Sukriye Dadali, MD, role: CONTACT, phone: +905333316636, email: sukriyedadali@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06345313, orgStudyIdInfo id: CIRCADIAN RHYTHM, briefTitle: EFFECT OF CIRCADIAN RHYTHM ON INFLAMMATORY PARAMETERS IN UNILATERAL INGUINAL HERNIORRAHIES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour., conditionsModule conditions: Inflammatory Response, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Day Group, interventions name: Night Group, outcomesModule primaryOutcomes measure: Change of IL6 (interleukin) (ng/ml), secondaryOutcomes measure: Quality of recovery from anesthesia according to difference in circadian rhythm, secondaryOutcomes measure: Change of NLR ( Neutrophil/ Lymphocyte Ratio ), secondaryOutcomes measure: Change of PLR ( Platelet / Lymphocyte Ratio ), secondaryOutcomes measure: Change of SII (Systemic immune-inflammation index ), secondaryOutcomes measure: Change of CRP (C Reactive Protein) (mg/dl), secondaryOutcomes measure: Change of Fibrinogen (mg), secondaryOutcomes measure: Change of Sedimentation (mm/hour), secondaryOutcomes measure: Change of Procalcitonin (µg/l), secondaryOutcomes measure: Change of Ferritin (ml/ng), otherOutcomes measure: Postoperative pain scores according to the difference in circadian rhythm, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Bilkent City Hospital, city: Ankara, state: Cankaya, zip: 06800, country: Turkey, contacts name: Burcu Dikmen Demiryorgan, role: CONTACT, phone: +905067611029, email: burcudikmen325@gmail.com, contacts name: Fatma Kavak Akelma, role: CONTACT, phone: +905327079113, email: fatmakavak@yahoo.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06345300, orgStudyIdInfo id: NCC4309, briefTitle: NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-12-12, completionDateStruct date: 2025-12-24, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, collaborators name: Jiangsu HengRui Medicine Co., Ltd., descriptionModule briefSummary: The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer, conditionsModule conditions: Borderline Resectable Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab, interventions name: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate, outcomesModule primaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Event free survival (EFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate(ORR), secondaryOutcomes measure: Disease Control Rate（DCR）, secondaryOutcomes measure: Safety and tolerability by incidence, severity and outcome of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijin, country: China, contacts name: Yongkun Sun, role: CONTACT, phone: 13141276041, email: hsunyk@126.com, hasResults: False
|
protocolSection identificationModule nctId: NCT06345287, orgStudyIdInfo id: 24/018-4298, briefTitle: Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients., conditionsModule conditions: Head and Neck Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 133, type: ESTIMATED, armsInterventionsModule interventions name: radical radiotherapy (60Gy), interventions name: radical radiotherapy (66Gy), interventions name: radical radiotherapy (70Gy), interventions name: anti-PD-1 or PD-L1 antibody, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Deep partial response, secondaryOutcomes measure: Local-Regional failure survival, secondaryOutcomes measure: Toxicity Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC, status: RECRUITING, city: Beijing, country: China, contacts name: Jingbo Wang, Doctor, role: CONTACT, phone: 15811166516, email: wangjingbo303@yahoo.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06345274, orgStudyIdInfo id: SP0077172, secondaryIdInfos id: K23DA050729, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DA050729, briefTitle: MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs), acronym: MBC2OTP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Measurement Based Care Training and Monthly Consultation, outcomesModule primaryOutcomes measure: Patient treatment attendance (effectiveness outcome), primaryOutcomes measure: Patient treatment attendance (effectiveness outcome), primaryOutcomes measure: Treatment provider measurement based care exposure (implementation outcome), secondaryOutcomes measure: Patient opioid abstinence (effectiveness outcome), secondaryOutcomes measure: Treatment provider measurement based care fidelity (implementation outcome), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Family Guidance Centers, Inc., city: Aurora, state: Illinois, zip: 60505, country: United States, geoPoint lat: 41.76058, lon: -88.32007, locations facility: Northwestern University Feinberg School of Medicine, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Kelli Scott, PhD, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Family Guidance Centers, Inc., city: Chicago, state: Illinois, zip: 60654, country: United States, contacts name: Kelli Scott, PhD, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Family Guidance Centers, Inc., city: Des Plaines, state: Illinois, zip: 60016, country: United States, geoPoint lat: 42.03336, lon: -87.8834, locations facility: Family Guidance Centers, Inc., city: Joliet, state: Illinois, zip: 60435, country: United States, geoPoint lat: 41.52519, lon: -88.0834, hasResults: False
|
protocolSection identificationModule nctId: NCT06345261, orgStudyIdInfo id: 2024-872, briefTitle: Diphenhydramine in Catheter Related Bladder Discomfort, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action ., conditionsModule conditions: Catheter Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: DiphenhydrAMINE 50 Mg/mL Injectable Solution, interventions name: Saline, outcomesModule primaryOutcomes measure: incidence of catheter related bladder discomfort postoperative, secondaryOutcomes measure: visual analog scale (VAS), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo university, city: Cairo, zip: 11562, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06345248, orgStudyIdInfo id: 2024-854, briefTitle: Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control, conditionsModule conditions: Transversus Abdominis Plane, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: US-TAP, interventions name: LAPTAP, outcomesModule primaryOutcomes measure: morphine needed, secondaryOutcomes measure: first analgesic request time, secondaryOutcomes measure: patients' satisfaction, secondaryOutcomes measure: opioid-associated side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo university, city: Cairo, zip: 11562, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06345235, orgStudyIdInfo id: ID DEC-2023/07/X/NZ5/00141, briefTitle: New Biomarkers and Plasma Prothrombotic Potential in Cardiac Transthyretin Amyloidosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-11, primaryCompletionDateStruct date: 2024-07-11, completionDateStruct date: 2024-07-11, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: John Paul II Hospital, Krakow, class: OTHER, descriptionModule briefSummary: The development of cardiac amyloidosis is caused by the deposition of misfolded, insoluble proteins in the extracellular matrix of tissues. An important element of the clinical picture of the disease is the increased risk of thromboembolic complications, independent of the occurrence of atrial fibrillation, and the presence of intracardiac thrombi. The pathomechanism may be related to an increase in filling pressure or amyloid infiltration leading to myocardial damage and endothelial dysfunction, which may activate the prothrombotic inflammatory cascade, resulting in increased thrombogenic potential. Currently, there is limited published data on the potential role of new heart failure biomarkers in the assessment of ATTR cardiomyopathy, particularly in the assessment of asymptomatic carriers of pathogenic TTR variants. Moreover, there are few literature reports on the direct assessment of the coagulation system in this group of patients, and the pathomechanism of the increased thromboembolic risk is unexplored.Purpose of the study: To assess the diagnostic value of biomarkers related to heart failure (growth differentiation factor-15 (GDF15), soluble suppression of tumorigenicity-2 (ST2), galectin-3), amyloidosis ( TTR, tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9, matrix metalloproteinase-9), neurofilament light chain (NfL)) and the generation potential thrombin as a marker of the prothrombotic state in the course of ATTR.Methods: This prospective, single-center study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3, n=20). Material for research was collected and secured from all study participants. After giving informed consent, all patients will be tested using the ELISA method from peripheral blood (enzyme-linked immunosorbent assay) GDF15, ST2, TTR, TIMP-1, MMP-9, galectin-3, NfL. The values of these biomarkers will be compared in subgroups and correlated with clinical data, laboratory test results, echocardiography including analysis of left ventricular global strain (GLS), and scintigraphy. Additionally, the prothrombotic potential of plasma will be tested in both groups of patients using the calibrated automatic thrombogram (CAT) method, in accordance with the protocol previously used in the laboratory Expected results: The project will provide information on the value of biomarkers in the assessment of ATTR cardiomyopathy, especially in the assessment of asymptomatic carriers of pathogenic TTR variants, which may translate into the creation of a diagnostic algorithm for early identification of the development of the disease. Moreover, it will allow us to determine whether patients with cardiac ATTR are characterized by a prothrombotic state, which has not yet been described in the literature and may have potential clinical implications., conditionsModule conditions: Transthyretin Amyloidosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: blood test, outcomesModule primaryOutcomes measure: Biomarkers, primaryOutcomes measure: Thrombin as a marker, primaryOutcomes measure: Biomarkers, primaryOutcomes measure: Biomarkers, primaryOutcomes measure: Biomarkers, primaryOutcomes measure: Biomarkers, primaryOutcomes measure: Biomarkers, primaryOutcomes measure: Biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: John Paul II Hospital, status: RECRUITING, city: Kraków, zip: 31-202, country: Poland, contacts name: Katarzyna Holcman, MD, role: CONTACT, phone: 608214249, phoneExt: 48, email: katarzyna.holcman@gmail.com, contacts name: Katarzyna Holcman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
|
protocolSection identificationModule nctId: NCT06345222, orgStudyIdInfo id: GETAT 23/05, briefTitle: Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Bursa Yüksek İhtisas Education and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: 92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month., conditionsModule conditions: The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Case control study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ACTUAL, armsInterventionsModule interventions name: Prolotherapy, outcomesModule primaryOutcomes measure: change in knee pain with prolotherapy application, primaryOutcomes measure: change in quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bursa Yuksek Ihtisas Training and Research Hospital, city: Bursa, state: Türkiye, zip: 16310, country: Turkey, geoPoint lat: 40.19559, lon: 29.06013, hasResults: False
|
protocolSection identificationModule nctId: NCT06345209, orgStudyIdInfo id: BM-D19, briefTitle: Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: BrosMed Medical Co., Ltd, class: INDUSTRY, collaborators name: Chinese Academy of Medical Sciences, Fuwai Hospital, descriptionModule briefSummary: To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 236, type: ESTIMATED, armsInterventionsModule interventions name: Sirolimus-coated Coronary Balloon Dilatation Catheter, interventions name: Drug-coated Coronary Balloon Dilatation Catheter, outcomesModule primaryOutcomes measure: Late luminal loss (LLL), secondaryOutcomes measure: Device success rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06345196, orgStudyIdInfo id: BozokUni, briefTitle: Motivational Interviewing Applied to Individuals With Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Bozok University, class: OTHER, descriptionModule briefSummary: This study will be conducted using a randomized controlled trial design to evaluate the effect of online individual motivational interviewing on well-being, stress and difficulties in individuals with diabetes. The study will be conducted between March 2024 and March 2025 with individuals with Type 2 Diabetes who are followed up in Yozgat Bozok University Health Practice and Research Center Internal Medicine Polyclinic. The motivational interview group will receive a motivational interview once a week, lasting a maximum of 40 minutes, consisting of a total of four sessions. Chi-square (X2), t-test, repeated measures analysis of variance, Pearson correlation coefficient, partial eta-square and linear regression analysis will be used to evaluate the data., conditionsModule conditions: Motivational Interviewing, conditions: Stress, conditions: Well-Being, Psychological, conditions: Diabetes Mellitus, conditions: Type2diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: motivational interview, outcomesModule primaryOutcomes measure: Change in coping with stress, secondaryOutcomes measure: State of Well-Being Change, otherOutcomes measure: Changing Strength and Difficulties in Diabetes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Akdağmadeni School of Health, status: RECRUITING, city: Yozgat, country: Turkey, contacts name: Betül Bal, role: CONTACT, phone: 0 (354) 314 14 15, email: betul.bal@yobu.edu.tr, geoPoint lat: 39.82, lon: 34.80444, locations facility: Bozok University, status: RECRUITING, city: Yozgat, country: Turkey, contacts name: Betül Bal, role: CONTACT, phone: 0 (354) 314 14 15, email: betul.bal@yobu.edu.tr, geoPoint lat: 39.82, lon: 34.80444, hasResults: False
|
protocolSection identificationModule nctId: NCT06345183, orgStudyIdInfo id: CA209-1275, briefTitle: Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy, conditionsModule conditions: Advanced Renal Cell Carcinoma (aRCC), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Nivolumab + Ipilimumab combination therapy, interventions name: Pembrolizumab + Lenvatinib combination therapy, outcomesModule primaryOutcomes measure: Participant year of birth, primaryOutcomes measure: Participant sex at birth, primaryOutcomes measure: Participant primary payer, primaryOutcomes measure: Participant race, primaryOutcomes measure: Participant ethnicity, primaryOutcomes measure: Participant U.S. state of residence, primaryOutcomes measure: Participant initial Renal Cell Carcinoma (RCC) diagnoses, primaryOutcomes measure: American Joint Committee on Cancer (AJCC) TNM stage, primaryOutcomes measure: Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis, primaryOutcomes measure: Participant renal cell carcinoma (RCC) histology results, primaryOutcomes measure: Participant tumor grade, primaryOutcomes measure: Participant biomarker or genetic testing method, primaryOutcomes measure: Participant molecular and/or genetic mutations reported, primaryOutcomes measure: Participant site of metastatic disease, primaryOutcomes measure: Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), primaryOutcomes measure: Participant Karnofsky score (KPS), primaryOutcomes measure: Participant comorbidities and/or chronic conditions, primaryOutcomes measure: Participant blood test results, primaryOutcomes measure: Participant Memorial Sloan Kettering Cancer Center (MSKCC) score, primaryOutcomes measure: Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score, primaryOutcomes measure: Participant smoking status, primaryOutcomes measure: Participant COVID-19 status, primaryOutcomes measure: Participant surgical history, primaryOutcomes measure: Participant radiation treatment history, primaryOutcomes measure: Participant treatment regimen received, primaryOutcomes measure: Participant treatment initiation and discontinuation dates, primaryOutcomes measure: Participant rationale for discontinuation of treatment, primaryOutcomes measure: Participant radiation therapy prescribed, primaryOutcomes measure: Participant total number of radiotherapy cycles, primaryOutcomes measure: Participant initial dose and frequency/schedule of index therapy, primaryOutcomes measure: Participant index treatment dose modifications, primaryOutcomes measure: Participant rationale for dose modifications of index therapy, primaryOutcomes measure: Participant date of dose modifications of index therapy, primaryOutcomes measure: Participant last dose and frequency/schedule of index therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cardinal Health, status: RECRUITING, city: Dublin, state: Ohio, zip: 43017, country: United States, geoPoint lat: 40.09923, lon: -83.11408, hasResults: False
|
protocolSection identificationModule nctId: NCT06345170, orgStudyIdInfo id: buhucgun05, briefTitle: Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIR/Floortime™ Therapy Program in Children With Developmental Risk, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-03, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-04-10, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: The term "developmental risk" is used as a general term for developmental delays observed in infancy and early childhood. Developmental delay refers to the delay in children reaching developmental milestones compared to their peers. The DIR/Floortime™ therapy program is an approach that uses play as a therapeutic tool, emphasising the importance of interaction involving affect and excitement in a child's development. DIR/Floortime™ therapy program aims to support the child's development with a family-centred perspective by evaluating the child and the family together. DIR/Floortime™ therapy program is known to contribute to the functional and emotional development of children and the development of parenting skills of caregivers. The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) is a parent-reported developmental screening test that aims to identify 'delays' in the social communication area skills of infants and children. The SCASI training program is a training program for children and parents developed on the basis of this screening test, which includes targeted activities to support the development process according to the child's developmental level. To the best of our knowledge, there is no study investigating the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. The aim of the study is to examine the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. A total of 34 children with developmental risk between the ages of 1 and 3 will included in the study. Participants will randomly divided into two groups: control group (n=17) in which the DIR/Floortime™ therapy program will be applied and intervention group (n=17) in which the SCASI training program will be applied in addition to the DIR/Floortime™ therapy program. The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks, and the SCASI training program will be applied by the parents at home, 2 days a week, for an average of 30 minutes a day, for 12 weeks. Demographic and clinic informations, SCASI test, Age and Stages Questionnarie (ASQ), Age and Stages Questionnaires: Social-Emotional (ASQ-SE) and Brief Infant and Toddler Social Emotional Assessment (BITSEA) will be used as outcome measures in the study., conditionsModule conditions: Children With Developmental Risk, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: The DIR/Floortime™ Therapy Program, interventions name: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program, outcomesModule primaryOutcomes measure: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI), primaryOutcomes measure: Age and Stages Questionnarie (ASQ), primaryOutcomes measure: Age and Stages Questionnaires: Social-Emotional (ASQ-SE), primaryOutcomes measure: Brief Infant and Toddler Social Emotional Assessment (BITSEA), eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 3 Years, stdAges: CHILD, contactsLocationsModule locations facility: Biruni University, status: RECRUITING, city: Istanbul, zip: 34015, country: Turkey, contacts name: Hikmet Ucgun, PT, PhD, role: CONTACT, phone: +905321616271, email: hikmetucgun92@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06345157, orgStudyIdInfo id: COMB157GIT02, briefTitle: ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting., conditionsModule conditions: Multiple Sclerosis, Relapsing-Remitting, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Ofatumumab, outcomesModule primaryOutcomes measure: Annualized relapse rate (ARR), secondaryOutcomes measure: Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test), secondaryOutcomes measure: Fatigue Severity Scale [FSS], secondaryOutcomes measure: Quality of life parameters assessed by EQ-5D-3L, secondaryOutcomes measure: Treatment satisfaction assessed by TSQM-9, secondaryOutcomes measure: Expanded Disability Status Scale (EDSS), secondaryOutcomes measure: Variation of NfL in plasma, secondaryOutcomes measure: Adverse Events (AEs), secondaryOutcomes measure: Discontinuation rates due to AE and/or other reasons, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06345144, orgStudyIdInfo id: 202307211RINC, briefTitle: Learning Experience of Undergraduate Nursing Students in Pediatric Oncology Ward, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-22, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Clinical practices are crucial experiences for nursing students as they prepare themselves for future nursing work. Despite some research having been studied among Taiwanese nursing students in the past, there has been limited research into the experiences within pediatric oncology wards, where diseases are complex and frequently involve life-and-death issues. Therefore, the purpose of this study is to explore the experiences of undergraduate nursing students in pediatric oncology wards., conditionsModule conditions: Pediatric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Explore the experiences of undergraduate nursing students practicing in pediatric oncology wards., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wei-En Li, status: RECRUITING, city: New Taipei City, country: Taiwan, contacts name: Wei-En Li, role: CONTACT, geoPoint lat: 25.01111, lon: 121.44583, hasResults: False
|
protocolSection identificationModule nctId: NCT06345131, orgStudyIdInfo id: KY20230829-06, briefTitle: Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: By observing the anatomical relationship and influencing factors of the radial artery through ultrasound, the optimal puncture location is selected, and puncture catheterization is guided to reduce the number of punctures, reduce complications, and improve safety and accuracy., conditionsModule conditions: Surgical Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Non invasive blood pressure monitoring, outcomesModule primaryOutcomes measure: Measure the transverse diameter of the radial artery at each anatomical point, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210006, country: China, contacts name: Liu Han, MD, role: CONTACT, phone: 18951670163, email: han_cold.student@sina.com, geoPoint lat: 32.06167, lon: 118.77778, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-07-22, uploadDate: 2024-02-14T20:25, filename: Prot_ICF_000.pdf, size: 166411, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2023-07-22, uploadDate: 2024-03-05T21:35, filename: SAP_001.pdf, size: 300501, hasResults: False
|
protocolSection identificationModule nctId: NCT06345118, orgStudyIdInfo id: FallpreventT2DMelderly, briefTitle: Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus, acronym: FallT2DMOLD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: National Geriatric Hospital, class: OTHER_GOV, descriptionModule briefSummary: .This randomized controlled clinical trial aims to evaluate the effects of fall prevention in older adults with type 2 diabetes mellitus. The main questions it aims to answer are:* Describe the current situation of falls, the risk of falls, and some related factors in elderly type 2 diabetic patients* Evaluate the results of fall prevention and related factors in the study population.Participants will be randomly divided into control and intervention groups. The intervention group will be trained to follow the Otago Training Program as the primary fall prevention method. On the other hand, the control group will receive the standard care following the treatment guidelines for type 2 diabetes mellitus and other comorbidities.At the end of the intervention, the study will mainly compare the rate of fall incidents after 6 months of intervention as well as other physical performance tests., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Fall, conditions: Elderly Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Otago exercise program, outcomesModule primaryOutcomes measure: Physical performance 1 - Timed Up and Go (TUG), primaryOutcomes measure: Physical performance 2 -Berg Balance Scale (BBS), secondaryOutcomes measure: Activities of Daily Living (ADLs), secondaryOutcomes measure: Health-related Quality of Life, secondaryOutcomes measure: Functional Reach Test (FRT), secondaryOutcomes measure: Instrumental Activities of Daily Living (IADLs), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Geriatric Hospital, status: RECRUITING, city: Hanoi, zip: 100000, country: Vietnam, contacts name: Huyen TT Vu, PhD, role: CONTACT, phone: +84913531579, email: vuthanhhuyen11@yahoo.com, geoPoint lat: 21.0245, lon: 105.84117, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-10-11, uploadDate: 2024-03-13T14:07, filename: ICF_000.pdf, size: 320767, hasResults: False
|
protocolSection identificationModule nctId: NCT06345105, orgStudyIdInfo id: AIeffectiveV4, briefTitle: Real Time Effective Withdrawal Time and Adenoma Detection Rate, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' baseline adenoma detection rate (ADR). The association between the AI derived EWT with ADR during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI, conditionsModule conditions: Colon Polyp, conditions: Colon Adenoma, conditions: Artificial Intelligence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 198, type: ESTIMATED, armsInterventionsModule interventions name: Endoscreener QC, outcomesModule primaryOutcomes measure: Adenoma detection rates of the endoscopists, secondaryOutcomes measure: Adenoma detection rate, secondaryOutcomes measure: Polyp detection rate, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Mary Hospital, the University of Hong Kong, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Thomas Ka Luen Lui, role: CONTACT, phone: +852 97360997, email: tkllui@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
|
protocolSection identificationModule nctId: NCT06345092, orgStudyIdInfo id: Omfs.3-3-3, briefTitle: Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-03-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement, conditionsModule conditions: TMJ Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Vitamin C, interventions name: Injectable platelet rich fibrin, outcomesModule primaryOutcomes measure: Pain management, secondaryOutcomes measure: disc position using MRI, otherOutcomes measure: maximum mouth opening, otherOutcomes measure: lateral excursion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry cairo university, city: Cairo, zip: +2, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06345079, orgStudyIdInfo id: AG0219NET, briefTitle: Cessation of Somatostatin Analogues After PRRT in Mid-Gut Neuroendocrine Tumours, acronym: STOPNET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Australasian Gastro-Intestinal Trials Group, class: NETWORK, collaborators name: Canadian Cancer Trials Group, descriptionModule briefSummary: Neuroendocrine tumours (NETs) are slow growing cancers, which commonly present as metastatic incurable disease. Some neuroendocrine tumours, termed functional NETs, overproduce hormones which result in a variety of symptoms. However, approximately 75% of NETs are considered non-functional meaning that they do not result in hormone overproduction. The main treatment for both functional and non-functional NETs is somatostatin analogues (SSA, a type of inhibitory hormone). These drugs slow tumour growth and reduce hormone production. Over time, the majority of patients will experience tumour growth despite treatment with SSA therapy. When this occurs, the addition of Peptide Receptor Radionuclide Therapy (PRRT, a type of targeted radiotherapy) in combination with ongoing SSA therapy is given. However, it is not known if continuing SSA therapy after commencement of PRRT is beneficial or not.The aim of this study is to estimate the outcomes of patients with grade 1 and 2 well differentiated mid and hind-gut neuroendocrine tumours who have progressed on SSA therapy and receive subsequent PRRT with or without concurrent SSA., conditionsModule conditions: Neuroendocrine Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Cessation of somatostatin analogues, interventions name: Continuation of somatostatin analogues, outcomesModule primaryOutcomes measure: 20-month progression free survival rate after PRRT, primaryOutcomes measure: Assess the barriers which would impede the feasibility of a subsequent phase 3 trial, secondaryOutcomes measure: Measure Quality of life using the European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) scales, secondaryOutcomes measure: Measure Quality of life using the EORTC QLQ-GINET21 scales, secondaryOutcomes measure: Cost-effectiveness of SSA therapy cessation, secondaryOutcomes measure: Psycho-oncological impacts of SSA therapy cessation: Decision Regret, secondaryOutcomes measure: Psycho-oncological impacts of SSA therapy cessation: Fear of Cancer Progression, secondaryOutcomes measure: Psycho-oncological impacts of SSA therapy cessation: Decisional Conflict, secondaryOutcomes measure: Time to commencement of subsequent therapy, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Rates of SSA being recommenced over time, otherOutcomes measure: Exploratory analyses, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Brisbane Women's Hospital, city: Brisbane, state: Queensland, zip: 4006, country: Australia, contacts name: Matthew Burge, role: CONTACT, phone: (07) 3636 8111, email: Matthew.Burge@health.qld.gov.au, contacts name: Matthew Burge, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False
|
protocolSection identificationModule nctId: NCT06345066, orgStudyIdInfo id: 18834, secondaryIdInfos id: J3R-MC-YDAC, type: OTHER, domain: Eli Lilly And Company, briefTitle: A Study of LY3841136 in Overweight and Obese Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks., conditionsModule conditions: Obesity, conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Tirzepatide, interventions name: LY3841136, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants With One or More Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration, secondaryOutcomes measure: Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136, secondaryOutcomes measure: Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fortrea CRU, Inc., status: RECRUITING, city: Daytona Beach, state: Florida, zip: 32117, country: United States, contacts name: Hugh Coleman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.21081, lon: -81.02283, locations facility: Fortrea CRU, Inc., status: RECRUITING, city: Dallas, state: Texas, zip: 75247, country: United States, contacts name: Archie Bowie, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Fortrea CRU, Inc., status: RECRUITING, city: Madison, state: Wisconsin, zip: 53704, country: United States, contacts name: Nicholas Siebers, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
|
protocolSection identificationModule nctId: NCT06345053, orgStudyIdInfo id: 203428, briefTitle: Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Norwegian University of Science and Technology, class: OTHER, collaborators name: Møre og Romsdal Hospital Trust, collaborators name: Oslo University Hospital, descriptionModule briefSummary: There are high rates of co-occurring posttraumatic stress disorder (PTSD) among patients receiving treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, but adults in SUD treatment are often not assessed for PTSD nor offered PTSD-based interventions. One of the reasons for reluctance in offering trauma focused treatment is increased risk of drop out. PTSD and related emotion dysregulation are related to elevated psychological burden, higher dropout rates and increased risk of relapse. this is a feasibility study, where the plan is to integrate a combination of Dialectical Behaviour Therapy for Substance Use Disorder (DBT-SUD skills) a therapy targeting difficulties in emotion regulation and Narrative Exposure Therapy (NET) a trauma focused therapy, for patients with co-occurring PTSD symptoms into standard SUD treatment . The plan is to assess its potential benefits by assessing whether adding this combination to standard SUD treatment is relevant, feasible, acceptable, and safe. Treatment outcomes are 1) Prevalence of PTSD, suicidal behaviour, and self-harm, as well as the severity of difficulties in emotion regulation and emotional avoidance among patients (N approx. = 100) in inpatient treatment for SUD. 2) Change post-treatment and at 3 and 12 months follow up, from baseline in PTSD symptom severity, depressive symptoms, emotion regulation, emotion avoidance, and experience of shame. 3) Rates of dropout and relapse compared to previous rates.This project can increase knowledge about psychological mechanisms in co-occurring PTSD and SUD and improve the quality of treatment for this vulnerable patient population., conditionsModule conditions: Post Traumatic Stress Disorder, conditions: Substance Use Disorders, conditions: Emotion Regulation, conditions: Suicide, conditions: Self-harm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a repeated measures follow-up feasibility study without control group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Narrative Exposure Therapy, outcomesModule primaryOutcomes measure: The intervention is relevant - prevalence of PTSD /SUP PTSD., primaryOutcomes measure: The intervention is relevant - prevalence of traumatic experiences., primaryOutcomes measure: The intervention is relevant - The severitiy of difficulties in emotion regulation., primaryOutcomes measure: The intervention is feasible, accepted and safe - The dropout rate from treatment., primaryOutcomes measure: The intervention is safe - Suicide behaviour while in treatment., primaryOutcomes measure: The intervention is safe - Self-harm behaviour while in treatment., primaryOutcomes measure: The intervention is accepted - participation in DBT-SUD skills sessions., primaryOutcomes measure: The intervention is feasible and accepted - Objective experience of treatment., secondaryOutcomes measure: The potential benefits of the intervention - Change in PTSD symptoms from base line to 3-and 12 month follow up., secondaryOutcomes measure: The potential benefits of the intervention - Change in Difficulties in emotion regulation from baseline to 3- to 12- month follow up., secondaryOutcomes measure: The potential benefits of the intervention - Relapse to alcohol abuse at 3- and 12-months follow up., secondaryOutcomes measure: The potential benefits of the intervention - Relapse to substance abuse at 3- and 12-month follow up., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Molde Treatment Center, Møre and Romsdal Hospital Trust, status: RECRUITING, city: Molde, state: Møre And Romsdal, zip: 6410, country: Norway, contacts name: Edvard Breivik, role: CONTACT, phone: +4793032613, email: edvard.breivik@helse-mr.no, contacts name: Johanna Vigfusdottir, role: CONTACT, phone: +4746746154, email: johannavigfusd@gmail.com, geoPoint lat: 62.73752, lon: 7.15912, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-15, uploadDate: 2024-03-18T06:41, filename: Prot_SAP_000.pdf, size: 766255, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-25, uploadDate: 2024-03-25T10:01, filename: ICF_001.pdf, size: 621574, hasResults: False
|
protocolSection identificationModule nctId: NCT06345040, orgStudyIdInfo id: H-22067692, briefTitle: The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Mental Health Services in the Capital Region, Denmark, class: OTHER, descriptionModule briefSummary: The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles., conditionsModule conditions: Eating Disorders, conditions: Anorexia Nervosa, conditions: Bulimia Nervosa, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Virtual-reality intervention, interventions name: TAU - specialized treatment, outcomesModule primaryOutcomes measure: Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire, secondaryOutcomes measure: Level of depressive symptoms post treatment, secondaryOutcomes measure: Motivation for change post treatment, secondaryOutcomes measure: Level of identification with the eating disorder and level of embodiment post treatment, secondaryOutcomes measure: Experience of the eating disorder voice post treatment, secondaryOutcomes measure: Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale, otherOutcomes measure: Total score of eating disorder voice characteristics post treatment, otherOutcomes measure: Level of quality of life post treatment, otherOutcomes measure: Perceived difference in power between eating disorder voice and eating disorder patient post treatment, otherOutcomes measure: Level of acceptance of and action in relation to the eating disorder voice post treatment, otherOutcomes measure: Level of self-compassion post treatment, otherOutcomes measure: Level of body dissatisfaction post treatment, otherOutcomes measure: Level of perceived self-efficacy post treatment, otherOutcomes measure: Ability to regulate emotion post treatment, otherOutcomes measure: Level of executive functioning post treatment, otherOutcomes measure: Participant satisfaction, otherOutcomes measure: Presence of childhood traumas, otherOutcomes measure: Level of simulator sickness, otherOutcomes measure: Level of dysfunctional cognitive beliefs post treatment, otherOutcomes measure: Positive and negative aspects of eating disorders as perceived by the participant post treatment, otherOutcomes measure: Personal recovery post treatment, otherOutcomes measure: Presence of comorbidity, otherOutcomes measure: Cost effectiveness of the intervention, otherOutcomes measure: Level of cognitive (in)flexibility post treatment, otherOutcomes measure: Monitoring and reporting of adverse and unwanted events, otherOutcomes measure: Level of immersion in virtual reality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen Research Center for Mental Health - CORE, status: RECRUITING, city: Hellerup, state: Copenhagen, zip: 2900, country: Denmark, contacts name: Nina K Hansen, MSc (Psych.), role: CONTACT, phone: 21699487, phoneExt: +45, email: nina.kappel.hansen@regionh.dk, contacts name: Louise B Glenthøj, DMSc, PhD, role: CONTACT, phone: 21452889, phoneExt: +45, email: louise.birkedal.glenthoej@regionh.dk, contacts name: Louise B Glenthøj, DMSc, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.73204, lon: 12.57093, hasResults: False
|
protocolSection identificationModule nctId: NCT06345027, orgStudyIdInfo id: H-53163 CASEY, briefTitle: CHIMERIC ANTIGEN RECEPTOR TREATMENT TARGETING CD70 (SEVENTY), acronym: CASEY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2042-04-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Baylor College of Medicine, class: OTHER, descriptionModule briefSummary: This study is for patients that have lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease and the patients condition has come back or has not gone away after treatment, including the best treatment we know for these diseases.Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV). This virus causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma. This suggests that the EBV plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction.T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in blood and affect the tumor. We have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses (meaning the cancer could no longer be detected).We think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study we will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. We know that T cells need substances called cytokines (substances such as proteins released by specific cells of the immune system) to survive and that the cells may not get enough cytokines after the cells are infused into the body. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on the cancer., conditionsModule conditions: Leukemia, Myeloid, Acute, conditions: Leukemia, B-cell, conditions: Leukemia, T-Cell, conditions: Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Treatment Arm A, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT) rate, secondaryOutcomes measure: Overall Response Rate, eligibilityModule sex: ALL, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Texas Children's Hospital, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Bilal Omer, MD, role: CONTACT, phone: 832-826-0860, email: baomer@texaschildrens.org, geoPoint lat: 29.76328, lon: -95.36327, locations facility: The Methodist Hospital, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Bilal Omer, MD, role: CONTACT, phone: 832-826-0860, email: baomer@texaschildrens.org, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
|
protocolSection identificationModule nctId: NCT06345014, orgStudyIdInfo id: 23CP40803, briefTitle: The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: AJU Pharm Co., Ltd., class: INDUSTRY, collaborators name: OM Pharma SA, descriptionModule briefSummary: This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), conditionsModule conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome, conditions: Chronic Prostatitis, conditions: Chronic Pelvic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 \[Uro-Vaxom® Capsule\]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks.In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26. The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Background treatment - Xatral® XL Tab. 10 mg (alfuzosin hydrochloride): With the treatment of the investigational product, it will be administered for the first 13 weeks (Administration of the placebo will be continued to maintain the treatment compliance and blinding for the rest 13 weeks).After week 13, Background treatment will be blinded for subject only until end of treatment period(Week 26)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 332, type: ESTIMATED, armsInterventionsModule interventions name: OM-89 [Uro-Vaxom® Capsule], interventions name: OM-89 Placebo [Uro-Vaxom® Capsule Placebo], outcomesModule primaryOutcomes measure: NIH-CPSI total score, secondaryOutcomes measure: NIH-CPSI domain score, secondaryOutcomes measure: Subject and Investigator's Global Assessment, eligibilityModule sex: MALE, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: AJU Pharm Co., Ltd., status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: JUNGMIN LEE, role: CONTACT, phone: +82-02-2630-0700, email: ajuf13001@ajupharm.co.kr, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
|
protocolSection identificationModule nctId: NCT06345001, orgStudyIdInfo id: 22261, briefTitle: A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-08-12, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: Researchers are studying a new potential treatment for liver cancer.To do this, researchers have developed a protein, called a monoclonal antibody, which can find and attach itself to another protein present on the surface of liver cancer cells. This can help the new treatment to specifically target cancer cells in the liver.In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer.Researchers will use the following two forms of monoclonal antibody as study interventions during this study:* BAY3630942: This is the monoclonal antibody attached to a tracer. A tracer emits radiation that can help researchers track the monoclonal antibody in the body using imaging tests like PET/CT (positron emission tomography / computed tomography). All participants will receive a fixed dose of BAY3630942 during the study.* BAY3547922: This is the monoclonal antibody without the tracer. Participants may receive different amounts of BAY3547922 during the study.In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help researchers develop a new treatment for people with liver cancer and find a dose to be tested in future studies.The main purpose of this first-in-human study is to check how BAY3630942 distributes among different organs in the body and how much of the radiation it emits is absorbed by the organs based on the total dose of BAY3630942 and BAY3547922 given. For this, the researchers will:* measure the amount of BAY3630942 radiation found in different organs over time.* measure the amount of BAY3630942 radiation absorbed by different organs.* use the above information to estimate the amount of radiation that would be absorbed by the same organs from the new potential treatment.Researchers will also monitor the number and severity of medical problems participants have after receiving BAY3630942 and BAY3547922. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study interventions.The study participants will first receive BAY3547922 as an infusion into a vein followed by BAY3630942 as an injection into the same vein. Both interventions will be administered only once, on the same day.Each participant will be in the study for around 44 days with up to 7 visits to the study clinic which includes:* a visit up to 14 days before the start of the study to confirm if the participant can take part in the study.* up to 5 visits during the imaging intervention period. During this period, participants: * will receive the study interventions and have blood tests on the first visit, * will have imaging and blood tests on the next 3 visits. The tests scheduled for the second visit may be performed during the first visit. * may have blood tests on the last visit.* a follow-up visit to check their health after 30 days of receiving the study interventions.During the study, the doctors and their study team will:* check participants' health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)* track and study BAY3630942 using PET/CT imaging testsAs the study interventions are not yet treatments for liver cancer, access to BAY3630942 and BAY3547922 after the end of the study will not be required., conditionsModule conditions: Hepatocellular Carcinoma (HCC), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: BAY3630942, interventions name: BAY3547922, outcomesModule primaryOutcomes measure: Radioactivity concentration (SUVmean, %ID/g) of BAY3630942 in normal organs (including but not limited to kidney, spleen, liver, and bone marrow) as a function of time using 3 post-administration PET/CT scans, primaryOutcomes measure: Zirconium-89 absorbed doses (mGy/MBq) in normal organs, primaryOutcomes measure: Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated, secondaryOutcomes measure: Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922, secondaryOutcomes measure: Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood), secondaryOutcomes measure: AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood), secondaryOutcomes measure: Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time), secondaryOutcomes measure: AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HonorHealth, city: Scottsdale, state: Arizona, zip: 85258, country: United States, geoPoint lat: 33.50921, lon: -111.89903, locations facility: University of Southern California Keck School of Medicine, city: Los Angeles, state: California, zip: 90089, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Biogenix Molecular, LLC, city: Miami, state: Florida, zip: 33165, country: United States, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False
|
protocolSection identificationModule nctId: NCT06344988, orgStudyIdInfo id: 2023/41-10, briefTitle: Physical and Functional Effects of Online Exercise Program on Musicians Playing Stringed Instruments, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Bandırma Onyedi Eylül University, class: OTHER, descriptionModule briefSummary: Musculoskeletal problems related to instrument playing or performance are frequently seen in musicians. Different interventions such as strength training, endurance training and yoga have been used in the management of these problems. The first specific exercise program for professional orchestra musicians was developed by Chan et al. However, it has been stated that it is difficult to encourage musicians' participation in exercise due to their constantly changing work schedules, and at this point, the use of digital media such as DVDs, USBs, and educational exercise videos may have a potential role.On the other hand, it has been stated that smart wearable devices with mobile applications (such as smart watches, smart band) as digital health interventions are an interesting, interactive and efficient psychological strategy to promote physical activity and can be used as an intervention to promote a healthy lifestyle. Based on the literature, in our study, the exercise program developed by Chan et al., will be done online via "Google Meet" and symptoms can be evaluated with objective evaluation methods. Unlike other studies using digital media, exercises will be performed synchronously and feedback will be given to the musicians simultaneously, as in face-to-face exercises. In addition, all participants will be given a smart band, they will be encouraged to use it until the end of the study, and the change in their physical activity levels will be evaluated., conditionsModule conditions: Musculoskeletal Diseases or Conditions, conditions: Musculoskeletal Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: The exercise program, interventions name: Online education presentation, interventions name: Smart band, outcomesModule primaryOutcomes measure: Musculoskeletal problems, primaryOutcomes measure: Muscle oxygenation, primaryOutcomes measure: Pressure pain threshold, primaryOutcomes measure: Reaction time, primaryOutcomes measure: Grip strength, secondaryOutcomes measure: Upper extremity function, secondaryOutcomes measure: Physical activity level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bursa Regional State Symphony Orchestra, status: RECRUITING, city: Bursa, zip: 16000, country: Turkey, contacts name: Umut Çanakçı, Musician, role: CONTACT, phone: +90 (224) 225 59 70, contacts name: Sule Kecelioglu, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Selnur Narin Aral, Assoc. Prof., role: SUB_INVESTIGATOR, geoPoint lat: 40.19559, lon: 29.06013, locations facility: Bursa Uludağ University Faculty of Education Fine Arts Education Department, Department of Music Education, status: RECRUITING, city: Bursa, zip: 16285, country: Turkey, contacts name: Gülnihal Gül, Assoc. Prof., role: CONTACT, phone: +90 (224) 294 09 42, contacts name: Sule Kecelioglu, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Selnur Narin Aral, Assoc. Prof., role: SUB_INVESTIGATOR, geoPoint lat: 40.19559, lon: 29.06013, locations facility: Bursa Uludağ University State Conservatory, status: RECRUITING, city: Bursa, zip: 16285, country: Turkey, contacts name: Görkem Çalgan, Prof. Dr., role: CONTACT, phone: +90 (224) 294 27 00, contacts name: Sule Kecelioglu, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Selnur Narin Aral, Assoc. Prof., role: SUB_INVESTIGATOR, geoPoint lat: 40.19559, lon: 29.06013, locations facility: Ege University State Conservatory of Turkish Music, status: RECRUITING, city: İzmir, zip: 35100, country: Turkey, contacts name: Nurdan Gürtunca, Assoc. Prof., role: CONTACT, phone: +90 (232) 311 29 44, contacts name: Sule Kecelioglu, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Selnur Narin Aral, Assoc. Prof., role: SUB_INVESTIGATOR, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
|
protocolSection identificationModule nctId: NCT06344975, orgStudyIdInfo id: Starna Therapeutics, briefTitle: A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy Adults, acronym: STR-V003, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Starna Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B., conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: STR-V003/Placebo, outcomesModule primaryOutcomes measure: Immediate unsolicited AEs for 30 minutes post-vaccination, primaryOutcomes measure: Solicited injection site (local) and systemic reactions for 7 days postvaccination., primaryOutcomes measure: Unsolicited AEs for 28 days postvaccination, primaryOutcomes measure: Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06344962, orgStudyIdInfo id: QYFYKYLL930611921, briefTitle: Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-28, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital of Qingdao University, class: OTHER, descriptionModule briefSummary: Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem., conditionsModule conditions: Suture, Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Absorbable Suture, interventions name: Non-absorbable Suture, outcomesModule primaryOutcomes measure: Incidence rate of anastomotic complications, secondaryOutcomes measure: Time of bronchial anastomosis, secondaryOutcomes measure: Number of stitches, secondaryOutcomes measure: 5-year survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Affiliated Hospital of Qingdao University, status: RECRUITING, city: Qingdao, state: Shandong, zip: 266000, country: China, contacts name: Zhe Wu, PhD, role: CONTACT, phone: +86 17863934867, email: 17863934867@163.com, geoPoint lat: 36.06488, lon: 120.38042, hasResults: False
|
protocolSection identificationModule nctId: NCT06344949, orgStudyIdInfo id: B2024-074, briefTitle: Ciprofol Versus Propofol for Tracheal Intubation in ICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients., conditionsModule conditions: Emergency Tracheal Intubation in Critically Ill Patients, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Ciprofol, interventions name: Propofol, outcomesModule primaryOutcomes measure: cardiovascular collapse within 30minutes from the start of the intubation procedure, secondaryOutcomes measure: Success rate of sedation, secondaryOutcomes measure: Successful intubation on the first attempt, secondaryOutcomes measure: Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes), secondaryOutcomes measure: The incidence of cardiac arrest within 30 minutes after tracheal intubation, secondaryOutcomes measure: The incidence of bradycardia within 30 minutes after tracheal intubation, secondaryOutcomes measure: The incidence of hypoxemia within 30 minutes after tracheal intubation, secondaryOutcomes measure: new requirement or increase of vasopressors, secondaryOutcomes measure: new requirement or increase of antiarrhythmic drugs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06344936, orgStudyIdInfo id: HRS-1780-103, briefTitle: Drug-drug Interaction Study of HRS-1780 Tablets in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Shandong Suncadia Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects, conditionsModule conditions: Chronic Kidney Disease(CKD), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules, outcomesModule primaryOutcomes measure: Assess the Cmax of HRS-1780 in plasma., primaryOutcomes measure: Assess the Tmax of HRS-1780 in plasma., primaryOutcomes measure: Assess the t1/2 of HRS-1780 in plasma., primaryOutcomes measure: Assess the AUC0-t of HRS-1780 in plasma., primaryOutcomes measure: Assess the AUC0-inf of HRS-1780 in plasma., secondaryOutcomes measure: Assess the incidence and severity of adverse events in healthy subjects after administration of HRS-1780 tablets., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Xin Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06344923, orgStudyIdInfo id: KYLL, briefTitle: Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated., conditionsModule conditions: Ileostomy - Stoma, conditions: Rectal Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing, interventions name: Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing, outcomesModule primaryOutcomes measure: postoperative complications related to ileostomy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06344910, orgStudyIdInfo id: 20230416-C1_v2, briefTitle: PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC, acronym: PROMPT-HF-AUMC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, collaborators name: AstraZeneca, collaborators name: Yale University, descriptionModule briefSummary: This is a prospective cohort study, where we aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies, outcomesModule primaryOutcomes measure: Use of guideline-directed medical therapy (GDMT), secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Hospitalisation for Heart Failure, secondaryOutcomes measure: other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke), secondaryOutcomes measure: renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06344897, orgStudyIdInfo id: mac1, briefTitle: The Effect of Kinesio Taping in Pediatric Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-03-21, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: KTO Karatay University, class: OTHER, collaborators name: Nigde Omer Halisdemir University, collaborators name: University of Health Sciences Konya Health Application and Research Center, descriptionModule briefSummary: This study was planned to determine the effect of kinesio taping (KT) applied to the abdominal area after surgery on pain and gas output in children aged 6-12 years who had open appendicitis surgery., conditionsModule conditions: Appendicitis, conditions: Surgery, conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The effect of kinesio taping on pain in children aged 6-12 years who had open appendicitis surgery., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The research is in a parallel group, single-blind randomized controlled experimental design.Simple randomization will be applied to children who have had open appendicitis surgery and meet the inclusion criteria, without any stratification in the study.In order to determine which group the 68 children who meet the sample selection criteria in the study group will be included in, numbers from 1 to 68 will be randomly distributed to 2 groups through a computer program (https://www.randomizer.org/) without number repetition. 34 patients will be assigned to the experimental group and 34 patients to the control group. Since the person who will actively apply the taping in the study is the researcher, only the children will be blinded, therefore a single blind design will be applied., whoMasked: PARTICIPANT, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: Kinesio taping, outcomesModule primaryOutcomes measure: Kinesio tape applying affects pain in children aged 6-12 years who have appendicitis surgery., primaryOutcomes measure: Kinesio tape applying affects fear in children aged 6-12 years who have appendicitis surgery., secondaryOutcomes measure: Kinesio taping affects gas output time in children aged 6-12 years who have appendicitis surgery, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Health Sciences Konya Health Application and Research Center, city: Konya, state: Karatay, zip: 42020, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
|
protocolSection identificationModule nctId: NCT06344884, orgStudyIdInfo id: 23-2619, briefTitle: Early Patient Removal of Urinary Catheters After Urogynecologic Surgery, acronym: CARES2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, descriptionModule briefSummary: Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4., conditionsModule conditions: Urinary Retention Postoperative, conditions: Postoperative Urinary Tract Infection, conditions: Catheter Site Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Early catheter removal, outcomesModule primaryOutcomes measure: Number of patients with ongoing urinary retention (noninferiority), secondaryOutcomes measure: Number of patient contacts for voiding dysfunction by Type, secondaryOutcomes measure: Total patient contacts for voiding dysfunction Combined, secondaryOutcomes measure: Number of patients treated for postoperative UTI., secondaryOutcomes measure: Number of patients with ongoing urinary retention, secondaryOutcomes measure: Patient Satisfaction Survey Score-Pain, secondaryOutcomes measure: Patient Satisfaction Survey Score-Ease of Use, secondaryOutcomes measure: Patient Satisfaction Survey Score-Satisfaction, secondaryOutcomes measure: Patient Satisfaction Survey Score-Likelihood to Use Again, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UNC Health Rex, city: Raleigh, state: North Carolina, zip: 27607, country: United States, contacts name: Lauren Tholemeier, MD, role: CONTACT, phone: 984-974-0496, email: lauren_tholemeier@med.unc.edu, geoPoint lat: 35.7721, lon: -78.63861, hasResults: False
|
protocolSection identificationModule nctId: NCT06344871, orgStudyIdInfo id: 002, briefTitle: Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Positrigo AG, class: INDUSTRY, collaborators name: University of Zurich, collaborators name: University of Leipzig, descriptionModule briefSummary: The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype., conditionsModule conditions: Brain Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: NeuroLF, interventions name: Conventional PET scan, outcomesModule primaryOutcomes measure: PET Image of the Brain, secondaryOutcomes measure: Ease of Placement (Usability), secondaryOutcomes measure: Usage of accessories for patient placement (Usability), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Leipzig, status: RECRUITING, city: Leipzig, country: Germany, contacts name: Henryk Barthel, Prof.Dr., role: CONTACT, phone: +49 341 97 18082, email: Henryk.Barthel@medizin.uni-leipzig.de, contacts name: Henryk Barthel, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.33962, lon: 12.37129, locations facility: University Hospital Zurich, status: NOT_YET_RECRUITING, city: Zürich, country: Switzerland, contacts name: Martin Hüllner, Prof. Dr., role: CONTACT, phone: +41 44 255 25 80, email: martin.huellner@usz.ch, contacts name: Martin Hüllner, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
|
protocolSection identificationModule nctId: NCT06344858, orgStudyIdInfo id: 124/2021, briefTitle: Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI, acronym: Keta-ANI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Pontificia Universidad Catolica de Chile, class: OTHER, descriptionModule briefSummary: Ketamine, an intravenous anesthetic, and analgesic agent has experienced a resurgence in its clinical application, particularly in subanesthetic doses. The aim of this observational study is to characterize the changes in the Nociception Analgesia Index (ANI) associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic (PKPD) modeling approach. The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose. An Emax model and a link model assuming a first order rate constant (ke0) will be used to fit the data. Modeling analysis will use the program NONMEM. It is expected to recruit a total of 20 patients between 40 and 80 years, ASA I, II or III, programmed for elective surgery with general anesthesia. ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose., conditionsModule conditions: Analgesia, conditions: Ketamine, conditions: Pharmacokinetic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine, outcomesModule primaryOutcomes measure: To measure ANI values after ketamine bolus dose administration., primaryOutcomes measure: To determine the time maximum predicted concentrations in each patient, primaryOutcomes measure: To determine the time to maximum effect of a bolus dose of ketamine, primaryOutcomes measure: To predict ketamine plasma concentrations values after ketamine bolus, primaryOutcomes measure: To calculate the difference between the time of maximum ANI effect, secondaryOutcomes measure: Patient weight, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pontificia Universidad Catolica de Chile, city: Santiago, state: Metropolitana, zip: 450881, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, hasResults: False
|
protocolSection identificationModule nctId: NCT06344845, orgStudyIdInfo id: PUMCH-NM-PBB3, briefTitle: Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through \[18F\]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of \[11C\]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications., conditionsModule conditions: Neurodegenerative Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: 18F-PBB3 PET/CT scan, outcomesModule primaryOutcomes measure: Diagnostic Performance, secondaryOutcomes measure: Clinical Stage, eligibilityModule sex: ALL, minimumAge: 49 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Chenhao Jia, M.D., role: CONTACT, phone: 18548703382, email: jiachenhao24@163.com, contacts name: Ruixue Cui, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06344832, orgStudyIdInfo id: K5098, briefTitle: SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2030-03-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: The research aims to prospectively include patients with GEP-NENs, undergo preoperative imaging assessment (including PET/CT and contrast-enhanced CT), and accurately delineate lymph node regions. Through postoperative pathological reports, the diagnostic performance of lymph node metastasis (LNM) in GEP-NENs is evaluated. Factors influencing the diagnostic accuracy of SSTR-PET/CT and contrast-enhanced CT are also investigated., conditionsModule conditions: Gastro-entero-pancreatic Neuroendocrine Tumor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: lymph node metastasis status, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06344819, orgStudyIdInfo id: 24-062, briefTitle: An Acupuncture Study for People At High Risk for Sepsis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2028-03-20, completionDateStruct date: 2028-03-20, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture., conditionsModule conditions: Sepsis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture, interventions name: Sham Acupuncture, outcomesModule primaryOutcomes measure: Number of participants recruited compared to the number of participants who complete study treatment., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering Cancer Center, status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Gary Deng, MD, PhD, role: CONTACT, phone: 646-608-8556, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
|
protocolSection identificationModule nctId: NCT06344806, orgStudyIdInfo id: oyunlastirmabeslenme, briefTitle: The Effect of Gamification on Breastfeeding Self-Efficacy and Infant Nutrition Attitudes of Pregnant Women, acronym: gamification, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-03-30, completionDateStruct date: 2023-05-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Lokman Hekim Üniversitesi, class: OTHER_GOV, descriptionModule briefSummary: Objective: This study was conducted to determine the effect of breastfeeding education given through gamification on breastfeeding self-efficacy and infant feeding attitudes of pregnant women.Method: This study is a randomized controlled pretest-posttest parallel group experimental study, and 28 women included in the experimental group and 28 women in the control group. In the study, "Sociodemographic Information Form", "Breastfeeding Self-Efficacy Scale Short Form-Antenatal Form (BSES-SF), ", "Infant Nutrition Attitude Scale (IOWA)" Form was used. The data analyzed in SPSS program.Breastfeeding education content integrated into the game program designed with the gamification technique. A training program was applied to the women in the experimental group in the last trimester. Women in the control group received the standard breastfeeding training in the hospital. Measurement tools was applied to all participants before and after the training.Conclusion and Suggestions: In this planned study, it was aimed to teach women about breastfeeding in a digital environment in a fun way. In this study, it is found that breastfeeding education given through gamification have a positive effect on breastfeeding self-efficacy and infant feeding attitudes of pregnant women., conditionsModule conditions: Breastfeeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Gamified Breastfeeding Education, outcomesModule primaryOutcomes measure: breastfeeding self-efficacy, primaryOutcomes measure: infant feeding attitudes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lokman Hekim University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06344793, orgStudyIdInfo id: YOUNGBC-30, briefTitle: Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: FEMALE, 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: Biyun Wang, role: CONTACT, phone: 18017312387, email: pro_wangbiyun@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06344780, orgStudyIdInfo id: YOUNGBC-28, briefTitle: Abemaciclib, Palbociclib or Dalpiciclib Combined With Endocrine Therapy as First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: FEMALE, 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: Biyun Wang, role: CONTACT, phone: 18017312387, email: pro_wangbiyun@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06344767, orgStudyIdInfo id: YOUNGBC-27, briefTitle: Positive ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-negative Primary Tumor, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-05-05, completionDateStruct date: 2024-05-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: To investigate the treatment pattern and efficacy of patients with negative primary ER lesion but positive ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT)., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 19, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Adverse events, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China,Shanghai, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06344754, orgStudyIdInfo id: gamifiedfamilyplanning, briefTitle: Gamification in Family Planning Education: Impact on University Students, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Lokman Hekim Üniversitesi, class: OTHER_GOV, descriptionModule briefSummary: More than 3 billion of the worlds population are young people under the age of 25. According to WHO data, one million girls under the age of 15 give birth each year, mostly in low- and middle-income countries, and 3 million adolescent girls between the ages of 15 and 19 are exposed to unsafe abortions. Failure to meet the family planning needs of young people in a timely, adequate and appropriate manner can have significant public health impacts. According to World Health Statistics, the global birth rate for girls between 15 and 19 years of age is 49 out of 1000, and early pregnancy and childbirth can lead to serious health and social problems. In addition, this age group does not have sufficient information about pregnancy and its complications, and their access to and utilization of health services is low. Inadequacies in the education of adolescents on sexual issues and sociocultural differences further increase the sexual and reproductive health risks of young people in the university period. Information and services that will enable individuals to understand their sexuality and help them protect themselves from sexual risks should be provided specifically for that age. Therefore, it is important for young people to know family planning methods. In this study, it was aimed to examine the effect of family planning education to be given with gamification method, which is different from the classical method in the literature, on the knowledge and attitudes of university students., conditionsModule conditions: Gamification, conditions: Reproductive Health, conditions: Family Planning, conditions: Students, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: pre-test and post-test interventional study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: the person doing the statistical analysis will be blinded, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Gamified education, outcomesModule primaryOutcomes measure: Knowledge and attitude towards family planning, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lokman Hekim University, city: Ankara, zip: 06300, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06344741, orgStudyIdInfo id: sdilek6, briefTitle: Consequences of Admission to the Delivery Room in the Early and Late Phases, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Kocaeli University, class: OTHER, descriptionModule briefSummary: This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G\*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses., conditionsModule conditions: Fear of Childbirth, conditions: Neonatal, conditions: Pain, conditions: Maternal Distress (During Labor), conditions: Satisfaction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Accepted in latent phase, interventions name: Accepted in active phase, outcomesModule primaryOutcomes measure: Neonatal pain and stress, primaryOutcomes measure: Birth satisfaction, secondaryOutcomes measure: Maternal Anxiety, secondaryOutcomes measure: Fear of Birth, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kocaeli University, status: RECRUITING, city: Kocaeli, zip: 41380, country: Turkey, contacts name: Sena Dilek Aksoy, Ph.D., role: CONTACT, phone: +902623034739, email: sena.dilek@kocaeli.edu.tr, contacts name: Cemile Gokce, role: SUB_INVESTIGATOR, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False
|
protocolSection identificationModule nctId: NCT06344728, orgStudyIdInfo id: INS1007-110, briefTitle: A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants, acronym: INS1007, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-05-21, completionDateStruct date: 2024-05-21, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Insmed Incorporated, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Brensocatib Oral Solution, interventions name: Brensocatib Oral Tablet, outcomesModule primaryOutcomes measure: Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma, secondaryOutcomes measure: Number of Participants who Experienced at Least one Adverse Event (AE), secondaryOutcomes measure: Concentration of Brensocatib in Plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: USA001, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
|
protocolSection identificationModule nctId: NCT06344715, orgStudyIdInfo id: SL-T10-001_P1, briefTitle: Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-17, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: SL VAXiGEN, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC)., conditionsModule conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: SL-T10, interventions name: GX-I7, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0, secondaryOutcomes measure: PSA response rate, secondaryOutcomes measure: PSA progression free survival, secondaryOutcomes measure: Radiographic progression free survival, secondaryOutcomes measure: Change of induced T-cell responses for SL-T10 vaccine, eligibilityModule sex: MALE, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
|
protocolSection identificationModule nctId: NCT06344702, orgStudyIdInfo id: 2024PHB065-001, briefTitle: The Effect of CPAP on Maternal and Infant Outcomes in Pregnant Women With OSAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the impact of CPAP on the maternal and infant outcomes of women with obstructive sleep apnea syndrome. The main questions aim to answer are:\[question 1\]Explore the impact of different CPAP treatment times on the maternal and infant outcomes of pregnant women with combined OSAS; \[question 2\]Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women.The CPAP treatment group received standardized CPAP treatment and routine prenatal care, while the non CPAP treatment group and non OSAS group only received routine prenatal care., conditionsModule conditions: Maternal Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: CPAP, outcomesModule primaryOutcomes measure: Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women., eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06344689, orgStudyIdInfo id: SH9H-2023-T477, briefTitle: Surgical Correction of Cicatricial Ectropion, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-03-27, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, class: OTHER, descriptionModule briefSummary: The main purpose of this study is to verify and compare the treatment effects of scarred ectropion surgery, perform statistical descriptions, compare patients undergoing tarsal strip and skin flap procedures with those undergoing simple skin flap treatment, and compare their pre- and post-operative Ectropion Grading Scale (EGS) and subjective and objective symptom changes.Secondary Objective: To observe the incidence and resolution of complications after lower eyelid ectropion surgery. Compare postoperative effects among patients of different ages undergoing the same surgery., conditionsModule conditions: Patients With Cicatricial Ectropion, conditions: Over 18-year-old, conditions: With Complete Clinical Record, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: Surgical treatment, outcomesModule primaryOutcomes measure: Ectropion Grading Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai ninth people's hospital, city: Shanghai, zip: 200011, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06344676, orgStudyIdInfo id: FSIE2024Robot, secondaryIdInfos id: 6773, type: OTHER, domain: CERec UAB, briefTitle: Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes, acronym: WITHPEPPER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Sara Domenech, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. The main questions it aims to answer are:* Can social robots reduce unwanted loneliness?* Can social robots improve quality of live and well-being? The selected centers are organized in several classes of living units. Living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). Living units of the same class gather persons with similar characteristics.To compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group.The persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. Namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. Furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities.The intervention will last 8 weeks. To assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention., conditionsModule conditions: Elderly People, conditions: Nursing Home Residents, conditions: Loneliness, conditions: Quality of Life, conditions: Wellbeing, conditions: Social Interaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive, interventions name: Mobility, interventions name: Social, interventions name: Relational, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Loneliness, secondaryOutcomes measure: Well-being, secondaryOutcomes measure: Quality of life, irrespective of the disease, secondaryOutcomes measure: Satisfaction with life, secondaryOutcomes measure: Depressive symptoms, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Communication, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06344663, orgStudyIdInfo id: KSIU-SBF-ES-02, briefTitle: Motivational Interviewing Inadequate Milk and Cortisol, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-03-25, completionDateStruct date: 2024-12-25, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Kahramanmaras Sutcu Imam University, class: OTHER, descriptionModule briefSummary: Motivational interviewing is a technique used in many fields. No study has been found in national and international databases investigating the effect of motivational interviewing on the perception of insufficient milk, breastfeeding motivation and cortisol level. The study aimed to evaluate the effect of motivational interviews on the perception of insufficient milk, breastfeeding motivation and cortisol level., conditionsModule conditions: Motivation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: motivational interview, outcomesModule primaryOutcomes measure: Insufficient Milk Perception Scale (ANN), secondaryOutcomes measure: Breastfeeding Motivation Scale (EMS), otherOutcomes measure: Visual Analog Scale (VAS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Eda Sever, status: RECRUITING, city: Kahramanmaraş, state: Onikişubat, zip: 46370, country: Turkey, contacts name: eda sever, role: CONTACT, phone: +90 531 232 10 96, email: edaseverr@icloud.com, geoPoint lat: 37.5847, lon: 36.92641, hasResults: False
|
protocolSection identificationModule nctId: NCT06344650, orgStudyIdInfo id: RF-2021-12373584, briefTitle: Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-28, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, collaborators name: Fondazione Policlinico Universitario Campus Bio-Medico, collaborators name: Istituto Auxologico Italiano, descriptionModule briefSummary: Prospective observational clinical, molecular, translational and basic study aimed at identifying the main determinants and predictive factors of risk of bone damage in acromegaly patients, conditionsModule conditions: Acromegaly, conditions: Bone Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample, outcomesModule primaryOutcomes measure: Identify the rate of morphometric vertebral fractures in acromegalic patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Andrea Giustina, status: RECRUITING, city: Milan, zip: 20132, country: Italy, contacts name: Gabriela Felipe, role: CONTACT, phone: 0226435062, email: felipe.gabriela@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06344637, orgStudyIdInfo id: 2566/081 I, briefTitle: Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-14, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: UdonThani Hospital, class: OTHER_GOV, descriptionModule briefSummary: This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration, conditionsModule conditions: Pain, Procedural, conditions: Lidocaine, conditions: Obstetric Surgical Procedures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 216, type: ACTUAL, armsInterventionsModule interventions name: 10 % lidocaine spray without adrenaline, interventions name: Placebo, outcomesModule primaryOutcomes measure: pain score during manual vauum aspiration, primaryOutcomes measure: pain score after manual vauum aspiration, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: UdonThani Hospital, city: Udon Thani, state: UdonThani, zip: 41000, country: Thailand, geoPoint lat: 17.41567, lon: 102.78589, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-10-30, uploadDate: 2024-03-20T05:36, filename: Prot_SAP_000.pdf, size: 178265, hasResults: False
|
protocolSection identificationModule nctId: NCT06344624, orgStudyIdInfo id: Mersin_U, briefTitle: The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-06-02, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Mersin University, class: OTHER, descriptionModule briefSummary: The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled trial with a pretest-posttest design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Using the block randomization technique, the sampled students will be split into two groups: the CBT group and the laughter group. Six will be the block size. Excel will be used to create blocks (allocation concealment) and random numbers will be generated by an assistant researcher who does not attend therapy sessions. The purpose of the program is to support mental health and evaluate its effectiveness; students will not be informed about which group they are in (participant blinding).Research data will be coded as A and B and entered into the computer database by someone other than the researchers conducting the therapy sessions, and statistical analysis will be performed using this coding (statistician blinding)., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: CBT group, interventions name: Laughter group, outcomesModule primaryOutcomes measure: The change in mental symptoms will be assessed using the Brief Symptom Inventory., secondaryOutcomes measure: Psychological resilience will be assessed using the Psychological Resilience Scale., secondaryOutcomes measure: Negative self-evaluations and thought patterns will be assessed using the Automatic Thoughts Scale., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Turkey, Mersin University, city: Mersin, zip: 33180, country: Turkey, contacts name: EMİNE ÖNCÜ, Assoc.Prof., role: CONTACT, email: eeoncu@gmail.com, contacts name: Zeliha Yaman, Doctorate, role: SUB_INVESTIGATOR, contacts name: Filiz Değirmenci, Doctorate, role: SUB_INVESTIGATOR, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False
|
protocolSection identificationModule nctId: NCT06344611, orgStudyIdInfo id: ILBS-DCLD-01, briefTitle: Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-07, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Institute of Liver and Biliary Sciences, India, class: OTHER, descriptionModule briefSummary: Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or chronic liver injury due to toxic, infectious, metabolic and genetic pathogenic factors. Traditionally, the natural history of cirrhosis has often been considered a one-way street, with a definite and irreversible progression from a compensated to a decompensated disease stage. But recent data has shown that if the underlying etiology can be successfully treated, cirrhosis can regress and recompensation of liver disease can occur. Hence, in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria. We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase (DCLD) subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis., conditionsModule conditions: Decompensated Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Other, outcomesModule primaryOutcomes measure: To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria, secondaryOutcomes measure: To evaluate the predictive factors of recompensation in pediatric DCLD subjects, secondaryOutcomes measure: To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in in pediatric subjects with decompensated cirrhosis., secondaryOutcomes measure: To assess incidence of re-decompensation in patients with recompensation., eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Liver and Biliary Sciences, city: New Delhi, state: Delhi, zip: 110070, country: India, contacts name: Dr Anmol Anmol, MD, role: CONTACT, phone: 01146300000, email: dranmol1991@gmail.com, geoPoint lat: 28.63576, lon: 77.22445, hasResults: False
|
protocolSection identificationModule nctId: NCT06344598, orgStudyIdInfo id: 0123РК00314, secondaryIdInfos id: AP19680262, type: OTHER, domain: Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan, briefTitle: Identification and Assessment of Risk Factors for the Development of Osteoporosis in Adults and Children Living in the Abay Region of the Republic of Kazakhstan Using the Method of Dual-energy X-ray Absorptiometry and Clinical and Epidemiological Research, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-11-15, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Semey State Medical University, class: OTHER, collaborators name: Ministry of Science and Higher Education of the Republic of Kazakhstan, descriptionModule briefSummary: A survey of people to identify risk factors for osteoporosis, which include age, gender, lifestyle, diet, physical activity, the presence or absence of somatic pathology. Diagnosis of osteoporosis by dual-energy X-ray absorptiometry. Conducting a correlation analysis of the relationship of the data obtained., conditionsModule conditions: Improving the Early Diagnosis of Osteoporosis in Adults and Children Living in the Abay Region of Kazakhstan, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Risk factors for the development of osteoporosis will be identified and quantified in the formed study groups of adults, primaryOutcomes measure: to determine the diagnostic value of the risk factors for the development of osteoporosis obtained during the examination, primaryOutcomes measure: to assess the state of BMD in adults using X-ray absorptiometry (DXA), primaryOutcomes measure: To carry out a correlation analysis of the relationship between the obtained data in adults of the Abay region of of the Republic of Kazakhstan, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Semey Medical University, status: RECRUITING, city: Semey, zip: 071400, country: Kazakhstan, contacts name: Madina MD Madiyeva, PhD, role: CONTACT, phone: +77085244745, email: madina.madiyeva@smu.edu.kz, contacts name: Gulzhan MD Bersimbekova, role: CONTACT, phone: +77023728412, email: gulzhan.bersimbekova@smu.edu.kz, geoPoint lat: 50.42675, lon: 80.26669, hasResults: False
|
protocolSection identificationModule nctId: NCT06344585, orgStudyIdInfo id: DROPOUT, briefTitle: Drop-out of Infertile Couples: a Large Single Center Experience Over 10 Years, acronym: dropout, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-01, primaryCompletionDateStruct date: 2021-12-31, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: Conducted at a single-center, this prospective-retrospective study focused on all couples who initiated their journey at the Fertility Center of Humanitas Research Hospital, Rozzano (Milan), Italy.The prospective study focused on the couples whose first consultation occurred in 2021. A tailored questionnaire was administered via telephone by staff members to gather insights into the personal reasons for treatment discontinuation among non-returning patients.Conversely, the retrospective study included all infertile couples initiating treatment between January 2012 and December 2021 at the Fertility Center. Data encompassing personal history and demographic details were extracted from the internal database of Humanitas Fertility Center to assess the factors involved in a treatment discontinuation., conditionsModule conditions: Infertility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 24773, type: ACTUAL, armsInterventionsModule interventions name: Drop out patients who had their first access in 2021 were additionally asked to answer to a phone -call questionnaire to assess their motivation of discontinuation, outcomesModule primaryOutcomes measure: Dropout rate, secondaryOutcomes measure: Reasons for dropout collected by a phone call questionnaire, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 46 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istituto Clinico Humanitas, city: Rozzano, state: Milano, zip: 20089, country: Italy, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
|
protocolSection identificationModule nctId: NCT06344572, orgStudyIdInfo id: SAT001-KP-002, briefTitle: Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: S-Alpha Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: SAT-001, interventions name: Single vision spectacles, outcomesModule primaryOutcomes measure: Change in Cycloplegic Spherical Equivalent Refractive Error, secondaryOutcomes measure: Change in Cycloplegic Spherical Equivalent Refractive Error, secondaryOutcomes measure: Change in Axial Length, secondaryOutcomes measure: Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia), secondaryOutcomes measure: Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Gachon University Gil Hospital, status: RECRUITING, city: Incheon, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.